Major Research Funders, Institutions Pledge Transparency In Clinical Trials

More transparency on clinical trials is expected after major research funders, research institutions, and international health groups agreed that the research they fund or support will publicly release results of clinical trials.

According to a World Health Organization press release today, about 50 percent of clinical trials go unreported, “often because the results are negative.” This situation leads to an “incomplete and potentially misleading picture of the risks and benefits of vaccines, drugs, and medical devices, and can lead to use of suboptimal or even harmful products.”

In a joint statement signed by major research funders such as the Bill and Melinda Gates Foundation pledged to “develop and implement a policy with mandated timeframes for prospective registration and public disclosure of the results of clinical trials that we fund, co-fund, sponsor or support.”

The signatories also include non-governmental organisations, such as Médecins Sans Frontières (MSF, Doctors Without Borders), and research centres, such as Institut Pasteur.

List of 12 signatories:

• Indian Council of Medical Research
• Research Council of Norway
• UK Medical Research Council
• Médecins Sans Frontières
• Epicentre
• CEPI
• PATH
• Institut Pasteur
• Drugs for Neglected Diseases Initiative (DNDi)
• Bill and Melinda Gates Foundation
• Wellcome Trust

According to the statement, the current bias in the reporting of the results of clinical trials is expected to be reduced and will allow for more informed decisions in areas such as marketing authorisation, public health policy recommendation on use, and financing decisions by public procurement bodies and multilateral agencies.

The statement said that modest costs will be associated with public disclosure of clinical trial results. “The costs of disseminating the results of research are a minor component of the overall costs of conducting such research, and results reporting is an essential component of the research enterprise. The resource allocation, public health and scientific benefits – together with the need to meet ethical imperatives – far outweigh the costs,” it said.

According to the WHO press release, the agreement reached today follows a 2015 WHO position and ethical principles on public disclosure of results from clinical trials.