Debate Grows Over EMA's Decision on Data Transparency
If the EMA also stops releasing data on old trials, everybody will be kept even more in the dark, according to an editorial posted by bmj.com on May 28.
Despite some setbacks, great strides have been made in the past three years towards clinical trial transparency, but a great deal of information still remains hidden from policymakers, clinicians, and patients, and if the European Medicines Agency (EMA) also stops releasing data on old trials, everybody will be kept even more in the dark, according to an editorial posted by bmj.com on May 28.
EMA’s management board is due to meet on June 12 to finalize the policy, and some observers have expressed concern over recent weeks that the Agency has decided to backtrack on its decision for public access to clinical trial data.
On the plus side, even with a “watered down policy”, EMA will be making visible vast quantities of new regulatory information about randomized controlled trials of drugs and other types of interventional or observational clinical research methodologies, noted the BMJ’s Head of Research, Trish Groves, and European Research Editor, Wim Weber.
However, if the new European policies for proactive disclosure close the EMA window that has been allowing ad hoc retroactive access to older clinical study reports and data, then decision-makers will be even less well informed when making decisions about current treatments, they noted.
“That is why AllTrials continues to campaign for all clinical trials to be registered and all results reported. The research, advocacy, haggling, and politics must go on,” the authors wrote.
Read the full release here.
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
