Patient recruitment and retention has continued to be one of the largest challenges in clinical development for biopharma companies, with most studies experiencing start-up delays and/or completing late.
Over 12 years, 50%new molecular entities (NMEs) failed to obtain approval when first submitted to the FDA. Some new applications were rejected because of inadequate drug performance, other, however, failed because of, what looks at first glance as, sloppiness.
From new healthcare products to the way we conduct clinical trials, “big data” is poised to transform the pharma landscape. But first, we’ve got to work out how to use it effectively – especially in the best interests of the patient, writes Nick de Cent.
The need for disruptive innovation in pharma has reached a precipice. In order to compete in the era of stratified medicine, cost-effectiveness considerations, and overall patient empowerment, the industry must rethink every aspect of the drug development continuum.
"And that is quite likely the biggest barrier to advocates of patient centered clinical trials today: not that they will be resisted, but that their message will be co-opted and their efforts shunted into high-visibility but low-impact initiatives".
Paul Ivsin explains how our attempts to make clinical trials more patient-friendly have, for the most part, been subverted by the need to collect more comprehensive and more patient-relevant data, which can prove burdensome to the patient.