Managing Clinical Trial Sites During the Holidays

Introduction

Clinical trial management during the holiday season is tricky, to say the least, but it can be done. We are presenting five essential tasks that work to minimize clinical trial interruptions based on the unique challenges principal investigators face this time of year. The holidays are a time when principal investigators must do significant pivoting to deal with a high number of staff vacancies and schedule manipulations.

Additionally, the holidays coincide with the cold winter months, which unfortunately tend to contribute to common illnesses such as colds and the flu. This increases the likelihood of difficulties in both staffing and protocol adherence. Consequently, investigators should be ready to implement contingency plans without hesitation. With the improvements in technology, remote and decentralized monitoring options can be easily facilitated and beneficial when in-person visits are difficult. [1]

The Five Essential Tasks to Help Minimize Clinical Trial Interruptions

Address the Needs of Clinical Trial Subjects with a Skeleton Crew

Most seasoned investigators forecast some obstacles surrounding staff availability during the holidays as year-end paid time off (PTO) scheduling comes into play. It is common for clinical trial management teams to oversee trials with just a skeleton crew in place for several weeks. Meeting the needs of the clinical trial subjects must continue and stay on track. Subsequently, anticipating foreseeable staffing shortages should be included in the clinical trial plan by performing a complete operational assessment. [2] Communication and attention to detail will factor heavily into this equation. The clinical management team must be vigilant to avoid possible clinical trial protocol deviations.

Pocket List:

• • Create a calendar of planned holiday vacancies for both subjects and staff.
  • Collaborate with other clinical teams to help bridge gaps ahead of time to ensure trained, qualified, and approved research teams are available to carry out study conduct.
  • Amp up routes of communication and regularly test remote accessibility options.
  • Assess wearable and remote technology options to collect study data (if the protocol permits).

Create a Flexible Clinical Trial Management Strategy to Accommodate Schedule Limitations

During this time of year, clinical trial subjects will undoubtedly have plans (both expected and unexpected) that may interrupt the intended flow of the trial. It is up to investigators to design a flexible alternative plan for both planned and unplanned interruptions. Accomplishing these complex calendar adjustments will require next-level organizational skills and much patience. Your team will often be forced to pivot to ensure samples are collected on time, medical check-ins are administered, and other data reporting activities are appropriately aligned with the required submission dates. [3]

Pocket List:

• • Include availability questions early during the recruitment process.
  • Take advantage of any available opportunity windows to fill in scheduling gaps.
  • Send email/text reminders at regular intervals with details about closures, limited hours, or alternate access routes.

Facilitate Electronic Source Data (ESD) Access and Remote Planning for Investigators

The type of ESD technology [4] that is available and used may change in the winter months, depending on the type and location of the study. Remote clinical trial site locations may present problems with connectivity. Also, accessibility may become limited since many technical systems are shut down for maintenance at year’s end. As a result, investigators should coordinate with system engineers for more details. This is especially important for mobilized clinical trial services [5].

Forecasting any potential lapses in connectivity due to harsh weather conditions (winter storms) is also recommended, in addition to outfitting clinical trial subjects with the tools needed for self-reporting. The devices should be user-friendly, and investigators must incorporate a plan for device training in advance. All data collection methods and devices should be included in the approved protocol before use.

Pocket List:

• • Review historical clinical site information to assess potential interruptions.
  • Contact service providers.
  • Triple-check emergency numbers and other relative information.
  • Regularly perform tech maintenance (battery testing, device back-ups, cloud access, and user controls).
  • Explore options for up-to-the-minute subject monitoring and remote adverse reporting tools.

Determine Regulatory Submission Holiday Deadlines

A well-organized investigator designs a clinical trial management strategy with holiday deadlines in mind. The investigator should anticipate the submission dates and prevent delays by ensuring the essential documents and regulatory binder are up-to-date. Sometimes, submission deadlines are extended to account for holiday absences, but it is not an accommodation to count on.

Pocket List:

• • Evaluate historical holiday trial data to gain insight.
  • Incorporate holiday regulatory considerations into an advanced staff training session.
  • Team up with clinical trial subjects and help them understand your deadlines to foster cooperation.
  • Review essential documents and regulatory binders to determine accuracy and completeness.
  • Place clinical trial and FDA sources of information at your fingertips for quick adjustments.

Coordinate Schedules with Adjunctive Service Providers and Clinical Trial Management Team

Though it may feel like playing Tetris with the calendar, consider all laboratory services, deliveries, radiology, sample collections, and other third-party providers when coordinating the holiday schedule. Investigators should also include timely training prompts for any necessary adjustments to trial conduct.

Identifying any communication gaps early in the clinical trial can also prevent miscommunication or missing communications in the future. Merging these navigation points into the emergency plan is imperative. Addressing some scenarios with a carefully articulated action plan can help alleviate potential staff panic. For example, examining a series of what-ifs is an effective way to identify areas of vulnerability. Consider the following possibilities:

• Failure to reach a clinical trial subject following a vacation or holiday.
• Failure to reach a team member or provider following a vacation or holiday.
• One or more senior staff members are out with unexpected illnesses.
• A clinical trial site becomes unreachable or closed because of hazardous road and weather conditions.
• One or more adjunct providers close for a week or more or have restrictive hours.
• The clinical trial physician is unable to continue delivering services due to illness.

Summary

The main objective of our essential five lists is to find ways to make clinical trial management during the holidays less stressful for your team and your clinical trial subjects. In addition to the five essential tasks, investigators should find innovative ways to bring a cheerful vibe to the trial process and show appreciation for both the team and the subjects.

For example, holiday mugs, blankets, thank-you cards, or special incentives might invite more collaboration on the part of the trial subjects. Clinical trial subjects may choose to partake in a trial to give back during the holidays. [6] Therefore, staying mindful of ways to improve their experience is essential.

References:

1. [1] Takei, Kuniharu, Wataru Honda, Shingo Harada, Takayuki Arie, and Seiji Akita. 2014. “Toward Flexible and Wearable Human-Interactive Health-Monitoring Devices.” Advanced Healthcare Materials 4(4):487-500.
2. [2] Smith, Sharon L., Galia Siegel, and Ashley Kennedy. 2020. “Assessing the Operational Complexity of a Clinical Trial: The Experience of the National Institute of Mental Health.” Clinical Researcher 34(3).
3. [3] Molloy, Síle F., and Patricia Henley. 2016. “Monitoring clinical trials: a practical guide.” Tropical Medicine & International Health 21(12):1602-11.
4. [4] S. Food and Drug Administration (FDA). 2013. “Electronic Source Data in Clinical Investigations.” Accessed December 14, 2022.
5. [5] Perry, Brian, Cindy Geoghegan, Li Lin, F. Hunter McGuire, Virginia Nido, Brigid Grabert, Steve L. Morin, Zachary P. Hallinan, and Amy Corneli. 2019. “Patient preferences for using mobile technologies in clinical trials.” Contemporary Clinical Trials Communications 15:100399.
6. [6] n.d. “How Digital Medical Devices Are Meeting the Challenges Of Clinical Trials.” Accessed December 14, 2022.
7. [7] Clinvest Research. n.d. “Why Phases of Clinical Trials Matter – Be a Medical Hero for the Holidays.” Accessed December 14, 2022.