My Career in Clinical Research and The Importance of Clinical Trials
In recognition of International Clinical Trials day, Clinical Professionals invites Deborah Bruce, Training Academy Manager, to provide some personal insight and reflect on the importance of clinical trials.
As today is International Clinical Trials Day, which marks the anniversary of the first clinical trial by James Lind in 1747, I find myself reflecting on my career in clinical research and the importance of clinical trials.
Just as clinical trials have significantly progressed since Lind’s trials in scurvy (I’m not sure any Ethics Committees or Regulatory Agencies would approve administration of sulphuric acid as a treatment arm!), so has my career.
After university, I began working in a research laboratory but my real interest and passion was in clinical research and pharmacology. I was fortunate to work with a team of doctors and scientists doing some ground-breaking translational research for paediatric oncology patients, and then moved onto a data manager / study coordinator role within the paediatric oncology department of a large teaching hospital in Australia. This was my first real introduction to clinical trials, as up until this point, I had only heard about it at university as clinical trials were not widely publicised in mainstream media. At this point I also realised how important clinical trials are to medical progress and the development of new treatments, but more importantly I was able to meet the real heroes of the clinical research industry, the patients who volunteer to take part in these trials.
My career then followed a fairly common pathway in clinical research in that I then went to work as a Clinical Research Associate (CRA) and then progressed onto a Study Manager (also known as a Clinical Project Manager) and then Senior Study Manager. During this time, I have worked across a number of therapeutic areas, worked in different phases of clinical trials, travelled extensively and learnt so much about this fascinating industry. However, two of the most significant highlights of my career was when a drug I had been working on received marketing approval from a regulatory agency. Both drugs are prescribed widely and are helping many patients manage their condition, which feels extremely rewarding to know that I have helped to extend and improve the quality of life for many patients. When I consider that only 1 in 10 compounds that enter clinical trials make it through to regulatory agency approval, I feel extremely privileged to have had these opportunities.
Over this time I have seen the many changes in the clinical research landscape. As a study coordinator, I recall phoning my CRA to randomise a patient into a clinical trial. Now the process is all automated with interactive voice and web response systems (similar to telephone banking). I’ve seen technology transform several other processes such as the use of electronic data capture; the transition from paper to electronic trial master files; and completion of patient questionnaires on hand-held devices. I’ve recently learnt about the use of electronic informed consent and telemonitoring to collect biometric data in patients’ homes and transmit it to a central database. All this in the space of 18 years! Soon we are to see the implementation of the first addendum in 20 years to the ICH GCP (International Conference on Harmonisation Good Clinical Practice) Guidelines in order to modernise the guidelines, as well as the implementation of the EU Clinical Trials Regulation. Clearly there are exciting times ahead for the industry!
Currently, I work as the Training Academy Manager at Clinical Professionals. Together with Nikki Harrison, Director of the Training Academy, we identify and train Life Science Graduates who are seeking a career in the clinical research industry, and then help them find their first clinical trial job as a Clinical Trial Administrator (CTA). The Training Academy is a two-week intensive modular course which introduces graduates to the fundamentals of clinical research – including historical events such as the first clinical trial by James Lind – as well as a comprehensive overview of ICH GCP, patient safety, the Trial Master File, and clinical trial regulations, designs, definitions and processes.
I have been involved in two Training Academies to date, training over half the 40+ graduates that have successfully completed the scheme. It has been so rewarding to see the transformation in the knowledge base and skillset of these graduates over the two weeks. When they walked into the training room on Day 1, very few of them were aware of ICH GCP and were daunted by the number of acronyms used within the industry. When they left on Day 10, they were able to participate in discussions about the clinical trials process using acronyms correctly in context, and successfully complete a multiple choice quiz written with industry-related terminology. We look forward to working alongside them as their careers progress and are humbled that we are able to share our knowledge and experience with them.
However, a surprising outcome of the Training Academy is that very few of the graduates were aware of where they could find a list of ongoing clinical trials in the UK. One graduate was aware of the https://clinicaltrials.gov/ website, a public registry and results database of all clinical trials conducted globally. However, no one was aware that all clinical trials conducted in the UK were also listed on the NIHR website,. At the time of writing this article, there were over 35,000 trials being conducted in the UK, in a wide range of therapeutic indications and phases.
So how is it that people who are actively seeking a career in the clinical research industry, let alone the general public, are not aware of the size of this industry in the UK alone, let alone globally? In order to recruit for 35,000 trials, a significant number of clinical research professionals are needed, from the doctors and nurses at the hospitals who run the clinical trials and recruit patients, through to the various multi-disciplinary teams that work for the pharmaceutical company or Contract Research Organisations (CROs) that manage and oversee the trials. One just needs to look at the various specialty sectors on the Clinical Professionals’ jobs page to glean a small insight into the vastness of this industry. But being such a niche industry, it is difficult for graduates to obtain entry level positions without the appropriate training, and thus there is a risk to the industry of a skills shortage of experienced candidates for core clinical roles (CTA, CRA, Project Managers, etc.). Clinical Professionals’ Graduate Academy was established to address this skills shortage and is helping to put trained entry-level graduates into the industry.
Which brings me back to the importance of clinical trials and how essential they are to advancing patient care and medical knowledge. In 2013, the NIHR launched the ‘OK to Ask’ campaign to encourage patients or carers to speak to their doctors about participating in clinical research and to promote awareness amongst healthcare professionals of clinical research. The campaign is now in its third year with many of the NHS Trusts participating and running events to promote awareness.
But what about the rest of the year and the rest of the clinical research industry? What can we do to promote not only the importance of clinical trials but in fact, their existence? Clinical Professionals often attend careers fairs at universities to promote job opportunities within the clinical research industry but is this enough? Should industry professionals be attending careers days at secondary schools and ensuring that careers advisors are aware of the career opportunities within the industry?
How can I personally utilise social media to promote clinical research? It is food for thought and something I’m aware I need to make a much more conscious effort to play my part in raising awareness.
Perhaps I should start here. I’ve already mentioned that only 1 in 10 compounds that enter clinical trials make it through to your medicine cabinet. But what do you know about the different phases of clinical trials? Let me give you a brief introduction:
- After rigorous testing in animals (known as pre-clinical testing), Phase I clinical trials begin. The primary aim of Phase I trials are to determine if the drug is safe in humans (usually healthy volunteers).
- Once a drug’s safety is established, Phase II trials in patients with the disease/condition begin. The aim of these studies is to determine if the drug is effective in treating the disease/condition, and to further evaluate the drug’s safety.
- Phase III trials are in large numbers of patients with the disease/condition, for a longer duration of time, and are the final stage to confirm efficacy and safety. These trials also compare the drug to treatments already available on the market.
- If a drug makes it this far and is approved for marketing, Phase IV trials are initiated to post-marketing surveillance to continue to collect information on the drug’s safety in the ‘real-world’.
If you’re interested to learn more, the NIHR website is an excellent place to start.
I can honestly say that I have enjoyed my time in the pharmaceutical industry so far. Like any industry, it has not been without its challenges, but these are the times I’ve learnt the most. I’m looking forward to seeing what the future has in store for the industry with the new changes on the horizon, and training the enthusiastic new recruits that pass through Clinical Professionals’ Training Academy.
Training Academy Manager
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