ClinPhone Presents Successful Adaptive Trial Designs Workshop with Cytel Inc. and Tessella

Nottingham, UK (16 August 2007) ClinPhone, the global leader in clinical technology solutions, together with Cytel Inc. and Tessella, co-hosted an in-conference workshop on the practical considerations of implementing adaptive trials at the recent prestigious CBI 2nd 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 II and III 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, "Adaptive trial designs are at the forefront of drug development and offer sponsors the potential to shorten timelines, decrease costs and improve patient safety. 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."

Having delivered more than 75 applications to support protocols with design adaptations, ClinPhone's solutions lead the way in delivering integrated products required to implement an adaptive trial design. This includes central randomization, trial supply management, EDC, ePRO and real-time integration with sophisticated statistical software required by some adaptive trials.

To find out more information on practical implementation of adaptive trial designs and to receive the materials shared at the workshop, please visit www.clinphone.com/registration/register.aspx.

For further information on ClinPhone's clinical trial management solutions, please visit www.clinphone.com, or alternatively email info@clinphone.com.