Change of Season

Springtime adverse effects can affect compliance and recruitment for clinical trials

The Change of Season May Impact the Conduct of your Clinical Trial

Happy Summer Solstice. As we enjoy a long midsummer day today in San Francisco I am considering the impact that the change of seasons has on clinical trials.

Most trial timelines will span several seasons so as Trial Managers, we try to predict the impact of seasonal challenges on the execution and length of our trial. Then we plan around the challenges and factor them into our timelines.

Whereas my puppy, Larry David only considers what impact the longer days will have on the length of his walks.

larry david Yorkshire Terrier

Summer: “Hot town, summer in the city”

In the US, summer makes me think of thunderstorms, floods, hurricanes and all the unavoidable pass-through costs I will receive from my CRAs who frequently get stranded due to cancelled and re-routed flights at this time of year. I brace myself for protocol deviation reports related to Investigational product temperature excursions. I also think about my colleagues and Investigators in Europe who seem to disappear for weeks at a time (sometimes months) on holiday.

Fall: “All the leaves are brown and the sky is grey”

image courtesy  G. Alttman - geraltOK, so the song lyric I picked is really talking about a winter’s day but just as the leaves change colors and we harvest the grains, winter weather starts in Autumn. Cooling temperatures will lead to delayed shipments, more shipping/storage temperature excursions, and transportation difficulties for trial subjects. In your Adverse Events, you may see a corresponding higher incidence of the common cold and flu-like symptoms.

Winter: “The sky is a hazy shade of winter”

Winter has always been my toughest recruitment challenge. Like many of our furry friends, potential trial participants seem to go into hibernation. The December/January timeframe can be a slow time for recruitment in the North East due to the inclement weather and holidays. However, if you’re recruiting in Florida for a trial that lasts less than 12-weeks, this time period is ideal for enrolling snowbird subjects and completing conduct before they migrate back home.

Almost forgot my coat on a winter day

Luckily I live in sunny California so one of my biggest challenges is simply remembering to pack an appropriate coat that is warm enough when I travel out of state.

spring flowersSpring: “Here Comes the Sun”

As the flowers start to bloom, I’m reminded of the corresponding increased reporting of adverse events. Blossoming flowers and trees bring with them allergic rhinitis, watery eyes, headaches, and fatigue to introduce noise into the database. These springtime effects can wreak havoc on a poorly timed early-phase pulmonary trial and impact recruitment and compliance in all trials.

Anything else to consider?

Regardless of which seasons your trial will cover always collect vacation schedules for the entire trial team (Principal Investigators, drug development colleagues, vendors, CRO staff, etc.) six months in advance and check back regularly to capture any changes of plan. It is much easier to plan for vacations than react to them if they were unexpected.

If you’re working on a global trial and you have sites in the opposite hemisphere don’t forget to plan for all the same seasonal effects, only in reverse. What have I overlooked in considering the impact of the seasons on clinical trial execution? I would love to hear your thoughts in a comment or you can contact me via email.

I hope you enjoyed this article (really just a fairly transparent and shameless excuse to post a picture of my dog). In any case, give yourself 10 points for reading the whole thing, 15 points if you think my yorkie is cute, 10 points if you happen to like all the songs that I snuck into the subheadings, and 10 additional bonus points if one of the songs is now stuck in your head. 😉 Feel free to post your score in the comments. Maybe I can come up with a prize.

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About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

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