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May 19, 2016

New Study Demonstrates NIH-Funded Clinical Trial on Premature Babies Inconsistent With Usual Care, Consent Forms Inaccurate


Research Shows Need for Institutional Review Boards to Be More Vigilant

WASHINGTON, D.C. – Contrary to statements made in consent forms signed by the parents of most premature babies enrolled in a controversial clinical trial, some key procedures being used in the trial were inconsistent with usual or standard care for such babies, a new study published by researchers at Public Citizen and the National Institutes of Health (NIH) on Wednesday in PLOS ONE shows.

The trial – known as the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) – was funded by NIH and involved the random assignment of more than 1,300 extremely premature infants to receive different amounts of oxygen. One group of babies was to be maintained at a low-oxygen target range (85-89 percent) and one at a high-oxygen target range (91-95 percent). The SUPPORT researchers used oxygen monitors that were programmed to display inaccurately low or high-oxygen values, depending on a baby’s group assignment, to prevent the babies’ medical teams from knowing which trial group the babies were assigned – a research procedure known as “blinding.”

For the new PLOS ONE study, researchers at Public Citizen and NIH performed the first systematic analysis of the consent forms approved by institutional review boards (IRBs) at 22 U.S. hospitals that participated in SUPPORT. Twenty of these consent forms explicitly or implicitly described the oxygen ranges used in SUPPORT as “standard of care,” “usual care” or “a desired approach.” Consent forms used at 11 hospitals had additional statements indicating that there was no predictable increase in risk to infants enrolled in the study.

To assess the accuracy of these consent statements, Public Citizen and NIH researchers systematically identified all studies published in the English-language medical journals from 1990 to May 2014 that examined usual care oxygen management for premature babies at any hospitals in the world. An analysis of these studies revealed the high–oxygen target range (91-95 percent) tested in SUPPORT – as well as in four similarly designed trials conducted by researchers in Australia, Canada, New Zealand and the UK – was consistent with usual care at the time the trial was designed and conducted. In contrast, the analysis documented for the first time, that the low-oxygen target range (85-89 percent) tested in the experiment had not been used clinically when SUPPORT was designed and conducted. During usual care, oxygen target ranges with lower limits less than 88 percent were used at some hospitals, but always combined with upper limits of 92 percent or higher.

“The use of the low oxygen target range and monitors that were modified so that caregivers did not know the actual oxygen levels of the babies enrolled in the trial clearly represented significant deviations from what was usual or standard of care for extremely premature babies,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group and a co-author of the PLOS ONE study. “To tell parents of the babies enrolled in SUPPORT that all of the trial procedures were consistent with usual or standard care — and therefore involved no predicable or expected increase in risk — was a significant misrepresentation, a violation of research ethics.”

The PLOS ONE study presents novel data that not only supports, but goes beyond the 2013 finding of the U.S. Office for Human Research Protections that the consent forms for SUPPORT failed to disclose to the parents of the babies the inherent risks of the trial.

The lead author of the study was Dr. Irene Cortés-Puch, a visiting fellow at NIH. The study was co-authored by Dr. Robert Wesley, a senior biostatistician at the NIH Clinical Center, now retired; Drs. Robert Danner and Charles Natanson, critical care physicians and senior investigators at the NIH Clinical Center; and Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group.

The study authors note that for critically ill patients with high mortality rates – such as extreme prematurity – basic interventions such as oxygen therapy may be lifesaving. Clinical trials that change care for such patients can have serious – even fatal – consequences. Prior to designing a trial involving critically ill patients, such as SUPPORT, researchers must:

  • Thoroughly review all available literature describing usual care practices;
  • Rigorously evaluate actual clinical practices at institutions intending to enroll subjects; and
  • Perform appropriately designed pilot studies to identity unexpected effects of experimental procedures (such as using oxygen monitors that display incorrect readings).

Following these steps will provide researchers with important information regarding how proposed trial interventions might affect care relative to usual clinical practices.

“Clinical trials trying to study usual care must first fully characterize and understand the range and complexity of current practices,” said Natanson. “Failure to do so can lead to an underestimation of the risks posed to research subjects.”

“One key lesson from our study is that IRBs must have access to detailed information about usual care before approving protocols and consent forms,” Carome added. “This is particularly important for research purported to be testing interventions consistent with usual care.”

Read the study.

See Public Citizen’s work on SUPPORT.

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