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European Pharmaceutical Contractor

Trial and Error

Olga Marchenko at i3 Statprobe explores the impact and potential challenges of adaptive designs in clinical trials

At the beginning of a clinical trial, knowledge about the compound understudy will always be limited. It seems logical, therefore, that the information from the trial itself can be useful in improving the trial design. Recent developments in the methodology of adaptive designs in clinical trials have the potential to improve the quality, speed and efficiency of drug development. While the increased flexibility of adaptive design methods has made this type of trial strategy increasingly attractive to clinical researchers and sponsors, these new statistical methods should never be used as a substitute for careful planning. This article discusses the types of adaptive design and their potential benefits and challenges.

INCREASED POPULARITY OF ADAPTIVE DESIGN

The number of publications in adaptive and flexible designs has increased significantly in recent years. Although the adaptive designs considered in most scientific papers are not widely used in practice, their theoretical popularity continues to grow. Several biostatistics journals have recently published special issues on adaptive designs, including a 2005 special issue in the Journal of Biopharmaceutical Statistics, and a special issue of the Biometrical Journal and the Journal of Statistical Planning and Inference in 2006.


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As Director of Biostatistics Consulting at i3 Statprobe, Olga Marchenko provides strategic leadership for the design and analysis of clinical trials, biostatistical oversight on projects, and biostatistical consulting services to clients. As Head of the Adaptive Design Consulting Group, Olga ensures that the group remains abreast of industry trends and academic research in the area. She provides consultation and support to clients and statisticians working on trials utilising adaptive design methodology, and trains the department in the area of adaptive designs and sequential methods as well as organising conference presentations
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Olga Marchenko
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Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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News and Press Releases

Azopharma Product Development Group, Inc

HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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