Getting all clinical trial results published – A funder’s perspective
In an effort to combat research waste and speed up the discovery of new drugs, medical research funders recently pledged to cut off funding to grantees who fail to meet basic transparency standards. To date, over a dozen funders, including heavy hitters like the Bill & Melinda Gates Foundation and the Wellcome Trust, have signed a joint statement demanding that their grantees publicly disclose the results of all clinical trials within 12 months. (Read this article to learn more.)
The Medicines for Malaria Venture (MMV) is among the signatories of the WHO-brokered statement. In this interview, its CEO, Dr David Reddy, explains why and how his organization ensures that the results of MMV’s clinical research do not go to waste.
Why is this initiative important to you?
From its very foundation, Medicines for Malaria Venture has ensured that all our clinical trials are registered and results shared when available on Clinicaltrials.gov, a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
We believe that public disclosure of intent to trial a drug in humans (volunteers and patients) as well as sharing results, positive or negative, is scientifically and ethically intrinsic to the research process; and non-negotiable. However, the publication of negative study results is not always easy to achieve, often due to the reluctance on the part of journals to publish such results. At MMV, however, we strongly encourage open access to data. MMV’s partners contractually agree to publish trial results and we oblige researchers to publish the results of studies on the MMV Malaria Box and Pathogen Box compounds that are available free of charge.
So signing up to this joint statement was an affirmation of long-standing MMV practice. We fully support the view that [citing from the statement] “timely results disclosure reduces waste in research, increases value and efficiency in use of funds and reduces reporting bias, which should lead to better decision-making in health.”
What does this mean for your grantees?
Before we commence any clinical trial, we ensure that our trial partners and CROs guarantee that the clinical trial sites planned for use are either already functioning at Good Clinical Practice levels or will be brought up to these high international standards before use. This includes training of all staff at the site.
All trials records are kept meticulously following ICH-GCP guidelines. This is essential for the quality of the trial. Our grantees also agree to disclosure of all trial results.
What should your grantees do to ensure compliance with this?
In all MMV’s clinical trial agreements, whether MMV is the sponsor, or just provides clinical and scientific expertise, together with funding, and in all clinical trial funding agreements, where MMV’s role is limited to funding, partners commit to publishing the results of the clinical trials.
Do you expect other funders to also sign up to this?
All our funders know our modus operandi when it comes to the ethics and conduct of clinical trials, and a number of these have already signed this joint statement on public disclosures of results from clinical trials.
Note: A recent study by TranspariMED shows that leading UK universities routinely fail to post the summary results of their trials onto clinical trial registries. Such lack of transparency directly harms patients, taxpayers and investors, and slows down the development of new vaccines, treatments and cures.