Clinical Trials Articles

Faced with regulatory uncertainty and an economy struggling to stabilize, pharmaceutical companies face increasing pressure to bring new drugs to market on time and on budget. Meeting enrollment goals is one critical success factor for addressing these pressures. But enrollment has its own challenges.

Asli Memisoglu
People

Jack Polidoro
As the new director of biostatistics and data management for WorldCare Clinical (Boston, MA), Asli Memisoglu, PhD, will oversee the development of image analysis performance metrics, statistical design, and database management between the company's project managers, sponsors, and independent reviewers.

PhotoGraphy: Bruce Laurance, Getty Images Illustration: Paul A. Belci

Photography: Odilion Dimier, PhotoDisc, Getty Images Illustration: Paul A. Belci

Sponsors know that clinical trials are one of the most expensive endeavors for their company. Many sponsors would like to manage their trials in-house, but lack the needed infrastructure. Yet, sponsors have reservations outsourcing clinical research due to problems experienced working with CROs.

The key challenge clinical trial supply chain (CTSC) managers face in global distribution is ensuring that supplies arrive at the trial sites on time and in good condition.

The goal of the Probability Sampling Study (P.S.S.) is to evaluate risk factors that contribute to the state of regulatory compliance for medical device clinical investigations. The results of the P.S.S. can be used to direct limited FDA resources into areas where there may be enhanced concern for human subject protection and/or clinical data quality systems.

I had the opportunity to visit the exhibit floor at the Healthcare Information and Management Systems Society (HIMSS) at Chicago's McCormick Place in early April, and it was quite an eye opening experience.

Peter O'Donnell
New perspectives are opening up for pharmacological treatment of post-traumatic stress disorder (PTSD), according to the European Medicines Agency (EMEA). So far, drug treatment options for this severe and prevalent pathology have been limited.

The Food and Drug Administration is stepping up oversight and enforcement activity for medical products, including the conduct of clinical trials. There are more warning letters going to investigators, and institutional review boards (IRBs) are under scrutiny following the recent exposé of lax reviews.