While patient representatives have been engaged since its inception, CTTI underscored the vital importance of meaningful patient engagement in the clinical trials enterprise (CTE) by launching its Patient Leadership Council (PLC) in January 2013. Through the PLC, 15 patient thought leaders representing a variety of organizations engaged in clinical trials came together, outside of disease or body part, to work hand in hand with CTTI’s diverse membership to create solutions. Since the establishment of the PLC, this group’s impact on CTTI’s work has been undeniable.

Not only did PLC members increasingly serve as project team leaders and integral team members, CTTI’s membership and Executive Committee fast-tracked approval of a project developed by the PLC entitled Patient Groups & Clinical Trials–which follows CTTI’s multi-stakeholder approach and aims to identify and promote best practices for effective engagements between sponsors of research and patient groups around clinical trials. The PLC also created presentations and events for CTTI’s membership that highlighted innovative programs and approaches developed by patient groups to overcome barriers in clinical trials.

In light of the impact made in the PLC’s first 18 months, CTTI convened a Summit with its patient representatives in July 2014 to explore lessons learned and define what Patient Engagement 2.0 should look like at CTTI. On this day, it was affirmed that the greatest accomplishments were achieved by working in direct partnership with other stakeholders and that panels had greater impact when voices from diverse stakeholder groups were included. Thus, the PLC decided it should be dissolved and its members integrated into CTTI’s Steering Committee as of January 2015. Furthermore, representatives of the patient community should have responsibilities and representation equal to all other stakeholders at CTTI. In the case of patient advocacy organizations, this includes applying and paying a nominal annual fee for membership rather than being convened as a distinct entity via invitation. The leaders recommended that individual patient and caregiver representatives should continue to be selected via competitive process for positions that include travel support to ensure their ability to participate.

In sum, the message from this body of thought leaders is clear: The patient community must be equal partners in every aspect of the clinical trial enterprise in order to improve the quality and efficiency of clinical trial; Patient Engagement 2.0 is a final step for achieving this at CTTI. Stay tuned for recommendations from CTTI’s project on Patient Groups & Clinical Trials. For information on applying for CTTI membership, click here.