Data Safety Monitoring Boards and the Case for Publishing Negative Results

Few formal pathways exist for learning how to serve on a data safety monitoring board (DSMB), and sponsors often seek members with prior experience. At the inaugural International Society of Glomerular Disease (ISGD) Clinical Trials Summit in Galveston, Texas, Barbara Gillespie, MD, MMS, chief medical and strategy officer at ISGD and adjunct professor at the University of North Carolina, spoke with Lesley Inker, MD, MS, a nephrologist at Tufts Medical Center, about how clinicians enter this work.

The pair also discussed engaging trainees in clinical research and why negative trial results deserve a place in the published literature.

How Do Nephrologists Learn to Serve on a Data Safety Monitoring Board?

Gillespie noted she is not aware of any manual for DSMB service. As experienced members retire, she said, the field needs to identify who will fill those roles next.

Inker said her first DSMB appointment came only recently, despite extensive prior work as a clinical trial site investigator and in analyzing clinical data. A former cardiorenal leader at AstraZeneca invited her, describing it as a valuable learning opportunity.

She described the first meeting as an exercise in interpreting new, early data with restraint. “You have to infer, but you don’t want to infer too much,” Inker said, adding members must remain respectful of patients, investigators, and the study itself.

Inker said her fellow members were thoughtful about what the data did and did not show, and the committee requested alternative data presentations from the statistical team to inform decisions. She did not rely on a mentor during the process, drawing instead on her own experience evaluating changes in proteinuria and GFR.

How Can Trainees Gain Early Exposure to Clinical Trial Design?

Inker said DSMBs are highly confidential, which complicates efforts to include junior members, unlike editorial boards where fellows sometimes participate. Still, she said junior investigators need broader involvement in clinical research overall.

She is co-chairing a Kidney Health Initiative conference on GFR slope with Tom Greene, PhD, and said she is deliberately including junior participants so they gain exposure to trial design issues. Inker also cautioned trainees to recognize experts in trial design discussions can speak with conviction without strong supporting data.

Gillespie agreed, noting trial design choices are often justified simply by how the last study was done. She said fellows, not only junior faculty, should be encouraged toward clinical research before completing training.

Gillespie recalled serving as an adjudicator on the clinical events committee for the CHOIR trial during fellowship, which showed her reaching an endpoint is not always straightforward.¹ The experience steered her away from a private practice offer and toward clinical research. She joined industry shortly after the trial’s 2006 publication, expecting the renal pipeline to dry up, and has now spent 20 years in the field.

Why Should Negative Trial Results Be Published?

Inker said the most provocative moment of the summit came when a venture capital panelist called for greater attention to negative results. She noted journals rarely publish them, leaving researchers who compile trials for meta-analyses unable to account for them.

The National Institutes of Health (NIH) has named acceptance of negative results among the principles of its Gold Standard Science implementation plan.² Inker said the agency’s reproducibility priorities specifically highlight the importance of publishing negative findings.

Gillespie said sponsors do not always want to publish negative results, even though the field still learns from them. Inker pointed to two early trials of angiotensin-converting enzyme inhibitors in nondiabetic kidney disease, which her group refers to by investigator names Brenner and Toto, as examples. Combined with other trials in the CKD Epidemiology Collaboration (CKD-EPI) meta-analyses, they contributed meaningfully.³

“Those participants in the trial, they did it to have impact. We want to make sure those participants still have impact,” Inker said.

References:

1. Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006;355(20):2085-2098. doi:10.1056/NEJMoa065485

2. National Institutes of Health. Leading in gold standard science: an NIH implementation plan. Published August 22, 2025. Accessed November 15, 2026. https://www.nih.gov/sites/default/files/2025-08/2025-gss.pdf

3. Greene T, Collier W, Haaland B, et al. Clinical implications of slope of GFR in clinical trials of CKD progression. Clin J Am Soc Nephrol. 2025;20(5):632-641. doi:10.2215/cjn.0000000662