Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
Reaching for the ‘White Spots’ in Rare Disease
EU proposal focuses on a subset of underserved rare diseases—exploring the gaps in those conditions for which there is no approved treatment option.
European Data-Sharing Rules Could Make a Reality of RWD and RWE
Legislative efforts seek a common framework in accessing and applying real-world data and evidence in clinical studies.
Speeding Up European Clinical Trials in Response to Emergencies
With lessons from COVID now established, concrete ideas on improving drug development strategy for future health threats are beginning to take shape.
Pharma Trade Group Giants Update Principles on Clinical Data Sharing
A look at the complexities—and potentially conflicting goals—in industry’s commitment to trial-result transparency.
Harnessing AI in European Clinical Trials: Regulation in Progress
EMA seeks to define the scientific principles relevant to using AI or machine learning in support of drug development.
Playing Catch-Up with Europe’s Decline in Attracting Clinical Trials
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.
Quiet Diplomacy Moving Clinical Trials Regulation Forward at the Global Level
ICH unveils new draft guidance on good clinical practice, with the aim of aligning trial conduct with advancing life sciences innovation and technology.
Defining the Boundaries in Clinical Trial Data Sharing
The EU has launched a public consultation on balancing the transparency of study information with confidentiality concerns.
European Legislative Proposals Presage New Rules for Clinical Trials
EU’s sweeping push for major pharma reforms to impact the daily practice of clinical trials community.
Transformations Past and Future for the European Medicines Agency
Dissecting the EMA’s new annual report on milestones reached in clinical research and public health.
Single-Arm Trials Start to Strong-Arm Their Way into European Regulation
EMA opens formal consultation on the pros and cons of basing pivotal evidence for new drug submissions on SAT data.
The End of the Beginning for Digital Endpoints?
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.
Agenda Aims to Recharge UK-Based Clinical Trial Innovation
Grading the government’s formal response to reform efforts hopeful of boosting UK’s sagging global standing in drug development.
Europe Enhances Regulatory Support for Tackling Unmet Medical Need
EMA operated-Priority Medicines scheme receives update which will expedite response to applicants.
Filling the Gaps in European Clinical Trial Reporting
The hopes for increased transparency in clinical research beginning to take shape as sponsors get up to speed with new reporting obligations.
EFPIA: Trials Hampered by New Rules on In Vitro Diagnostics
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.
Is Europe Inching Toward a Common Approach to Personalized Medicine?
Latest project centers on partnership to align PM innovation with sustainable healthcare.
Hints on Looming Changes to European Clinical Trial Rules
Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.
UK Gov’t Offers a ‘Review’ Amid Clamor Over Declining Clinical Research
The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.
EU Seeking Wider Views in Its Push to Promote Clinical Trials
EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.
Eight Years Later, Europe’s ‘New’ Clinical Trial Rules Finally Come into Force
Formal compliance with EU’s Clinical Trials Regulation takes effect, designed to speed up the application and approval of studies.
Get it Right Next Time? EU Legislation Under Critical Review
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.
A New Year, a New Clinical Trials Committee—with Global Reach
WHO in midst of forming group focused on developing guidance on best practices in clinical trials.
Countdown to Mandatory European Clinical Trials System
With compliance deadline at end of month, concerns over readiness remain.
Decentralized Guidance Is the Best That Europe Can Do for Decentralized Clinical Trials
Despite agreement on recommendations between European regulators, DCT unclarity remains.
Europe’s Debate on AMR Becomes Another Proxy War Over Money
Debates caught between focusing on existing antibiotics and developing new agents.
Real-World Evidence Makes Further Headway in Europe’s Healthcare Planning
Inaugural group of members added to EMA’s new data network focused on RWE.
Bringing Further Certainty into Platform Trials in Europe
New guidance to drill down on more specifics in hopes of harnessing the growth of these types of studies.
‘Dogma’ About Innovation vs. Access Impeding EU Fixes for Rare Diseases
Rare disease stakeholders speak out ahead of anticipated EU changes.
Pushing and Dragging the New European Clinical Trials Rules into Shape
Smoothing path to CTIS compliance will be key in overall effort to transform clinical trials in Europe.
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