Last week’s MAGI Clinical Research Conference was attended by a fervent group of clinical research partners representing research sites, CROs, sponsors, and vendors (I’d estimate the proportion of attendees in each category as 50%, 20%, 20%, and 10% respectively). In each of the sessions I attended, an honest discussion and dialogue took place between these parties on one or more pain points. As I listened intently throughout the day and interacted with other conference attendees, I kept hearing the same root cause of pain across several surface level problems – transparency.
The first session I attended concerned the conduct & management of research at small sites – those sites with around a dozen or fewer clinical research staff. The consensus was that once a few solid relationships have been established, business development for a small site is not as much of a concern. But it was very clear that establishing those first key relationships with sponsor or CRO organizations which lead to the site being selected for a study is a very difficult challenge and one that site personnel think about quite a bit. When I think about what is at the heart of this problem, it comes down to a lack of sponsor/CRO visibility to and awareness of a site’s capabilities. If sites could be more visible to sponsors/CROs and if sponsors/CROs had the capabilities to find these relatively ‘research naive’ sites when they need them, we might make some strides against this set of problems.
When I attended a sponsor & CRO-focused session on best practices in outsourcing to CROs, almost every single issue I heard reeked of a lack of transparency:
- Keeping the study moving and keeping all parties aware of status & work effort coverage
- Sponsors feeling increased pressure from FDA to provide oversight of partner CROs
- Sponsors needing to deeply understand the capabilities and cultural fit of a CRO as part of the partner selection process
The dialogue was really no-holds-barred at a panel discussion entitled “Site Operations Challenges: Do You Really Expect Us To Do That?” (though I suppose from the title I should have been ready for such an open discussion!). Hot topics during this session included the additional effort required due to staff turnover (both for sponsor/CRO monitors and for site coordinators), the varying expectations of scope & completeness related to site delegation logs, and the many challenges that arise when a monitor’s expectations don’t match those of the site personnel they are visiting (or planning to visit). Particularly for the monitoring issues raised, it was glaringly obvious to me that in most cases, the people collectively working on the ‘study team’ (and I include site personnel in this definition) just are not on the same page and do not have access to information that should be accessible to all.
The most heavily attended session I witnessed was “Improving the Study Startup Process with Sites” – and I was very happy to see that the presenter had leveraged a graphic from a recent article in The Monitor by my colleagues at goBalto (Brenda Reese, the presenter & facilitator remarked upon displaying the graphic that “it gives me a headache just to look at this”!). As noted in a recent Tufts study, the #1 cause of delay in startup is thought to be budgeting & contracting. When one starts to peel the onion around this issue one finds some potential root causes all with a similar theme – contracts that sit in the sponsor’s hands while a CRO tries to play middleman, lack of reuse of old budgets & contracts that requires the same back and forth for each study, confusion over what master services agreements are in place (or need to be place) between the sponsor & site and/or the CRO & site.
Across all of my interactions & discussions with others in the field at the MAGI conference, I kept hearing problems that when probed (using a lean startup technique known as “the 5 whys”), kept coming back to the same answer – transparency. Whether between potential partners that have never worked together on a clinical study or between partners that have been working successfully together for years, the sharing and availability of easily understood information is critical to achieving clinical research outcomes more easily and more quickly.
If you liked this article and are interested in learning more about how goBalto is making clinical trials simpler and faster, send an email to ttullis@gobalto.com
About the Author
Todd Tullis is a 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 and operational innovations.
