Regulatory agencies are doubling down on compliance – and withholding funds – as the clinical research industry enters an era of accountability and transparency, say NIH officials.
In an open letter to the US Food and Drug Administration (FDA) AllTrials implores the agency to fine clinical trial sponsors that don’t publish trial results on ClinicalTrials.gov – as no fines have been issued to date.
The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies filed to suspend the release in 2016.
The US Food and Drug Administration (FDA) is launching a new pilot program this month aimed at increasing clinical trial transparency – though many opportunities remain to improve the scope, clarity, and usability of data, says TrialScope CSO.
The Patient Engagement Collaborative will include 16 patients, caregivers, and patient group representatives who will provide “a collective, all-encompassing patient voice,” says CTTI project manager.
The Good Pharma Scorecard aims to quantify what makes a “good” pharmaceutical company – as 91% of Americans think companies put money before people, says Bioethics International founder.
A proposed regulation in New Jersey demonstrates a lack of understanding regarding the clinical trial process and has clear collateral damage to research conduct in the state, ACRO testifies.
A year after implementing its policy on the publication of clinical data, reports on 50 medicines have been published and more than 80,000 documents downloaded – outcomes achieved through industry collaboration, says EMA.
Clinical trial sponsors plan to release more trial results summaries over the next year as part of patient engagement efforts, according to a recent survey.
ATLAS Global Compliance is a Software-as-a-Service (SaaS) solution that helps clinical trial sponsors to “disclose locally and comply globally,” says TrialScope CEO.
The EMA recently appealed two interim orders made by the President of the General Court of the European Union (EU) to suspend the release of clinical trial documents.
The Obama administration recently finalized new rules that require researchers to make trial data public as the industry grapples with evolving data standards and looks to uphold its pledge to clinical trial participants.
