The relationships between sponsors, clinical research organizations (CROs) and study sites present many challenges to a clinical trial. Indeed, the way in which these parties interact with each other can have a significant impact on the overall success of the study. With the increasing trend towards patient-centric trials, it is my opinion that sites and investigators are being somewhat forgotten in the process. They need to be re-engaged. Relationships are increasingly being created via email, Skype etc., and while technology has clear benefits in terms of both time and cost efficiencies, today’s researchers can still learn a lot from the time when communication and processes weren’t electronic. It is important that the industry continues with its patient-focused activity, however, it is also crucial for sponsors and CROs to balance this with increased site engagement, to forge and maintain strong relationships with site study teams ‘on-the-ground.’ An engaged site can serve as a key advocate at every level.
Ultimately, CROs and sponsors should want to make it easier for sites to work with them as they are the ones carrying out the work, and therefore can provide valuable input to support effective protocol development. The majority of sites which Worldwide works with relish the opportunity to be more involved. They can offer insights on operational issues, before, during and after a trial, which if used effectively can improve protocol assessment, study start up, patient recruitment, and data quality. Ultimately, a collaborative design process will benefit all involved.
In building and enhancing site relationships, there are several factors which sponsors and clinical research organizations should consider.
1. Managing Site Relationship Processes
Building and maintaining site relationships needs to be a structured process which starts with early engagement with site leaders. A solicitation meeting should take place as soon as possible, at which a mutual confidential disclosure agreement (CDA) can be put in place so information can be shared back and forth freely. A face-to-face meeting should also be set up with the main study coordinators, including the principal investigator at which lines of communication will be agreed. This meeting should also discuss potential pain points for the sites, sponsor and CRO, and how these could be addressed.
Next, high level processes need to be agreed for the following; Pre-award input: how is the sponsor/CRO going to reach out to get a site’s input on protocols, rather than just perhaps issuing a survey? Site identification: how is the site going to become one of the sponsor/CRO’s preferred sites and vice versa? Issue escalation: how will this be handled (by all parties) without undercutting the CRA? Communication: frequency is key but it should also be with purpose, so how will this be managed? To create effective processes, collaboration at all levels is vital.
2. Increasing Sponsor and CRO Interaction
Clinical research organizations and sponsors will benefit from working very closely together when interacting with study sites. When possible, they should attend meetings together to set up relationships, even when there is an existing relationship, and maintain this throughout the trial. Ultimately, better site engagement and strong relationships come from great communication. Being proactive in communication can not only improve site commitment, but will avoid delays in responses which can result in strained relationships, accelerate the consultation process, speed up the start-up process, and result in higher quality outcomes.
3. Delivering Site Benefits
For sites, fostering strong relationships with sponsors and CROs also has its benefits. Early, as well as frequent engagement with protocol design and program development will result in a clinical study which is easier for them to execute, and consequently, most sites will thrive off the opportunity to contribute not only at the start, but throughout the study. Being involved in planning will mean clinical study sites know what to expect, and are aware of exactly what they should be looking for when it comes to patient recruitment, allowing them to be proactive and optimize start-up in a tailored fashion, giving the study the best chance of retention.
4. Engaging Physicians
As well as engaging sites from an operational point of view, it is also important for sponsors and CROs to seek advice on clinical excellence. By reading articles, attending conferences, working with associations including the Center for Information and Study on Clinical Research (CISCRP), the Association of Clinical Research Professionals (ACRP) and Mission Model Agreements & Guidelines International (MAGI), and linking with relevant support and advocacy groups, sponsors and clinical trial companies can aid understanding, learn about the latest developments and create opportunities to information share.
5. Communicating with Purpose
While we can talk about the importance of regular communication, it is also incredibly important that sponsors and CROs manage the frequency and nature of it, to avoid becoming a burden, which could result in the opposite desired effect. Visiting sites shows dedication, and face-to-face interaction is essential, however, this should be balanced with phone calls, Skype meetings and emails etc., to ensure communication is time and cost effective.
By improving communication and setting clear expectations and goals, sponsors and CROs can make it easier for sites to conduct clinical trials and improve commitment. However, to achieve this, they must consider sites as true partners throughout and beyond the study.