spacer
home > ict > spring 2006 > adapting to adaptive studies
PUBLICATIONS
International Clinical Trials

Adapting to Adaptive Studies

Adaptive studies promise significantly lower costs and shorter timelines. Michael J Rosenberg of Health Decisions reviews the organisational foundations for conducting adaptive studies most productively and explains why web-based EDC systems are not up to the task

Adaptive clinical research promises profound and dramatic benefits to the pharmaceutical industry. Adaptive programmes, which allow changes during a trial based on analysis of data collected up to the time of the change, provide major advances such as shortening development time, reducing the incidence of treating patients with ineffective or unsafe doses, and allowing regulatory agencies a more nuanced assessment of both efficacy and safety.

Several trends have converged to enable adaptive methods, including increased computational power, more efficient communications technology, and powerful supporting statistical methodologies. Agencies such as the US Food and Drug Administration and the EMEA have acknowledged the significance of adaptive methods in a variety of ways. Moreover, the direct experience of research groups that deal regularly with relevant design and reporting issues, including my own, confirms not only a growing receptiveness of regulators to adaptive methods, but also encouragement of well designed adaptive studies.

This article summarises the organisational and process issues in adaptive research. After briefly discussing the principles of adaptive research and the types of optimisations an adaptive trial can enable, the focus for the balance of the article will shift to what is required to make the powerful engine of adaptive research deliver maximum benefits.

WHAT IS ADAPTIVE RESEARCH?

The term ‘adaptive research’ broadly denotes changes that can occur during the course of a study or development programme without compromising validity or integrity. An adaptive trial design can correct mistaken assumptions or seize an opportunity to optimise the trial. Often the result is shorter timelines, lower costs and superior information for sponsors, regulators and future prescribing physicians.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr Michael Rosenberg, MPH is the founder and CEO of Health Decisions. He was awarded Ernst & Young’s Entrepreneur of the Year in Health Sciences in 2002, and has led Health Decisions to recognised success. The author of more than 150 scientific articles, Michael serves on advisory groups in business, technology and medicine. He is Clinical Professor of Obstetrics and Gynaecology for the School of Medicine and Adjunct Professor of Epidemiology for the School of Public Health at the University of North Carolina. He practiced emergency medicine for more than 20 years. His professional achievements have been recognised by fellowship in the American College of Physicians, American College of Preventive Medicine, and the American College of Epidemiology. Michael received his undergraduate and medical degrees from the University of California and his master’s degree in Epidemiology and Biostatistics from Harvard University.
spacer
Dr Michael Rosenberg
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine.
More info >>

White Papers

Six Strategies to Stretch Your Limited Drug Supply for Clinical Studies

PCI Pharma Services

Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex therapies not only increase risk in drug development but also drive costs even higher. A recent analysis of the investment needed to develop a new prescription medicine shows the total cost can be as high as $2.6 billion (1). That number becomes even more staggering when you consider the fact that only about 12 percent of drug candidates that make it to Phase I testing are eventually approved by the FDA (2). The investment companies lose as a result may be too devastating to their bottom line to ever recover.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement