Contributed article by Art Weber, Director of Clinical Affairs, Banyan Biomarkers Inc.
One of the most important relationships that sponsors of clinical trials must manage is the one they share with their investigative clinical trial sites. As any CRA or clinical research coordinator will tell you, there is no more critical key to a successful study than a collaboration built on trust and open communication. Maintaining the excitement and enthusiasm that accompanies the start of a new study can often become more challenging than it seems. Sponsors of clinical trials will be well served by recognizing and emphasizing this critical relationship that may become overlooked or taken for granted throughout the course of the study.
With the increased outsourcing of trial-related activities, much has been written about strategies and keys to success for managing the sponsor/CRO relationship. However, it’s important to remember that no matter how good your CRO may be at whatever you have contracted them for, ultimately your study’s success depends upon the subjects enrolled by your sites, and the quality of data that they are providing to you.
CROs are contractors, vendors who we pay for performing a given task or service for us, while our sites are our partners, collaborators who are experts in their own right without whom we would not be able to conduct our studies. CROs who fail to perform as expected can be replaced, much as any site could, but the relationship between the sponsor and site is fundamentally different. While you may choose to replace or terminate a CRO for a variety of reasons, the decision to shut down a site in the middle of a clinical study can be a much different proposition that will require careful consideration and is beyond the scope of this discussion.
Sponsors often take fail to realize, or take for granted, why a site is participating in their study to begin with. In many cases, they are participating because they are good at what they do – enrolling subjects and doing research. At least you hope that is the case! However, the reality is that many times the best sites are conducting multiple concurrent studies, and will at any given time have new ones starting up or shutting down, and competing for priority with your study.
You can never safely assume that a site’s initial weeks or months of performance will be indicative of how that site will perform over the course of the study. It is important that the sponsor, and not just the CRO, communicate regularly with the study PI and study team, which will help to ensure that your study remains a priority, and that their hard work and dedication to quality is recognized and appreciated from the top. Although a CRO is “managing” the sites, we cannot assume that the sites are receiving the attention and support they need to be successful.
In the long run, you want your sites to associate you, the sponsor, with a well-run study. A sponsor of clinical trials should always consider making the investment of time and opportunity to develop a personal relationship with open lines of communication with all of their trial sites. As a general rule, when a sponsor representative is present at all site qualification and initiation visits, this demonstrates a commitment from the sponsor that cannot be replaced. Periodic visits throughout the study, or co-monitoring visits, will go a long way to help develop relationships with your sites that will pay dividends in the long run.
It’s important for sponsors to hear feedback from your sites directly. This is critical information that you as a sponsor will need as you plan future studies and commercialize your product. In the long run, you want your sites to associate you, the sponsor, and not your CRO, with a well-run study.
Another way that a sponsor can encourage success from your sites is to think ahead about the challenges they may face with your study, and do your best to address them prospectively. If there are things you can do at the sponsor level that make your site’s job easier, or that would allow them to focus on study enrollment or the quality of data, why would you not? I am often surprised hearing from sites about how much they appreciate simple things that I wouldn’t think twice about assisting them with, that other sponsors or CROs didn’t care to bother with.
There are critical activities that sites must do and assume responsibility for themselves, but why burden them with tasks you could just as easily assist them with? Streamline and simplify the study logistics and administrative activities; it allows the sites to remain focused and dedicate their time to the most critical aspects of the study.
Solicit feedback on what is working or not working for them, and listen to suggestions they have from other studies that could make your study work better for them. If sites are encountering frustration and problems with issues like data entry, ordering of supplies, shipping of samples and training of new study staff, it’s likely that they are not spending as much time on the tasks you want them to.
Perhaps the most important and rewarding benefit of a strong sponsor/site relationship is the quality of the data produced. The benefits of having your site’s work recognized and appreciated by the sponsor, as well as the CRO with whom they may interact most routinely and often with, cannot be underestimated. I often ask my sites to notify me directly when they enroll a new subject- not only because I want to be kept in the loop with overall enrollment, but also because I want them to have the positive reinforcement and feedback from the work they are doing on behalf of the study. I want them to feel free to communicate to us if problems or deviations occurred.
I don’t want to be the last one to hear about a personality conflict between a study coordinator and a CRO CRA. I don’t want a relationship in which the sites feel they need to hide mistakes or problems from us. I want all members of the site study teams to feel like their work is as critical and important as anyone’s on the study- because it is! A strong sponsor/site relationship is critical to any successful study, and you should welcome and encourage anything that will promote this, at every stage of your study.
~SOME LESSONS FROM EXPERIENCE~
- Communicate regularly with the Study PI and Study Team
- Develop a personal relationship with open lines of communication with all of your trial sites
- Be present at all site qualification and initiation visits
- Visit the sites periodically throughout the study, or conduct co-monitoring visits with the CRO
- Streamline and simplify the study logistics and administrative activities
- Solicit feedback on what is working or not working for the sites