Peter O'Donnell, ACT's Brussels Correspondent

EU proposal focuses on a subset of underserved rare diseases—exploring the gaps in those conditions for which there is no approved treatment option.

Legislative efforts seek a common framework in accessing and applying real-world data and evidence in clinical studies.

With lessons from COVID now established, concrete ideas on improving drug development strategy for future health threats are beginning to take shape.

A look at the complexities—and potentially conflicting goals—in industry’s commitment to trial-result transparency.

EMA seeks to define the scientific principles relevant to using AI or machine learning in support of drug development.

The Accelerating Clinical Trials in the EU initiative formally kicks off, with many stakeholders weighing in on what should be the top priorities and goals.

ICH unveils new draft guidance on good clinical practice, with the aim of aligning trial conduct with advancing life sciences innovation and technology.

The EU has launched a public consultation on balancing the transparency of study information with confidentiality concerns.

EU’s sweeping push for major pharma reforms to impact the daily practice of clinical trials community.

Dissecting the EMA’s new annual report on milestones reached in clinical research and public health.

EMA opens formal consultation on the pros and cons of basing pivotal evidence for new drug submissions on SAT data.

New European report digs deeper into the potential of digital health-driven outcome measures—perhaps a hopeful step in the journey from theory to practice.

Grading the government’s formal response to reform efforts hopeful of boosting UK’s sagging global standing in drug development.

EMA operated-Priority Medicines scheme receives update which will expedite response to applicants.

The hopes for increased transparency in clinical research beginning to take shape as sponsors get up to speed with new reporting obligations.

Europe trade and lobby group says implementation issues related to the legislation could impact 420 trials—and 42,200 patients—over the next three years.

Latest project centers on partnership to align PM innovation with sustainable healthcare.

Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.

The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.

EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.

Formal compliance with EU’s Clinical Trials Regulation takes effect, designed to speed up the application and approval of studies.

The issues engulfing compliance with the Clinical Trials Regulation signal that even the best intentions with these types of laws may not be enough to avert unintended consequences.

WHO in midst of forming group focused on developing guidance on best practices in clinical trials.

With compliance deadline at end of month, concerns over readiness remain.

Despite agreement on recommendations between European regulators, DCT unclarity remains.

Debates caught between focusing on existing antibiotics and developing new agents.

Inaugural group of members added to EMA’s new data network focused on RWE.

New guidance to drill down on more specifics in hopes of harnessing the growth of these types of studies.

Rare disease stakeholders speak out ahead of anticipated EU changes.

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