December 14, 2010 09:08 ET

Regulation of Clinical Trials to Improve Drug Development

ROCKVILLE, MD--(Marketwire - December 14, 2010) - has announced the addition of Business Insights' new report, "Advances in the Design and Regulation of Adaptive Clinical Trials," to their collection of Pharmaceuticals market reports. For more information, visit

As the pharma industry comes under increasing pressure to replenish revenues which are under threat from generic competition, there is an increased focus on technologies and trial designs which aim to maximize success and reduce development time.

The large majority of adaptive trials currently being undertaken in the pharma industry are Phase 2 -- 'Learning' -- trials that aim to establish the most effective dose and the dose response curve. Exploratory trials may also aim to combine proof of concept with dose finding, stop early for futility or investigate biomarkers and patient subsets.

Ground-breaking research using adaptive designs with biomarkers is currently shaping the future of research in the field of oncology. The highly collaborative I SPY2 study may deliver changes to the field on a number of levels such as demonstrating the feasibility of cooperation at this level and the efficiency of the adaptive design.

Companies are learning how to implement adaptive studies in the confirmatory stages of drug development and regulators are developing their views on what is acceptable. Interaction with regulators to gain acceptance for a particular design and implementation plan, and proper documentation of decisions and actions, are key success factors.

This report reviews the use of adaptive designs across all phases of development. Dose-ranging and seamless trials are explored through case studies of important adaptive trials. Regulation by the FDA and EMA is covered in detail. The report also reviews logistical and technological aspects of adaptive designs as well as presenting an outlook for their use in drug development.

The report answers the following questions:

  • What is the current regulatory position on the use of adaptive trials in the exploratory and confirmatory stages of drug development?
  • Where and how have adaptive trials been used by the industry already? Which companies are pioneering their use?
  • How can adaptive trials improve drug development?
  • What are the costs associated with adaptive trials? Can they save money?
  • How can adaptive trials be used in clinical trials with biomarkers?

For more information, visit

Contact Information