pharmaceuticals biosimilar bright colours mixed

What Is… A Biosimilar, and why do we test them here?

Here at our Leeds clinic, there’s another huge study coming our way. Over the next few months, we’ll be enrolling 240 healthy men and women aged 18-55 including smokers of up to 10 cigarettes per day to help us test a potential new treatment for Rheumatoid Arthritis. I’ve written about this chronic and debilitating illness before in this blog post, and it left me in no doubt that a solution for RA must be found. But what’s so special about this particular study drug?

Well, to be honest… at first I found that question quite difficult to answer!

The drug is what’s known as a biosimilar. This means it is meant to closely resemble another drug, one which is already licensed and available. So, a copy then?  It’s not quite that simple.

To understand a biosimilar, we must first look at a class of drugs called biologics. Unlike a typical drug which is created by mixing chemicals, a biologic is a drug containing ingredients which were manufactured inside a living cell. Often, synthetic DNA created in a lab is used to produce biologic ingredients.

biosimilar research growing grapesIn recent years biologic drugs have revolutionised the way we treat a huge range of illnesses, including cancer, heart disease, skin conditions like eczema and psoriasis, and rheumatoid arthritis. However, creating an effective biologic is no easy task. Creating a biologic drug is sometimes compared to making wine – temperature, variety of grape, location, soil quality, rainfall, all make a huge difference to the finished product. Like our grapes, biologic ingredients are unpredictable, and their effectiveness depends on a massive range of factors.

The result? Biologic drugs take many years to develop, and the cost is nothing short of astronomical. The reality is that this expense is passed on to patients and to healthcare trusts. Biologic treatment costs in the region of £2500-3000 per month, and when many of the patients who rely on it have incurable chronic conditions, this cost mounts up very quickly! The sad fact is it’s too expensive to prescribe biologics to everyone who could benefit from them. They are usually offered when an illness has progressed and nothing else works.

Enter Biosimilars!

So – the patent expires on a biologic, another company copies the idea and sells it much cheaper? Right? Um, no.

When the patent runs out on a typical drug, rival companies can easily access the chemical ‘recipe’ and recreate the drug without incurring the costs of research and development (this is why you can buy paracetamol from the supermarket so cheaply!). But remember we said that biologics are a bit like wine? Developing a biosimilar is a bit like trying to recreate a bottle of wine as closely as possible – same grapes, same weather, same location- and working all of this out just by tasting the wine. Like creating the original drug, it requires a shedload of skill, patience, and money.clinical trials patient care

Developing a biosimilar is no ‘easy way out’ for a pharmaceutical company. The time, energy and cost of creating a biosimilar is tremendous – but any saving which can be made by creating biosimilars is an advantage, and will lead to the drug becoming more accessible to the patients who need it.

If you’d like to help us develop a biosimilar which could benefit thousands of Rheumatoid Arthritis patients and earn from £100 per day, apply now to become a clinical trials volunteer.

big bees on frame

Covance Geneva Demonstrates How to “Bee Real”

What’s the buzz at the Covance office in Geneva, Switzerland? The team is celebrating its first honey harvest. Yes, you read bees blue backgroundthat correctly—its first honey harvest. You see, in May of this year, Covance Geneva’s Three Rings (or R-ings) Committee—representing “Rethinking, Reducing and Recycling”—worked with a local startup to install three beehives on the roof of the company’s four-story building in downtown Geneva. The Committee hopes this initiative will send a strong message about the vital importance of sustainable development and the difference each of us can make.

 

“The Three Rings Committee is empowered to identify positive initiatives for the company that further environmental awareness and responsibility,” says Bertrand Jaton, Associate Director, Master Data Management and Business Reporting, Covance, Geneva, Switzerland. It was Bertrand who first suggested the idea of rooftop beehives to the Committee, as it had proven to be a successful initiative at his wife’s company, but the project was conducted by Vally Kordorouba, a former QA auditor who retired just after the beehives were installed. In order to recognize her dedication to this project, one beehive was dedicated in her name.

 

“Many people don’t realize that more than 70 percent of all fruits and vegetables need bees to provide cross-pollination,” explains Bertrand. “Unfortunately, the bee population continues to decline due to pesticides, parasites and monoculture (the cultivation or growth of a single crop, especially on agricultural or forest land). This can lead to a decline in the diversity of fruits and vegetables available to all of us. The Three Rings Committee is committed to raising awareness about this issue and contributing in our own small way to the solution.”

 

The 30-member Committee and their 600+colleagues at Covance Geneva are learning a great deal about bees and beekeeping, and it’s proving to be quite fascinating. Each of the three rooftop beehives serves as home to approximately 80,000 bees, so Covance is hosting some 240,000 bees. The hives are visible through the glass windows of an indoor hallway that circles the building. Each hive has only one queen bee whose role is to give birth to all of the other bees. There are 100 to 200 male bees per hive, while the remainder are working bees. Approximately half of the bees leave and return each day, collecting pollen to feed the baby bees. That pollen is then transformed into honey.

 

honey pot on blue backgroundThe first honey harvest at Covance Geneva occurred on August 8 and yielded 55 kilos of honey—enough to fill 380 small jars. While Covance will gift some of the honey to clients, most will be sold with all proceeds being donated to the Autisme Genève, a nonprofit organization supported by Covance Geneva for several years now. Future harvests may yield as many as 300 kilos per year, or about 2,400 jars. Two harvests are anticipated per year.

 

Based on numerous employee submissions, the honey has officially been named “Bee Real.” Employees also suggested the language for the label, which includes the slogan “Covance and Bees Working Together for a Greener and Sweeter Environment,” and accompanying text that reads “This honey, harvested on the roof of our laboratory, attests to the commitment of Covance toward the protection of bees, essential players pollinating flowers and trees.” Of course, the label will also feature the Covance logo and tagline, “Solutions Made Real.”

 

The Three Rings have created a series of ten posters about bees, designed to inform and engage the Covance Geneva team, which are now on display in the stairway of the four-story building. The poster series is part of a health and wellness campaign also created by the Three Rings that encourages people to use the stairs and to learn something new in the process. The previous poster series featured the history of Switzerland. In addition, Covance Geneva will host an annual bee workshop, where interested employees can learn more directly from the beekeeper.

 

Bertrand reports that the beekeeper is very impressed with the heartiness of the beehives, especially since Covance Geneva ishoney yummy gone located in an industrial area. The team shares in that excitement and has expressed great pride in its ability to sustain the rooftop beehives. Five employees who keep beehives at home are currently accompanying the beekeeper during his weekly visits, asking questions that will help them with their own hives.

 

“We have seen great interest from our team,” says Bertrand. “Covance is dedicated to diversity and bees are part of that diversity. No bees means much less diversity in our fruits and vegetables. We want to send a firm message that at Covance Geneva, we take that very seriously.”

green pathogens antibiotics

Antibiotics – Resisting the Resistance

Since the accidental discovery of penicillin in 1928, antibiotics have become an absolute cornerstone of medicine. Used to treat everything from meningitis to acne, and often prescribed to prevent infections after surgery or serious injury, it’s hard to imagine a world where we cannot rely on antibiotics to cure what ails us. However, with the onset of resistant ‘superbugs’, and with no new antibiotics being developed in the last 20 years, this world we can barely imagine could well become a reality.

The Arsenal – an overview of our antibiotics.

  • Penicillin, macrolides and fluoroquinolones – penicillin, the mother of them all, is usually the first line of defence against apenicillin petri cultures broad spectrum of bacterial infections. Macrolides like erythromycin and fluoroquinolones are a useful alternative for anyone who has a penicillin allergy
  • Tetracycline – most often used to treat bacterial skin conditions like acne and rosacea
  • Aminoglycosides – these are the ‘big guns’; as they can produce some unpleasant side effects, they are most often used to treat dangerous infections such as meningitis and sepsis.

All of the above work by preventing bacteria from repairing itself, preventing bacteria from multiplying, or by penetrating and bursting the bacteria’s cell walls.

 

 

The Battleground – challenges facing our antibiotics

  • Over-prescription: As antibiotics have proven so effective at treating bacterial infections, they have arguably become a pharmaceutical ‘crutch’, prescribed to quickly dispatch illnesses which may have resolved by themselves given time and careful management. Additionally, antibiotics are sometimes mistakenly prescribed for viral infections such as colds and ‘flu. Antibiotics are not effective in treating viruses! However, the antibiotic will target harmless bacteria present in the body, and these encounters make it easier for the nasty bugs to resist that antibiotic in the future.
  • Incorrect usage: It might seem counterintuitive to carry on taking medicine once you’ve stopped feeling poorly. But when it comes to bacterial infections, starting to feel better doesn’t necessarily mean that the ‘bugs’ are all dead and gone. Stop taking antibiotics before the course finishes and there’s a good chance that the remaining bacteria may recover, multiply and adapt to resist the antibiotic you’ve exposed them to.

The Enemy – the next generation of superbugs

red bacteriaHearing the word ‘superbug’, you might immediately think of MRSA and C Difficile. While these infections can spread rapidly and may lead to dangerous complications, they can usually be treated with high-dose antibiotics.

An even greater concern is Multidrug-resistant Tuberculosis (MDR-TB). Despite treatment and vaccination programmes which gave us good control over the disease in the 20th century, TB is becoming resistant to many antibiotics, meaning that patients often require medicines which are expensive, not readily available, or which cause unpleasant side effects. What’s more, TB is changing fast. Currently, around 9% of MDR-TB cases are diagnosed as ‘extensively resistant’, meaning that even our most powerful TB treatments are ineffective against it.

Just as TB has adapted quickly, there is a real danger of other infections including gonorrhoea and E Coli retaliating against this generation of antibiotics.

 

The Future – Where do we go from here?

Even before Phase 1 Clinical Trials can begin, drug development is a lengthy process. It can take up to 20 years for a drug to progress from Research and Development to the pharmacy shelves.  Fortunately, there are already a few promising new antibiotics in the pipeline which could hold the key to resisting the resistance!

  • Tarocin A and Tarocin B – these molecules attack and damage the cell walls of harmful bacteria. By itself it may not be antibiotics from soil-dwelling microbesparticularly effective, but it is hoped that a combination of tarocin and another antibiotic could attack bacteria on 2 fronts, rendering even resistant bacteria vulnerable to treatments once again. Lab tests of tarocins have shown promising results, and human clinical trials are expected to begin soon.
  • Teixobactin – Lab tests have shown that teixobactin attacks infection in a completely new way, meaning that bacteria have little or no resistance to it. It is naturally present in soil, and does not flourish in the typical, sterile environment of a laboratory. Special technology has been developed to extract teixobactin from soil-dwelling microbes. As this process has been particularly complex, teixobactin is not as far forward in development as the tarocins, but it is believed that it could be used to develop as many as 25 potential new antibiotics.

In The Meantime

It is highly likely that all of us will need to use at least 1 course of antibiotics at some point in our lives. It’s in everybody’s best interest to resist the resistance! Here’s how you can help

  • Practice good hygiene – the majority of superbugs are spread through contact with contaminated surfaces. Ensure thathandwashing hygeine health you clean your hands after visiting the loo, and after any visits to the GPs surgery or hospital. Using your own towels, flannels etc can help with this too – this is one instance where it’s okay not to share!
  • Don’t ask your Dr for antibiotics – trust his or her judgement. You may not be prescribed antibiotics immediately if your Dr suspects you have a viral or a mild bacterial infection. You can always return if your symptoms persist or worsen!
  • If you’re given antibiotics, use them all – even if you’re feeling better. That bug could come back with a vengeance and be much harder to shift this time!
  • Consider taking part in Clinical Trials – drug development can take up to 20 years, even when there is an urgent need for a new medicine. Healthy volunteers who take part in paid clinical trials with Covance help to speed up the process and get essential treatments on the market sooner.
smoothie recipes pineapples on the beach

A Smoothie For All Seasons!

Fancy a change from your morning coffee? Craving something deliciously sweet, but without the extra minutes on the treadmill? A smoothie is an excellent way to enjoy some colour and flavour while working towards your 5 fruit and veg a day. But you don’t need to shell out for something bottled or in a take-away cup. By using produce which is perfectly in season, you can save some pennies while ensuring you get your fruit at its freshest, tastiest and most nutritious. These 3 recipes use seasonal fruits and make the ideal substitute for sugary snacks.

 

July – August: Peach Melba Smoothie (guilt-free dessert in a glass)raspberry smoothie recipe punnet and glass

Ingredients: 2 Peaches, stones removed and chopped into quarters

150g punnet Raspberries

1 glass ice cubes

2 tbsp fat-free vanilla-flavoured yoghurt

 

Method: Place all ingredients into a blender and blast until combined. If you do not have a smoothie maker, a hand blender and a large jug works fine for this!

 

Why it’s good: This recipe is based on the classic dessert which was super popular in the 1970s. But by swapping vanilla ice-cream for fat free yoghurt, you get the benefits of protein and calcium without unwanted carbs and fats.

Despite their sweetness, both peaches and raspberries are very low in calories. Raspberries contain just 52kcal per 100g, while peaches contain only 39kcal per 100g (for perspective, chocolate contains 546kcal oer 100g!). Raspberries also contain natural xylitol, a complex sugar which is absorbed slowly and doesn’t cause blood glucose levels to spike, making this an excellent option for diabetics.

Add refreshing ice, and the healthy dose of vitamins A, C and E found in both fruits and you have a delicious energy-boosting drink without the sugar or caffeine crash later in the day.

 

September – October: Fig and Blackberry Warmer

 

frozen blackberry smoothieIngredients: 1 Pear, cored and chopped

2 Fresh Figs, whole

150g blackberries or brambles

½ glass skimmed milk

2 tsp cinnamon (optional)

 

Why it’s good: You can’t get much fresher than blackberries in the early autumn. Take a Tupperware box to any nearby hedge or public foot-path, and you are bound to find an abundance of them, perfectly ripe and completely free!

Pears and figs will help to give a smooth texture whilst also being rich and filling. Cinnamon compliments the fruit flavours  and adds a little bit of cosiness to get you ready for the longer nights and chillier days.

Mix all these ingredients and you have a drink which tastes delicious and provides you with plenty of fibre, a good dose of vitamins, folic acid, potassium and even calcium. Studies suggest that cinnamon may help to reduce blood sugar and LDL cholesterol, so choosing to add this will not just flavour your drink, but make it even more healthy too!

 

banana tree seasonal fruitJanuary-February: Totally Tropical Winter Smoothie

Ingredients: 1 ½ ripe bananas

Flesh and seeds of 2 passionfruit

Flesh of 1 pineapple

½ glass orange juice

 

 

Why it’s good: The best thing about this seasonal smoothie is that you can easily pick all the ingredients in your own garden… okay, I jest! But when the British winter feels as though it will never end, tropical and citrus fruits are at the peak of their ripeness. Although you’ll find tropical fruits in your supermarket year-round, fruits bought at this time are likely to be cheaper, tastier and fresher, benefiting from not being artificially grown or ‘forced’.

This smoothie is a perfect tonic at a time when we Brits are often in the throes of cold and flu season and when we may even be suffering with the ‘winter blues’. Orange, pineapple and passion fruit are all rich in immune-system boosting vitamin C. Bananas, which are often used to give smoothies a thick texture, also contain tryptophan which encourages the brain to produce serotonin, the happy hormone. So if you’ve overindulged at Christmas and are feeling run-down, head for the tropics (via the greengrocers!)

Do you have any favourite smoothies? We’d love to share your recipes!

Rio 2016 banner Olympics

Olympic Spirit – A Potential Treatment for National Gloom

As recent news would suggest, taking part in a clinical trial and taking part in the Olympic Games may be more similar than you would think. You’d be forgiven for thinking that both would require you to be administered with some form of drug, if you are a Russian athletics competitor anyway. In the midst of the recent negative controversies surrounding the upcoming Games in Rio de Janeiro, now would be a perfect time to remind ourselves of how the Olympic Games can be the perfect distraction, in the short term at least, to everyday worries. And also how the Olympic spirit is the embodiment of the values that we should all promote and aspire to live by.

Olympic Games 2012 Rings on Tower BridgeNaturally, we can’t think about the Olympic Games and not recall that special fortnight in 2012, where the oldest and greatest sporting competition came to these shores for the first time in 64 years. After years of doubt and cynicism surrounding whether hosting the Games was worth the cost at a time of deep recession, the opening ceremony of London 2012 arrived. Before we knew it, the gold rush began and the cynicism that once threatened to overflow, had been replaced with unreserved optimism. The widespread optimism was a welcome culture change to the traditional British pessimism and for that particular moment in time it was as though anything was possible. It’s hard to put a finger on it, but for those two weeks in 2012, we were together, and it felt like the little problems that we all share were a distant memory. Memories which were exchanged with national pride and a celebration of just what we could acheive if we put our minds to it.

The sense of togetherness is also created through the worldwide coverage of The Olympic Games. The knowledge that so many Olympic rings peace sign and Brazilian flagothers, from all around the globe, are equally as hooked to the action as yourself, makes you feel just as part of the Games as the athletes themselves. The vast reach of the Games can make it the perfect place to demonstrate the value of togetherness and friendship. Sometimes in the face of adversity. Proof of this was shown at the 2008 Olympics in Beijing. During the time of the Games, tensions between Russia and Georgia were at breaking point as the countries went to war. In an odd twist of fate, two female competitors from both countries, shared a medal podium in the shooting event. In a stand of defiance against the ongoing war, both competitors also shared an embrace along with the sentiments that “There should be no hatred among athletes and people”. Sentiments that we can all echo.

Another value that is a paramount element of the Olympic spirit is that of excellence and determination. The athletes taking part can be a shining example to those watching of how hard work can get to you to the top of your game. We could all learn a lot from an Olympic athlete’s mentality of stretching every sinew to its absolute limit in pursuit of that illustrious medal. It is definitely a mentality we try to promote here at Covance when carrying out clinical research, in order to develop new treatments.  The Olympic Games also emphasizes the importance of taking part. Winning isn’t everything and sometimes just making it to the start line can be an achievement in itself. Consider the performance of the Jamaican bobsled team at the 1988 Winter Olympics; although they didn’t even register a time in the Games after crashing dramatically in their qualifying run, their determination to succeed against all odds won the hearts of the world. Just watch “Cool Runnings” and see for yourself!

Christ the Redeemer Rio and Olympic Rings 2016These are just a few of the values associated with the Olympic Games and one of the many reasons we are all enticed by it every time those rings roll back around. The Games in 2012 invoked a special spirit across the country where it just seemed as though we were all extremely positive. We would no doubt love for that spirit to return, if only for a little while, at a time where the national outlook is less certain. Hopefully Rio will be able to provide this, and do the same for Brazil that it did for us four years ago.

So with the Rio Games just a javelin throw away. Don’t be surprised if you find yourself becoming an expert judge in the sychronised diving 10 metre platform final, or being able to distinguish the difference between an ippon and a waza-ari as your recently adopted favourite judoka goes for gold!

ethnically diverse ladies matching study

What Is… An Ethnic Matching Study?

The details of a brand new study land on my desk, and I prepare myself to start researching a new (to me) and particularly nasty-sounding condition called Trigeminal Neuralgia. But there’s something even more unusual about this study: it’s a type of clinical trial called an ethnic matching study.

stethoscope medical equipment for clinical trialsFor this trial, our volunteers will be split into 3 groups of Caucasian volunteers and 3 groups of Japanese volunteers. The idea is that for every Japanese volunteer who enrols, we have a Caucasian volunteer to match them; so if a Japanese woman weighing 51kg checks in, we must also check-in a Caucasian woman weighing around 51kg on the next group, so that we can compare their details as closely as possible.

Now, I might’ve mentioned this already – but I’m NOT a scientist! My gut tells me there must be a very good reason for us to introduce such a complicated study design. So I decide to find out!

I start by learning a little more about Trigeminal Neuralgia (TN), and almost straight away I wish I hadn’t.

TN is a form of chronic pain affecting the trigeminal nerve – the nerve which controls sensitivity in the face. It starts above and behind the ear and has branches stretching across the jaw, cheekbone and eye socket. If the protective sheathing around this nerve is damaged, patients can experience pain so intense that TN has been ‘fondly’ nicknamed ‘The Suicide Disease’. That’s right. People have committed suicide rather than experience more of the pain. It’s that bad.

trigeminal neuralgia face painShuddering, I try and find out what a patient’s alternatives to suicide are. I’m pretty sure this is not a job for paracetamol or ibuprofen.

I’m not really comforted to learn that one option is using radiation or surgery to permanently damage the trigeminal nerve. This method effectively removes the source of the pain, but can also result in facial numbness.

The other option is to take anti-convulsant drugs which block pain signals from the nerve. These are the most effective and least invasive option for TN patients. They are, quite literally, a lifeline. But they aren’t perfect.

In very rare cases, some anti-convulsants can trigger a serious skin condition called Stevens-Johnson Syndrome, which can be lethal if not diagnosed and treated quickly. To reiterate, this is a very rare side effect, affecting as few as 1 in 10,000 patients. However, it is most often found in patients of Asian descent.

Suddenly, I’m starting to appreciate why we do ethnic matching studies.

This isn’t the only example of patients from different ethnic groups reacting differently to medications. For instance, warfarin, which is commonly used to treat high blood pressure, is prescribed in different doses to Black, White and Asian patients, because each group metabolizes the drug at different rates.

Japanese volunteers ethnic matchingIn this study, we are testing a new anti-convulsant. Well, newish, to be more precise. The drug has already passed safety testing in healthy volunteers, and it has been found to be effective in treating patients with trigeminal neuralgia. And while this is all extremely positive, we need to closely scrutinize the effect of the drug on our Japanese volunteers to ensure that Asian patients are not being exposed to a higher risk of serious side effects. Clever, eh?

This clinical trial is a vital stage in bringing a new treatment, and new hope, to patients who need it. If you’d like to be a part of it, and you can commit to spending 5 nights in our Leeds clinic, apply to become a Covance paid volunteer.

suitcases diabetic patient study

Our Type 2 Diabetic Study has started!

Recently, we have started recruiting type 2 diabetics for one of our longest (and most highly paying) studies on record. The clinical trial got off to a start earlier this month when 2 lovely chaps checked in for their first residential stay. I caught up with them to find out what they thought of the experience so far, and what made them decide to become volunteers in clinical research.

 

Douglas and Peter are looking very relaxed when I track them down on their second day on study, with one of our largest bedrooms to themselves.
Douglas tells me ‘I recently retired and I’ve got used to spending a lot of time relaxing since then. The only problem is I’m now climbing up the walls! I’ve run out of walls to climb up at home, so I started looking for something useful to do with my time. When I saw this advertised, I thought it seemed a much more worthwhile thing to do than washing cars or anything like that!’
Both men are in agreement that this sense of doing something which could improve healthcare for others was what motivated them to call us – much more so than the monetary reward. The two of them joke that they’re hoping to win a Nobel prize for their contribution to science.
I asked them about their experience of being diagnosed and living with type 2 diabetes, and it’s a subject which they seem to chocolate biscuits on heart shaped platemake light of: ‘I found out I was diabetic after I went to the Doctor with a rash on my leg’, says Peter ‘I’ve always been prone to mosquito bites, so I thought that I must have fleas. Imagine my surprise when the Dr told me I’d been eating too much chocolate! Fortunately, I have been able to manage the condition by making changes to the way I eat, and since then I haven’t had many other serious symptoms’
Douglas adds ‘I found out about my diabetes in a routine check-up, and like Peter I haven’t had any symptoms which have worried me too much. To be honest, it was more of a nuisance than anything else to begin with. I felt fine, but I was always having to attend this appointment here and that appointment there. After a while, I started to ignore the letters from my Doctor and all the reminders I was getting. I just sort of acted like it wasn’t happening.

 

type 2 blood glucose monitoring equipment
‘When my granddaughter was diagnosed with Type 1 diabetes, it completely changed my attitude. Although Type 1 and Type 2 are different, my concern for her made me more aware of what could go wrong if this was left untreated and gave me more respect for the condition. I’ve put a lot more effort into controlling my diabetes since then.’
This study has a number of non-invasive but unusual procedures, and the gentlemen tell me what they’ve been up to since checking in. We compare notes about the Human Appetite Lab (which I’ve experienced myself as part of our clinicians’ staff training), and I think it’s clear that they’d rather sit and talk to each other at mealtimes than sit in separate small white rooms.
bod pod type 2 diabetic study‘The best bit so far has been the BodPod’, Peter tells me. ‘It was a bit like sitting inside a giant eggshell.’ The BodPod is a body scanner which is used to accurately measure body constitution. ‘I thought it was going to be an ordeal and that I’d be in this little chamber for half an hour or so, but it only took a few minutes. But if a few minutes had been too much for me, it’s good to know that there was a panic button in there’ the two of them laugh.

 
‘Next visit, we’re going on the treadmill, which will be a first for me’ says Douglas ‘They always remind me of Peter Kay in the video for Amarillo’. All volunteers on this study will be asked to use a treadmill for 10 minutes at 5km/h (a brisk walking pace). Peter adds ‘I’ve run on a treadmill, but this will be the first time I’ve walked on one.’
type 2 glucose testing older manIt’s good to hear that, from the start, this trial has been a positive experience for them both ‘I feel like I know more about my diabetes now than I did when I came in.’ Peter tells me ‘My blood sugar is being tested regularly, and I feel like I’ve got a better understanding of what the highs and the lows mean’.
Is it measuring up to their expectations?
‘I don’t think we had any idea what to expect, we’re just going along with things!’ says Peter
‘Everyone has been really friendly and professional, so I feel confident and safe in their hands. They’re great at telling us what we need to do, and we like that’
Douglas adds ‘Mostly it’s women telling us what to do, and I’m very used to that!’
These 2 will be visiting the clinic a total of 19 times between now and early 2017, so it’s good to see that they’re already bouncing off each other like a real double act.
‘We are going to be seeing a lot of each other, so of course it’s good to know you’ve met someone you can have a smile and a laugh with’ says Peter.
I asked would they be happy to share the Nobel prize with each other?
‘Definitely!’

 

 

If you have any questions, or you would like to take part in this study, call us on 0113 394 5200 or apply here .

Meet Danny – Our First Psoriasis Patient!

This year, we’ve been working hard to find men and women with psoriasis to help us test a promising new treatment for the disease. Patients have responded to us in droves, but for this early stage of testing we specifically need people who are quite severely affected (having psoriasis covering an area on the body larger than 10 handprints) but who are not currently using the strongest forms of medication.

Enter Danny! A long time psoriasis sufferer, Danny is the first volunteer to have checked into our clinic and been dosed with this potentially breakthrough drug – and he’s travelled all the way from Swansea to get involved. We had a long chat about how psoriasis has affected him and his hopes and expectations for the clinical trial.

‘In Welsh folklore, there’s a goddess called Olwen, which means ‘white trail’. Wherever she goes, she leaves a trail of white flowers in her footsteps, and I feel a bit like that- leaving white flakes behind me. I don’t normally sit on dark-coloured furniture like this!’ he tells me, pointing to the navy blue settee in our rec room.

‘Generally, other people are very accepting of my psoriasis – they either don’t notice it or are too polite to say anything. The worst effect it has is on my own self-esteem. It makes me feel unattractive. I feel as though other people will see me as a little bit freaky.’

stinky shed coal tar treatment for psoriasis
Danny says that while using coal-tar he smelled like a newly-creosoted shed!

‘I have tried several different treatments in the past. This is where I used to apply coal-tar’ he shows me patches on his shin where his skin has actually been stained brown. ‘It wrecked my clothes and it smelled awful! It’s very hard to love yourself or even anyone else when you’re stinking like a shed!

‘I’ve also tried acupuncture, which was costly and time consuming and can take years to work. I started taking Vitamin D after noticing that it was improved by holidays in hot, sunny countries. But I got to a point where I just felt like my psoriasis was too severe, and that nothing I did would make a significant difference.

‘In my experience, it is hard to find helpful information about psoriasis – I haven’t found any good advice on the internet or even a good explanation of how and why people are affected by it. So far, I haven’t even found a Doctor who has been able to do anything other than be sympathetic. In a way, I feel like I’ve become an expert on my own psoriasis, but I’ve had to learn everything through trial and error. It would be great if research like this made it easier for patients to be diagnosed, to understand their condition and to control it effectively.’

I asked him if he had any concerns about taking part in testing a brand new drug?psoriasis trial test tube and pills colourful

‘Fortunately, I have a family member who works in a clinical environment, so I already knew that trials like this happen all the time and that safety is taken really seriously. I was a little bit nervous when I learned that the drug is an immunosuppressant (a type of drug which works by reducing the body’s immune response), but once it was explained I thought -Well, somebody has to do this and I’m willing to be the one who gives it a try. It’s a bit like air travel or riding a rollercoaster – there is some risk involved, but wasn’t going to let that stop me.

‘What worried me more is that I really don’t like being told what to do, when to eat, things like that, so I thought the residential part of the study might not agree with me. But the staff have been so welcoming and good humoured – there’s a real sense of community in the clinic and that’s made me feel very comfortable. Also, I’m really enjoying having this time to think – I’m a musician, I run a business (http://www.trac-cymru.org/en/) and I have a family, so life can be pretty hectic.

‘One thing I am really missing is caffeine, which I can’t have while I’m staying here. I am surprised at how much I’m craving a really good cup of coffee. I am actually fantasising about making up a pint of hot water with two teabags and downing it!’

With new drugs like this one, we cannot guarantee patients who volunteer that they will see a therapeutic effect. We need to answer a range of questions like ‘What is the right dosage level? Should this be taken on a full or empty stomach? How long does it remain in the system?’ before we can start assessing how successful it is. With this in mind, I asked Danny what his hopes were for the study?

Danny psoriasis clinical trial volunteer smiling‘In the short term, I’m seeing the study as a chance to better understand the condition and to think about how I manage it. I’ve accepted it as part of my life for a long time now, and this has made me reconsider whether there could be a medical solution. I will certainly start managing it more actively.

Of course I do hope that this research has a positive outcome for psoriasis patients in the future. Some people just get psoriasis, no-one really knows why, and that sucks. It would be great to think that something I’d done made a difference. That motivated me to take part much more than the money (volunteers receive from £100 per day for participating in clinical research)’

But does he think there’s any chance he might see more of an immediate improvement in his own skin?

‘No, I don’t think so. At least, I don’t want to let myself think so. I’ve got used to being disappointed, so at this point I really don’t want to let myself believe that it might work. If the treatment improves it a little bit, fantastic. If it makes it go away (which I don’t think it will)… well, that’d be fun.’

I’m pleasantly surprised when Danny comes back 2 weeks later for a follow-up appointment and asks to see me. He shows me his arms and legs, where the psoriasis plaques are significantly less red and inflamed, and he tells me that the ‘scalyness’ which meant he left a white trail is almost gone.

Of course, we cannot say that all of our volunteers on this study will see such dramatic results, but we’re all delighted that the trial has made such an encouraging start.

‘The physician I’ve just seen tells me that it could end up looking even better than this once the dying skin cells have sloughed off and been replaced. I’ve not known my skin to ever improve so drastically over such a short period, so I am very happy with the result. I’d definitely recommend anyone who’s considering it to get involved.’

If you think you might qualify for the study or you would like to find out more about any of our current trials, give us a call on 0113 394 5200 or apply for our paid clinical trials and we will call you within a few days.

Leeds Beckett Clinical Trials Rose Bowl Holidays

5 Reasons to Seriously Consider Clinical Trials in your Uni Holidays

Aaaaah, Uni Summer holidays! Several months of freedom to enjoy lazy sunny days, international travel, catching up with friends… or (more likely) fighting your classmates for a 4-hours-a-week contract at your local bar or coffee-house! Have you considered making this year the year you do something really different by volunteering for a paid clinical trial? Besides the fact that you’ll receive from £100 per day for your time, here are 5 reasons to give it some serious thought.

1) Bragging Rights

The vast majority of clinical trials conducted at Covance Leeds are very uneventful. In fact, we’ve been conducting studies here for the last 30 years with no major incidents.

However, this shouldn’t let this stop you from using your experience on a drug trial as a wicked conversation starter!

your bragging rights after a clinical trialLap up the attention as your housemates ask you strings of questions like:

“Weren’t you nervous about it?”

“How many needles did you have?”

“Is it true that you spent half your time playing Xbox?”

“You got paid HOW MUCH!?”

 

It beats hearing about that time Pete pulled a pint for some bloke off Emmerdale (again!).

2) Low-Cost Living 

It’s the Catch-22 of every student’s Summer. You want to stay in your Uni home, you get a job in the city, you barely earn enough to pay rent and eat, let alone pursue any of the fun activities which made you want to stay in the first place.

students saving pennies, low cost livingMost of Covance’s clinical trials involve a residential stay. This can be anything from 1 night to 30 nights – it’s entirely up to you how long you’d feel comfortable staying. But however long, for the duration of your stay you’ll not only be earning money, but saving it too.  Full board and 3 square meals per day are provided for all volunteers; you can use all of our facilities including fast wifi and Sky Sports + Movies, and if you stay for 10 days or more we’ll even do your laundry!

 

Residential volunteers are required to stay within the clinic grounds at all times, so there is nothing you need to spend money on. But relax, you can always order from the internet if you really need a retail fix!

3) Getting Ahead in your Uni Studies

Okay, maybe you weren’t planning to spend Summer doing Uni work, but you’ll be glad you did during term-time when students study hard textbookeveryone around you is freaking out over their workload.

 

As well as our large, comfy rec room, we have a couple of self-contained quiet spaces for our volunteers to use. In between clinical functions you can always retreat to one of these to make a start on next year’s reading list or plan your dissertation without any distractions.

 

4) Getting the Lowdown on your Health

Here in Leeds, we specialize in Phase 1 clinical trials – the early stages of testing in healthy adults. We have different criteria for each of our studies, but as a general rule you must be in pretty decent health to make it onto a study panel.

 

one does not simply walk onto a clinical trial memeWhen you call to register your interest in medical testing, we’ll take you through a detailed health questionnaire. Don’t worry – you certainly don’t need to be Usain Bolt to qualify, but to see if you’re eligible we need to know about any notable medical history or ongoing health issues. (We’ll also speak with your GP, so don’t worry if you forget anything at this stage!)

 

 

If everything checks out, we will invite you in for screening, which is a bit like a health MOT. Typically, we perform tests like blood and urine sampling, ECG heart monitoring and a physical examination. The results of these tests tell us (and in turn, you) about anything that’s going on under the surface. Usually, if test results are out-of-range, this is down to something simple like dehydration or your body fighting off an infection. But whatever the outcome, it pays to know exactly where you stand with your health.

5) Actually, Really, Properly Making a Difference

Phase 1 clinical trials in healthy adults are an essential part of bringing every new medicine onto pharmacy shelves. Without healthy volunteers taking part in these studies, there would be no ibuprofen, no inhalers for asthmatics, no antibiotics, no insulin pumps, no vaccines, and no chemotherapy drugs, to name but a few. So next time you brew up a Lemsip, say a small ‘thank you’ to the volunteers who made it possible!

 

Covance works with many of the biggest names in pharmaceuticals who have their sights set on a vast range of conditions. In the past 2 years, we have worked on treatments for:

 

Amongst many others. We couldn’t have done this without our volunteers, who are all heroes in our eyes!

 

Taking part in Clinical Trials is not a decision to be taken lightly, and it’s not for everyone. But if you are interested in taking part you can apply here, or if you’d just like to know a little bit more to help you make up your mind, you can always call us on 0113 394 5200.

lemon International Clinical Trials Day Scurvy

It’s International Clinical Trials Day!

…But why?

According to the annals of history, 20th May 1747 is the day that British ship’s Doctor James Lind began the world’s first randomized clinical trial, a study which pointed the way towards preventing scurvy and effectively cured 2 men of the disease in the process.

What is scurvy?

International Clinical Trials Day, masts, sea travelInitially, anyone who contracted scurvy would display cold-like symptoms – extreme fatigue, pallour, and often a sense of listlessness or depression. As it progressed, the disease caused fever and rashes, a swollen tongue, and for the gums to become ‘spongy’, resulting in tooth loss. Eventually, untreated scurvy became fatal, causing heavy bleeding.

Although rarely seen today, scurvy was extremely common in sailors when Lind conducted his study. The disease had a long history, having been recorded by Hippocrates as well as the ancient Egyptians. In 1740, 1900 men had set out to circumnavigate the world and 1400 had died along the way, mostly from scurvy. At the height of global exploration, scurvy was a massive hindrance to naval travel. Finding a way to treat this scourge of the seas would allow longer and more lucrative voyages – so something had to be done!

 

Lind’s Experiment

When 12 men on board the HMS Salisbury contracted scurvy, Dr James Lind separated them into 6 groups of two, prescribing each group with a different potential treatment. Now, keeping in mind that they were in the middle of the ocean, Lind’s treatment options were limited! He gave the respective groups:

  • Cider
  • Vinegar
  • Seawater (yummy!)
  • A paste of garlic, horseradish and mustard
  • Diluted sulphuric acid
  • Citrus fruits

Of all of these would-be medicines, citrus fruits were the hardest to come by, and the ‘citrus’ sailors ran out of supplies after just 6 days. Fortunately, they were both well on their way to a complete recovery by this point!

How big a difference did Lind’s Clinical Trial make?

You might be surprised to learn that Dr Lind’s research did NOT represent a turning point in the treatment of scurvy!

citrus fruits, curing scurvy, James Lind, International Clinical Trials DayAlthough he noted the benefits of citrus, James Lind did not challenge the medical establishment, who believed that scurvy was caused by food decomposing in sailors’ stomachs. As citrus fruits were rare and expensive, Doctors and Captains alike were unwilling to give them to crews routinely.

Cases of scurvy decreased as citrus and other vitamin c-rich foods became more commonplace, but the disease remained an issue until the Mid-20th Century – some 200 years after Lind’s research took place.

So why is Lind’s experiment still celebrated on International Clinical Trials Day?

Well, perhaps we are celebrating the process, rather than the outcome? Lind’s study was a beautifully simple and efficient way of comparing different treatments. By ‘randomizing’ his patients and pursuing different treatment options, Lind created a model which we still use at Covance today to answer questions like:

  • Does this treatment perform better than existing products?
  • Does it work better than a placebo?
  • Is it more effective when taken on a full or empty stomach?
  • Does introducing a second drug make this treatment more or less effective?

Fortunately, although clinical trials still resemble Lind’s experiment, we now have cutting-edge technology to monitor and record a huge range of  the body’s responses, and an office full of boffins who spend months or even years analysing the results – so unlike Dr Lind, we won’t be overlooking any miracle cures!

If you’d like to get involved with shaping the future of medicine, we’re currently recruiting healthy men and women aged 18-55 to take part in studies at our Leeds clinic. Apply now to participate in one of our paid clinical trials. You won’t have to drink any seawater. We promise!

sunset, tall ship, James Lind, International Clinical Trials Day

 

 

 

This post was written for International Clinical Trials Day 2016 by Ruth Smethurst. All views expressed are her own, and do not represent Covance.