Industry experts have been calling for public registration of clinical trials of drugs and medical devices since the 1980s, and the subsequent sharing of the research data and results. Global health organisations have been less than proactive on the issue, but have had to respond in the wake of revelations about serious problems with the hiding and misrepresentation of research results, duplication of research, and misleading and fraudulent presentations of findings in medical publications.
Now that health advocates, including the World Health Organisation (WHO) and Pan American Health Organisation (PAHO), are on board – along with influential drug regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) – steps are being taken to address the situation.
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Key recommendations: transparency is crucial
A cutting-edge paper published this month in the British Medical Journal, by the University of Toronto’s Trudo Lemmens and Carlos Herrera Vacaflor, recommends important changes be made in this regard, to improve clinical trial transparency and regulatory coordination in the Americas.
“Well-intended regulatory requirements have had the unfortunate result that much of the scientific research related to drug safety and efficacy is conducted under the control of those who have a huge commercial interest in the outcome,” says Lemmens, university professor and Scholl chair in health law and policy. “Transparency measures are an imperfect solution to a problem created by our model of drug regulation, but they are increasingly seen as crucial to restore integrity to the system.”
Lemmens believes research ethics committees should play a coordinating role in the promotion of transparency standards, but in some countries these organisations are not adequately regulated or fully independent.
“They are not sufficiently publicly accountable and hardly in a position to impose norms that run counter to the commercial interests of their clients,” comments Lemmens, “particularly not when they are fully embedded in the commercial context that underlies the push for data secrecy. We therefore recommend that research ethics governance itself also needs to be strengthened and made more independent from industry.”
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By GlobalDataFollowing the EMA’s lead
Drug regulatory agencies in PHAO member states should follow the approach taken by the EMA with regard to data obtained from clinical trials, say the report’s authors. They argue that this data does not constitute commercially confidential information and the burden of proof should be on drug companies to make a case for why specific data should be kept confidential. In 2015, the EMA created a policy based on this premise which was legitimised by a European Court ruling; the first time a court has explicitly endorsed this approach. This meant that data of this type would, in principle, become publicly available.
Since its change in policy, the EMA has published millions of pages of previously hidden research data. The so-called Restoring Invisible and Abandoned Trials (RIAT) project has enabled researchers to issue re-evaluations of existing publications and flag up those based on data that appears flawed.
“Enabling independent analysis will strengthen the reliability of regulatory decisions and the integrity of research that underpins drug development and thus protect patients,” continues Lemmens. “It will also save costs for drug development, since it should help reduce waste in clinical research and reduce duplication of clinical trials.”
However, the EMA recently announced that it will start scaling back its transparency initiatives.
“This comes in the wake of Brexit and as a result of substantial reductions in the EMA’s staff and increased access demands,” explain Lemmens. “The most serious measure it announced is that it would now only provide data access to European citizens, and it would also reduce its efforts to prospectively publish data sets.”
Regulators to harmonise transparency across jurisdictions
The report recommends that national regulatory agencies involved in health-related research governance should ‘harmonise and streamline both research ethics committee governance and transparency requirements in different regulatory regimes’.
“Our analysis of three jurisdictions reveals that it is not sufficient to have good policies on paper, but that there also has to be a strong governmental commitment to implement the measures,” says Lemmens. We point out, for example, how Brazil has a good research ethics governance system, but that Brazilian experts raise concern about the lack of proper resources.”
The recent announcement by the EMA to reduce its transparency measures because of staff and budget shortages reveals the same budgetary challenge. If they take public health seriously, governments will have to provide the appropriate financial support for transparency measures.
“We cannot make one broad recommendation for all countries because jurisdictional issues, for example in federal states, may complicate matters,” explains Lemmens, “but one important step could be implemented easily – all drug regulatory agencies in the Americas should introduce a presumption in their regulatory policy that pharmaceutical data produced to provide evidence of safety and efficacy is not commercially confidential information. They should make this data publicly available, unless there are specific compelling reasons why certain aspects should remain confidential.”
It will be important in all jurisdictions to make sure that other legal regimes, for example in relation to intellectual property, do not contradict this approach.
A new regulatory model
“It seems clear to me that independent governmental agencies (or those under governmental control) should be running the clinical trials and produce the evidence to be used in the drug approval process,” observes Lemmens, “but in the absence of such a radical reform, transparency of data is essential.”
However, the pharmaceutical industry continues to put pressure on regulatory agencies to restrict data access and there is concern that this may result in a lack of enforcement of transparency requirements.
While recent court cases in Canada and Europe, and some EMA policies, are promising in terms of transparency, it will be a long haul before real and lasting change is possible on a global scale.
“EMA’s recent announcement that it is scaling back its transparency measures is in this context disappointing,” he concludes, “These restrictions are a serious step back, but it reflects the ongoing political struggle over transparency, and further demands will not go away.”
