The success of a clinical trial depends on the successful collaboration between sites, CROs, and sponsors. This means that timely and effective communication between the sites and the sponsors is pivotal.
Miscommunication and missing to address each other’s queries on time can lead to a strained relationship that can affect the clinical testing.
To build a strong rapport from the start of the trial, here are the best practices that CROs and sponsors can adopt to make site collaboration and communication better.
1) Improve communication and collaboration
Often sponsors don’t have enough visibility on what’s going on in the research site, especially on day-to-day operations that are time-sensitive. Hence the demands on sites to do more often get overwhelming for sites. Thus, it is important to streamline information exchange for faster and effective communication. Often sponsors and CROs use different communication modes like emails, file sharing, portals, and eTMF applications to exchange clinical trial data.
A site can use almost 12 different electronic systems at a time to gather data. Moreover, a site may support multiple studies at a time, which means they need to learn using all the technologies and be agile in capturing and recording data. Using cloud-based solutions to share clinal testing information can streamline data sharing, improve communication, and help sites and sponsors collaborate better.
2) Share enrollment updates regularly
During the enrollment phase, sponsors can share enrollment updates with the sites regularly. Sharing updates keep the sites engaged in the trial. When multiple sites are involved in a trial, it helps sites know how they are performing than other sites in terms of patient enrollment. This often leads to healthy competition between the sites too. Finally, at the end of the trial, sponsors can summarize the enrollment data with sites. This will help sites to compare their predictions versus realities and use these data in future trial planning. Sponsors, too, can use the data to plan recruitment strategies.
3) Ask sites about hindrances
During filling out the site assessment questionnaire, ask sites to highlight their hindrances in every aspect of the study. It has also been noticed that challenges in site payment are also a common problem. With effective information sharing, sponsors can take proactive measures to eliminate site challenges and help sites work more efficiently.
4) Involve sites for better trial design
One of the best ways to gain success in study protocols is to design the clinical trial with the effective involvement of trial sites. When sites are included in the study protocol, they are better positioned to evaluate the inclusion/exclusion criteria and different data collection methods along with timelines. This will help them determine if the site staff would be able to implement the trial as designed and planned. These data can also help in better trial planning and avoid any last-minute hassles.
5) Provide feedback to sites
It is essential to communicate to the sites when they are not selected to participate in a clinical trial. Instead of providing just a rejection letter, sponsors should aim at providing detailed feedback on why the site was not included in the study. While this will help the sites to improve and prepare for the future, it will also strengthen the relationship between the site and the sponsor in the coming days.
6) Provide database access, if needed
Sites often don’t have the fund to invest in a dedicated CTMS. Sponsors may give such database access to sites to increase their professional efficiencies. Providing CTMS access to sites can help sites keep track of the progress while simplifying their operating and reporting requirements, thus improving overall operational efficiencies.
There is a lot that sponsors, and CROs can do to help sites increase their operational efficiencies in clinical testing. Effective communication will enable the preparation of dynamic reports and ultimately drive rational decision-making. The resultant effect will be reported in a significant reduction in adverse events and increased trust.