There are a number of perspectives related to the clinical research study start-up phase and how sites can best manage issues during this critical time frame. A number of elements are involved to efficiently achieve study start-up; however, these moving parts increase the likelihood of an opportunity for delay. Many experienced research sites aim to shorten timelines by taking advantage of the lag time that occurs between receipt of the contract and awaiting finalization for actual start-up. Streamlining the study start-up phase will not only facilitate smooth management from an internal standpoint, but it also may strengthen the relationship the site has with the sponsor or CRO, thus positioning the site well for the potential to gain more opportunities in the future.
To develop efficiency in the study start-up process, it’s important to have well-established timelines and a communication strategy in place. It is extremely beneficial to explicitly outline all study start-up activities and define which staff member is responsible for each task. It may also be helpful to have an understanding of the dependency one activity might have on another so that each study staff member will be able to identify the impact his or her actions have on the entire team.
Traditionally, there could be a significant amount of downtime during the start-up phase as different tasks are handed off between the multiple steps in the process. Many electronic platforms, including CTMS, are set up to track the workflow process in real time, and can alert a team member immediately once an activity is required to be reviewed or completed. The desired outcome of tracking the workflow process in real time is to eliminate the potential of downtime. If the sponsor or CRO largely relies on traditional, paper-based methods, there could be considerable delays during the start-up process affecting timelines and study budgets. Proactively, a site will consider how communication between the site, sponsor and/or CRO is facilitated during the site selection phase and modify internal processes accordingly.
A seasoned research site is no stranger to delays and changes to the protocol during the start-up phase. It may be tempting to wait until all study information is finalized, but this can lead to significant delays further along in the process. It can be of great benefit to begin early development and production of all recruitment materials. A number of materials are useful for enrollment, including subject screening scripts, print advertisements and radio or television copy, among others. A proactive site will create the framework for these materials, and will be able to adjust accordingly should any changes be made that might affect the wording or design.
In addition to creating patient recruitment materials, there are a number of screening activities the site may conduct prior to study enrollment. A designated study team member can be assigned to review the charts of all in-house patients, and pinpoint those who may qualify for the upcoming study. The site can craft an outreach strategy based on what is learned from auditing in-house patient charts. For example, if a direct mail campaign is chosen to reach out to current patients, there are a number of tasks that can be completed early. While study-specific text directed toward the patient will need to wait until all study materials are finalized, there are a number of administrative tasks that can be completed such as printing envelopes or creating document templates. It can be difficult to carve out time to complete many of these administrative tasks once the study is actively enrolling.
Depending on the indication, there may be patient advocacy groups either online or in the community that are accessible. Researching and identifying opportunities through these groups is one proactive step in the patient screening process. Once the site receives the go-ahead, they will be prepared to engage these communities to reach out to potential patients.
Enforcing proactive measures during the start-up phase is critical not only to the successful outcome of the study, but to create internal processes that can be implemented and followed for future studies. Creating a framework and continuing to enforce these guidelines will decrease the administrative burden that is often the culprit of study delays. A proactive, versus a reactive, approach will ultimately allow for the time and resources to focus on patient care, while finding the right patient for the right study at the right time.
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. Synexus is proud to be the patient’s choice for clinical research. Email comments and questions to firstname.lastname@example.org.
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