COVID-19 Highlights Clinical Trial Training, Contract Limitations

Deena Bernstein

Deena Bernstein, Vice President for Customer Success, Datacubed Health

It’s probably an understatement to suggest the COVID-19 pandemic altered our lives in ways both significant and unimaginable. In a matter of days back in early 2020, the entire clinical trial industry infrastructure was upended, as site visits became uncertain and, in many cases, untenable, the workforce risked health and life daily on the front lines of care, and patients were buffeted by the challenges of dealing with their conditions in daily life in a brave new world.

For the panelists at an upcoming ACRP webinar, now is the time to “reflect [on] and apply what we learned” to make clinical trials better today and tomorrow, says moderator Deena Bernstein, vice president for customer success with Datacubed Health. She’ll be joined by representatives of some of the “best site networks in the industry,” including Pamela Nelson, president/CEO of Bracane Company Inc.; Melissa Holbrook, executive vice president for operations with Velocity Clinical Research; and Karri Venn, chief operating officer of Centricity Research.

Bernstein believes COVID-19 demonstrated that industry training is behind the times. “Sites need the training they need on demand,” not months later, she notes, especially when it comes to learning new technologies. “Site coordinators are not generally tech savvy,” she says. It’s also an unfair burden to train them on a technology they won’t ultimately be using for six months or later when patient enrollment finally begins, she points out.

Webinar – In the DCT Journey, Every Cloud Has a Silver Lining

Join Bernstein for this webinar on August 17, when she will moderate a panel discussion of the advantages and takeaways learned from the introduction, implementation, and adoption of decentralized clinical trials. Get tips for operationalizing DCTs with insights into budgets, contract language, remote monitoring practices, virtual visits, and more. Registration is free for ACRP Members!

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Further, it’s time to revisit clinical trial contract language, Bernstein suggests. “We have to develop new language to protect sites from things over which they have little to no control,” such as visits to patients’ homes by third-party healthcare workers during a trial, or centralized principal investigator activities.

“The goods news, if there was any coming out of [the pandemic], is it has produced this reflection point where we can look at what worked well—[at] what good came out of COVID in terms of advancing clinical trial operations [and] how to adapt new technologies”—and benefit from lessons learned during the “fight or flight” phase early in the crisis, Bernstein says.

Author: Michael Causey