The WHO Statement: Report of Clinical Trials is an Ethical Imperative, now the practical implementation.
The recent statement from the WHO on Clinical Trials recalls the Declaration of Helsinki and states that “every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject” and that “researchers have a duty to make publicly available the results of their research. Negative and inconclusive as well as positive results must be published or otherwise made publicly available”.
The Declaration of Helsinki is the statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. It was adopted by the 18th WMA General Assembly in 1964. Indeed it is unethical to conduct human research without publication and dissemination of the results.
Clinical trials are investigations designed to assess the effects – wanted and unwanted – of healthcare interventions in people. Millions of volunteers have participated in clinical trials to help find out more about the effects of treatments on disease, yet that important ethical principle about reporting has been widely ignored. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. This is what led to the AllTrials campaign in January 2013, a campaign which is now supported by thousands of individual patients, clinicians and researchers across the world, and by hundreds of organisations representing millions of people.
There are four levels of information in clinical trial reporting: (1) knowledge that a trial has been conducted, from a clinical trials register; (2) a brief summary of the trial’s results; (3) full details about the trial’s methods and results; (4) individual patient data from the trial. The AllTrials campaign is concerned with the first three. There are now initiatives in many countries to work out how individual patient data can be shared with other researchers.
On April 14th the WHO published the Statement on Public Disclosure of Clinical Trial Results, following the exhortation of those hundreds of individuals and organisations.
According to this statement:
- Results from clinical trials should be publicly reported within 12 months of the trial’s end
- Results from previously unpublished trials should be made publicly available
Which are the most important consequences?
- Less misinformation;
- Future patients volunteers can be protected from unnecessary risk;
- Pharmaceuticals industry must guarantee that doctors have access to all drug data, less suboptimal and harmful treatments;
- Decision makers can drive proper health interventions and set the research agenda accordingly;
- Healthcare professionals and patients can make informed decisions about which treatments are the best;
The fact that the WHO has no legislative power means that we need an implementation by the ethics committee, investigators, hospital, governments and funders to guarantee that clinical trials regarding drugs, medical devices and vaccines are reported and public disclosed.
Medical students can give their contribution and raise awareness in their Universities and hospital, among their friends and families as it matters to everyone. Students interested and involved in Research can also follow the webiste Alltrials http://www.alltrials.net/ and to get involved.
As Ben Goldacre, co-founder of the advocacy group AllTrials, wrote, positive statements require practical implementation.
- WHO Statement on Public Disclosure of Clinical Trial Results: http://www.who.int/ictrp/results/reporting/en/
- How to Get All Trials Reported: Audit, Better Data, and Individual Accountability: http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001821
- Declaration of Helsinki: http://www.wma.net/en/30publications/10policies/b3/
Entry written by Ivana Di Salvo, IFMSA Liaison Officer for Research and Medical Associations