A couple weeks ago, the Forte Forum, an industry conference dedicated to promoting and supporting excellence in clinical research, took place in Dana Point, California. Attendees engaged in the half-day Site Empowerment workshop, led by Beth Harper of Clinical Performance Partners. A very interactive session, the workshop revolved around techniques for ensuring more productive sponsor/CRO communications. The primary areas of focus were reverse feasibility questionnaires and standard site profiles and scorecards.
Related article: A Look Back at the 2015 Forte Forum [Conference Recap]
Reverse feasibility questionnaires – know your site’s stopping point
There are a number of challenges sites are facing when it comes to deciding which studies they should take on. Workshop participants gathered in small groups and considered which questions have a significant impact on whether they move forward with a study opportunity. For example, one attendee stated, “We find it’s very important to establish that the CRO/sponsor will accept our site’s SOPs rather than trying to dictate how the site conducts the study. If this isn’t done up front, it can cause a lot of problems and result in failed relationships and/or trials.”
To decide what they need from the sponsor/CRO, each group determined their “must-haves” and “nice-to-haves”, each split into two categories – up front during the feasibility phase and then if selected for the trial. From those discussions, a list of the top prioritized “must-have” reverse feasibility questions was developed. All of this was compiled into a “consensus document” that represented the thinking of the group with regard to the primary reverse feasibility questions that can really drive study acceptance decisions and foster more productive sponsor/CRO communications. It serves as a good starting point as sites embrace more proactive engagement strategies during the feasibility and start-up stages.
The key takeaway from this exercise was that sites need to know how to limit the time and money they spend on activities before getting the mandatory information they need to know if they will move forward with a study. Sites need to look at what can be applied up front to help sponsors understand the importance of having the answers to these questions. The questions to which they need answers are different at each stage – feasibility questionnaires, site selection and final acceptance – and sites need to know what they won’t spend time doing (whether that’s IRB approvals, budget negotiations, etc.) until they have those answers. Knowing how much time can go unaccounted for and how much money can be wasted, sites need to be more proactive and enforce what it is they need to advance to the next stage.
What can sites do?
- Be choosy early. Know what your “must-haves” are right away and find ways to thoughtfully explain and firmly hold to the questions you need answered.
- Be choosy in the middle. If the budget doesn’t fit, don’t move forward.
- Be choosy at the end. Hopefully this will be rare, but do not open a trial just because you’ve gotten this far. Remember the costs of managing amendments, training, and more just to keep a study open.
- Explain “why” clearly via phone and in writing. Create evidence of your request.
- Get to the heart of the sponsor’s/CRO’s concern or lack of information. Ask them questions on why your proposal doesn’t make sense (but make sure you go in with a solid proposal).
- Know and communicate your deal breakers, and stick to them. Clearly explain the consequences of the sponsor/CRO not giving you what you need in writing. Give examples such as, “I’m ready to move forward with this study once you do x….”
- Some things don’t apply here. You want to stay on good terms with your CRO/sponsor contacts, long-term, but it doesn’t mean you can’t escalate. If your CRO dropped the ball, ensure you have a path of written attempts, and escalate from there. If they are not giving in to your request, let them know you’d like to speak with someone else about it. Get your PI involved if he/she is key to the study.
Site profiles and scorecards – promote your strengths and stand out in front of sponsors
From there, the group talked about what can be done to aid in the site selection process. Discussion ensued around standard site profiles, documents that provide all of the basic information about a site’s research experience, interests, and capabilities to reduce duplicate time and effort spent on providing this information for multiple studies and sponsors. Although some participants had the experience of the sponsor or CRO not accepting it or insisting on using a different form, the information is still valuable to have for both internal and external marketing purposes. An informational resource with everything in one place can help address and answer the most redundant and time-consuming questions and be easily pulled when needed.
In addition to telling sponsors what your site does, you can also show them how well your site does it. Data is a powerful language, especially with sponsors. Attendees discussed how to market their organization and attract sponsors by sharing their metrics from the Sight Insights Dashboard, a free tool in Site Benchmarks®. Sponsors are always interested in performance, so showing them visualizations on your past performance conveys your dedication and capabilities in successfully completing clinical trials. Sharing this relevant data helps back up your site’s needs and requests.
What can sites do?
- Create a marketing brochure with all of your site’s capabilities. Even if it doesn’t reduce duplicate data entry, it markets your site well and shows the capabilities in a good light, regardless of what the questionnaire asks.
- Join Benchmarks. It’s free and enables sites to provide evidence of the their ability to deliver quality results on time by easily tracking, managing, and benchmarking their performance compared to their peers, and aids in process improvement initiatives.
Related article: [Recap] Metrics Workshop – Empowering Sites With Data
All in all, the workshop was a great success. Attendees even discussed ways to keep the momentum going forward. Ideas included having regional meet-ups, a continuation of this workshop at future conferences, and participating in metrics collaboration calls. We all need to be patient as sponsors, CROs, and sites shift from older unproductive feasibility and start-up practices to these new approaches. Influencing such relationships starts with awareness. It will become easier in time, but why not start improving them now?
Learn more about site empowerment techniques
Leading up to this workshop, Forte hosted a webinar presented by Beth Harper, Site Empowerment – Envisioning New and More Effective Ways to Work with Sponsors and CROs, and published a series of site empowerment articles.