Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
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.