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.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Making the Grade: Registries as Sources of Regulatory-Grade Real-World Evidence (RWE)
February 13th 2025Dr. Peter Wahl, MLA, MS, ScD, VP and Global Head of Scientific Affairs at CorEvitas, part of the PPD™ clinical research business of Thermo Fisher Scientific, discusses the critical role of protocol-driven registries in generating regulatory grade RWE to serve multiple and evolving evidence needs across the drug development life cycle. He covers key considerations for selecting the right type of registry, the advantages over EMR datasets, and how registry data contextualizes safety and effectiveness to fulfill FDA and EMA post-marketing requirements.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
SCOPE Summit 2025: Enhancing the Patient Experience Through Site Centricity
February 12th 2025In an interview with ACT senior editor Andy Studna at SCOPE Summit, Ashley Davidson, vice president, product lead - sponsor tech strategy, Advarra, highlights the need for more site-centric approaches in study startup.