What's New in Clinical Trials at Westat

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06/07/2010

Jonathan Ratner, Ph.D., Presents Paper at Pharmacoeconomics Meeting

Jonathan Ratner, Ph.D., gave a presentation at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 15th Annual International Meeting in Atlanta, Georgia, on May 18, 2010.

Dr. Ratner is a Westat senior economist specializing in health and labor topics. He took part in an ISPOR Issues Panel, Pragmatic Clinical Trials: How Broad Is Too Broad and How Early Is Too Early? Dr. Ratner's presentation for the panel was titled, Pragmatic Clinical Trials: Health Care Payers' Views of PCT Features and Trade-offs.

Pragmatic clinical trials (PCTs) are a relatively new variant of traditional randomized clinical trials (RCTs). In an RCT—usually funded by a pharmaceutical manufacturer—researchers test a new drug against a placebo. The drug manufacturer makes the RCT's results available to the U.S. Food and Drug Administration (FDA), which approves the new drug for use if convinced that the drug is safe and effective. "However," Dr. Ratner explained, "health care payers—private insurers and public payers such as the Defense Department—typically want to know more than what most RCTs tell them. To adopt a new drug, payers want to know: Is the new drug better than existing drugs, not just a placebo? Will it work well for its patients (who often differ from the RCT's study population)?"

Randomized trials that are designed to answer such questions are called pragmatic or practical clinical trials. They typically have head-to-head comparators, broader patient populations, and outcome measures that patients and providers care about (e.g., fewer heart attacks rather than just lower cholesterol).

Dr. Ratner and a colleague interviewed formulary decisionmakers at private and public payers. These decisionmakers described their views of PCTs and discussed the trade-offs they would make if cost considerations forced trial sponsors to choose between, for example, a broader patient population and an active (non-placebo) comparator. Dr. Ratner's preliminary study results are part of a project for a commercial client.

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04/14/2010

Clinical Research Professionals Meeting Includes Westat Staff

Westat staff will be participating in this year's Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition [*]. The meeting will be held in Tampa, Florida, April 23-27, 2010. More than 2,500 clinical research professionals from pharmaceutical, biotechnology, medical device, hospital, academic medical center, and physician practice settings are expected to attend.

Westat will be exhibiting at Booth 434 in the exhibit hall. Westat project staff Karen Stewart and Marsha Johnson will be available to provide meeting attendees an opportunity to learn about our projects and capabilities.

Ms. Johnson will be presenting a poster at the conference: Regulatory and GCP Compliance in an International Setting. The poster represents the challenges and solutions to conducting clinical trials in an international setting.

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03/30/2010

NIAID Selects Westat to Support the Development of a Research Network in Mexico

Westat has been chosen by the National Institute of Allergy and Infectious Disease (NIAID) to provide administrative, technical, and management support for the development of an infectious disease network in Mexico. The H1N1 influenza virus (Swine Flu) will be the first disease of interest.

The network will be a joint collaboration between the Mexican and U.S. governments and will conduct time-sensitive infectious disease research. This collaboration will also work to develop a robust independent research capacity in Mexico.

Westat staff will provide a variety of support services:

  • Provide administrative, technical, and managerial support to network investigators; and
  • Identify and manage subcontractor(s) to assist with:
    • Hiring study coordinators, data managers, and information technology staff in Mexico City; and
    • Supplying essential equipment to the network sites.

Westat will work with this Mexican-U.S. research collaboration to:

  • Develop and implement an influenza/influenza-like respiratory syndrome natural history study;
  • Assess and continuously identify opportunities to improve the existing clinical research infrastructure of the network clinical research sites in Mexico; and
  • Explore ways to enhance research expertise through training and capacity building.

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