Working in Clinical Trials
By Sarah Goddard, Clinical Professionals Divisional Director
In celebration of Clinical Trials Day this year, the Clinical Professionals group will be answering some of the most common questions related to process and all matters related, to help highlight their importance and to bring about awareness.
Welcome to the world of acronyms!
Working in clinical trials is a hugely rewarding, challenging and fascinating career, with great variety and scope for development and progression. Our customers are very passionate about what they do, about developing drugs and products for patients and above all patient safety. Furthermore, clinical research and the life science sector forms a very valuable contributor to the UK economy, contributing over £30billion GDP, supporting an estimated 482,000 UK jobs (2015 figures), and creating new business.
What is a clinical trial?
A clinical trial or study allows researchers to test new ways to prevent, detect, or treat disease. Treatments might be new drugs or combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. Clinical trials can also test other aspects of care, such as ways to improve the quality of life for people with chronic illnesses. A well-designed clinical trial is the gold standard for proving that a treatment or medical approach works, but clinical trials can’t always be used. For example, scientists can’t randomly assign people to live in different places, or ask people to start smoking or eating an unhealthy diet. Clinical trials are conducted in 4 phases. The patients are ‘monitored’ at various sites such as hospitals or clinics, usually lead by an Investigator.
What types of companies do clinical trials?
For clinical research the primary organisations that conduct trials are pharmaceutical and biotech companies, CROs (contract research organisations), public sector including the NHS, Academia and not-for-profit/charities (often in collaboration with private sector), medical device and technology companies.
What locations can you be based in?
Clinical trials are conducted all over the world, so starting your career in this sector allows for global travel and even relocation. In the UK over 50% of companies and job roles are based in London and the South East, however the public sector and medical devices sector are more spread out across the country.
What trials may you be involved in?
There is huge variety within the sector, the FDA website states 7 different types, but to keep it simple (and brief!) you can be involved in a clinical trial within any phase between I and IV, and these can be diagnostic trials, prevention trials, Epidemiological studies Treatment research, Screening, Quality of life, or Genetic studies. These studies will be in a specific therapy area such as Oncology (cancer studies), Respiratory, Cardiology, Neurology, Diabetes, Immunology, Haematology, etc. In some roles you may work on multiple studies in different therapy areas/phases.
Key roles within clinical trials
There are 2 core sides to clinical trials – the R&D side and the commercial side of marketing and selling the drug and looking at the economics behind it and accessibility to patients. In terms of the R&D side (once into clinical trials) the core functions can be broken down into:
- Clinical Research (trial administrators, monitors, study managers, etc)
- Regulatory Affairs
- Pharmacovigilance (drug safety)
- Data Management, Biostatistics and Programming
- Medical Information
- Medical Affairs/Physicians
- Quality Assurance and Quality Control
- Medical Communication & Medical Writing
- Product development
For all roles, you need to have attention to detail, great organisation, planning and prioritisation skills, ability to multi-task and work in a matrix management environment, assertive and problem-solving nature, excellent written and verbal communication skills and of course – passion for science and research!
There are some horror stories and ‘urban legends’ which also make for interesting reading… all unproven I might add:
Ethnographer Jill A. Fisher offers a fascinating look at the rumours and urban legends that circulate among the volunteers who get paid to take part in medical research: Stopped hearts, amputated toes and NASA “The “flat liner” study concerns a clinical trial in which, in exchange for a hefty fee, participants agree to be put into cardiac arrest for a brief period and then resuscitated. As one serial participant told Fisher
“I don’t know if it’s a myth going around or something that actually happened. I heard a story about the university that stops your heart for 60 seconds or whatever and they pay you, I don’t know, $50,000 or whatever. I don’t know anybody that’s ever done it. [Laughs]. I just hear everybody talking about it. Maybe nobody ever lived to come back and talk about it.”
Some participants even ask researchers in unrelated clinical trials for help on how to enrol in the flat liner project. One investigator says he has repeatedly been asked for information on the high-paying study where “you let the unit stop your heart”. The rumour may have originated in the movie Flat liners. A variant of this story is the “amputated toe “, about a study where the researchers cut off people’s toes and then reattach them. Fisher says that this story, however, is widely regarded as implausible.
Clinical trials are a great place to work!
Published alongside the UK government document Strength and Opportunity 2015, the Life Science Competitiveness report shows a higher-level picture of the UK life sciences ecosystem and performance relative to a set of comparator countries. This overview highlights the strong academic base and clinical research environment in the UK, as well as high levels of health and life sciences industry productivity.
If you are interested in a career working in clinical trials, you may be interested in attending the Clinical Professionals Training Academy.