The scope and complexity of requirements for global clinical trial disclosures and data sharing have increased substantially over the last 20 years. Most leading countries have specific regulations pertaining to trial conduct, and many have set up patient registries for collecting and analyzing data on patient outcomes. More recently, authorities have initiated inspections relating to disclosure to ensure compliance with regulations, and transparency advocates continue to ...

The US Food and Drug Administration (FDA) needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. Not doing so will continue to undermine the public’s trust in the agency, said a panel of former FDA commissioners and others at the Food and Drug Law Institute (FDLI) annual conference on Tuesday.   Califf ad...

Over the last decade, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada (HC) have gotten better at disclosing previously confidential clinical data, a study published in The Journal of Law, Medicine & Ethics has found.     However, each agency discloses this data in a variety of different ways, according to Alexander C. Egilman, with the Center for Outcomes Research and Evaluation at Yale–New Haven Hospital in New Haven, CT,...

The Dietary Supplement Health and Education Act struck a balance between protecting public safety and promoting consumer access to dietary supplements, but it did not address the Food and Drug Administration’s inability to “see” into the marketplace. This article discusses how a mandatory product listing can benefit the industry through increased transparency and accountability. It outlines criticisms from industry skeptics and provides considerations for legislation of th...

The World Health Organization (WHO) on Tuesday adopted a resolution to urge countries to publicly share the net prices of health products and the costs of clinical trials. The resolution, adopted after three weeks of negotiations, also calls on United Nations member countries to better facilitate the public reporting of patent status information and marketing approval status of health products, as well as to improve national capacities for open and collaborative researc...

Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on and the agency and device regulatory system. The plan also identifies additional opportunities for TGA to increase transparency, with stakeholder consultations on proposed changes to regulatory requirements and forthcoming guidance materials. Until early 2020, potential c...

The UK government issued a policy paper to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report offered in 2018. “Research findings must be communicated in ways that are timely, meaningful and relevant to evidence users,” Parliamentary Under-Secretary of State for Health Baroness Blackwood said, welcoming the chance to address the October 2018 report . “Only with a system which values transpar...

Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...

As part of a push to be more transparent about its decision making and enhance access to data for researchers, the US Food and Drug Administration (FDA) on Tuesday announced it will launch a pilot project to publicly release portions of clinical trial-related summaries from pivotal trials after a drug is approved. The pilot will select up to nine recently-approved new drug applications (NDAs)  whose sponsors volunteer to participate to release the partially redacted ...

Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements. Back in 2007, section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) established a requirement that "applicable clinical trials" must be registered and information must be submitted to Clinicaltrials.gov. ...

Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ. Researchers from New York University, Yale, Stanford and the International AIDS Vaccine Initiative reviewed data from more than 45 sources on 505 trials for 14 drugs approved by the US Food and Drug Administration (FDA) in 2014. "On the drug level, about half of FDA-approved drugs have publicly ...

In the early days of the priority review voucher (PRV) programs, back in 2014 and 2015, companies publicly disclosed who they sold their PRVs to, how much they cost and which products they were eventually used to speed the review of. But now that 17 PRVs have been issued by the US Food and Drug Administration (FDA), news of PRV sales has slowed to a trickle of SEC filings and the rare press release. Three times already in 2017, with GlaxoSmithKline and Teva’s...