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Holiday Hurdles in Clinical Research
With the holiday season upon us, the focus shifts from daily work tasks to planning for vacations and festivities. The holidays can be especially challenging in clinical research where strict adherence to timelines is imperative for success. Many common holiday situations can put a clinical trial at risk if not addressed early on. It is important to be as proactive and flexible as possible to plan for potential problems before they arise.
For example, working with a “skeleton crew” during the holidays can affect a clinical trial greatly if proper planning around staffing does not take place. Early review of the study timelines and activities may provide insight into where efficiencies can be gained or what accommodations may need to be made. Study team and study patient schedules need to be coordinated early on to prevent site resource shortages and protocol deviations. Failing to plan around these sorts of inevitable holiday challenges could result in an undesired outcome for both patients and sponsors alike. Below are some ideas to manage some common “holiday hurdles” in the clinical research industry.
Being Smart About Site Start-up
If planning to activate sites over the holiday season, it is important to recognize the disruption caused by site staff travel and time-off, and to keep one’s mind on the “big picture.” From an operational perspective, nobody likes a delay, so the pressure may be to initiate as many sites before the break as possible. However, in many cases it may be more prudent to delay site activation until after the holidays. While a delay may alter the trial schedule superficially, waiting until all key staff are present and engaged will prove beneficial as training efforts won’t be lost over a long break. Furthermore, performing an initiation just after the long holiday allows the study teams to proceed directly into patient recruitment activities when they are working with a full crew. In other words, understanding the effect of the holidays on information retention, engagement and momentum will prevent unnecessary and costly retraining and avoiding a “hurry up and wait” scenario.
It can be difficult to schedule a productive monitoring visit during the holidays as some sites have reduced hours, are closed on days they are normally open, or are just generally unavailable because of PTO. Being proactive and creating a holiday calendar for monitoring visits can help avoid these challenges without jeopardizing study plans. Schedule monitoring visits well before the holiday break or if possible, develop a plan with the site to provide documents remotely so that data can be verified off-site (aka central or remote monitoring) even when site staff is on vacation.
Patients’ schedules also need to be considered. Monitors and site staff should work together to develop plans around each patient in the trial, so that important visits and dosing schedules aren’t missed or delayed beyond protocol allowance. The key is preparing beforehand and providing patients with the tools and information they need before they go on vacation.
Avoid Database Lock Delays
If database lock is planned near or during the holidays (it always seems like it is, doesn’t it?), it is important to proactively schedule sufficient time with the PI to sign off on the data so as not to stall the database timeline. Many doctors plan lengthy family vacations during the holidays and are unable to visit clinical sites in person. One way to mitigate this problem is to maintain a constant line of communication with each PI. Make sure the PI has access to the EDC system from his or her home or personal computer so that sign-off can be accomplished even when the PI is unable to come to the site. The additional effort required with troubleshooting access from a different machine is minimal compared to jeopardizing database lock, since timely lock is essential for sticking to project timelines and ultimately a successful trial.
Coordinate with Outside Vendors
Everyone is worried about their packages arriving in time for the holidays, however in clinical research timely deliveries are even more critical. Clinical trials run on strict protocols and any delays in IP or biological sample shipments could have a major impact on the trial. It is imperative that medication inventories are done prior to the holidays to ensure stocks are supplied and attention is given to potential issues with sample shipments. For example, arrangements should be made with labs to avoid delays in providing samples and/or results. Special shipping arrangements may be necessary to get specimens and/or products to their destination on time. Perhaps visits must be moved to the following business day to ensure that a courier is working when important biological samples must be picked up.
It is also important to consider the holidays when planning for regulatory submissions as many of these agencies are closed and unable to receive submissions. You should know the last submission deadlines and meeting dates prior to the holidays, and do everything possible to meet those dates. Otherwise, a couple of days delay in submission could easily turn into a delay lasting at least a couple of months. Planning for regulatory submissions early on will help to assure adherence to the project schedule and start the new year off right.
Celebrate and Avoid Holiday Stress
The clinical research industry is in the business of discovering therapies to save lives and help patients with unmet medical needs. Even though times can be stressful, especially during the holidays, we must take the time to celebrate and remember what brought us all here in the first place. The most important thing is to keep your perspective cheerful and with a little planning, the holidays can still be a productive time in clinical research.