Peter O'Donnell, ACT's Brussels Correspondent

Smoothing path to CTIS compliance will be key in overall effort to transform clinical trials in Europe.

New EU clinical trial regulation places heavy importance on patient-submitted documents.

The hope is to build a formal framework for using digital health technology in clinical trials in Europe and beyond.

Proposed US merger could threaten innovation in cancer diagnosis, Commission officials assert.

Commission pushes for a “more unified” approach to drug development following a period of fragmented coordination during the pandemic.

Orientation pursuits hit high gear as formal rule compliance inches closer.

Newly unveiled workplan focuses on harnessing the impact of big data on drug development—and ultimately public health.

The scope of RWE’s use in developing and approving new medicines is pitting key healthcare stakeholders against each other.

Payers join the push for better demonstrations of efficacy of new medicines.

Largely discarded topic beginning to grab hold in policy discussions.

Battle lines being drawn among key healthcare constituencies, as discussions around new approaches to drug evaluation and decision-making heat up.

The reporting of one man in Europe is changing accountability with compliance.

But despite showing a tightening of focus on clinical trials and evidence, the annual report doesn’t paint the full picture.

EMA’s new release factors in scientific advances, clarity on trial designs.

Just-released analysis by Prescrire contends that the agency “is backtracking on commitments to clinical data transparency.”

EMA continues to familiarize industry with new clinical trial legislation.

‘Independence’ the priority for the longstanding European Organization for Research and Treatment of Cancer, Winette van der Graaf tells Applied Clinical Trials in interview.

Stress the importance of clinical studies today—and urge for formal approach to managing the pandemic and addressing specific public health needs more sustainably.

ICH draft guideline advocating a more comprehensive framework in optimizing pediatric drug development reaches next step.

What to make of UK’s draft resolution set for review on the international stage.

Agency report reveals solid results from the first five years of its PRIME scheme, but also calls for improvements in focus.

Organization says either reform European drug development rules—or lose out on global competition.

EU’s new health innovation center unveils several projects focused on advancing R&D, medical countermeasures, and related technologies.

2022 EU initiative provides hope for improvement of trial regulations.

EMA officially launches coordination center to systemize data analysis and real-world interrogation.

New EU guidance now officially in effect.

New guidance looks to streamline safety assessment process.

The European Union is reaching out for independent experts to help advise on its health development programs in needy areas of regulatory science.

The Innovative Health Initiative is expected to launch its first call for proposals early this year.

Object lessons in implementing next-generation sequencing in cancer diagnosis in Europe.