2021 LS&HC Horizons - Flipbook - Page 17
Life Sciences and Health Care Horizons 2021
visits)? For example, will those systems need
to comply with the agency’s regulations for
electronic records at 21 CFR Part 11?
• How will FDA ultimately view the integrity of
data from clinical studies that were temporarily
suspended due to supply chain disruptions or
where there are numerous protocol deviations
and missing data points?
We are closely monitoring these issues, as well
as FDA’s longer term adoption of more flexible
standards for clinical trials.
Diversity in clinical trials
It is increasingly important that clinical trial
populations reflect the racial and genetic diversity
of the ultimate users of the product under study.
In November 2020, FDA finalized a guidance on
enhancing diversity in clinical trials. The guidance
recommends several approaches to increase study
population diversity with regard to demographic
characteristics (such as age, sex, race, ethnicity, and
location), as well as non-demographic characteristics.
The new recommendations include broadening
study subject eligibility criteria by using real-world
data to find participants and using mobile medical
professionals to visit participants at their locations
instead of requiring clinic visits. The final guidance
also has new information on the inclusion of racial and
ethnic minorities, advancing community engagement,
and making recruitment events more accessible. Last
fall, we analyzed the guidance in a piece titled “A step in
the right direction,” and we see this trend – highlighted
by vaccine wariness and the conditions surrounding
the pandemic – as likely to continue especially as the
Biden Administration promotes racial equality as a
chief priority.
Since FDA issued the final guidance, we have seen
many study sponsors implement new strategies to
enhance diversity in their clinical trials. For example, as
part of the routine evaluation process for new clinical
sites, many companies now include a standard set
of questions asking potential investigators about the
diversity of patients under their care. In other cases, we
have seen sponsors implement recruitment strategies
to attract more diverse patients into their studies. Of
course, in rolling out new programs such as these, it is
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important for study sponsors to assure that they are
complying with all ethical standards related to subject
recruitment, as well as with privacy laws that may limit
what type of race and ethnicity data may be collected
about patients before they have signed a privacy
authorization or informed consent form.
Despite the benefits of the tools we discuss above, the
pandemic has delayed subject enrollment and left
operational gaps in many ongoing clinical trials,
which in turn has had a negative impact on trials
programs and clinical data integrity – all in a time of
regulatory uncertainty.
Our clinical trials team helps companies tackle some of
the most challenging clinical research issues. We have
advised many clients on the impact of COVID-19 on
clinical trials, including issues related to patient travel,
force majeure claims from clinical trial vendors, travel
reimbursement, study conduct, supply chain issues,
maintaining compliance with good clinical practice,
and minimizing risks to data integrity. In these
challenging times, our unmatched global resources
and industry experience can assist you in developing
practical strategies for clinical trial design and negotiate
the necessary agreements to enable you to quickly and
smoothly initiate or restart your clinical trials around
the world.
Rob Church
Partner, Los Angeles
robert.church@hoganlovells.com
Heidi Gertner
Partner, Washington, D.C
heidi.gertner@hoganlovells.com
Meredith Manning
Partner
Washington, D.C. and Denver
meredith.manning@hoganlovells.com
