U. MICHIGAN (US) — Large amounts of missing data in clinical trials undermine the scientific credibility of the studies and can lead to unjustified conclusions about the efficacy of drugs, biologic products, and medical devices.
Published in the New England Journal of Medicine, new research shows that results of clinical trials could be improved by trial design to limit missing data, use of flexible treatment regimens that allow for patient differences, better follow-up of participants, and employment of more scientific methods to adjust for missing data.
“Too many investigators think that you can fix up missing data at the analysis stage,” says Roderick Little, professor of biostatistics at the University of Michigan School of Public Health.
“There was a strong consensus that people are using data adjustment approaches that are too simplistic. There are better methods to handle missing data in clinical trials.”
The report, which was requested by the Food and Drug Administration, offers guidance to those who sponsor research, suggesting they work with investigators who have a good track record of following up with participants, and to consider incentives for complete data collection.
The report was commissioned as part of the FDA’s Critical Path Initiative, which its website calls a “national strategy to drive innovation in the scientific processes through which medical products are developed, evaluated and manufactured.”
The initiative’s goal is to get scientific discoveries translated into medical products that serve to prevent, cure, and treat disease. The panel’s report is expected to lead to revised FDA guidelines on how to handle data in clinical trials.
Little chaired the National Research Council-commissioned expert panel, which included researchers from Johns Hopkins University, University of Washington, University of Pennsylvania, Brown University, and other institutions in the US, Belgium, and Argentina.
Source: University of Michigan