One of the challenges with clinical trial site investigators has been the lack of long-term engagement. The George Institute for Global Health along with George Clinical, their clinical research organisation recently took part in a joint effort to develop new guidelines and recommendations to encourage greater long-term engagement and participation by clinical site investigators.
George Clinical is a leading CRO in Asia. We recently were privileged to be a part of developing the Clinical Trial Transformation Initiative (CTTI): The Recommendations for Strengthening the Investigator Site Community. The project aimed to tackle one of the biggest challenges that clinical research organisations around the globe face with the retention of clinical investigator retention.
About the Clinical Trial Transformation Initiative
The Clinical Trials Transformation Initiative (CTTI) co-founded by Duke University and the FDA is a public-private partnership whose mission is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. The CTTI vision is a high quality clinical trial system that is patient-centered and efficient, enabling reliable and timely access to evidence-based therapeutic prevention and treatment options. For more information about the Clinical Trial Transformation Initiative and these recommendations, please visit their website: http://www.ctti-clinicaltrials.org
The recommendations focus on strengthening four key categories of site-based research activity:
- Developing site-based research infrastructure and staff;
- Optimizing trial execution and conduct;
- Improving site budget and contract negotiations; and
- Discovering additional trials to conduct.
The “Recommendations for Strengthening the Investigator Site Community” report stated that:
‘…evidence suggests that many investigators are leaving clinical research due to difficulty balancing workload, time requirements to conduct trials, data and safety reporting burdens, and financial issues… Substantial time and resources are needed to initiate and train new site investigators in clinical trial processes … High attrition rates for U.S.-based investigators and the resultant need to initiate new investigators to sustain an adequate pool of investigators increase the costs of performing clinical trials and threaten the quality and efficiency of trial conduct.’
Dr Marisa Petersen, CEO of George Clinical explains, “Our business of managing clinical trial programs is highly dependent on well-equipped and supported investigational sites. George Clinical has always believed that a greater emphasis on supporting the principal investigators, co-investigators and research coordinators will positively influence all aspects of site-based research activity. As such, we welcome the recommendations that highlight their contribution, along with providing a suite of other key components that are needed in order to support and retain investigators.”
The new recommendations from the CTTI mean for us at George Clinical an important formal framework for the sector. That is why we welcome these recommendations; they align well with our unique integrated scientific leadership service and the program is designed to provide peer to peer support for investigators. While the number of clinical trials is increasing in the Asia-Pacific, it creates a greater need for regulations and guidelines for clinical trial investigator retention. Dr. Petersen adds, “These clear and transparent guidelines will be a great asset and reassurance for sponsors looking to bring their compound into the world’s most dynamic market.”
About George Clinical
George Clinical is a leading independent Asia-Pacific based clinical research organisation (CRO) with global capabilities differentiated by scientific leadership, innovation and extensive investigator networks. With staff operating in 13 countries, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device and diagnostic customers, for all trial phases, registration and post-marketing trials. George Clinical combines scientific and clinical leadership with expert trial delivery capability to create a distinctive world-class service.
George Clinical has grown from an academic group conducting trials to a CRO delivering clinical trial services primarily for industry but also academic researchers.
George Clinical provides a range of clinical services across a variety of therapeutic areas, predominantly in the areas of chronic disease: oncology, renal health, endocrinology, respiratory health, cardiovascular health, neurology and for the implementation of medical devices.