NCI-funded trials and spotlights key information from the patient perspective (
Eligibility criteria are prioritized over other information, and one-on-one assistance is offered via
web chat, phone and email.
Advocates and advocacy groups also use the
internet to share news of promising trials. Some do
so via social media sites like Twitter and Facebook.
These groups often have a large number of follow-ers affected by a particular type of cancer, making
it easier to ensure that people who might be eligible are aware of the trial. Other groups host their
own disease-specific trial finders, like the curated
search tool provided by the Fight Colorectal Cancer
advocacy group (
trialfinder.fightcrc.org). The NCI
offers an open version of the framework that powers
its search engine to any groups that are looking to
build a searchable trials tool.
PARTICIPATING IN TRIALS
Goldfarb lived about eight miles from her trial site
on the campus of the National Institutes of Health
in Bethesda, Maryland, so she avoided some of the
challenges faced by trial participants who don’t live
near the trial location.
In the future, technology may be able to help cut
down on travel requirements for patients who do
live a long way from their trial site. For instance,
an investigator could make contact with a trial
participant via video call in lieu of an in-person
visit. This provides the researcher with a better
sense of the patient’s condition and general well-being than a phone call, while allowing the patient
to remain at home. Routine data collection like
blood tests could be carried out at a local medical
facility, with the sample and its results being
shared with the investigator either physically or
digitally. Certain patient data could be collected
on an ongoing basis using wearable technology—
from something as simple as a step counter that
measures daily physical activity to an electrocardiogram to evaluate damage to the heart
caused by chemotherapy or radiation.
These methods for conducting clinical trials,
sometimes referred to as “virtual” or “siteless”
trials, are still taking shape as researchers learn
more about what works and what doesn’t. Most
current trials of this type focus on conditions
that are not life-threatening, which reduces
the risk of unintended consequences due to less
One issue with siteless trials that has already
been identified is the challenge of providing
remote oversight for participants. To address this
issue, Center Point Clinical Services, a private
company based in Fargo, North Dakota, that helps
pharmaceutical companies carry out trials, is
testing a technique that expands the role of the
pharmacist. On behalf of the investigator, a phar-
macist from the same geographic area as the trial
participant works directly with the individual
and with the participant’s regular pharmacist to
monitor health and catch any unintended out-
comes of the trial.
In the past, data collected during clinical trials
have been kept private for a variety of reasons. A
pharmaceutical company might be more likely to
publish clinical trial results that are positive rather
than negative, or hold off on publishing successful
outcomes lest they give competing companies a head
start on creating a rival product. Others would prefer
to avoid the risk of infringing upon patients’ privacy,
rather than commit to sharing the data widely.
The Food and Drug Administration Amendments
Act of 2007 introduced monetary penalties against
anyone who fails to submit required clinical trial
information. These rules aren’t always followed—
results from the first trials subject to these penalties were due in January 2018. According to
All Trials, a project that promotes more open access
to research, required information from nearly 700
trials has not yet been submitted by researchers
since that deadline.
Various projects are underway to bring together
the data that’s collected from clinical research.
One such effort led by the nonprofit organization
Vivli has developed a global data-sharing platform
expressly intended to foster the reuse of clinical
research data. The platform allows researchers to
analyze anonymized data from different clinical
trials that have already been completed.