Columns | View from Brussels

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

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

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.

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.

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.

The Sudan Ebola virus outbreak in Uganda spotlights this dilemma in responding to public health crises.

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.

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.

Leaked draft gives glimpse into potential new research proposals as part of the EU’s Horizon program.

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.

Pressure grows for advances in drug development.

Increased public engagement leads recent change in EMA profile.

The European Union has at last agreed on how HTA should be coordinated among Europe's multiple HTA agencies, bringing to an end a three-year process of discussion.

European authorities have announced a proposal for a framework to support not-for-profit organizations and academia in repurposing authorized medicines.

A new straw has appeared in the wind that may mean something more substantial will emerge than the customary rhetoric...

A proposal to address inequities in access to critical COVID vaccine commodities is still deadlocked a year after it was submitted.

The EU is offering some $13 million for advice on bringing to the market medicines that combat antimicrobial resistance—and there's only one month to claim the grant...and then nine to do the work.

Pandemic sparks new advancements in clinical trial development.

Slovenia brings EU health officials together for increased emphasis on repurposing.

Promises of "more equitable access for those with severe diseases," "decision-making flexibility where it counts," and more in a bid to win post-Brexit business.

European Commission proposes new bio-defense preparedness plan.

A draft report from parliament's cancer committee highlights the benefits that precision and personalized medicine offer.

Not just COVID is changing the landscape of pharmaceutical policy in Europe.

Allegedly more than 4,000 clinical trials of medicines are missing results on the European trial registry, in violation of transparency rules.

A new report from the EMA and EUnetHTA shows a shift towards a more efficient form of collaboration.

Conclusions from the Global Health Summit provide plenty of support for research, innovation, investment, and incentivization.

A major international collaboration within ICH features big hitters from across the world's major regulatory authorities and drug firms

Pressure mounts in Brussels as calls for new ways to debate pharma policies come from all directions.

Parliament's health committee is answering calls for a firmer grip on policies affecting the well-being of its 450 million citizens.

European Group on Ethics in Science and New Technologies issues cautious opinion on the use of gene editing amidst COVID vaccination controversy.

Rate of adoption in Europe for advanced diagnostics is falling behind that of others' globally.

A new partnership, to be known as EP PerMed, aims to bring public and private sector interests together.

Upcoming study reveals challenges faced by Europe over the pricing of pharmaceuticals.

The latest initiative against COVID, the European Health Emergency Preparedness and Response Authority, is taking shape with intentions of revealing the vulnerabilities in global supply chains and more.

After three years, member states of the EU have yet to make any real progress on legislation that would coordinate their clinical assessments more closely.

Cancer still a primary focus of EMA in light of COVID and vaccine development.

The $4 billion program will embrace the disease's entire pathway, from prevention to quality of life of patients and survivors.

After issuing a conditional marketing authorization issued just a week ago for the Moderna vaccine and receiving applications for more, the EU has reserved vaccines sufficient to treat more than 80% of the European population.

As the EMA gives Moderna's COVID vaccine the thumbs up, the European Commission has quickly followed up with its own approval.

Despite all the hopes and wishes for a better new year, the start to 2021 in Europe is proving to be grimly similar to the end of 2020.

The EU has its first COVID vaccine authorized.

Europe's leaders find themselves in a strange situation as their defense of their systematic approach to drug registration via the EMA has come under fire not only externally, but from some of their own politicians as well.

As the UK's Medicines and Healthcare products Regulatory Agency gave approval to the Pfizer/BioNTech COVID vaccine—questions about how they had been so quick, or why the EU had been so slow, have risen.

European health ministers are meeting later this week to review what has been, and what can be, done to strengthen future defenses to counter the COVID pandemic.

While the UK's departure from the EU is imminent, NICE will continue to influence thinking around the continent.

Dilemmas are multiple and stakes are high as the framework for thinking about medicines development frequently fluctuates because of the COVID-19 pandemic, making it harder to foresee all implications for the future.

As the EU moves towards the next stage in its review of intellectual property incentives for pharmaceuticals, some unusually direct exchanges occurred between those who advocate patents—and those who oppose them.

Declarations made by Beate Wieseler don't align with those of many regulators and HTA bodies in Europe and will prove tough to transform.

Europe's research ministers are will meet to attempt to reach agreement on European Union research plans for the next seven years, including a cluster devoted to a broad range of health goals that range from general objectives to subjects of more specific interest to the community.

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available.

EMA has launched a "communication perception survey" looking for honest views from among the widest audience on how well it is doing.

Amid the COVID-19 pandemic, the EU is allowing trials to start before the requirements of directives dating back as far as 2001 have been met.

Teenagers with cancer could benefit from a proposed initiative to lower the age barrier for participation in trials for new oncology drugs.

Social media uses transparency to highlight alleged gaps in clinical trial transparency and offers a more powerful approach to health campaigners.

Peter O’Donnell explores where the EU stands today in R&D pursuits for new antibacterial therapies.

The regulatory path for virtual studies is nebulous and potentially difficult to navigate-finding a way forward requires a thorough understanding of the terrain and how to apply existing legal frameworks.

Higher screen failure and patient dropout rates are raising the imperative to pilot and implement new study conduct models in trial recruitment and retention.

A shift in emphasis in healthcare strategy could reduce attention and funding to therapy and impose tougher controls over research projects, or possible mean a boost for innovative healthcare. A look at where these trends may go.

The two-year inquiry into possible maladministration at the EMA has intensified.

The consequences UK faces after being pulled out of the EU without any healthcare and research deal may affect all of Europe.

The World Health Organization tries to find a balance with its Road Map for Access on how to best approach research and pricing in Europe.

As elections near, politicians in Europe make promises to prioritize the fight against cancer.

A statement from Europe’s drug industry and Europe’s medical societies calls for a “bold vision” to ensure proper funding and coordination for translational research.

Recent initiatives demonstrate that European health authorities are serious about combatting the proliferation of threats and opportunities from big data.

Survey uncovers deeper learnings of patient perceptions of clinical research and the motivations to participate.

European Union faces a critical view on its pediatric drug development situation, highlighting a lack of treatment, infrastructure, reimbursement, and regulatory agreement.

All of Europe, from MEPs to WHO, aims to develop a comprehensive health policy, with a current priority on nutrition and physical activity.

Blockchain is moving toward definitive uses in clinical trials to enhance clinical supply capabilities, with the potential of enabling data ownership for patients.

A new report on EU's digital health strategy also calls for closer coordination of national HTA arrangements-but both policy initiatives couldn't be more different.

Peter O’Donnell gauges the impact of FDA guidance on igniting the adaptive pathways debate in Europe.

A continued struggle for healthcare and healthcare innovation to be taken seriously by the EU.

Switching from paper records to an electronic drug accountability IRT system can benefit sites during FDA trial site audits.

Assessing the benefits of using blockchain technology as a notary service in the network sharing of clinical data.

Analyzing data to reveal site performance patterns for better trial planning and execution.

Peter O’Donnell explores the convergence of policy and science in new vaccine R&D pursuits in Europe.

Relocating the European Medicines Agency was always going to be hard-but no-one ever expected it to degenerate into farce.

Peter O’Donnell weighs the varying views in Europe on the risks of going the adaptive pathways route for drug approval.

Peter O’Donnell looks at efforts in Europe to improve R&D communication and trust with investors and the public.

With the literal toss of a coin officially sending the EMA to Amsterdam post-Brexit, it's worth reflecting on what might have been if the decision went differently.

Collaboration focuses on the use of a digital toolset in medication management and patient engagement during studies.

New safety review of epilespy treatment puts spotlight on issues such as communication between regulators and prescribers.

The European Health Data Network (EHDN) initiative kicks off-a challenging and resource-intensive effort designed to harmonize data analysis and conversion amid the push toward outcomes-focused healthcare in Europe.

Several projects in works illustrate the importance of those unsung heroes in Europe's R&D engine room.

Is the much anticipated Europe action plan on personalized medicines, unveiled recently by an EU-sponsored international consortium, worth paying a close eye on?

Europe is issuing a significant update to its ethical guidelines governing health-related research involving humans.

Q&A explores the evolution and challenges of new technology implementation in clinical trials.

With bidding starting to intensify among member states, several factors will determine the EMA’s next home.

New actions underway seek to find a consensus on the role of HTAs in the decision-making chain, including with clinical trials.

The discussion on the main characteristics and implementation of the new Clinical Trials Regulation is heating up in Europe.

A look at the EMA’s proposed guidance revisions for first-in-human studies.

Janssen releases key findings from its pilot study evaluating the use of electronic informed consent technology in clinical trials.

Renewed attention on ways to tackle this age-old scourge is building in Europe and beyond.

European forum tackles the problem of limited elderly patients involved in clinical trials.

New policy hopes to calm the fervor around clinical trial data disclosure and confidentiality issues.

Incoherencies in Europe’s drug-access arrangements raise questions, debate.

Despite orphan-drug R&D and approval being all the rage, issues such as patient access could leave these treatments out in the rain.

Several initiatives are focused on integrating biomarkers and personalized medicine techniques into studies.

Officials tackle such areas as early diagnosis and treatment, patient access, and personalized medicine

The tone of agency’s annual report contrasts its recent candid stance on regulatory vision for Europe

Patients in Europe have been increasingly vocal in their demands for engagement in drug development and regulatory processes-and they have been increasingly effective.

Novel Approach May Help to Prevent False Positive Cardiac Safety Findings in New Drug Development

Technology-Amplified dCRO Model Accelerating Personalized Approach to Targeted Therapies, Including Greater Collaboration, Higher Data Quality, and Reduced Development Costs

Camargo Pharmaceutical Services is adding expertise to its projects and helping postdoctoral researchers gain real-world experience through a unique internship program.

Partnership offers developers full service biosimilar expertise on a global scale

Lisa Henderson interview Gerd Arold or PRA about patient recruitment factors in early phase trials

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Formulation Considerations for Over-Encapsulation of Clinical Trial Materials in DBcaps® Capsules - Capsugel Whitepaper

The Business of Recruitment

Release takes adverse event reporting to a new level, complies with FDA's new rules

A new report from the European Union grades member states on their orphan drug incentives.

DIA President, Theresa Kane Musser, Executive Director, Development Operations, Rigel Pharmaceuticals, presented the awards

Exhibitor Profiles from the DIA meeting hall

The European pharma industry struggles to regain its former prowess in R&D.

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Andy Richardson, Zenetar Ltd; Case Study: Use of EDC at Boehringer Ingelheim, Stephane Collet, Boeringer Ingelheim, Andrew Cooper, Oracle Corp.;

Presenters included Jean-Pierre Isal, Consultant, UK; Jean-Marc Husson, Prof, Eur Acad of Pharm Med, France; Astra Zeneca. The system has been changed from the Notification System, established in 1988 to a formal Clinical Trial Authorization, 2004-5.

2005 ACT Directory and Buyers Guide

Welcoming attendees to the EuroMeeting were Brigitte Franke-Bray, DIA Director, European branch office, Switzerland; Theresa Kane Musser, DIA President, Rigel Pharmaceuticals, USA; Jean Marimbert, Director General, Afssaps, France; and David Maola, DIA Executive Director. Opening remarks were followed by brief speeches from the two candidates running for DIA President: Ron Fitzmartin, Vice President of Global Technical Services, Daiichi Medical Research, USA, and Dr. Jeffery Sherman, Executive Vice President, NeoPharm, USA.

Orphan drug development may take a back seat to profit and loss concerns.

Pharma's finger of blame once again points outward, never inward.

The pharma industry won't be the only group rewarded for conducting new pediatric research.

Dismay over the level of anti-pharma feeling in the EU is not just "crying wolf."

To present the new scheme as a time-saver rather than a time-waster, the new guidance points out that the data required is a subset of the data required in any case for the request authorization.

Welcome to ACT's Washington DC Exhibitor Profiles Supplement for 2004.

The EU offers up market advantages in exchange for pediatric trials.

In many parts of the globe, intended and actual effects of GCP legislation often differ.

The passing of the EU Directive deadline next month is unlikely to quell the stormy debate over its far-reaching impact.

With increasing authority, the EMEA is indeed living in interesting times.

Find out what the new EU framework entails; a think tank finds that too much health care energy is going into medicine.

Even as the EU implementation deadline looms, clear clinical trial definitions remain elusive.

European Research Commissioner Philippe Busquin tours Africa to bring attention to the plight of developing nations unable to afford modern medicines.

The issue of prioritizing clinical trials of pediatric medicines continues to simmer, as plans for planning the possible future legislation develop.

Pediatrics and geriatrics are the latest hot topics in the EU, so the CPMP is at least starting to help companies develop new clinical trials for children.

After committing itself to researching poverty-linked diseases, the EU is working to decide what responsibilities it has to EU-funded research activities in developing nations.

The latest wrinkle in the European Union?s clinical trials rules debate comes from modifications of the draft text at the core of its proposal.

European organizations express their concerns over the implications of the EU guidances issued in response to the 2001 directive.

The consumer press has its spotlight on clinical research again, and some commentators are focusing on subject recruitment.

With 2003 fast approaching, all we know for sure about the EU?s legislative changes is that nothing is final yet.

The World Summit on Sustainable Development may have fizzled, but a promising new long-term clinical trials partnership between the EU, industry, and developing countries is in the works.

Integrating IVRS with in-house clinical trial management solutions can provide a powerful project management tool.

The EU?s progress in the battle against cancer measures how effective it is as research supporter instead of regulatory enforcer.

A set of trials carried out by the Collaborative Ocular Melanoma Study Group at eye centers throughout the United States and Canada led to improvements in the care of patients with choroidal melanoma.

Many stakeholders have already commented on the EU?s incentives for pediatric drug development.

The European Union is working to develop pediatric rules to ensure that medicines prescribed for children are safe, effective, and of high quality.

At work and play, he?s devoted to children.

EU proposals are finally available for the pharmaceutical industry to begin commenting on, and you can bet the industry will take advantage of it.

A new guideline details basic requirements for submitting a successful application for a proposed orphan drug in the European Union.

Improving adverse event reporting can lead to improved safety profiles and, consequently, fewer drugs pulled from the market.

With the impending expansion of the EU and the revamping of current policies, the pharmaceutical industry is on edge, wanting to know what the future holds.

To help protect patient safety and cut red tape, the European Union is working to create tougher standards of pharmacovigilance.

European Parliament debates on the allocation of research funds reveals Euro-MPs views of clinical research in medicines development.

A high-level group explores ways to support EU pharmaceutical industry research without too much cost to the EU health agencies that pay for medicines.

The EU?s Committee for Proprietary Medicinal Products describes the process clinical investigations should follow.

Patients, research companies, and regulatory authorities may all benefit from proposed changes to current pharmaceutical legislation, but the proposals will provoke much debate.

The EMEA updates its positions on placebos, Crohn?s disease trials, and postmarketing surveillance of drugs used by pregnant women.