Clinical Trials Articles

At the start of 2007, the European Union grew again to 27 member states, with the accession of Bulgaria and Romania boosting the EU's patient population to nearly 500 million. And European regulatory affairs have continued to become more complex.
In part this is a result of the rapid growth of the EU itself—with a total of 12 member states still trying to master the requirements they have had to take on board since they joined.
But it is equally a consequence of developments in technology and in health care. This year has been marked by uncomfortable reminders of the risks as well as the benefits of new medicines. Regulators have struggled to get a satisfactory grip on first-in-man trials in the wake of the disastrous Tegenero trial in 2006. There has been new emphasis on pharmacovigilance and on patient information. And clinical trial rules have come in for criticism for making medicines development more difficult while putting patients at greater risk.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office for Human Research Protection

Director

NIH Institutes, Center, and Divisions

Ivor Pritchard* (240) 453-6900

Deputy Director and Director, Office of International Activities

Melody Lin (240) 453-8126

Associate Director, Regulatory Affairs

Michael Carome (240) 453-8237

Director, Division of Compliance Oversight

Kristina Borror (240) 453-8132

Director, Division of Education and Development

Shirley Hicks (240) 453-8227

Director,Division of Policy and Assurances

Irene Stith-Coleman (240) 453-8138

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Country study managers (CSMs) are pivotal players in patient recruitment for multinational clinical trials. They are the gatekeepers who can make decisions that affect which recruitment tactics and materials are submitted to ethics committees and ultimately implemented. These individuals hold a world of invaluable knowledge about their countries and cultures that can positively inform a recruitment strategy. Ironically, it is this body of knowledge that can make a small number of CSMs impediments to successful patient recruitment. Their reliance on cultural precedent or tradition can limit success.

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India and China offer attractive environments for clinical studies, with India emerging as a major market for clinical trials and China not far behind. Both countries provide huge and accessible treatment-naïve patient populations and cost-effective research opportunities with low procedure and professional fees. While these countries presently account for less than 1% of the total FDA-regulated clinical research,1 forecasters estimate an expanding market for new clinical trials in both countries.

The number of new clinical trials worldwide has increased significantly, forcing the biopharmaceutical industry to look for new markets to conduct studies. Double-digit growth in the number of clinical trials conducted over the past five years in regions like Central Eastern Europe, Asia, and Latin America is a clear indication of this trend.

The globalization of clinical trials has resulted in changes to clinical research regulations around the globe. Regulatory authorities, particularly in emerging regions, have continued to introduce changes to existing clinical trial legislation and requirements to ensure patient safety. This situation has created a more complex scenario for project managers who now need to deal with several parties, fully understand updates to regulations, address increasing logistic and operational issues (as well as import/export requirements of products and supplies), and grasp cultural differences.

To read more about how sponsor and vendor relationships are changing in a world where outsourcing is the norm, check out the following articles:
Laying with the Lions by Brian O'Neill
Vendor Quality Assurance Audits: A Formula for Success by Carl Anderson, Cathy Tashiro, and Laurie Taddonio
Successful Outsourcing: Tracking the Evolving Use of Full-Service and Niche-Service CROs by John R. Vogel and Kenneth A. Getz
A Clinical Development Solution Tailored for Biopharmaceutical Companies by Vincent Charlon
Master Service Agreements (MSAs) and Preferred Vendor Agreements have been used for years to provide pricing predictability and consistency in contracting to outsourcing departments. While generally successful, the extent to which they ensure companies are extracting maximum value from them is difficult to measure.

For years now, clinical research professionals across a variety of disciplines—from government- and industry-funded research sponsor professionals to investigative site staff, bio-ethicists, and IRB members—have spoken passionately about the need for improvements in the informed consent process. Numerous initiatives have been implemented, including those utilizing multimedia technologies, those simplifying and streamlining consent form language, and those modifying approaches to communicating and educating study volunteers. Despite all of these well-intentioned initiatives, however, little has been done to fundamentally and sustainably improve the informed consent process.

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October 3, London—A major meeting hosted in London by the European Medicines Agency provided plenty of examples from industry and academia of what doesn't work in this 2001 legislation (Directive 2001/20/EC). Even Thomas Lönngren, the Agency's executive director, acknowledged that there are problems in the implementation of the directive, and that there was "a need to find a way forward." But the contributions that European Union officials made to the debate fell a long way short of offering any dramatic improvements in the foreseeable future.

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Europe remains as challenging as ever for clinical trials, but also for everyone trying to make sense of Europe as a political entity. The jumbo meeting on clinical trials at the European Medicines Agency in early October—on which a report appears at http://www.actmagazine.com|~www.actmagazine.com/appliedclinicaltrials/Clinical+Trials/Composite-Endpoints-Proceed-with-Caution/ArticleStandard/Article/detail/463968—provided further evidence of just how complex life can become in the European Union. This unique organization binds 27 member states together tightly, voluntarily, legally—but not completely. And the conduct of clinical trials is one of the activities that keeps slipping between the gaps in the curious configuration of EU rules, which resemble wickerwork more than cast-iron.

Just when Food and Drug Administration officials thought they could relax a little after months debating legislation to ensure safe drug use, federal investigators leveled charges that agency oversight of clinical research is weak, disorganized, and thus unable to ensure the safety of clinical research participants. This criticism came from the Office of the Inspector General (OIG) in the Department of Health and Human Services (HHS), which has called repeatedly over the past decade for stronger efforts to monitor clinical research and to take action against rule violators. Sen. Charles Grassley (R-Iowa), who requested the OIG investigation as part of his campaign to uncover FDA malfeasance, promised to keep a close watch over how FDA implements the OIG recommendations.