The development of new drugs across the spectrum of chronic diseases is vitally important for both the pharmaceutical industry and the public, many of whom are suffering long-term ill health from a young age. Conversely, clinical trials are failing because of a lack of patient stratification prior to clinical trial design and enrolment. The “all-comer” approach to drug testing, combined with a lack of appropriate stratification, means that non-responding patients are often included in inappropriate trials.
This is ineffectual for patients and can result in trial failure caused by the masking of efficacy in “responders” by “non-responders.” In Scotland, a nationwide multidisciplinary collaboration — led by regenerative medicine company ReproCELL Inc. — is attempting to address these issues by linking genomics to the prediction of clinical efficacy at an earlier stage in drug development.