Fun and frolic prevail during the holidays, but when it comes to the conduct of clinical research, there can’t be any reindeer games. In order for clinical trials to run smoothly, timelines must be maintained and all areas of compliance must be upheld. When patients don’t follow protocols, “Nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects…” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5066799/) In addition to concerns surrounding patients, there are also issues around site management that need to be addressed. Here are three quick tips for clinical trial sites navigating the most wonderful time of the year.
Anticipate Staffing Issues
While many individuals request paid time off during the months of December and early January, operating without a full staff may negatively impact study timelines and patient care. Well ahead of the season, review schedules and keep communication clear with colleagues to avoid gaps in coverage.
Optimize Operations Proactively
Initiating trials is resource intensive and a successful study start-up “…sets the tone for clinical research and is crucial to the overall success of a program. The critical nature of this phase places significant pressure on all stakeholders.” (https://www.centerwatch.com/cwweekly/2018/03/12/successful-clinical-trial-begins-study-start-phase/) It may seem counterintuitive to delay the start of a trial, but it’s essential to ensure that both study staff and patients have adequate bandwidth and engagement levels to meet and adhere to protocol objectives. Is the clinical trial already initiated? Schedule monitoring visits with the holiday dates in mind. Make plans for the PI (Physician Investigator) and staff to share, review and submit documents remotely so data can be verified off-site, if necessary.
Verify with Vendors
Getting packages in the mail is part and parcel of holiday excitement. Receiving packages in a timely manner is critical in clinical trials, since biological samples and medication can be date sensitive in the extreme. Do you need to make special arrangements to ship specimens, etc.? Avoid delays and unnecessary drama with a proactive approach to shipping.
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