ExL Pharma’s Clinical Research Operations and Worldwide Networking Summit (CROWN) for 2012 took place in Phildelphia, PA in mid-March. The CROWN event is a combination of five conferences, all co-located in one networking hall, with individual session rooms for each. goBalto sponsored one of the five conferences which was focused on clinical site feasibility, selection, and startup. The other four co-located conferences were focused on complementary areas of patient engagement technologies, forecasting & optimization of the clinical supply chain, lean sigma for pharma R&D, and Latin America clinical trials. Here are a few of my highlights and takeaways:
- The proliferation of electronic health records (EHR) at investigator sites is raising new operational questions. As more and more physician practices in the US adopt electronic health records, the industry is beginning to get real experience applying these technologies to clinical trials – several stories were shared from the sponsor, site, and regulatory perspectives. For feasibility, EHR presents a new tool to be used in assessing the enrollment potential of a particular site. For monitoring and audits, EHR presents new challenges with regards to source data access. In each of these areas, questions about patient data privacy still cause practitioners to tread carefully.
- The resource-sharing initiative kicked off in 2009 between FDA & EMA has helped highlight differences and spur hope of further harmonization. Having experienced an increase in the number of EMA inspections in the US, the impressions of conference attendees was that FDA is becoming influenced by EMA, who in general are observed to have higher expectations of scientific, detailed discussion of the protocol and whose audits generally have a wider scope, but fewer patient level findings than comparable FDA audits.
- Difficulty defining standard of care presents risks for both sites and sponsors. There is rarely consistent agreement on what “standard of care” is and how much standard of care procedures should cost. This makes it challenging for sponsors and sites to come to agreement, as the perspectives differ by region and/or by institution. The confusion may also lead to some sites both billing Medicare and getting reimbursed from sponsors for study procedures. With increased scrutiny on physician payments, this was deemed a risk worth mitigating for all parties.
- Principal Investigator responsibilities (including oversight) are facing increasing scrutiny. Experiences shared during discussions from both sponsors and sites has brought renewed focus on the importance of role of the PI as the ultimate accountable party for all research conduct under their purview. Agencies, sponsors, and even sites are being more deliberate in making sure PI responsibilities are very clearly understood and that adherence to regulations can be proven. This emphasis has also contributed to recognition that the PI need not be a physician – one site has started experimenting with using nurses as study PIs, and has seen some operational benefits.
The two days at the conference provided a forum for lively discussion between a diverse mix of sponsors, CROs, sites, IRBs, and vendors. I think all parties came away with a better understanding of each others’ perspectives and challenges when starting a new clinical trial. Feasibility, selection, and start-up continue to be challenging waters to navigate for industry; there’s a common understanding of what needs to be done, but enough variation to make each study startup a distinct project. Success requires coordinated, collaborative efforts from all parties, something that at goBalto we’re striving to make easier one study at time.
About the Author
Todd Tullis is a Senior Director of Product Management at goBalto. He has twelve years experience helping pharma, biotech, device, CRO, and research site organizations identify, select, and implement clinical development technologies andoperational innovations.