A new policy paper warns that progress on the Sustainable Development Goals is threatened by the current lack of transparency in clinical trials, hindering the attainment of seven out of 13 health targets.
Published by the U4 Anti-Corruption Resource Center in Norway, it argues that international donor agencies should actively tackle the problem.
Recommended actions for donors:
Require grantee institutions, including universities, to adopt WHO best practices as a precondition for receiving future grants
Fund systematic efforts to retrospectively publish the results of clinical trials concluded in the past that have failed to report their results
Provide technical assistance to strengthen clinical trial governance in the Global South
Support research and advocacy on clinical trial transparency
The policy paper notes that around half of clinical trial outcomes remain unreported, contributing to $170 billion in medical research funding that goes to waste every year.
Three important Sustainable Development Goal targets are most strongly affected:
Target 3 (ending the epidemics of AIDS, tuberculosis, malaria by 2030)
Target 9 (access to safe and effective medicines and vaccines)
Target 11 (development of vaccines and medicines)
“Unreported and misreported clinical trial outcomes result in the misallocation of public health funds, reduced pandemic preparedness, and a slowdown in the development of new vaccines, treatments and cures. Promoting clinical trial transparency is a highly cost-effective way to support the achievement of Social Development Goal 3, access to effective and affordable medicines, and wider global health objectives... Compared to the high cost of conducting clinical trials, the cost of making trial outcomes publicly available is minimal.”
“The level of transparency of clinical trials will directly affect the extent to which seven out of the 13 health targets set out under Social Development Goal 3 will be achieved. Most obviously, the non-reporting of trials undermines Target 3 (ending the epidemics of AIDS, tuberculosis, malaria by 2030) and Target 11 (supporting the research and development of vaccines and medicines). In addition, as long as the evidence base of medicine remains severely distorted, Target 9 (access to safe and effective medicines and vaccines) will be difficult to achieve because public health agencies are currently unable to reliably evaluate the safety and effectiveness of drugs. This, combined with the overall slower pace of scientific progress, will also hinder the achievement of Targets 1, 2, 4, and 5.”
"The experiences of recent transparency initiatives strongly suggest that making institutional performance visible in and of itself can incentivise significant improvements at that level... [T]here is also considerable scope for research and advocacy focused on specific disease areas, especially Neglected Tropical Diseases, and for efforts that compare transparency performance at the national level."
“[D]onors could commission a review of all completed clinical trials of Neglected Tropical Diseases that have not posted summary results onto trial registries to identify those that have also failed to publish their results in the academic literature. Donors could then fund research institutions or medical writing companies to rescue these ‘lost’ trials by retrospectively posting their summary results onto trial registries and publishing their outcomes in medical journals. While the data generated by some of these trials will already have been irretrievably lost, experience shows that rescuing ‘lost’ trials is practically feasible.”
The policy paper was published in September 2018 by the U4 Anti-Corruption Resource Center, in Norway, which shares research and evidence to help international development actors get sustainable results. U4 is housed at the Chr. Michelsen Institute, an international development think tank. The study was authored by Till Bruckner, the founder of TranspariMED, and edited by Monica Kirya of U4.