Improving Site-Sponsor Relationships Leads to Transparent Clinical Trials
One of the most complicated and multi-faceted relationships in clinical research is the relationship between sites and sponsors. As clinical trial numbers rise – as of June 15, there are 73,157 open studies listed on clinicaltrials.gov – so does the demand to bring the drug product to Food & Drug Administration (FDA) approval and market. The need for communication and understanding between sites and sponsors is prevalent now more than ever.
For Sites: Be Thorough
Leading up to site selection, a lot of time and effort is placed on sites to complete a protocol feasibility assessment. Therefore, while taking the time to be detailed in an assessment may initially seem time-consuming, it may save sites time in the end and could increase their chances of securing a specific protocol at their site.
There are many different ways to be thorough in a protocol feasibility questionnaire and answering some questions may require some sifting through previous studies. Understanding trends in past studies can help sites prepare for future ones and makes it easier to predict factors such as enrollment. If at all possible, don’t inflate enrollment estimates – it’s better to underestimate numbers rather than overshoot. Don’t be afraid to ask for an extension in enrollment, either. If a site has been efficient in enrollment, extending a deadline can make all the difference in meeting recruitment requirements.
Detailing a site’s capability to enroll a certain amount is key – sites need to understand the metrics they are providing and be able to explain those numbers as well. Guessing or anticipating what sponsors want to hear will ultimately hurt sites, sponsors, and the research in the end if they underdeliver on their protocol. At the end of the day, sponsors want to execute a successful protocol design and to be mindful of which sites will carry out the protocol. If one protocol doesn’t suit a site, that doesn’t mean the next one won’t. If there are any confusing portions of the feasibility questionnaire, seek clarification from the sponsor. Not only does that show a vested interest in the protocol, but it ensures the questionnaire will be answered fully and correctly.
For Sponsors: Practice Open Communication
Communicating with sites about expectations will go a long way to help sites be successful and sponsors meet their goals. Additionally, by stating clear expectations on the protocol feasibility questionnaire, a sponsor is more likely to receive well thought-out answers by sites. The benefit of clearly explaining feasibility also helps sites determine if the protocol is a good fit. Making changes such as allowing comments or free text spaces encourages sites to expound on their answers, further giving sponsors a greater idea of how a site could be a good fit for the protocol.
Throughout the process, keep sites’ statuses updated. Oftentimes, sites go weeks and months until they hear feedback from sponsors relevant to the protocol they applied for. If they are rejected for a potential protocol, take the time to send a rejection notification and rationale behind it. While it may seem awkward or there may be pushback from the site, receiving rejection notifications will help build a relationship long-term by building trust. The more details a sponsor can provide to the site as to why they weren’t selected for a certain study, the more sites can begin to understand what exact information is needed when pulling together the feasibility assessment.
Providing feedback to sites also helps them build stronger programs or identify which opportunities in the future they would be best suited for. Helping sites become aware of their strengths and what they can provide to future studies also allows sponsors to identify the sites best fitting their protocol needs and abilities. Like any relationship, this process will take time. The more efficient the relationship between sites and sponsors, the better the chance of moving a drug through the protocol in its entirety, getting to market quicker.