Strong Ethical Programs Can Improve Patient Recruitment, Retention

Alison Bateman-House, PhD, MPH, MA, NYU Langone

Alison Bateman-House, PhD, MPH, MA, NYU Langone

One of the biggest hurdles holding back clinical trials as a care option is the physician’s and/or patient’s misperception that participating in a trial is directly beneficial to the patient, said Alison Bateman-House, PhD, MPH, MA, an assistant professor with the Division of Medical Ethics at NYU Langone Health.

“We’ve got to address that,” Bateman-House told attendees of the Clinical Trial Collaborations conference this week in Cambridge, Mass. “The objective of treatment is to benefit the patient,” she explained. “The objective of research is to obtain generalizable data.”

Those are two different goals that hopefully overlap in most cases. However, the challenge is to better explain the real dynamic during the informed consent process without making a cumbersome process worse. “In many, many cases” trials are of tremendous benefit to participants’ health, Bateman-House said. However, the benefit might also come more in the form of a long-term impact on broader research efforts.

Failing to make this distinction clear at the outset threatens to reduce participation in clinical trials, Bateman-House warned. Otherwise, patients may begin to believe a trial isn’t being done for them as much as it is being done for the sponsor or contract research organization, she said.

Ensuring Patient Safety and Ethics in the Trenches – Join us at ACRP 2018 in just two weeks for this interactive exploration of ethical issues in clinical research. This session will address the importance of ethics and patient safety with passion, props, and audience participation. Speakers will lead an active discussion of ethical and patient safety considerations related to informed consent, inclusion and exclusion criteria rationale, the difference between clinical care and clinical research, and much more. View Session Details

ACRP 2018

While she remains an enthusiastic proponent of using clinical trials as part of clinical care, Bateman-House voiced several other concerns as an ethicist, including:

  • Which questions are being investigated in a trial—and which aren’t.
  • Who has access to trials—and who doesn’t.
  • Quality of informed consent/comprehension of trial purpose or lack thereof.
  • Post-trial access to the trial treatment. “I deal with this a lot,” she said. In some cases, it’s because the data aren’t valuable enough to publish, but patients are frustrated because they feel they gave time and effort to the trial.
  • Transparency of data post-trial. Where this had been constricted in the past, Bateman-House sees “a huge sea change” here where information sharing is on the rise. Social and governmental change are the big drivers, she said.
  • Lack of compensation for research-related injury. Unlike most industrialized nations, the United States does not offer this inducement.

Finally, Bateman-House echoed other presenters at the conference, saying that it’s not easy to share clinical trial information with the public. She expressed some optimism about one solution in that, while there have been many complaints about its value, recently wrapped up a two-year overhaul.

Author: Michael Causey