Clinical Trial Success: How Relationships Are Key
Jeffrey Zucker, Vice President of Feasibility and Recruitment Optimisation at Worldwide Clinical Trials, offers strategies for establishing and maintaining key relationships, and advice on how sponsors and CROs can build and enhance site partnerships to optimise study execution, from trial start-up and recruitment through to implementation.
The relationships between sponsors, Contract Research Organisations (CROs) and study sites can present many challenges in clinical trial planning and execution. Any relationship can be complicated, but the way in which these parties interact with each other can have a significant impact on the overall success of a clinical trial.
Site Relations and Alliances
With the evolving trend towards patient-centric trials, combined with the introduction of technological solutions that improve clinical trials outcomes such as risk-based monitoring and electronic clinical outcome assessments, there is a need for sites and investigators to be re-engaged to improve the clinical trials process. Relationships are increasingly created via email, Skype, text etc., and while technology has clear time and cost benefits, today’s researchers can still learn a lot from when communication and processes were less reliant on technology.
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.’ While traditionally, communication between a site and the sponsor or CRO has been driven via the CRA, if all parties want to improve interaction and build stronger relationships, they need to create additional communication links and structured processes. CROs and sponsors need 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.
Most sites relish the opportunity to be more involved. They can offer insights on operational issues which can improve the protocol assessment, study start up, patient recruitment, and data quality. Ultimately, a collaborative design process will benefit all involved and result in more positive study outcomes.
Site Relationship Process
Building and maintaining site relationships should be a structured process. Starting with early engagement with site/network leaders. A solicitation meeting should take place as soon as possible, at which a mutual confidential disclosure agreement should be put in place to share information 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 should 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 should 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? Site identification: how is the site going to become one of the sponsor/CRO’s preferred sites? Issue escalation: how will this be handled without undercutting the CRA? Communication: frequency is key but it should also be with purpose, so how will this be managed?
Collaboration at all levels is vital to create effective processes. To execute the process effectively, all involved must follow the escalation and communication strategies established during planning. One or two site visits per year, in addition to ad-hoc meetings as needed, is practical. That said, this will vary from site-to-site and should always be tailored for each relationship.
Additionally, group meetings with key investigators can be a successful way of gaining feedback. Industry conferences can create a forum where people can raise issues and come up with solutions together. Finally, collegial relationships, based on openness and trust are important, to build lasting relationships and successful partnerships.
Sponsor and CRO Benefits
CROs and sponsors should work very closely together when interacting with study sites and utilise strengths of any existing relationships. When possible, they should attend meetings together to set up relationships, and maintain this throughout the trial.
Ultimately, better site engagement and strong relationships come from great communication. Proactive communication can not only improve site commitment, but will avoid delays in responses which can result in strained and difficult relationships, accelerate the consultation process, speed up the start-up process, and result in higher quality outcomes.
By creating a strong synergy with sites, sponsors and CROs can utilise the site’s relevant experience and knowledge to improve protocol design. Sites can provide information which sponsors and CROs may not know. For example, a site may be experienced with running trials for a specific indication, and are therefore ideally placed to offer valuable insights on how the study should be executed from a practical operations point of view.
This information sharing does not always have to mean changing protocols, but could be used to support recruitment and retention, and will also assist in highlighting any challenges that are likely to occur. Transparency is key – even if alterations to the protocols cannot be made. Gaining input from the sites will mean sponsors are aware of the potential impact of a suggested design before the trial begins.
For sites, fostering strong relationships with sponsors and CROs also has its benefits. Early and frequent engagement during 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 throughout the study.
Furthermore, by agreeing upon processes and operating procedures in advance, all parties are aware of the expectations from the outset. Sites can also share best advice from previous similar studies, and recommend other suitable sites to engage with if appropriate.
As well as engaging sites from an operational point of view, sponsors and CROs must seek advice on clinical excellence. By reading articles, attending conferences, working with associations, including the Center for Information and Study on Clinical Research and the Association of Clinical Research Professionals, and linking with relevant support and advocacy groups, sponsors and CROs can aid understanding, learn about the latest developments and share information.
Communicate with Purpose
While the importance of communication has been highlighted, it is important that sponsors and CROs manage the frequency and nature of this, to avoid becoming a burden.
While visiting sites shows dedication and is critical to building site relationships, this can be balanced with phone calls, Skype meetings and emails, etc. to ensure communication is timely and cost effective. Most sites appreciate hearing from sponsors and CROs on a consistent basis, as it demonstrates that they are being supported.
Despite the increased complexity of today’s clinical trials, by improving communication and setting clear expectations and goals for each other, sponsors and CROs can make it easier for sites to conduct trials and improve commitment. However, in order to achieve this, they must consider sites as true partners throughout and beyond the study. Furthermore, by maintaining post-study communication, sponsors and CROs can not only sustain the important relationships they have created, but also take learnings from the work carried out and use this to influence future trial design and execution.
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