As a follow up to his recent webinar, “Learn When To Accept or Decline a Study Opportunity: It’s Ok To Say No,” ClinEdge’s Associate Director of Clinical Operations, Doug Cavers, provides answers to attendee questions.
How do you recommend declining a study once you receive the protocol and even after you receive the CTA?
First, it’s absolutely acceptable to decline a study opportunity at any point during the start-up process, even if your site has been awarded and received a template CTA. Some causes for a site declining a study at this late stage of the process may include an inadequate budget, a more attractive study being awarded to the site, or a more thorough review of the protocol revealing additional issues with feasibility.
However, once you have been awarded a study and received a CTA, the sponsor/CRO team has often invested considerable time in pursuing your site. In order to preserve a positive relationship, it is helpful to provide constructive and specific feedback regarding why your site is declining the study. Sponsors/CROs will appreciate if you cite the specific areas of the protocol or budget that are leading you to decline the study. If your site has chosen a different study, let them know that you have taken on a competing trial but you would like to be considered for future studies.
As a site that sees very rare diseases, we are often pressured to participate in difficult studies focused on rare conditions where it is very hard to enroll participants. Is it reasonable to request additional funding, above per patient amount, to support staff activities throughout the study?
In such instances, it is very important to be upfront with the sponsor regarding the difficulties that your site sees in recruiting subjects for the trial. If you are not confident that your site will be able to recruit the targeted number of participants, you will want to state this clearly to the sponsor in order to maintain trust in the relationship.
If the sponsor is pressuring your site to participate and you are candid about the potential difficulties in recruitment, it is perfectly acceptable to request additional funding to support enrollment on the study. Some focus areas include:
- Patient database outreach
- Advertising for new patients
- Compensation for screen failures
However, if your site is not completely confident that these additional measures will successfully bring in the required participants, you’ll need to manage the sponsor’s expectations. Here’s a good way to frame your conversation, “We are willing to accept this study and will try very hard to recruit the participants using these additional resources, but I want to be transparent with you that we may not be able to fully enroll.” If the sponsor is pushing your site to participate in their study, it means they are in need of sites, and such statements are less likely to negatively impact your chances of being awarded.
Do you have any recommendations on how to best structure the study selection process (reviews, discussions and decisions) within a site?
First, I highly recommend creating a list of potential indications of interest to serve as a “first-line” screening tool for the studies your site should decline. This allows lower-level staff to filter out studies in areas that aren’t a good fit, pursue studies that may potentially be of interest, and escalate high priority studies to upper management.
Next, it is important that staff reviewing potential study leads are aware of your site’s capabilities. This way, if certain studies require equipment/procedures that your site cannot access, your staff will save time by declining that trial.
Are there certain websites or services that best lend themselves to attracting appropriate studies to sites?
There are a lot of databases where your site enters its information, including your key indications of interest, and receives potential study leads. However, many of these websites work through automated email blasts and you can spend a lot of time sifting through uncompetitive study leads that may not be beneficial in terms of developing direct sponsor/CRO relationships.
A large number of sites are taking advantage of a greater diversity of study opportunities they see through site networks, such as ClinEdge Network. These companies provide outsourced business development efforts to expand the number of studies your site is reviewing. At the same time, they collaborate with your site team to identify key areas of interest and develop a strategy for accepting or declining studies that will play to your site’s strengths and goals.