A 3-Step Guide to Improving Sponsor-Site Relationships

6th October 2016 (Last Updated July 18th, 2018 11:56)

Adeline Mullin, Clinical Business Analyst, Vertex Pharmaceuticals, provides advice on how to improve the relationship between sites and sponsors

A 3-Step Guide to Improving Sponsor-Site Relationships

For educators, the difference between a good day and a bad day comes down to the student’s motivation to learn. A particular teacher may walk into the school room with a beautifully crafted, highly organized, seemingly thought provoking lesson plan that they’d spent an entire week preparing, but if the students are not inspired to participate, the lesson may well devolve into chaos. I know. I taught 14 year-olds.

I didn’t anticipate that I could make comparisons between my teaching experience and clinical research when I made my transition from high school teaching to the clinical setting. However, I’ve come to realize now that there are clear parallels when thinking about what motivates those around us to do high quality work. As adults, it seems we begin to assume that money is incentive enough and simply demand that the work be done rather than encourage productivity by focusing on what drives our colleagues. In an industry such as clinical research, one in which the key stakeholders are almost entirely motivated by their personal commitment to the patient, this approach won’t work. In clinical research, the relationship between the two major contributors, sponsor and site, is essential to the outcome of the clinical trial, but it is too often taken for granted. As sponsors, we are constantly looking for ways to expedite enrollment, reduce protocol deviations, and decrease query resolution time. We pressure our sites with reminder phone calls, emails and alerts. What we lack is the human element of involvement, teamwork, ownership and pride in contributing to something that will help others.  There are three concepts that I learned in my time in education that can help us to motivate our clinical sites:

1. Your favorite teacher is the one that listens to you

In high school, the student feels like everyone is telling them what to do. Each teacher assigns them a given amount of homework to stay on track within their own curriculum with little consideration for the seven other courses in which their students are enrolled. Before the student knows it, they’re up until 2 AM with eight hours of homework per night and absolutely no extensions granted by any of their teachers.

The parallel to research is obvious here. Large clinical research centers are often working on 8-10+ studies at once, all enrolling at the same time for the same patient population. Each sponsor, or even each study team within the same sponsor, feels that their study is critical path and must be prioritized. The study coordinator feels overwhelmed by the demands on his or her time.This problem can be solved by an internal communication method on the sponsor side that utilizes a robust knowledge management system to capture site information and contacts but, more importantly, values actual human interaction with sites. Sites want to speak with a designated single point of contact that can answer questions in real time, help streamline work across different trials, and provide guidance for prioritization of competing studies. This single point of contact within the sponsor can be a voice between the site and the study teams assuring that communication is clear and timely. This person will know each CRA assigned to the site and ensure that lessons learned from one visit can be applied to the next. The feeling of being listened to, supported and valued will be indispensable in changing the site’s attitude toward the sponsor. In turn, the sponsor will see a reduction in startup delays due to response time and sites will see a decrease in the amount of redundant work.

2. No one likes busy work

For my own sanity, I had almost every lesson planned well in advance while I was teaching. There were rare days, however, that I would wing it and every time I did I would later swear to myself that I’d never do it again. My students could always tell that I was unprepared. Similarly, study sites can see right through a poorly planned clinical study. 

An essential step in the planning of a clinical trial involves thinking from the site perspective. How can we make the lives of the site staff easier? How can we make our processes as efficient as possible? First, we can reduce busy work by utilizing site performance metrics and feasibility data collected from previous studies. This will demonstrate immediately to the sites that we’ve taken their time into consideration and have acknowledged their focus is on the patient, not paperwork. We can apply this same mindset to site trainings by allowing training completed within one study to apply to the next, saving the site staff hours of time. As an industry, we should move towards universal GCP trainings that can satisfy studies from multiple sponsors. Furthermore, sponsors can adopt more creative and engaging training materials and provide options for methods of completion. Does the study coordinator take the commuter rail to work? Load trainings into a mobile app for quick on-the-go completion. Does the PI like to leave the Investigator Meeting with the ability to enroll patients the next day? Offer an optional extension for attendees that prefer to get all requirements out of the way in person. By making these fairly simple updates to our processes, it will be apparent to sites that we’ve listened to them and planned ahead with their best interests in mind rather than our own.

3. If no one understands the directions, the teacher wrote them wrong

There were a few occasions during my time teaching when nearly every student got the same question wrong on the test. Though I was certain that I had covered the material, I still threw out the question and gave everyone the point. This principal can’t be directly applied to clinical data. However, we can acknowledge areas that need improvement and use site feedback to develop our future protocols and study documents.

We can begin with the early review of the protocol by the principal investigators (PI) and study coordinators. The PI and coordinator will each review the protocol with a different eye, calling out issues of complexity, order of assessments, or anything that might be particularly difficult for patients during their time in the clinic based on age or severity of illness. This feedback must be gathered prior to protocol finalization so that it can be incorporated into the first version of the protocol. Not only will this greatly reduce protocol deviations and the need for amendments, but it will also give the sites ownership of the protocol and a true partnership with the sponsor. This will allow site staff to feel confident about the clinical study into which they are enrolling patients, excited to submit high quality data, and proud that they were so closely involved with the study upon its successful completion.

Conclusion

The three teaching principals described above may seem obvious, but over time, as the educator teaches the same course year after year, these principals can be forgotten. Through repetition, a teacher can lose sight of how the student is best motivated. Similarly, sponsors can run clinical trials like a well-oiled machine. But sponsors, too, can forget that on the other side of the paperwork are doctors, nurses and coordinators executing clinical studies as an addition to their daily work helping patients. In order to motivate our colleagues at the sites, we must ensure they know they are appreciated, valued, listened to and part of the team dedicated to developing medicines that will enhance the health of their patients.