Clinical Trials

Biography

Biography: Deepti Goel

Abstract

A clinical trial site is an epicenter of clinical research, as the core action of clinical research in terms of subject screening, recruitment, retention, medical care and data entry etc. happens here. Alone a site can achieve nothing if not partnered by a committed, experienced and quality cautious investigator. But natural, they are the biggest stakeholders and success of any clinical trial rests heavily on them. Time and again sponsors and Clinical Research Organizations (CROs) have tried and used various parameters to assess and evaluate a site. These parameters have been subjective, objective, and pragmatic. With effect from the year 2013, Indian regulatory law, Schedule Y has enhanced the roles and responsibilities of Investigators and Institution's watchdog, i.e. Ethics Committee, which in turn has made a ‘‘site’’ more accountable. It is evident that the key stakeholders, e.g. sponsors, CROs, and regulators, are looking for objective data to support decisions like, which sites are the best and serve as long-term partners. After all, relationship between a sponsor and a site/investigator, if turns out be a win–win, goes a long way. It is imperative that site identifies its core action points, monitors its performance and improve. Having spent considerable years at sponsors/CROs and sites, author strongly believes that some data points need to be identified to assess site’s quality and functionality. We have attempted to lay down some practical yet important top metrics (data points), site should focus on as part of their own continuous improvement initiatives and also help decision makers like sponsor/CROs to get the right results by choosing the right clinical site.