Improved Access to Patient Data Holds Key to Future Therapies
Better access to patient information would enable researchers to answer new questions with existing data, validate findings, and combine the power from individual studies.
Difficulties in obtaining patient data on the effects of heart failure drugs from previously published clinical trials are making it impossible to assess the outcomes of these drugs on patients, according to an article published yesterday in the BMJ.
These problems accessing data from clinical trials means that only part of the evidence base is available, and this may lead to erroneous clinical decisions, writes lead author Robert Fleetcroft, MD, clinical lecturer in general practice at the Norwich Medical School at the University of East Anglia, UK.
The research team carried out a systematic review of the effectiveness of heart failure drugs for patients with minor symptoms. They found 30 studies that looked at the effect of these drugs -- beta blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers -- on heart failure. However, none of the studies included enough data to assess outcomes for patients with the varying degrees of minor symptoms required.
Fleetcroft and collegues said they were surprised at the difficulties they faced, even though most studies were published between the 1990s and 2010. Four had been published since 2010.
"We need central national repositories for trial data based in the country of the trial sponsor," they noted, adding that mechanisms of data sharing must be developed and coordinated actions from funders, journals, ethics, committees, and national guideline developing bodies are vital.
Better access to patient information would enable researchers to answer new questions with existing data, validate findings, and combine the power from individual studies, and it may also prevent selective reporting and research fraud, according to Fleetcroft et al.
Furthermore, bodies involved in national guidelines have a role to play, and it is unacceptable for these groups to make decisions about new drugs based on clinical effectiveness data that are not in the public domain, they stated. Such transparency is essential to bolster trust in the process of evaluation of new treatments.
Finally, they recommend that research ethics and funding committees should make future access to data a mandatory requirement, and funders should cover the costs of archiving data and journals should require evidence of archived data.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
