Author: Valerie Martin, Commercial Director, MRN Integrated Trial Services
After attending SCRS West in early June, I left feeling quite sympathetic to many of the burdens sites face in today’s environment. While there has been an enormous push towards patient centricity and viewing patients as partners, there seems to be less of a push in supporting sites as partners. Sites voiced frustration with not having an appropriate seat at the table and feeling undervalued and underpaid for their efforts. It seemed evident that sponsors maintain a sort of control over sites, usually dictating the technology they must use, the training they must complete and how much their time and effort is worth. It’s this off-balance power dynamic that leads to sites using unfamiliar tech, struggling to follow complicated protocols, and needing more resources than they realistically should. This current dynamic hardly seems reflective of the fact that sites are paramount to a study’s success – if anything, sites are an equal entity to sponsors, both needing each other to succeed as a business.
Let’s consider this dynamic within the context of another industry. Imagine hiring an experienced contractor to complete a basement renovation. Then, being the primary stakeholder of the project as the homeowner, you take it upon yourself to design the project according to what your family needs. You lay out the floorplan, create the timeline to be followed, give the tradesman tools you want them to use, and create a budget that you think is reflective of the work. But without consultation or agreement from your expert contractor, you’ve handed them a plan that isn’t achievable – your floorplan doesn’t work structurally, the timeline and budget are not realistic, the team struggles with their new tools, and you’ve likely damaged the relationship you have with your contractor. You can also expect to be billed for every hour of additional work this has caused. Would we not expect the same outcome when a sponsor determines how sites should run a trial?
The role of the contractor is to guide the homeowner to the best outcome, deciding when and how certain tasks should be completed. It’s almost non-negotiable that a homeowner and a contractor would need to work as partners to achieve the best outcome for the family. It seems just as non-negotiable for a sponsor to work hand-in-hand with sites to achieve an efficient and successful study.
The focus of SCRS West was on technology that can ease site burdens and improve trial experiences for patients and sites. But before our industry can bring forth tech that truly benefits all parties, we must view and treat our sites as partners in trial design and execution.
There is wide consensus that a single sign-on system is needed and that more centralized tech platforms are necessary. But, until these solutions come to fruition, how can we move as an industry towards this equal partnership between sponsor and site? Some “quick win” solutions may be:
- More Centralized Site Budgets/Costs
This was a point raised during several panel discussions at SCRS and one that seems generally agreeable amongst sites and CROs/Sponsors. Maintaining a level of standardization will allow newer sites to better acclimate to the trial landscape and would decrease negotiations during site contracting. - Site perspective review of protocols, tech and trial planning
It would be counter-productive to include every PI or similar in the planning of trials, but there needs to be more emphasis on site partnerships outside of KOL sites. Additionally, sponsors would do well to seek individuals at their own organization with site management backgrounds that can offer their unique insights as well. This insight work is growing rapidly in the patient insights realm, but should expand to sites as well. - Consider or allow sites to maintain their own technology
This is more controversial, as many would argue it’s in the best interest of the study to have a consistent platform(s), however the reality is that the training time, learning curve and cost associated with centralizing all tech solutions for a trial may outweigh the benefit. The focus must shift to ‘how can we design a trial that is flexible enough for sites to use what is familiar to them?’