An invisible hand in clinical research, the research site coordinator plays a critically vital role in the clinical trial. They are a backbone and foundational pillar for any site’s effort in protecting patients. Put simply, study coordinators are in our opinion a nexus of the research site enterprise. By collaborating with principal investigators and other research center staff, they help bring together extraordinary results by assisting with protocol development, consent form creation, patient identification and patient recruitment, patient education, patient logistical coordination, and ongoing upkeep of various GcP compliant systems from electronic data capture to integrated web/voice response to site master files. Past studies have demonstrated that the addition of well-trained coordinators significantly improves recruitment numbers, enhances retention, and increases study efficiency.
Many study coordinators belong to a leading clinical research industry organization called the Society for Clinical Research Associates (SOCRA). Founded in 1991, SOCRA is a non-profit, charitable and educational membership organization committed to providing education, certification and networking opportunities for those involved in clinical research. SOCRA has emerged as a leading educational and networking organization for clinical researchers across therapeutic areas supporting industry and academia.
It was, therefore, an honor and privilege for TrialSite News’ Daniel O’Connor to present to SOCRA Phoenix/Valley of the Sun Chapter on Tuesday, September 11, 2018. The event took place in the preeminent Barrow Neurological Institute in downtown Phoenix. The event’s organizers were welcoming and there was a fantastic turnout of members.
O’Connor’s presentation centered on emerging disruptive technologies and the growing trend toward patient-centered clinical trials. Facing an experience and engaged audience, O’Connor first introduced the mission of TrialSite News (clinical research transparency, networking and information sharing). He then discussed his organization’s partnership with Alliance for Clinical Research Safety and Excellence (ACRES) and their imminent progress made toward dynamic, system’s approach to research site accreditation.
O’Connor highlighted the growing pressures facing commercial sponsors including productivity declines, mounting competition and value-based pricing stresses to mounting struggles associated with the status quo model of clinical trials. He also introduced the disruptive technological forces at work moving trials toward patient-centricity including:
- Social Networks/Social Data
- Big Data/Personalized Data
- Cloud Computing and
- Mobile/Telehealth Disruptions.
The audience learned about real world examples as to how these disruptive technologies are beginning to transform their industry.
O’Connor discussed the implications for the research coordinator and the importance of continuous learning in a few key areas, inluding new technologies and risk-based planning and management. O’Connor presenter finished with a regulatory update on the FDA’s position on use of electronic health records to the changes brought by ICH E6 R2.
TrialSite News was thrilled to present to this wonderful Phoenix-area group. It was clear that they are fiercely committed to their profession and scientific discipline and most importantly, to ethical clinical research that helps progress desperately needed medicines.