A great deal of emphasis has traditionally been placed on the sponsor-site relationship and the sponsor-CRO relationship; however, given the complexities of the current clinical research environment, these relationships are being redefined. CROs have recognized the importance of developing new approaches in order to ease the administrative burden typically placed on sites.
A common frustration for sites is the length of time it takes to receive grant or start-up payments. Many sites struggle to maintain the cash flow necessary to continue operations. Late payments from Sponsors and CROs contribute to this problem. This is obviously not sustainable for sites, and CROs are implementing stricter rules for payments to sites in order to ensure that research can continue without interruption.
Another issue for sites is CROs that do not ensure monitors are well-trained and understand the protocol. CROs should respond to these problems by restructuring their training procedures and making sure sites are equipped to support new monitoring initiatives, such as risk-based monitoring or centralized monitoring. Most specific monitoring approaches for potential issues should be identified and discussed during the feasibility process to assess the research location’s capabilities. This will also ascertain how certain responsibilities would change compared to more traditional methods.
Significant pressure is placed on sites to enroll patients quickly in order to adhere to a specific timeline. This can be challenging if sites don’t feel they have been equipped with adequate information related to the study, or were not given any opportunity to provide input during protocol development. Some CROs may attempt to alleviate this burden by stepping up the level of support offered for patient recruitment. They may increase training and other site-specific services related to each study. Sites should be encouraged to convey anticipated challenges to the CRO and collaborate to create site-specific recruitment plans aimed at minimizing delays.
As CROs search for ways to ease the burden placed on sites, technology continues to play a large part in determining new methods and approaches. This is not without its challenges, however, especially as the market is saturated with technology companies developing new products geared toward the clinical research industry. There is no doubt technology offers a solution to many problems that arise at all levels, but sites are often left to deal with multiple electronic platforms as they simultaneously conduct several studies. This can increase confusion among the staff as they must be trained to operate all systems and software, and must keep up with an ever-increasing list of login information and passwords.
These issues will continue to be a heavily discussed topic, and sites and CROs can work together to leverage better relationships. Creating preferred relationships between sites and CROs will help both sides operate more efficiently, particularly at the site level, as the start-up process is simplified and the administrative burden is lessened. Emphasizing this relationship is a win-win for both parties. CROs benefit from having a network of preferred sites that are ready to activate immediately on a new study. This gives sites access to more studies and provides a channel for sites to voice concerns and stay abreast of what may be coming down the pipeline.
CROs and sponsors are certainly taking notice of the importance of ensuring site success for all studies; however, it is important for sites to be proactive about setting the tone for stronger CRO-site relationships. Active communication is key in this process; remain clear and direct regarding what information and tools are needed to successfully conduct a study. Consider a “Reverse Feasibility” questionnaire when a new study opportunity is presented. The questionnaire might vary depending on the needs of the site and the state of the existing relationship with the CRO, but it will likely include requests for more detailed information regarding the protocol or clarification of inclusion/exclusion criteria. Information gained from the questionnaire will enable the site to make an informed decision regarding participation in the study and will further provide the CRO with better data to make more accurate enrollment and timeline predictions.
Ultimately, a site that is assertive and proactive about requesting information to clearly determine expectations will operate more efficiently. The site may also be less likely to make commitments that are not likely to be met. Traditional methods may need to be challenged, but overall, maintaining active, two-way communication with a CRO will not only benefit the site, but ultimately lead to more successful study outcomes.
Dr. Christophe Berthoux has been the chief executive officer at Synexus since September 2010. Synexus is the world’s leading site management organization (SMO), dedicated to the recruitment and management of clinical trials across the globe for over 24 years. Email comments and questions to firstname.lastname@example.org.
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