Background
Clinical trials in healthcare are not a rare thing. They are the way to market for all new treatments, drugs, therapies and medical devices. Thousands of studies are carried out every year around the world, involving billions of euro of investment and thousands of jobs. Most critically, the lives and well-being of all of us depend on them. So why are more clinical trials not conducted? The clinical trials arena has changed over the years, and undoubtedly patient safety has improved. This is positive and reassuring, but the corollary is that the environment in which clinical trialists now operate is highly regulated.
There is much to learn and many systems to navigate: a solid research question, suitable outcomes, protocol development, ethical approval, regulatory approval (for IMP (investigational medicinal product) and medical devices), study sponsor, monitoring, data management, statistical analysis, etc. The list is endless. This makes it daunting for PhD students and early career researchers, and without adequate training, these enthusiastic, bright, leaders of our future may not be able to bring us the best therapies and medical devices. Urgent training is needed. The COVID- 19 crisis has put clinical trials on the map. There is an appetite amongst patients and the public for good clinical research. However, the training required to implement this is not adequate.
1. Increase flexibility and availability of clinical trials training,
2. Increase dissemination of opportunities for clinical trials training,
3. Explore linking trials training into the broader research pathway.
4. Consider key skills for different stages of clinical trials training,
5 Consider how research training awards can best prepare trainees for a career as a trials leader when developing recommendations into concrete proposals.
The National Institute for Health Research (NIHR) in the UK (2016) identified a gap in the number of people it funds who are on a pathway to become future leaders of clinical trials, compared to how much the NIHR invests in clinical trials. In order to support the clinical trials of tomorrow, it is vital that the right people are supported now to lead these trials. The NIHR identified several barriers to embarking on a clinical trials career and made five recommendations to overcome these barriers:
Our CONSCIOUS II proposal addresses four of these five needs which are definitely not just UK focused.
Amongst our CONSCIOUS partners, the lack of clinical trial training for healthcare practitioners and scientists in our respective schools and colleges is also evident. We saw this need when we formed the CONSCIOUS consortium and the CONSCIOUS curriculum and online platform has addressed this at undergraduate level. It enables the generation of undergraduates to develop a fundamental knowledge of clinical trials, to allow them to develop research questions, read and interpret clinical trial publications, and understand the basic composition of the conduct of a trial. We now wish to deepen the understanding, and address the training needs of “how to become a clinical trialist”, and provide participants with the knowledge and skills to lead their own trial. Our proposal is web based and thus inclusive and will be accessible to PhD and early career researchers around the world, providing equal access, regardless of race, gender, ethnicity, age, religion or sexual orientation.