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The Avoca Group’s Quality Consortium’s fifth annual Summit took place in May and June of this year bringing together over 250 attendees from 50 companies. This years event brought out unifying themes around innovation and patient centricity.
In May and June, The Avoca Group’s Quality Consortium (AQC) held its fifth annual Summit in Princeton, NJ and Basel, Switzerland respectively. The Consortium’s goal is to provide best practices for optimizing proactive approaches to achieve quality and mitigate risk in the outsourced clinical trials environment. According to Avoca representatives, this years’ Summits brought together over 250 attendees from over 50 companies whose discussions brought out some unifying themes around innovation and patient centricity. Several examples of process innovation that were discussed included initiatives that are being done with AQC, such as centralizing of RFI’s and audits; platforms for sharing preclinical data; evolving inspection readiness to submission readiness; and moving from lagging metrics to predictive metrics. Other innovations included crowdsourcing of protocol input and marrying Big Data with Small Data-how companies can take findings from a particular site or clinical trial (small data) and map it against their database of all trials conducted (big data) to reveal interesting patterns, trends and learnings. Patient centricity was a significant area of discussion at the meetings and keeping patients at the heart of drug development is key but represents a challenge for industry. The attendees felt that drug development stakeholders recognize the disconnect between patient expectations and industry operations, yet struggle with coming up with the “optimal” way to engage patients in this journey. However, companies are still willing to move forward with the patient-centric movement. According to Tufts Center for the Study of Drug Development, in 2012, 48% of 95 companies surveyed had patient-centric initiatives or were planning to embark on this journey. In 2015, this number had jumped to 67%. In addition, data from Tufts CSDD also shows impressive returns on patient engagement--67% of 63 companies report reducing number of amendments; 53% see a reduction in site work effort to administer protocol; and 44% note improvement in study conduct cycle time. Some patient-centric ideas coming from the Consortium attendees included the following:
But on the other hand, the challenges that were cited include:
The two 2016 Summits revealed that our industry is often at the frontier of invention: executives admit that while innovation is easy for some forward-thinking companies, proliferating new practices is hard for most, if not all companies. The Summit attendees also discussed the CROs’ role in innovation, and issued call to action issued to them to drive and share innovation based on the large volume of data, patients, and investigators handled. For example, “CROs have tremendous data of inspection findings…if there is a way to create a shared platform for these findings it will have a significant positive impact.” In the AQC’s role, one executive said, “A robust Consortium, engaged members, and a jolt of courage, may just be the right combination to accomplish the necessary paradigm shift.” Sponsored by Eli Lilly and Pfizer and led by The Avoca Group, AQC brings together 60 pharma, biotech, and clinical service companies that share a commitment to collaboratively improving the execution and management of outsourced trials.