Author: Edward Triebell, Commercial Executive Director, MRN Technologies
With the ending of “SCRS West 2024: Clinical Tech & Innovation Summit,” and a little time to reflect upon the valuable sessions, presentations and conversations I enjoyed, I am left with several thoughts, influenced by an announcement shared last year at DPharm by Andy Lee, SVP, Head of Global Clinical Trial Operations at Merck – he asked the audience if we were aware that post COVID, we have lost more than 3000 sites.
Some information shared included:
- The operational challenges and frustrations faced by sites as shared last year at SCRS West 2023 seems to have made little progress.
- Florence Healthcare shared some startling statistics:
- 90% of clinical trial data the sponsor needs lives in more than 1 site system.
- Each site manages on average over 50 application log-ins.
- 81% of sites are reporting continuing or worsening turnover in the last 12 months.
- The imposition of repeated mandated training for each study, even for the same Sponsor/CRO using the same system, and no Sponsor/CRO led process for certification to reduce the training burden.
So, what has changed from SCRS West last year? Last year the foundational challenge to the industry was site staff having to operate with multiple portals, each with a unique sign-in credentials (e-mail and password), even for the same Sponsor/CRO, that often had to be written down in a binder and then the exhaustive training mandated by the Sponsor/CRO. So, in the year that has passed, has the industry sought opportunities to improve its operational challenges in supporting the success of sites?
Also, during the closing session, in a room filled with attendees, there was an informal “raise your hand if you are experiencing this situation” survey accomplished with disappointing results for our industry:
- Are Sponsors/CROs engaging sites and patients on technology to ensure usability/meets needs of protocol design? Majority Response – “NO!”
- Are Sponsors/CROs transparent to sites regarding use of technology being deployed? Majority Response – “NO!”
- Sites that have their own technology – are they having to use Sponsor/CROs’ technology to get selected? Majority Response – “YES!”
- Are Sites being compensated for training required to use technology? Majority Response – “NO!”
- Do sites have access to all portals/technology at SIV? Majority Response – “NO!”
The real question to our industry is “Why?”
Why aren’t we listening to sites? If we want positive changes to the success of clinical studies, there needs to be change and listening to the sites that are the path to patients.
Why don’t we allow more sites to operationalize through their own eSource/eClinical platforms when the industry talks about Open APIs for seamless sharing of data across portals?
One interesting aspect of MRN’s 18-year long history of supporting clinical research sites, further defined with 105,000+ home visits across almost 300 studies, implemented through MRN’s own eSource solution, not one client has ever asked MRN to use an API for patient data. WHY or maybe the question is WHY NOT?
Technology can empower significant improvements in operational capabilities and efficiencies so, why, as an industry, are we not being better allies and advocates for sites when deploying and relying on technology?
I hope SCRS West next year presents and reports on positive changes to sites.