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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.