Contract Research Organizations (CROs) play a vital role in the clinical trial process, providing Sponsors with a range of services, including project management, monitoring, protocol development, site selection, regulatory submissions, and data management. However, CROs also face the challenge of managing complex communication between a variety of stakeholders, including Principal Investigators (PIs), site staff, and Sponsors. With that being said, effective communication is essential for the success of any clinical trial.
The multifaceted nature of CRO-led clinical trials can often lead to communication challenges, with stakeholders having different priorities, perspectives, and communication styles. Additionally, time zone differences, language barriers, and cultural differences can further complicate communication. Sensitivities to the language and cultural differences are paramount in developing a respectful and understanding attitude towards these business relationships.
PIs may be juggling multiple trials and time to communicate with CRO staff is limited. Therefore, the volume of communication being disseminated from the Sponsor or study related requirements can often be seen as overwhelming. Moreover, site staff themselves may be overwhelmed by the demands of multiple studies and have limited time for communication. Site staff may also require more robust training or experience to complete source collection, data entry and regulatory obligations. PIs may also be reluctant to share negative feedback, for fear of jeopardizing the trial. CRO teams may be spread geographically, across time zones, which may prove to be a challenge for response time expectations and meeting scheduling. CROs may have their own communication styles and preferences which may differ from that of the Sponsor and sites. Sponsors may have different expectations of the CRO to meet deliverables. Additionally, Sponsors may delay trial decisions which in turn may delay the trial process.
By taking steps to improve communication, CROs can create a more collaborative and efficient environment for successful clinical trials to take place. Clear communication channels and expectations should be established at the start of a trial. This includes identifying key stakeholders and defining their roles and responsibilities and establishing preferred methods of communication. There are a variety of communication tools and technologies available to help stakeholders stay connected and collaborate effectively. This includes video messaging, email, and document sharing platforms which are cloud-based. A combination of these measures should be used efficiently so the volume of communication is under control and value is provided for key meetings and updates to deliverables.
All stakeholders are encouraged to promote transparency and open communication. This includes sharing positive and negative news, and promptly raising concerns which, gone unresolved, could become findings in an audit. CRO teams should provide regular updates and feedback to Sponsors and PIs on the trial status, while Sponsors and PIs should provide regular feedback to the CRO team. More specifically, the CROs weekly reporting of study metrics to the sites should be robust, as problems can be identified, corrected, and minimized as the trial progresses. The role of the Clinical Research Associate (CRA) is vital in keeping this communication consistent with the requirements in the Clinical Monitoring Plan (CMP).
CROs investing in communication skills training has proven to be helpful. For example, CROs like Linical provide a comprehensive CRA Academy, where Sponsors can be confident that CRAs have a solid foundation in monitoring as well as communication among stakeholders. See-one and do-one visits with seasoned staff help CRAs to “speak the language of a study” while utilizing what they learned in CRA academy. Ongoing training on SOPs and study related updates further solidifies this knowledge base.
By implementing these strategies, CROs and their stakeholders can create a more collaborative communication environment that will contribute to the success of current and future studies and, most importantly, the safety of patients.
Author:
Alaina Dobos
Senior Clinical Trial Manager - Linical