Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
News, developments and strategies related to eClinical, data management, data collection, ePRO, and more information technology used in the drug development chain. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
Pharmaceutical companies are under tremendous pressure to lower costs and improve the ROI on their R&D spending. How bad is it? In a relatively unprecedented move, large pharmaceutical companies have actually come together to work together for the sole purpose of reducing clinical trial costs. Ten of the world’s largest pharmaceutical companies indicated they would cooperate on research aimed at accelerating drug development, starting with streamlining clinical trials.
Initiatives like TransCelerate, increased biomarker development, the enabling of triggered/ risk-based monitoring, and yes, adaptive clinical trials are all focused on making faster, better decisions. The notion of adaptive clinical trials has been around for some time, the concept is not new. However, as financial pressures in the pharmaceutical industry mount and CROs find it difficult to differentiate themselves, we have seen maturation in the field of adaptive clinical trials over the past three years. Companies have been created based primarily on the ability to provide adaptive clinical trial services.
ISR recently launched our second look at the Adaptive Trial marketplace with our “Adaptive Trial Market Dynamics” report. Since 2010 we have seen some changes in the marketplace and momentum seems to be growing. However, barriers still exist that are preventing a more rapid adoption of adaptive trial designs.
One consistent finding from this report is that “regulatory” matters are of the utmost importance regarding the future adoption of adaptive clinical trials. Respondents noted the lack of regulatory guidance as the major barrier to adaptive trials being more widely used within their organization. They also stated that a CRO’s experience with the regulatory bodies in planning adaptive designs was the second most important attribute a CRO could possess. However, only 27% of respondents indicated they are “very confident” or “confident” in outsourcing the regulatory planning for an adaptive trial.