Applied Clinical Trials
Devoting time to work on "correctable weaknesses" of research design will pay off in the long run.
Making advances in the appropriateness of research design, methods, and analysis are essential to increase value and reduce waste in clinical studies, particularly because these "correctable weaknesses" can produce misleading results, according to leading experts.
"To maximize motivation for change, reductions of waste in research will need behavioral changes, not only from researchers, but also from publishers and regulators. These changes will need external pressure from stakeholders such as funding agencies," noted John Ioannidis, PhD, Professor in Disease Prevention in the School of Medicine and Professor of Health Research and Policy in Stanford, US, and colleagues in an article published by Lancet on January 8. "Funders are eager to ensure that they get a good return on their investments; inadequate research diminishes the fiscal investment that they have made. Patients and the public also have an important voice."
They concede that minor effects can be difficult to distinguish from bias introduced by study design and analyses. However, an absence of detailed written protocols and poor documentation of research appears to be surprisingly common and insufficient consideration may be given to both previous and continuing studies, and arbitrary choice of analyses and an overemphasis on random extremes might affect the reported findings.
Several problems relate to research staff, including failure to involve experienced statisticians and methodologists, the lack of training for clinical researchers and laboratory scientists in research methods and design, and the involvement of stakeholders with conflicts of interest. Inadequate emphasis is placed on recording of research decisions and on reproducibility of research, while reward systems incentivize quantity more than quality, as well as novelty more than reliability, the authors continued.
To address these problems, they propose improvements in protocols and documentation, consideration of evidence from studies in progress, standardization of research efforts, optimization and training of experienced and non-conflicted scientific workforce, and reconsideration of scientific reward systems, among others.