The Holiday season often brings mixed feelings for many. While it can be a time of relaxation with friends and family for some, for others, preparing for this time means ensuring business continuity despite a typical slow down. This can be a source of undue stress if it is not suitably planned for.
Clinical Trial Holiday Planning
Like other projects, clinical trials slow down but don’t stop during the holidays. Many sponsor and vendor companies have shutdowns (sometimes lasting up to a week) and site staff and clinical trial subjects take vacations.
Because of this, subject screening and enrollment typically slow down or stop, and project milestones aren’t worked on (or scheduled).
However, for ongoing subjects, trial activities must continue, to maintain both trial quality and subject safety. On large, complex trials, the suite of holiday contingencies that need to be enacted makes up a mini project in itself.
To ease the planning for clinical operations teams, we’ve created the following checklist. These activities should be completed at least a month before the holiday period. The exception is timeline planning, which should account for the holidays when each timeline is being created.
Clinical Trial Holiday Checklist
Clinical Trial Timelines (non-health authority/EC submission related)
- Examples: Overall study timeline, Poster presentation timeline, Database lock timeline
- Action: As cross-functional clinical trial teams create various timelines, they should take note of milestones that are likely to coincide with the Holidays or dates when site staff team members are likely to be out and create adequate contingencies.
Clinical Trial Timelines (health authority/EC submission related)
- Examples: Protocol amendment submission, DSUR submission
- Action: As teams create these timelines, they should account for not only internal resources, but also ask health authorities and EC if there are periods before/during/after the holidays when the HA/EC is not accepting submissions or doing reviews. Depending on the submission type, these “blackout” periods may impact overall study timelines.
Subject Enrollment
- While it’s expected that screening and enrollment will slow during the holidays, sponsors usually don’t disallow sites from doing so, and if so, so should support it.
- Action:
- Allocate at least one clin ops person on the sponsor team to review and/or process eligibility packets, etc.
- If the process requires a clinical scientist or medical monitor, this second person also needs to be allocated to the process.
- As enrollment activity can be related to IP shipments, also allocate at least one supply chain person who can address IP issues during the holiday. There may also be non-enrollment related IP issues such as temp excursions, that this person will need to advise on.
- The clin ops person needs only check email once a day and do the minimum activities required to support enrollment.
- Inform the site of each person’s email and effective dates
Subject Safety
- As lab assessments will continue to be performed and AEs identified, safety signals can arise at any time during the holidays.
- Action:
- Allocate a qualified person on the sponsor team (typically a clinical scientist or medical monitor) to address site safety inquiries or concern.
- Because safety issues can be urgent matters, this person should check their emails at least twice a day and be available by phone at all times.
- Inform the site of this person’s email and phone # and effective dates
Subject Travel
- On longer trials, there may be subjects who wish to travel during the holidays. This may require investigational product (IP) to be shipped to another location/site or other arrangements to be made.
- Action:
- Email all clinical sites to ask if there are any subjects who will be traveling.
- This will give plenty of time for the sponsor team to create and implement a unique plan for each affected subject.
Site Supplies Receipt
- Sites also need to allocate one or more people to facilitate the holiday contingency activities the sponsors put in place.
- Action:
- Email all clinical sites to ask if there are any subjects who will be traveling.
Vendor Services
- Vendors will also have their own shutdowns and contingency plans.
- Email all trial vendors to ask for this information, and to include contact info for available staff and the effective dates
- Vendors will usually send their own individual email notices with this information to sponsors and/or sites, but it may be more thorough/timely/efficient to ask for this info proactively in a mass email, collate it, and then mass email the information to sponsor team members and sites.
- For lab vendors, it’s also important to get information on:
- Sample processing schedule changes (i.e. if samples can only be received or processed on certain days)
- Shipping schedule changes (i.e. if samples can only be picked up on certain days).
- Sometimes the lab vendor will know this info; otherwise you must ask the courier (FedEx, UPS, World Courier, etc.)
- This particularly affects samples that have short stability and must be picked up on the day of collection
- If clinical sites should package samples in a different way to prolong stability due to shipment delays due to bad weather
- If clinical site local labs can accept/store/process samples in extenuating circumstances and guidance around that
- If the sponsor should send extra kits to clinical sites before the holidays to ensure sufficient inventory during the holidays
- For IP vendors, it’s also important to get information on:
- If depot staff should package IP in a different way to prolong stability due to shipment delays due to bad weather
- If the sponsor should send extra IP to clinical sites before the holidays to ensure sufficient inventory during the holidays
Timely and thorough planning can ensure your trial’s continued success. It also ensures a smooth transition to a well-deserved break for the people working on and participating in trials.
