Decentralized Clinical Trials Raise Concerns About Informed Consent

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The growing use of decentralized clinical trials has raised serious concerns regarding verification of patient comprehension and proper informed consent. The solution, says Dr. Harsha Rajasimha of Jeeva Informatics, is to leverage the full potential of digital technology.

Due to the pandemic, clinical trials have taken a more digital approach, but recent research shows a worrying lack of patients’ informed consent to the treatment they are undergoing.

With digital communication, prospective clinical trial participants can ask questions, discuss the trial with investigator team, to complete a proper informed consent remotely. Trial sponsors can translate background material, including educational videos, into as many languages as needed.

Under pressure of the COVID-19 pandemic, multitudes of clinical trials of new medications and treatments have moved to a decentralized model, bringing them to the patients rather than having patients come to a central trial site such as an urban medical center.(1) At the same time, recent research shows a worrying lack of patients’ informed consent to the treatment they are undergoing.(2) “This,” says Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics, “is not an acceptable situation. The extent to which patients comprehend the consent they grant is essential to the ethical conduct of medical research.”

Informed consent as defined by the U.S. Food and Drug Administration does not, Rajasimha points out, mean simply getting a research participant’s signature on a consent form. It includes:

  • Providing enough information to allow for an informed decision about participating in the clinical investigation
  • Verifiably ensuring the potential participant understands the information
  • Enough time for the potential participant to ask questions and discuss the trial with friends and family
  • Obtaining the potential participant’s voluntary consent to participate
  • Continuing to provide clarifications as the study progresses.(3)

Objections to clinical trial management
Both regulators and participants, says Rajasimha, have raised objections to decentralized clinical trials. Regulators including institutional review boards (IRBs) view informed consent as a divine contract between researchers and patients that is foundational for trust building. Their objections include a lack of ability to:

  • Verify the patient’s comprehension via a quiz or questionnaire;
  • Provide convenient means for the patient to ask questions;
  • Document—presumably through a signed letter of agreement—that the patient has understood to what he or she is consenting.

Participants, says Rajasimha, raise their own objections to the informed consenting process. They tend to include:

  • A sense of compulsion—that this may be the only chance they have to see the doctor before making a decision;
  • A sense of being hurried to make a decision within a 15-min consultation;
  • Cultural humility and aspects such as language or religion—having a faith, for example, which precludes their doing something on a seven-day-a-week schedule.

The best way to deal with these issues, suggests Rajasimha, is to use human-centric technology to resolve these objections. For both trial regulators and participants, the basic concerns are free information exchange and verification—both parties understanding what has been told—and a way to resolve side issues.

With digital communication, he notes, prospective clinical trial participants can ask questions, discuss the trial with investigator team, to complete a proper informed consent remotely. Trial sponsors can translate background material, including educational videos, into as many languages as needed. Enabling participants to join a trial from any browser enabled device that they are already comfortable with—smartphone, tablet, or laptop—can also create better ties with the community.

“Both sides need options,” says Rajasimha. “Clinical trial participants need to be able to get information from the comfort and safety of their own homes. Trial sponsors need to make the field of participants as diverse as possible, and at the same time they need to make sure they’re getting informed consent. Digital technology—particularly bring your own device (BYOD)—is the way to satisfy all stakeholder requirements.”

In Other News…
Dr. Rajasimha will be at the 40th Annual J.P. Morgan Health Care Conference, which is currently under way until this Thursday, Jan. 13. The conference, which is taking place in a virtual format, gathers global industry leaders, up-and-coming companies, innovators, and investors at the largest and most informative health care investment symposium in the healthcare and life sciences industry.(4)

The conference gives hundreds of companies the opportunity to connect with thousands of investors from around the world. Present at the event are companies representing the entire health care community, including pharmaceutical firms, health care service providers, medical device manufacturers, profit and non-profit health care companies, and others.(5)

About Jeeva Informatics
The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology in itself is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company’s modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. Visit https://jeevatrials.com/

1.    “No Place like Home? Stepping up the Decentralization of Clinical Trials.” McKinsey & Company, 28 July 2021, mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials.
2.    Pietrzykowski, Tomasz, and Smilowska, Katarzyna. “The Reality of Informed Consent: Empirical Studies on Patient Comprehension-Systematic Review - Trials.” BioMed Central, 14 Jan. 2021, trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04969-w.
3.    “Informed Consent for Clinical Trials.” U.S. Food and Drug Administration, fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials.
4.    JP Morgan; About the 40th Annual J.P. Morgan Health Care Conference”; Accessed 04 Jan 2022; jpmorgan.com/solutions/cib/insights/health-care-conference#about
5.    Digital Health Today, Events; January 2022; Accessed 4 Jan 2022; digitalhealthtoday.com/events/jp-morgan-global-healthcare-conference/

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