Compliance Corner – News Round Up

February 28th, 2017 by Sharon L Nelson, MSN, RN, CNS, CIP, Executive Director, Consulting and Compliance Services

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Clinical Promise and Safety in First-in-Human Studies

In our January wrap up of 2016 events, we speculated the ripple effects of the French Phase I trial gone wrong would endure as we continue to learn and seek ever better means to protect the rights, safety and welfare of research participants. In this month’s Nature, bioethicists Jonathan Kimmelman and Carole Federico, argue that current human subject research oversight systems are not adequate to protect volunteers in first-in-human trials.

They call on ethical review boards to “focus on clinical promise as well as safety to hold the first tests of drugs in humans to a higher standard.” As counterpoint to claims by “[IRBs] and clinical investigators…[that] they lack the resources and background to conduct such assessments,” the authors propose creating a centralized first-in-human advisory system combining ethical and scientific review.

The writers offer three questions to assist reviewers in assessing clinical promise:

  1. What is the likelihood that the drug will prove clinically useful?
  2. Assume the drug works in humans. What is the likelihood of observing the preclinical results? How well do animal models reflect human disease?
  3. Assume the drug does not work in humans. What is the likelihood of observing the preclinical results?

Read more here.

Addressing Participant Diversity in Clinical Research

IRBs routinely evaluate equitable subject selection during new study review, considering inclusion/exclusion criteria within the context of the study’s purpose and setting. Depending on the specific situation, an IRB may question why a certain demographic is not included in the study’s target population.

Arthur Allen, eHealth Editor for Politico Pro, asks whether our new drugs and medical devices are being tested on the wrong mix of people. In “Do We Have the Right Guinea Pigs,” Allen addresses the concerns that arise when the safety and efficacy of new treatments are assessed in and approved on the basis of testing in individuals who do not reflect the make-up of the current US population.

Citing the findings of University of California researchers, Allen points to underrepresentation of minorities in clinical trials for cancer, cardiovascular disease, diabetes and asthma. Failure to honor diversity in clinical trial recruitment and enrollment raises the potential for serious impact on our health delivery system to provide quality care to our diverse population. An example is the antiplatelet medication clopidogrel: decreased response to clopidogrel is common among Asians, yet in some US cities with large Asian populations, clopidogrel is on the formulary as a drug treatment of choice. Allen speculates that racial differences in response “might have been found earlier if the clinical studies that led to FDA approval had been more racially inclusive.”

But not all scientists and clinicians agree. David Jones, physician and historian, holds “that racial differences in response to drugs or treatment are relatively uncommon, and rarely clear enough to guide treatment decisions.” Asserting that social and economic factors affecting access to and compliance with medication may have a stronger bearing on an individual’s response to a drug, proposes research focused instead on treatment non-adherence.

So, how to reconcile the differences? Allen closes with an eye toward the NIH’s Precision Medicine Initiative – recently renamed “All of Us.” The program aims to enroll participants from diverse social, racial/ethnic, ancestral, geographic and economic backgrounds, from across the age and health spectrums, representing “the hope for all of us to come together to change the future of health care.”