Shepherding Therapeutic Cancer Vaccines through Clinical Development | Page 7

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Designing and conducting clinical trials
Study design. When planning phase 2 trials, the advantages and

A digital CRO can
provide benefits
in terms of
managing
complex trial
logistics.

disadvantages of single-arm versus randomized should be considered (FDA
Guidance, 2009). Randomized phase 2 trials typically lack statistical power for
conclusive demonstration of efficacy, but they can provide valuable information
for designing the statistical plan in phase 3 confirmatory trials.
Placebo-controlled clinical trials are preferred for scientific reasons, and the FDA
strongly encourages sponsors of novel cancer vaccines to perform pivotal
studies with such controls. However, for obvious ethical reasons, placebocontrolled designs may compromise the provision of the best standard-of care
treatment to the study population. Either cancer vaccines or co-administered
immune stimulatory agents can cause reactions that make the patients treated
with cancer vaccines easily identifiable. To maintain blinding, the team
administering the investigational agent may need to be separate from the team
performing post-procedure subject care and endpoint assessment.
The effects of other cytotoxic or immunomodulatory treatments on the
investigational treatment are important to consider. The use of concomitant
therapy should be clearly justified, with consideration for its mode of action,
dose, and administration schedule.

Better study management with technology. Most Sponsors and

CROs use some level of eClinical technology, but their platforms are usually not
integrated. A digital clinical research organization (dCRO) can provide benefits in
terms of managing complex trial logistics, especially when it is necessary to
coordinate surgical oncologists and pathologists with medical oncologists,
apheresis centers, and immunotherapy manufacturing sites. In addition, a
digital approach enhances safety and data collection. A fully integrated
technology platform enables viewing and monitoring the number of patients
enrolled at every investigator site, which can help ensure the study is on track
from the start. If enrollment is below expectations, study teams can quickly
adjust strategies to drive enrollment. Once the study is fully underway, the
ability to view data, across all sites at every level, allows for quick identification
of trends and potential problem areas.

Investigators and study centers. Investigators must have access to
the specific types of patients needed for a trial, and it is best when their staff
members are engaged in the clinical research process and know good clinical
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