All Trials Registered | All Results Reported
“Thousands of clinical trials have not reported their results; some have not even been registered.” All trials registered | All results reported
This is a problem.
A petition was launched today that calls on governments, regulators, and research bodies to put measures in place to register and report the methods and results of clinical trials. This initiative, led by Bad Science, Sense About Science, BMJ, James Lind Initiative and CEBM is important. This issue effects all of us: patients, researchers, clinicians, politicians, scientists, and industry.
The petition was followed with a rip roaring editorial by Iain Chalmers, Paul Glasziou and Fiona Godlee in the BMJ that calls for all trials to be registered and their results published. This excellent piece details the consequences of our collective abstention from action and provides advice to patients whom are invited to participate in clinical trials; name:
“Agree to participate in a clinical trial only if: (1) the study protocol has been registered and made publicly available; (2) the protocol refers to systematic reviews of existing evidence showing that the trial is justified; and (3) you receive a written assurance that the full study results will be published and sent to all participants who indicate that they wish to receive them.”
Don’t wait, sign the petition now.
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Be proud you are taking a step for transparency and improving patient care. I know I am.
Inseparable bedfellows: serendipity and research
On the train-ride back from the Joint Annual Medical Research Society/Academy of Medical Sciences/Royal College of Physicians Clinician Scientists in Training Day, I was feeling inspired about basic science research, which does not happen often enough to epidemiologists like me. Every year they invite young researchers to present their findings and invite eminent speakers to encourage the next generation to stick with research. It is rare to go to a meeting where scientists from all disciplines from genetics and haematology to cardiology and epidemiology all present their work, but this meeting works.
I heard about some genuine “bench to bedside” research, from MRI scans to gauge neural function in intensive care patients to novel treatments for liver cirrhosis and metastatic breast cancer. The overall Young Investigator Prize winner was a very deserving Tamir Rashid from Cambridge. His research group has firstly produced stem cells from skin cells, which raises the possibility of not needing donor cells or embryonic cells in future. They have then developed new technology to correct the error in the genetic code in a form of liver cirrhosis (alpha-1 antitrypsin deficiency) using stem cells with the correct code. Finally, they have shown that these cells restored liver function in humans and the therapy is about to be tested in a clinical trial. This is a brilliant example of “bench to bedside” research starting with a hypothesis, testing in animal models and then developing a strategy of treating disease in humans, later to be tested in a trial. But how does research like this happen?
In plenary speeches, Professor Sir John Tooke and Professor Andrew Hattersley repeatedly stressed four important aspects of successful clinical research: good mentors, collaboration, serendipity and patient involvement. Professor Charles Warlow, the eminent stroke researcher, has written that “Good luck should be exploited, and very often barriers can be not just overcome but put to good use as well”.
Turning to Pubmed or to Google, we find countless examples of serendipity in scientific discovery and research. Luck has been important in the development of drugs, whether for cardiovascular diseases, malaria or depression. One of the most fascinating examples of good fortune and medical discovery in my own area of cardiology is the accidental injection of the right coronary artery by Mason Soanes in 1958 which led to the development of coronary angiography, and most of the advances in modern cardiology in the last half-century.
The social scientists refer to healthcare organisations and research organisations as complex adaptive systems(CASs) and as such, serendipity will always play a major role. A recent study looked at researchers' perspectives on “how high impact publications are developed and why they are consistently produced by a small group of researchers”. Interestingly, the researchers consistently found five factors: (1) rules of thumb; (2) these rules of thumb were reinforced by positive feedback from peers and mentors; (3) good communication skills allowing researchers to provide feedback to their peers, thus closing a positive feedback loop; (4) curiosity, open-mindedness and motivation; and (5) randomness and serendipity. The study found, unsurprisingly, that some researchers were better than others at capitalising this randomness. So the message for aspiring researchers, from the available evidence, is to be in the right place at the right time,stick with it if you get lucky, and don't forget to talk to your research team!