The complexities involved in conducting clinical trials extend well beyond clinical trial protocols and study design and into a realm where we often find the greatest return — relationships. The relationship between a research site and a CRO is particularly unique and gaining more attention in the clinical research industry.
The need to establish long-term, mutually beneficial relationships is important to nearly every business. Clinical sites and CROs are no exception to this rule. In this instance, the potential return of a well-developed relationship between a site and CRO is priceless, and potentially provides life-changing therapies to others.
Working with a small-to-midsize CRO has afforded me the opportunity to work closely with investigators and study site staff on numerous trials. As studies progress, the critical nature of these relationships and the direct effect they have on successful study outcomes becomes more evident. Most, if not all, of our success as a CRO can be attributed to our mutually invested relationships with clinical research sites.
When a CRO emphasizes a site-focused approach and considers the site’s needs as a top priority, sites are able to focus on patients, thus ensuring needs are met across the board. Equally, when a site has the full support of a CRO, investigators and study staff are set up to deliver successful study outcomes. This translates to optimized startup, increased study efficiencies and meeting (or exceeding) enrollment targets.
Making the time to evaluate and understand these relationships is almost as important as the relationship itself. There is no shame in declining to participate in a study if previous experience has led to a negative return. This allows the ability to focus on opportunities to work with a site or CRO that shares a common focus on quality in a collaborative environment.
When calculating returns, zooming in on the time invested in a relationship is a good place to start. In relationship terms, time should be evaluated from the perspective of quality versus quantity. A 30 minute weekly meeting can be equally or more productive than an hour-long call every few days, as long as both sides are tuned into each other’s needs and communicating effectively.
The potential for future growth is another factor in calculating the relationship return. A mutually beneficial relationship invites challenges and motivation. The insight from a research site is invaluable to a CRO; conversely, the CRO can provide a site with a big-picture perspective and facilitate the transfer of new ideas and methods between sites. This value extends beyond a specific study, and often leads to the CRO and site going to bat for each other in regard to new opportunities from sponsors.
Finally, it is important to consider the emotional energy invested in the relationship. Any value derived from the CRO/site relationship must be offset by the emotional expense invested. When interactions leave one party feeling drained, it can outweigh the value and growth potential exponentially. Likewise, interactions that motivate and heighten energy levels between both parties can have long-lasting effects. When evaluating the energy input into the relationship, sites and CROs should take into account the long-term potential rather than focus on short-term issues. We are human, after all, and conflict is not always avoidable. The most productive relationships are those when all parties are able to resolve conflict and use it to their advantage. Ultimately, what matters most is that both parties are equally invested in cultivating a productive, mutually-beneficial relationship.
Building relationships is arguably the most important element in business and identifying the relationship ROI is the first step. Once a relationship is established, both parties can find areas for shared improvement. Sites and CROs have no limit in terms of elements to focus on strengthening the relationship — study feasibility, patient recruitment and monitoring strategy, to name a few. Fostering open, two-way communication between investigative sites and CROs is essential to identifying key areas for improvement in the relationship.
A reciprocal commitment to evolving the CRO/site relationship will ultimately benefit the research community as a whole, with the end goal of effectively bringing new treatment options to patients.
Brittany Parker is the Director of Marketing and Communications at Total Clinical Trial Management. She works closely with research sites and study staff to execute current programs and develop ongoing, long-term relationships.
This article was originally published February 12, 2018 in CenterWatch Weekly