A coalition of 28 groups today call on European decision-makers to adopt key clinical trial transparency provisions in their future plans and operations.
In an open letter, they write that:
“[B]illions of public funds have been spent on COVID-19 R&D and clinical trials as well as on expensive COVID-19 treatments . Transparency of clinical trial data prevents duplication and allows for crucial insights into treatment effectiveness, and therefore enables more efficient expenditure of such funds.”
“To avoid unnecessary duplications and to accelerate the development of new therapies and vaccines during a public health emergency, it is crucial that information on clinical trials is made available in a timely, user-friendly, and complete manner as proposed by the European Parliament (amendment 107 of the EP text).”
“The proposed amendment ensures that study protocols, summary results, clinical data submitted in support of a marketing application, and the eventual approval decision, are published in a timely manner and with more details than during normal times. We support this call and believe this should also be part of a wider effort outside of public health emergencies.”
In addition, the 28 groups call for monitoring data from the incoming new European drug trial registry CTIS to be made publicly available:
“Looking ahead, we call … [to] ensure that any Clinical Trials Information System (CTIS) monitoring data capturing stakeholders’ performance is made publicly available in full and on an ongoing basis through the public CTIS interface. This will facilitate public accountability and translate into greater compliance.”
The extent of missing medical data on the current EudraCT trial registry only became visible when a team from Oxford University built an online tracking tool showing that some of the largest companies and universities were failing to meet their obligation to make clinical trial results public. Since the tool was launched, most major institutions have considerably improved their trial reporting.
More recently, monitoring data generated by members of the same Oxford team showed that many national medicines regulators too were failing to upload key data onto the registry. Regulators immediately pledged to address the issue.
Based on these experiences, the letter argues that public monitoring data can “significantly and at zero cost increase the quality and quantity of trial data available to patients, medical professionals and public health agencies, both during public health emergencies and beyond.”
Till Bruckner, founder of TranspariMED, said:
“TranspariMED fully supports this call. European patients have a right to access key data on clinical trials, and to know whether pharma companies, research institutions and national regulators are following the rules."
"Making such data public has a clear public benefit: it improves our understanding of the benefits and harms of new drugs and vaccines. Any monitoring data generated by the new European trial registry should be made publicly available.”
Today’s letter was initiated and coordinated by the European Alliance for Responsible R&D and Affordable Medicines.
It has been signed by 28 national and regional groups, including the Drugs for Neglected Diseases initiative, the European Public Health Alliance, France Assos Santé, the International Society of Drug Bulletins, Médecins du Monde, the Médecins Sans Frontières Access Campaign, and Transparency International Global Health.
See here for more information on the new CTIS trial registry, which will launch on 31 January 2022.