Study Conduct

Merck Report Could Alter Clinical Trials, Marketing

Monday, August 25, 2008 01:00 PM

A new report criticizing the use of seeding trials to drive pharmaceutical marketing efforts and jump-start sales could have far-reaching implications for pharmaceutical companies, research sites and clinical trials in general.

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APPI Joins Clinical Trials Transformation Initiative

Monday, August 4, 2008 05:59 AM

The Academy of Pharmaceutical Physicians and Investigators (APPI), a nonprofit group of nearly 1,200 physician members involved in the clinical research enterprise, has joined the Clinical Trials Transformation Initiative (CTTI).

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The Psychology of Clinical Trials: Understanding Physician Motivation and Patient Perception

Wednesday, October 4, 2006 03:49 PM

The clinical trials industry has been at the center of public scrutiny following recent news reports of unethical patient recruitment and manipulated trial results. Are these well-publicized stories causing doctors and patients to shy away from experimental treatment? What are the key factors that drive physicians to refer patients into clinical trials and what are patients’ biggest concerns?

To gain a better understanding of the psychology of the clinical trials patient and referring physician, CenterWatch conducted a series of in-depth doctor and patient surveys. The results and related observations, which were presented this June at the Drug Information Association Annual Meeting, are outlined in this CenterWatch Research Brief...

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Fighting The Logjam In LatAm Drug Trials

Monday, September 18, 2006 10:24 AM

Clinical research in Latin America has grown significantly over the past 10 years but obstacles to continued growth still exist. In our first-ever survey of investigative sites in Latin America, we at Thomson CenterWatch found that bottlenecks at the site level continue to hinder growth of clinical research in the region as researchers strive to improve the system.

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Prisoners As Study "Volunteers"

Thursday, August 17, 2006 11:58 AM

A recent Institute of Medicine Report has recommended that drug testing be allowed on prisoners, thereby lifting a decades-old ban on this practice. The recommendation is drawing both criticism and support from government and industry.

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Is India Ready For Phase I Studies?

Tuesday, August 15, 2006 08:32 AM

India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer - and others would agree - is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies...

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British TaskForce Submits Recommendations for Phase I Guidelines

Monday, July 24, 2006 12:47 PM

The Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) taskforce has established recommended guidelines to enhance patient safety in phase I studies with novel agents. The taskforce was created to address safety concerns following the events during the TeGenero trials with the immune stimulate TGN1412...

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Wyeth Overhauling Phase II Program

Tuesday, July 18, 2006 08:19 AM

Wyeth plans to make bold changes to its phase II program, cutting the number of sites participating and using more sites in China, India, Latin America and Central and Eastern Europe. Wyeth also plans to use more sites in emerging regions for its entire clinical program.

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Challenges in Communication

Wednesday, June 14, 2006 10:14 PM

Recently, the well known industry chemist and blogger Derek Lowe, PhD discussed an important issue plaguing the drug development industry; a general lack of public knowledge with regard to how drugs are brought to market. Given the need for direct patient involvement in clinical trials, the issue is especially of great concern for our industry. The challenges and complexities of drug development are not easy tasks to relay to the layperson, but a greater attempt to bring public clarity to this process, would only benefit our shared goals: finding new therapies to treat disease...

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NPR Interviews David DeMets on Drug Safety Monitoring Boards

Tuesday, June 13, 2006 11:04 AM

In the wake of Vioxx and the recent events during the German biotech TeGenero AG’s trial, involving a severe immune reaction in six British subjects given an investigative monoclonal antibody, the industry has made a major effort to review trial safety precautions. Among other areas under scrutiny, the work of independent review boards (IRBs) has received much attention. Recently, the roles and challenges of Data Safety Monitoring Boards (DSMBs) have also been discussed in preventing further safety issues during clinical trials AND after market approval...

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