How to Set and Meet Expectations for Your Clinical Trials: Track Staff Effort

Kristina Lopienski
November 28th, 2017

It’s not uncommon for sites to make inaccurate estimates before a trial kicks off, whether it’s enrollment predictions or how much time it will take to complete certain activities. This often leads to delays down the road and (unpaid) time spent on various activities that take much longer than originally anticipated.

To ensure the right expectations are set and met, we share an excerpt from the free eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials.” Here are a few ways sites can better estimate the required resources for their studies.

Document work effort throughout the study

Since there is often disparity between site and sponsor perceptions of work effort, it’s best for sites to capture the true work effort involved in performing clinical research. During study conduct, sites can track how much time it takes coordinators, regulatory, financial and other staff to complete various activities, including those that result from protocol changes and amendments.

In the absence of objective supportive data, sites may underestimate the true effort and related costs (including staff salary costs) involved in performing any given task. Protocol acuity and complexity and patient population play a large part in determining work effort. Evaluating and managing these are critical aspects that affect workload. Understanding the time and effort needed from study startup through closeout (and every step in between) makes for better decision-making.

To start effort tracking at your site, download this eBook and gain insight into the time your staff spends on certain activities. Learn how to start small, stay focused, communicate and use your results.

Take time to evaluate if the study went according to plan

It’s always a good idea to look back and see if the expectations that were set match the reality. Clinical trials are typically delayed, so the more you can go back and see where inaccurate estimates and prolonged activities occurred in the process, the more you can use this information for future planning.

Sites can do this throughout the life of the trial. If there’s a good relationship and communication with the sponsor, sites can renegotiate the budget to ensure the appropriate resources are paid for and can be dedicated to completing the study according to plan.

Sites can also give feedback to the sponsor to close the communication loop and also use this information when making decisions about which trials to take in the future. In turn, sponsors can use this information for developing future protocols and setting expectations with sites that conduct them.

Learn More

The tips above can help with trial planning and budgeting, but that’s just the beginning. For more advice on improving feasibility, and other topics to improve communication, download the eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials.”