Reuters Events | Pharma

Thought leadership and innovation for the Pharmaceutical Industry

New adaptive trial design software ensures that pharmaceutical manufacturers can plan time and cost-effective clinical trials through extensive simulations.

By Anonymous on Nov 21, 2012

US-based contract research organisation, Pharmaceutical Product Development (PPD) have expanded their design facilities for adaptive clinical trials through a licensing deal with consulting services firm Tessella and statistical consulting group Berry Consultants. This three-way deal on Bayesian design and analysis in clinical research was initiated by PPD last year. This agreement allows PPD to use the consultancy firm’s FACTS software which permits designers to produce simulations that detail how a clinical study would potentially develop. This helps PPD in its early planning for the design of the trial and could allow adaptive trials to be designed at a more rapid pace or the alteration of a clinical study based on its earlier findings to improve its chances of success.

Additionally, this adaptive trial design allows PPD to narrow the focus of the trial by reducing one of more of its treatment arms. Therefore, PPD could take a more ‘flexible, intuitive approach’ to designing adaptive and fixed trials which is very different from the rigorous and focused traditional method. The FACTS software contains programmes which can simulate interim as well as end patient responses, patient drop-outs and patient growth in clinical trials. It can deliver a range of simple and complex designs which allows PPD, for example, to run a simulation on the features of a competing design that reduces the time, cost and occurrences of failed phases of a study.

Through FACTS, PPD could help drug manufacturers employ innovative trial designs that better the chances of drug development. PPD’s senior vice president of global biometrics added to this by saying: “The simulations generated by this software will help us create richer designs so that our clients can make better informed decisions about their trials. This agreement also demonstrates our commitment to enhancing our position as a leader in adaptive trial design among full-service contract research organizations.”

In the future, adaptive trial designs like the above could also reduce spending on the collection of non-core data for supplementary secondary, tertiary and exploratory endpoints in clinical trials. Through the use of simulations, pharmaceutical companies could simplify protocol design, improve clinical research routines and reduce drug development costs in their trials.