CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cytel Inc., a provider of software and clinical research services to the biopharmaceutical industry today announced the successful implementation of a software interface for go/no-go decision-making within its client AstraZeneca. The software is the result of extensive collaborative work by the two organizations and marks a significant advancement in quantitative decision-making capabilities for the biopharmaceutical industry.
Since 2014 AstraZeneca has operated a quantitative standard decision-making framework across its Early Clinical Development (ECD) group. Based on a statistical method initially proposed by Lalonde et al (1) and extended by AstraZeneca ECD Biometrics (Frewer et al (2)) to include Bayesian as well as frequentist assessments, the approach ensures that studies are designed from the outset with the decision in mind. Once results are available they can then be interpreted against pre-determined criteria, allowing clear decisions to be made faster, and supporting the management of risk across the clinical portfolio. This also provides a quantitative framework for interim assessment of futility and efficacy. The goal is to ensure effective compounds may be accelerated through the development process, while ineffective ones are terminated early. To support robust go/no-go decisions, every early phase trial within the group must produce decision criteria as part of the governance review.
Cytel has collaborated with AstraZeneca to enhance the efficiency of the established process by developing a user-friendly interface which simplifies the creation of decision information and reduces programming time. James Matcham, Head of ECD Biometrics at AstraZeneca, said, “The software collaboration with Cytel has added value to our decision-making approach. The creation of consistent, presentation quality decision plots eases communication between stakeholders. With this software tool in place decision information can now be generated in real-time. As well as saving time for the statisticians and the clinical project team, improving decision-making will help us to develop the right medicines for areas of high unmet medical need, and get these medicines to patients more quickly.”
Vice President Consulting and Software, Yannis Jemiai of Cytel said, “We are passionate about using statistical expertise to help our clients make better decisions, faster. We believe that this kind of go/no-go framework has the potential to positively impact clinical trial success, and we are delighted to have created software that supports its implementation.”
The software is a web-based platform using a Windows based server for statistical computations and frequentist and Bayesian based approaches may be accommodated. Biopharmaceutical companies interested in developing a software interface to underpin their own decision-making frameworks may contact Cytel via the details below.
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1) Lalonde, R., Kowalski, K., Hutmacher, M., Ewy, W., Nichols, D., Milligan, P., Corrigan, B., Lockwood, P., Marshall, S., Benincosa, L., Tensfeldt, T., Parivar, K., Amantea, M., Glue, P., Koide, H. and Miller, R. (2007) ‘Model-based drug development’, Clinical pharmacology and therapeutics., 82(1), pp. 21–32.
2) Frewer, P., Mitchell, P., Watkins, C. and Matcham, J. (2016) ‘Decision-making in early clinical drug development’, Pharmaceutical Statistics, 15(3), pp. 255–263. doi: 10.1002/pst.1746.