Tag Archives: Clinical Trials

cystic fibrosis breathing through colourful straws

Cystic Fibrosis – Join the Fight for Breath!

Cystic fibrosis is a rare, hereditary disease which affects about 70,000 people worldwide. Although its origins can be traced back as far as 3000BC, no cure has been found as of yet. Put simply, CF is a condition which causes sweat, digestive fluid and mucus to become abnormally thickened. But the effects of this seemingly minor change have a devastating impact on a patient’s daily life.

cystic fibrosis red-lungsPerhaps the most well-known symptom of CF is respiratory difficulty. Breathing with cystic fibrosis is sometimes likened to breathing through a thin straw 24/7. Patients with cystic fibrosis are prone to frequent chest infections, resulting in constant production of extremely thick and sticky mucous which is hard to shift by coughing. If this doesn’t sound bad enough, prolonged coughing fits cause inflammation to the lungs, causing more mucous to be produced, and so on and so on. One of the body’s most basic and automatic functions becomes a never-ending vicious cycle. It is hardly surprising that 80% of deaths associated with Cystic Fibrosis are caused by breathing difficulties.

But that isn’t where the nightmare ends. Changes to the consistency of digestive fluids means that the body can’t effectively absorb nutrients from food, resulting in malnutrition. Children with Cystic Fibrosis may grow or gain weight at a slower rate than their peers – often, this is the factor which leads to the illness being diagnosed. In later life, malnutrition can lead to yet more complications including osteoporosis, diabetes and infertility.

The good news is that treatment for Cystic Fibrosis is improving all the time. 70 years ago, most patients died in infancy before the age of 1. The life expectancy of a Cystic Fibrosis patient born now is upwards of 50. But there’s still lots of work to be done to increase this figure and ensure that patients have quality of life for as long as possible.

We are testing a potential new treatment for Cystic Fibrosis in our Leeds clinic, and about 120 healthy volunteers are needed to help us complete our investigations. A new medicine is under development which could potentially correct the genetic mutation which causes Cystic Fibrosis, but before this is given to CF patients, we’re aiming to answer questions like –

  • What is the ideal dosage?
  • Will this work best as a pill, an oral solution or an IV injection?
  • Will this treatment complement or counteract existing CF treatments?
  • How long does it take for the medicine to break down in the body?

cystic fibrosis snuggling-coupleBecause we’re aiming to answer all of these questions, the clinical trial is split into a number of groups, with various start dates and length of commitment.  We’re currently recruiting men and post-menopausal or surgically sterile women aged 18 – 60 for an 18 night stay and one outpatient visit, paying from £100 per day. As we continue to answer the important questions about this medication we will be adding more groups, so if you would like to play a role in the fight against Cystic Fibrosis, keep a close eye on our current studies, and apply for any group with the study number 8349680.

Thank You!

world aids day tube advertising

10 Things you should know about HIV/AIDS on World AIDS Day 2016

Throughout the 80s and 90s, the AIDS epidemic dominated headlines making this one of the most feared diseases in living memory. In recent years, the word ‘epidemic’ is perhaps more quickly associated with emerging diseases like ebola and the zika virus. But while its progress has slowed AIDS has by no means gone away, and it’s worth reflecting on some facts this World AIDS Day.

aids-ribbon1 – AIDS has caused over 7 million deaths since 2000

We tend to think of the 80s and 90s as the height of the AIDS pandemic. Since then, the incidence of AIDS has decreased and the life expectancy of HIV patients has increased, but the disease remains a serious threat to world health.

2 – There were 2.1 million new cases diagnosed in 2015

That’s a big number. By comparison, there were 29,000 reported cases of ebola between March 2014 and Jan 2016. Clearly, this is no time to become complacent about AIDS!

3 – The rate of infection is slowing

It’s not all bad news! Since 2010, the number of new cases has decreased by 6%. The huge public awareness campaigns of the late 20th Century have had a huge effect on slowing the spread – all the more reason why AIDS should still be on our minds and in our newspapers.

4 – Routine screening is ESSENTIAL

The first symptoms of the HIV virus are easily mistaken for a cold or ‘flu. After this patients can carry HIV/AIDS for many years without showing any symptoms. By the time patients feel ‘ill enough’ to get tested, it may be too late for meaningful help. Screening is confidential, widely available through your GP surgery or sexual health clinics. Increasingly, results can be returned within 1 day, and certain tests may not even require a blood sample.

hiv-myths-ver5_05 – It is NOT spread through bodily contact

You cannot catch HIV by touching or kissing an infected person, or by sharing their cutlery, towels, clothes or living space. When AIDS was en emerging disease and not fully understood, myths and misconceptions like these heaped stigma and social isolation on top of patients’ suffering.


6 – Its origins are not fully known

AIDS was first observed in 1981 and named in 1982; however, it is believed that HIV might have originated in West African Primates, and may have been transmitted to humans as far back as the early 20th century.

Until very recently, a man named Gaetan Dugas was widely regarded as ‘patient zero’, responsible for introducing and spreading AIDS around North America in the early 80s. However, news broke in October 2016 that Dugas was one of many individuals with the same generation of the virus, and that circulation of AIDS in the US most likely began at least a decade earlier.


7 – The drugs DO work

There is currently no cure for AIDS, but antiretroviral drugs slow the progress of the virus and can give a near-normal life expectancy for HIV positive patients. Without treatment, the prognosis is around 11 years from the point of infection. With antiretroviral treatment, patients are generally expected to live into their 70s.

8 – PEP can help patients who have been exposed

PEP stands for ‘Post Exposure Prophylaxis’ – a course of drugs given to healthy individuals who have been exposed to the HIV virus – for example through unprotected sex, or a needlestick injury. It can also be given to the newborn babies of HIV positive mothers. If introduced within 72 hours of exposure, PEP is highly effective at preventing HIV from being contracted.

9 – PrEP can prevent transmission to healthy men and women

For someone who anticipates that they could be at risk of exposure, PrEP (Pre-Exposure Prophylaxis) is an effective way to prevent HIV transmission. PrEP involves healthy individuals taking a course of drugs which are normally used to treat HIV/AIDS. PrEP is not currently available on the NHS, but after a parliamentary debate, it was recently recommended that PrEP be made available to high-risk individuals, such as gay and bisexual men, or people whose partner is HIV positive.

aids vaccination clinical trials10 – A vaccine could be next

Vaccinations have allowed us to combat polio, measles and rubella, and to globally eradicate smallpox. A vaccination against HIV is one of the Holy Grails of clinical research, and a huge clinical trial is about to begin in South Africa. 5400 healthy men and women will be testing a new injection, which it is hoped will prevent HIV in at least 50% of cases.


Since it was first classified in 1982, AIDs has gone from being a life sentence to an increasingly manageable condition, and the development of an effective vaccine could sound the death knell for this destructive virus.

None of these developments would have been possible without clinical research, and without volunteers like you, medical developments would grind to a halt.


volunteers executive full time work

Meet Our Volunteers – Mike T’s Covance story!

Recently, I was chatting with one of my colleagues about Covance Clinical Research – he was helping them work on an ad campaign.

Many moons ago I had taken part in some studies at the Leeds clinic. At the time, it was called Hazletons. As a student with a bit of time to spare, I could commit to some of the longer studies which involved staying as a resident for 7 – 10 days. It had been quite a positive experience, and the study payments certainly came in handy at the time!

When I looked at Covance’s current studies and realised there were some shorter clinical trials which I could easily fit around full-time work, I thought – why the hell not!?

male volunteer informed consent documentThe study that caught my eye had a three-night stay and checked in on a Thursday – meaning that most of it fell on the weekend and I wouldn’t be giving up precious holiday. I called the recruitment team who caught up with my medical history since my last trial and booked me in for a screening appointment. Once I’d passed screening, I was invited to check in to the residential part of the study along with 11 other volunteers. I was surprised that many of the others were at a similar age and stage to me – I’d expected to see mostly students, but because this was a shorter study and it fell over half term, many of the people I met were full-time workers.

Because I’ve taken part in clinical trials before, I knew that nothing too scary was going to happen to me in the clinic. You hear urban myths and horror stories about mad scientists amputating and re-attaching toes, but I knew that in reality the procedures on a clinical trial are much more basic, like analysing blood samples. There has already been a great deal of testing carried out on the study drug before it reaches human testing.

However, I must say that I did have some reservations when I learned that the drug I was testing was a potential treatment for cancer. Obviously, cancer treatments like chemotherapy can have unpleasant side effects, so I was a little apprehensive about what I might experience.

When I came for screening, the member of staff I spoke to was very honest and informative, which was reassuring. She read through an Informed Consent Document with me – this contains all the information about the study drug, including how many people have already tried it and any potential side effects. There were a few things in there which I hadn’t noticed when I read through it by myself. She didn’t hide or try to ‘gloss over’ any of the risks, but she gave me all the information I needed to make up my own mind. It’s always good to be treated like a grown-up!

stand-up-to-cancer-soundbite-orangeAfter my appointment, I felt more relaxed about the study drug. But the thing that really put the tin hat on it was watching Channel 4’s Stand Up To Cancer fundraiser on 21st October, just before I was due to check in. There were so many heartbreaking stories from so many different families – it was pretty relentless, to be honest! One way or another, cancer affects everyone. Volunteers on this study get to contribute to the fight against this awful disease. From that point, I was resolute. If I had any worries about taking part, I put them to one side then and just thought about the benefits.

My time on the study passed really quickly. Everyone was friendly, the staff were fun and energetic, but also professional and very capable. Not much has changed since my last visit, but the attention to detail seemed to be even more meticulous than before. Everything is timed to the minute – when you are given the drug, when blood samples are taken, when you go for your meals – you’re actually kept quite busy!

Did I experience any nasty side effects? No! The day after I’d been given the study drug I did feel a little bit ‘snotty’, and one or two of the other volunteers said the same thing; but I’m not sure whether that was actually caused by the drug or not. I might’ve even been given a placebo, I’m not sure!

hair-colour-change-bright-wigsI suppose people often associate cancer treatment with hair loss – but I don’t have much up top anyway, so I wasn’t really worried about that! We were told that the drug might potentially cause a change in hair colour, and I remember joking with one of the nurses, trying to guess what colour it might go! White? Bright orange? It might actually be a benefit if it turned your hair a really nice colour!

I never got to find out, as none of the 12 volunteers did notice any change in their hair colour. And everyone left with just as much hair as they had when they checked in! Like me, all of the volunteers said they’d be happy to come back and take part in more studies.

When it was time to leave, I was given a cheque for £688. It’s nice to get a financial boost like this, particularly with Christmas just around the corner, but I didn’t go into the study with a particular plan for how I was going to spend the payment. After a bit of thought, I decided I’d donate part of it to cancer charities. It feels good to have given some of my free time to cancer research, so why stop there?

If this post inspired you, and you’d like to follow in Mike’s footsteps, why not apply for one of our clinical trials?

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.

Diabetes Featured

Volunteers With Type 2 Diabetes Needed to Participate in Clinical Trials

[fullwidth background_color=”” background_image=”” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_repeat=”no-repeat” background_position=”left top” video_url=”” video_aspect_ratio=”16:9″ video_webm=”” video_mp4=”” video_ogv=”” video_preview_image=”” overlay_color=”” overlay_opacity=”0.5″ video_mute=”yes” video_loop=”yes” fade=”no” border_size=”0px” border_color=”” border_style=”” padding_top=”20″ padding_bottom=”20″ padding_left=”0″ padding_right=”0″ hundred_percent=”no” equal_height_columns=”no” hide_on_mobile=”no” menu_anchor=”” class=”” id=””][one_full last=”yes” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” border_size=”0px” border_color=”” border_style=”” padding=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ class=”” id=””][fusion_text]

Type 2 Diabetes occurs when the body does not produce enough insulin, or the insulin produced does not function properly, causing glucose to build up in the blood. If not carefully controlled, it can affect the circulatory and nervous systems and cause damage to the vital organs.

Continue reading