ClinPhone, Cytel and Tessella Co-Present “Successful Adaptive Trial Designs” Workshop

Nottingham, UK and Cambridge, MA – July 16, 2007 – Global clinical technology solutions leaders ClinPhone, Cytel Inc. and Tessella together co-hosted an in-conference workshop on the practical considerations of implementing adaptive trials at the recent CBI 2 nd Annual Congress on Clinical Supply Chain Management held in Princeton, New Jersey. The workshop materials are available on www.clinphone.com/registration/register.aspx

The workshop was attended by over fifty biopharmaceutical professionals demonstrating the industry’s heightened interest and focus on adaptive clinical trials due to their promise to solve real challenges currently facing clinical researchers. In particular, effective selection of the optimal dose and shortening the time taken between Phase 2 and 3 are major benefits that can be gained by implementing adaptive trials.

Adaptive trial designs refer to study designs that use accumulating clinical response data to decide how to modify aspects of the study without undermining the validity and integrity of the trial. This may include, for example, dropping a treatment arm or reducing the proportion of patients assigned to that treatment if it is determined less optimal by the analysis of accumulating study data.

Drawing on the wealth of accumulated experience and expertise of all three companies, the workshop identified that technology has a crucial role to play in the successful execution of adaptive study designs which rely upon rapid access to clinical data and the ability to change the number of treatment groups and allocation ratios as the study progresses.

Graham Nicholls, Product Manager, ClinPhone, comments, “Understandably we see a growing interest in these designs. Technology solutions are rapidly becoming a key focus in clinical trials in the pharmaceutical industry’s continuing efforts to improve the drug development process. Flexible technology solutions to randomize, manage supplies, and collect clinical data are the foundation of successful adaptive trial implementation.”

Ranganath Nayak, Chief Executive Officer, Cytel Inc., states, “Adaptive trials promise enormous benefits to clinical development programs. However, the costs of overage and the risk of a stockout are significant considerations. The solution is very thorough cross-functional planning for each trial, and leveraging the appropriate manufacturing, packaging, and IT resources for implementation.”

Kathy Reinold, Project Manager, Tessella, says, “While the benefits are potentially huge, adaptive clinical trials are still a challenge, and few have determined exactly how to implement them successfully. As the use of adaptive designs grows, we can also look forward to innovations in drug supply management.”

Click here to examine case studies of Cytel-designed adaptive trials
Click here for information on Cytel’s clinical trial design services

About Cytel
Celebrating its 20th anniversary, Cytel Inc. is a leading provider of clinical trial consulting services, specialized statistical software, and outsourced clinical study reports for the biopharmaceutical, medical device, academic, and research institute markets. Cytel’s validated trial designs reduce development lead time and costs while increasing the probability of clinical trial success. Cytel Inc. is headquartered in Cambridge, MA, with software development and outsourcing facilities in Philadelphia, PA and Pune, India.

About ClinPhone
ClinPhone plc is the largest and most accomplished Clinical Technology Organization (CTO) with experience in over 2000 clinical trials spanning 88 countries and 71 languages. ClinPhone offers a wide range of innovative clinical trial products including Electronic Data Capture (EDC), Interactive Voice and Web Response (IVR and IWR), Clinical Trial Management Software (CTMS). Electronic Patient Reported Outcomes (ePRO) and Patient Recruitment Solution.

Media contact:
Michael Weitz
Cytel Inc.
+1.617.661.2011
mike@cytel.com

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