May is upon us, which can mean only one thing: International Clinical Trials Day is here.
It all started on May 20, 1747, when James Lind took 12 patients on board the Salisbury who were suffering with scurvy and investigated whether citrus fruit would alleviate their symptoms. His rationale was the observation that in the British fleet scurvy caused more deaths than in the French and Spanish fleets combined.
This gave rise to one of the first ever recorded clinical trials and it’s why International Clinical Trials Day is celebrated globally on May 20.
Since Lind’s pioneering work 268 years ago, medical research has come a long way; innovations in study designs, statistical analyses, outcome reporting, and data sharing, to name but a few, have all contributed to the improvements we see today.
Developments in the transparency and reproducibility of medical research have also gained momentum and are now snowballing, with recent calls from the World Health Organization (WHO) to this affect.
From our perspective, as a publisher, there are some great developments underway that we are involved in. This includes the ‘threaded publications’ cross-publisher initiative which links all reports from a single clinical trial together, the pilot of which will begin very soon.
This year, to celebrate International Clinical Trials Day 2015, we asked those closely involved in conducting clinical trials the following question:
What do you think is the single greatest development that will help improve clinical trials in the next 5–10 years?
We’ve collated these insights into a series of blogs; to kick things off, we have the perspectives from the funder and trialist. Check out Part Two for perspectives from a pharmaceutical company and patients involved in research.
From the funders’ perspective, Simon Denegri, National Director within the National Institute for Health Research (NIHR), speculates that public involvement in clinical research will result in a new ‘golden age’ in its history:
“The public’s relationship with clinical research is shaping up to be very different in the future than it has been.
“Patients, carers and the wider public are increasingly helping to unlock new knowledge that might provide a path to more effective treatments and care: identifying research priorities, designing clinical trials, sharing their personal data and disseminating the results.
“We must do everything we can to ensure this exciting partnership between researchers and the public becomes a happy and enduring meeting of minds. Whether we will, is entirely in our own hands.
… perhaps the truth is that the golden age is just about to begin. For now, at last, it involves the public.”
National Institute for Health Research
“The public wants their National Health Service (NHS) to conduct research. They are pleased to help make this happen by taking part in clinical studies and the majority will willingly participate when asked. If only they were asked.
“Too many barriers stand in their way. These barriers are often remnants of a time when research participants were seen as ‘subjects’ and not partners, when the prevailing attitude was ‘what they don’t know won’t hurt them.’
“I hope that the positive relationship that is evolving between researchers and citizens, is increasingly mirrored in the environment in which they are striving to work together: hospitals and surgeries where research (and our part in it) is visible and engaging, regulation that is based on real knowledge of patient preferences when it comes to information, consent rather than second-guessing it and finally; research governance that is driven by patients on whose money and knowledge it is fundamentally founded.
“There are those who talk about a golden age of clinical research now past. But perhaps the truth is that the golden age is just about to begin. For now, at last, it involves the public.”
From the trialists’ perspective, Dr. Abebaw Fekadu, Associate Professor at the College of Health Sciences of the Addis Ababa University in Ethiopia, iterates the importance of establishing leadership as an essential factor for developing clinical trials:
“Almost always, no single factor is adequate to accomplish a task as complex as establishing and running a successful clinical trial program. Most lower-to-middle income countries (LMICs), particularly Africa, are in a great transition, politically and socio-economically, as well as in health.
“The single greatest development that may have a critical impact on clinical trials at this juncture is leadership development.
“Leaders have a more decisive role in LMICs than anywhere else. The Medical Research Council has identified this very important area of need and is focusing its attention on leadership development through the ‘African Research Leader’ scheme.
“Leadership that will have the most transformative impact will need to have all of the following qualities:
The single greatest development that may have a critical impact on clinical trials at this juncture is leadership development.”
Dr. Abebaw Fekadu
Addis Ababa University
- Visionary leadership: Clinical trial programs in LMICs are extremely weak at present. Leaders should have clear and ambitious vision of what should happen in the next five-to-ten years. They will need to make a persuasive case for their vision, and create the environment and infrastructure that can deliver on their vision.
- Nurturing leadership: Most research leaders in Africa are senior scientists. To ensure we establish effective leadership, nurturing young scientists to become leaders in clinical trials is crucial.
- Collaborative leadership: A leader should be open and confident in creating collaborations within and outside of the country. With current globalization movements, the very limited capacity of most LMICs makes broader support and collaboration essential.
- Safe leadership: Protection of participants and trialists is an area of utmost priority. There is a high potential for risk, particularly in phase 1 and phase 2 trials. A leader has to ensure safety mechanisms are in place and followed.
- Sustainable leadership: A leader should keep continuity in mind and should work with sustainable technology.
- Selfless leadership: Leaders who could make a transformative impact in LMICs may not receive the material incentives or the ‘visible’ moral incentives.
“An example of this is what is happening at Addis Ababa University. Last year, we celebrated International Clinical Trials Day for the first time. The University has established a trial steering committee and a clinical trial unit; a mental health Clinical Trial Unit has been built, a Unit for phase 1 trials is being completed, and a proposal is being submitted for expanding the Unit. This is all because of the critical input from the leadership of the College and the University.”
Check out Part Two for insights from a European pharmaceutical company and patients involved in research from the USA and Australia.