I am pleased to announce a second guest writer for Trials without Tribulations. Allyson Cygnarowicz is a project manager at Health Decisions with more than 13 years of experience in clinical research, including phases I through IV pharmaceutical studies and all levels of pre- and post-market device studies. She has a particularly strong background in diagnostics starting with her days in microbiology, when she developed assays that remain in use today. Ally holds a Bachelor of Science degree in Microbiology from the University of Pittsburgh and Masters of Business Administration and Business Management degrees from Point Park University, Pittsburgh, PA.
As evidenced by the Metrics Champion consortium, the pharma industry’s appreciation for metrics-driven trial management is growing. At Health Decisions, we have been utilizing a metrics-driven approach for years. We rely on a trial management portal that provides more than 30 KPIs and comprehensive, continuously updated dashboards. However, we never forget that the performance of site personnel is critical to trial success. The hypothetical performance indices in the dashboard shown reveal not only specific concerns, but also the need to work more effectively with site personnel.
Many investigative sites are involved in multiple studies, often for different indications and patient populations, with myriad participants returning for multiple visits per protocol. Dealing with all that on top of caring for non-research patients can sometimes leave site personnel feeling overwhelmed. A study of paramount importance to a sponsor and CRO may slip in the site’s priorities.
What can sponsors and CROs do to motivate sites to meet timelines, screen and enroll subjects and progress rapidly through our studies? Here are six tips and tricks for successfully motivating sites:
1. Remember the Fine Line Between Motivating and Nagging –There is a fine line between requesting information or discussing issues and nagging. Like people everywhere, site personnel respond better if you have the skill and diplomacy to stay on the right side of that line.
2. Prioritize Establishing Good Working Relationships with Sites – There is no substitute for getting to know site staff. This requires attention because it doesn’t always happen spontaneously. Establishing working relationships doesn’t mean allowing chitchat to interfere with monitoring, but it does mean asking how the site feels the study is progressing and fostering a sense of shared goals and common involvement in an important project.
3. Train, Train, Train! –Ensuring that sites are confident in their ability to perform study procedures is among the most important startup tasks because such confidence motivates sites to enroll subjects and meet target dates for FPI. The Investigator Meeting and/or Site Initiation Visit should ensure that site personnel understand study procedures. The Study Procedures Manual should outline all tasks, especially those not included in the protocol.
4. Offer Financial Incentives –Most sites can’t accept incentives such as gift cards for meeting or exceeding enrollment targets. However, there are effective incentives that sites can accept. For example, the site agreement can stipulate greater compensation for participants 20-40 than for participants 1-19. This can motivate sites to enroll as quickly and efficiently as possible.
5. Make Study Tasks Easier for Sites –Making tasks easier for site staff minimizes time demands on site personnel and stress associated with participant visits. Focus on making it easy to follow the protocol, complete CRFs, collect data and ensure participant safety and adherence. Create aids such as laminated summaries of inclusion/exclusion criteria and study procedures. Ensure availability of easy-to-access packets of necessary supplies for subject visits. Provide easy-to-follow CRFs and clear instructions for completion.
6. Be Available and Responsive – Sponsor and/or CRO staff need to make addressing site questions or concerns a top priority if they want site personnel to make their study a top priority. Sites must be able to trust their Sponsor and CRO to answer questions promptly.
Dashboards and performance metrics allow project managers to understand study status at a glance, identify problems and decide on corrective actions. Because actually fixing most problems falls to site personnel, closing the loop that starts with performance metrics requires motivating site personnel to do what metrics indicate has to be done.
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