15
Dec2021

This edition of Research Ethics Roundup covers overdue trial results and ClinicalTrials.gov, increasing use of hybrid trials, reproducibility issues in cancer studies, and the Smithsonian Tropical Research Institute's #MeToo moment.

When FDA rattles its sabre, drug makers and universities start reporting overdue trial results
STAT+ | Ed Silverman

Last month, researchers published an analysis in JAMA that showed that, once FDA warns trial sponsors and universities that they need to publish their results to ClinicalTrials.gov, those institutions respond quickly, with more than 90% submitting the information after having been warned. This finding, STAT's Silverman suggests, "arrives amid an increasing push to convince regulators in the U.S. and elsewhere to boost their oversight of clinical trial results and registrations" and shows that FDA outreach is usually successful when it makes the effort to do so. FDA has not warned NIH or any other federal agencies to submit their data to ClinicalTrials.gov, the study found.

Hybrid Trials May Overtake Traditional Studies in 2022, New Data Show
WCG CenterWatch | James Miessler

Spurred on by the COVID-19 pandemic, clinical trial sponsors and contract research organizations are expecting to run more hybrid trials in 2022 than trials that are either fully remote or fully in person. Compared to the previous year, 77% of clinical trial planners said they expected to run hybrid trials in 2022, in a survey conducted by clinical trial technology company Science 37 and summarized in CenterWatch. In the same survey, Phase II and III trials are expected to become more decentralized, while Phase I trials are not expected to significantly change in that regard.

Study Finds Reproducibility Issues in High-Impact Cancer Papers
The Scientist | Catherine Offord

In 2013, researchers at the Center for Open Science launched a large-scale project to reproduce results from several dozen prominent cancer studies published between 2010 and 2012. On December 7, those researchers published two papers describing their findings. Offord reports that "the researchers managed to repeat experiments from a little under half of those studies, and found that the results they obtained were typically far less clear-cut than the ones reported in the original papers." These results mirror other findings in recent attempts to reproduce studies, both in cancer research but also in other fields, that find replicability and reproducibility lacking in many published papers.

The Center for Open Science was co-founded by Brian Nosek, MS, MPhil, and PhD, who gave a keynote address at PRIM&R's 2020 Advancing Ethical Research Conference.

The Smithsonian’s #MeToo Moment
BuzzFeed News | Nishita Jha

The Smithsonian Tropical Research Institute (STRI), according to Jha, is an "epicenter" for research climate change, biodiversity, and other fields, and is an aspirational location for scientists working in those disciplines. However, Jha reports, the workplace culture at STRI has, for years, enabled powerful men employed there to maintain a culture of sexual misconduct. This behavior includes sexual assault, intimidation, and harassment of women scientists by their colleagues. This culture, reportedly an open secret among STRI scientists, has led to a wave of departures from women scientists who were working at STRI, a "#MeToo brain drain that has cost science an incalculable toll of lost research," according to Jha.

Leave a Reply

Your email address will not be published. Required fields are marked *