Clinical trial transparency: new publications and tools (summer 2021)

What happened in the world of clinical trial transparency while you were on vacation? This blog highlights key publications and some useful new resources from summer 2021.

NEW PUBLICATIONS

Covid vaccine trials: mapping transparency gaps

Writing in BMJ Evidence-Based Medicine, a group of experts presented a table breaking down availability of key documents and data for eight Covid vaccines of global significance. They concluded that “the overall picture is one of varied transparency,” with state-developed vaccines from Cuba, Russia, India and China having the largest transparency gaps. (In May, a report by Transparency International had reached similar conclusions.) The study sets high benchmarks for transparency that could potentially be applied to trials of other vaccines, drugs and medical devices as well.

Which clinical trial registry performs best?

Worldwide, 18 separate trial registries feed data into the WHO’s global ICTRP trial registry. But as everyone who has spent time surfing the various registries knows, not all registries are made equal. Rating all 18 registries against the WHO’s own standards, the authors of a new study found large differences in performance, and set out features that an ideal registry should possess. They concluded that “it is clear that some of the registries have much work to do, although even a few improvements would significantly improve them.”

Most clinical trials in Sub-Saharan Africa violate registration requirements

Over 4,500 clinical trials were conducted in the SSA region over the past decade, a study analysing data from three trial registries has found. Most trials were concentrated on only a handful of the region’s 46 countries. Over half of trials for which data was available were only registered retrospectively, a clear breach of global ethics requirements. Of completed trials, only 17% had their results linked in ClinicalTrials.gov; ISRCTN, which sends reminder emails to investigators, performed far better with 58%. (The authors did not search the academic literature.) The paper also analyses trials by key characteristics, including trial phase, design and intervention type.

German universities fail to consistently link clinical trial records

German universities often fail to ensure that their investigators link data between trial registries and publications in academic journals, a study published by a team of QUEST researchers has found. 75% of trials fail to meet CONSORT and ICMJE publication guidelines, and less than half of registry entries contain a link to results publications. The team developed automated approaches to analyse a cohort of over 1,800 registration-publication pairs, covering all German universities and spanning two trial registries. The preprint provides practical advice on how to improve registration-publication links in order to make medical information easier to find. Registry managers and journal editors, please take note.

JAMA features delayed publication of ‘negative’ trial result

JAMA published the results of a long-completed sickle cell disease trial with a ‘negative’ outcome, explaining that the company holding the “rights to the trial” was reportedly “not interested in publishing the results.” Thankfully, the original investigators were able to piece together the data and report the trial’s outcomes on their own initiative – but only after a delay of several years. “The investigators deserve recognition for their determination to publish the results of this study,” JAMA concluded.

Over 8,000 trials now listed on clinical trial data sharing platforms

A new study evaluated six prominent voluntary data sharing platforms for clinical trials, which between them list over 8,000 trials, and assessed the types of data available, requests for data made, and requests for data granted. It found that “The vast majority of data requests approved by data sharing platforms were for secondary analysis and the development or validation of methods.” Earlier this year, the WHO and major drug regulators had called on industry to voluntarily grant access to Clinical Study Reports (CSRs) through such platforms. Only two medicines regulators worldwide currently provide access to CSRs, and no regulator grants access to Individual Patient Data.

An open science pathway for drug marketing authorization

A prize-winning essay proposes to adapt the concept of ‘registered reports’ to regulatory drug approval. The general idea for regulatory approval criteria and detailed trial protocols to undergo separate transparent peer review processes before any trials involving patients are given the green light. The authors concede that the pharma industry is unlikely to welcome this idea.

New book on transparency and pharma power

A new edited volume featuring contributions by several leading experts in the field takes a deep, deep dive into the politics of clinical trial transparency. Read the review here.

Improving reporting practices: what works and what does not?

The “Scoping review on interventions to improve adherence to reporting guidelines in health research” was already published in 2019, but it’s a great resource if you want to improve things in practice. Just ICYMI.

NEW RESOURCES FOR TRIAL SPONSORS

• Useful case study. A new paper describes in detail how Johns Hopkins University School of Medicine developed a program to support its research teams with clinical trial registration and reporting requirements, boosting institutional compliance rates from 56% to 98% in the space of five years.

• Essential: new CTIS handbook. EMA has published a new handbook to guide trial sponsors in using Europe’s new CTIS trial registry, which will launch at the end of January 2022. For the first year of CTIS’ operation, sponsors can choose whether to register new trials on the old EudraCT registry or on the new CTIS, but from January 2023 onwards, sponsors must register all new trials on the new platform. EMA is continually adding more training materials to its website to help sponsors prepare for the change.

• More help coming for trial sponsors. This autumn, TranspariMED will expand its collection of tools for trial sponsors to include the above resources, plus new slide shows and videos. In addition, TranspariMED will announce forthcoming webinars and training sessions for universities and hospitals across Europe. Please keep checking the TranspariMED blog for forthcoming events.