Topic

Mark P. Mathieu is a writer and editor with PAREXEL International Corporation.

Vernette J. Molloy, MBA, RN, is vice president of GCPA, Inc., Fairfax Station, Virginia.

Douglas R. Mackintosh, DrPH, MBA, MSHyg, is president of GCPA, Inc., Fairfax Station, Virginia.

Articles

A new reference guide clarifies uncertainty surrounding this sometimes misunderstood document.

A Closer Look at the 1572: Interpreting the FDA's Statement of Investigator Form

Faiz Kermani, PhD, is a budgets, proposals, and marketing executive with Chiltern International Limited, a CRO in Slough, Berkshire, UK.

Long overlooked as global drug innovators, Japanese pharmaceutical companies are gaining attention for their novel clinical development programs.

Japanese R&D: Branching Out

Arthur L. Caplan, Ph.D., chair of the University of Pennsylvania's Department of Medical Ethics, expressed his frank views about issues that are ailing the drug industry today during his DIA Keynote Address in mid-June.

A Closing Thought: Prescribing Fixes for a Broken System

New requirements for clinical research teams, and administrative responsibilities and constraints for investigators conducting noncommercial trials.

The EU Directive: Practical Implications for Clinical Research Teams

Informed consent is a process, not just a form signed by prospective study subjects. Documents such as the Code of Federal Regulations describe the elements of informed consent, but lack substantive direction on the process of obtaining consent.1-2 The purpose of this article is to provide guidelines for obtaining informed consent. This guide can be useful to anyone involved in clinical research, particularly newcomers to the industry.

Guidelines for Obtaining Informed Consent for Clinical Research

Vincent Charlon is CEO of Hesperion Ltd., Gewerbestrasse 24 CH-4123, Allschwil, Switzerland, fax +41614871401, email: vincent.charlon@hesperion.com

The rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs. Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical development operations, or outsourcing the clinical development to contract research organizations (CROs).

A Clinical Development Solution Tailored for Biopharmaceutical Companies

Clinical trials sponsors seek quick subject enrollment and high data quality, expressed by both strict adherence to good clinical practice (GCP) requirements and completeness and correctness of the data collected from investigative sites. However, the most informative sources of detailed information on data quality such as site monitoring visit reports, sponsor, and CRO audit reports are maintained as strictly confidential documents and are not publicly disseminated. Therefore, a substantial proportion of the information on data quality in clinical research that is available to the general public is based on anecdotal reports rather than well-referenced and organized observations. The U.S. Food and Drug Administration found no evidence of poor GCP compliance during inspections in the emerging clinical research countries, including Eastern Europe and the former Soviet Union.1-2

Recruitment Rates and Data Quality -- Are They Linked?

Earlier this year, Applied Clinical Trials published "Clinical Monitoring: Answers to Questions about Good Clinical Practice," another excerpt from the book, Good Clinical Practice: A Question & Answer Reference Guide. Readers are referred to the July 2003 issue (pages 27-29) to read the full text of the reference guide introduction.

Investigators and Sites: Answers to Questions about Good Clinical Practice

Damian McEntegart, MSc, is statistics and medication forecasting manager for ClinPhone Group Ltd., Lady Bay House, Meadow Grove, Nottingham, UK, +44 115 955 7333, fax +44 115 955 7555, email:dmcenteg@clinphone.com.

Interactive voice response systems are commonly used in clinical trials to manage the flow of trial medication supplies to sites and to manage the allocation of these supplies to individual subjects. Other advantages and uses include access to real-time information for trial managers, collection of diary card data directly from subjects, and as an aid to subject recruitment.1

Forced Randomization: When Using Interactive Voice Response Systems

Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.

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