In a recent Veeva survey, 81% of respondents reported the ongoing use of manual processes (like spreadsheets and emails) to manage study start-up. More worryingly, despite the recognized need for increased clinical operations transparency and efficiency, the same survey report cites that study start-up is no faster than it was a decade ago, even considering the widespread adoption of multiple types of clinical applications.
Regardless of the ongoing industry-wide challenges of study start-up, however, a successful start-up phase is crucial for the overall health of your TMF and clinical trial. Initial essential document creation and collection continues to be the central and most resource-intensive component of study start-up. The success of the start-up phase greatly impacts the quality and speed with which these initial documents enter the TMF. Miscommunication, delays, and issues related to initial essential document collection can produce regulatory risks that may linger well into trial conduct and beyond.
So how can study start-up set you up for TMF success, even if the available tools and processes aren’t reaching their full potential? LMK’s top three principles for smart study start-up are actionable steps designed to maximize your TMF resources and build a strong foundation of TMF health.
Find the Starting Line
Employing the latest clinical application technology to streamline study start-up is a goal we should all strive for. However, for the 81% of us still using varying degrees of manual processes in study start-up, understanding the types of media generated during start-up (paper or electronic) and the workflows those media will flow through (email, eTMF, mail, etc.) will greatly inform how we prepare a study start-up plan. Considerations like access control and training for electronic media, as well as chain-of-custody mapping and storage requirements for paper media will begin to inform the people, processes, and timelines that will contribute to the success your trial’s first step. Jumping into start-up without understanding the needs and idiosyncrasies of your clinical trial greatly increases the potential for unforeseen risks and challenges to derail your start-up phase.
Develop an Ideal Scenario
After fully understanding the resources and constraints associated with your specific project, a true clinical operations and start-up plan can be developed and implemented. Just as the TMF should contain the story of the harmonious execution of your clinical trial, a study start-up plan should begin by envisioning the ideal scenario for study start-up within the constraints you’ve identified. Identifying the multiple sources of documents and the associated workflows that bring these documents to the TMF is a great start. Beyond tracing document workflows (and revising them if necessary), your start-up plan should also include metrics to help your team understand the health of your start-up phase once it is underway. Start-up metrics could include items like time duration between essential document pack availability and completion, cycle count of revisions to the regulatory document pack, or first-cycle completion percentages for specific regulatory documents. Even after the start-up phase is complete, your archived metrics provide a clear path to learn from mistakes and allow the efficient incorporation of lessons learned into your next trial’s start-up plan.
Practice Makes Perfect
Study start-up is a social undertaking. Many diverse trial stakeholders will be in contact with one another, therefore the strength of interpersonal relationships across your team contributes greatly to the success of study start-up, the TMF, and the trial as a whole. Respect these relationships by ensuring communication flows equitably across your trial and by giving all stakeholders the chance to practice their role before the workload truly ramps up. Consider validating your start-up plan by competing some or all of the start-up document workflows with your most experienced or most collegial staff. Identifying and mitigating a class of risks or a specific issue before study-wide start-up activities begin could save the start-up timeline, your TMF’s health, and valued professional relationships.
Finally, remember that study start-up comes with real world challenges. The realities of a dynamic clinical trial ensure that your ideal scenario will be tested with unforeseen factors. But, by building a strong foundation for your trial by understanding constraints, planning and communicating achievable start-up goals, and practicing your plan before study-wide deployment, the early health and quality of your TMF during the start-up phase will be a sign of the good things to come.