1. Create one point of contact for sites
Oftentimes, research centers work on roughly 10 or more trials at the same time, each recruiting participants all for the same patient population. Perhaps unsurprisingly, every sponsor involved believes their study needs to be put first, and typically, the study coordinator is under duress due to the demands of the clinical trial. By setting up a system that accounts for site information and contacts, sponsors can manage developments on site more efficiently. Furthermore, establishing a single point of contact for the sites makes life easier (and more convenient) for site staff. The ability to answer queries and address issues in real time, can aid processes for site staff, especially when considering the workload of juggling multiple trials at the same time. Such a move on the part of the sponsor could go some way toward changing the relationship between sponsors and sites, and may end up reducing delays in study start-up.
2. Streamline processes by cutting out unnecessary tasks
When planning a clinical trial, it’s crucial to include the site’s point of view. By engaging their input from the planning stage, you can put in place procedures and processes that make life easier for site staff, ensuring operations can run in an orderly manner. How can you achieve that? For a start, draw on past studies, gathering previous feasibility data and site performance metrics. By doing so, sponsors are showing sites they’ve considered their efforts to put the patient first.
The same logic can be applied to onsite trainings whereby the same training can apply to multiple studies, ultimately saving staff hours of time. Furthermore, trainings should also be accommodating to site staff; if the study coordinator has a long journey into work, ensure they can access training modules online to make life easier. By taking simple steps to cut out the bureaucracy and busy work, it demonstrates to sites that the sponsor has considered the needs of the staff.
3. Harness the power of the Feedback form
Always recognize and acknowledge areas you as a sponsor can improve processes by having site staff complete feedback forms. The insight gleaned from those can help guide future study documents and protocols. If you take the protocol, both the principal investigator and the study coordinator, more often than not, will review it with differing perspectives. They might spot various problems with the study that were especially difficult for the patient based on either their age or the advanced stage of their illness.
This feedback will aid in constructing future protocols as it will help avoid potential deviations and amendments. What’s more, it will allow site staff to take greater responsibility over the protocol and the trial, fostering trust between the sponsor and the site. It will also allow staff to feel more assured in conducting the trial, recruiting participants, and gathering accurate, pertinent data. Placing great trust in site staff to carry out their roles and responsibilities will augur well for a successful clinical study.
*Adapted from A 3-Step Guide to Improving Sponsor-Site Relationships by Adeline Mullin