This study aimed to assess the feasibility of applying two recent phase I meta-analyses methods to protein kinase inhibitors (PKIs) developed in oncology and to identify situations where these methods could be both feasible and useful. This ancillary study used data from a systematic review conducted to identify dose-finding studies for PKIs. PKIs…

Background: The National Institutes of Health (NIH) announced a revised, expanded definition of 'clinical trial' in 2014 to improve trial identification and administrative compliance. Some stakeholders voiced concerns that the policy added administrative burden potentially slowing research progress. Methods: This quasi-experimental study examined…

Alzheimer's disease (AD)-focused recruitment research registries can help identify eligible participants for AD studies, but registry participation is limited among racial and ethnic groups most at risk for AD. Using the Reasoned Action Approach (RAA), this study is part of a larger project to design theory-based persuasive recruitment messages…

Since 2001, the National Institutes of Health (NIH) have funded the Institutional Development Award (IDeA) Network of Biomedical Research Excellence (INBRE) to expand biomedical research capacity among states in which NIH funding was historically low. The Western IDeA Region comprises seven states: Alaska, Hawaii, Idaho, Montana, New Mexico,…

Immunosuppressive therapy is vital for the success of a kidney transplant, yet it entails potential risks and side effects. The challenge lies in finding the right balance between suppressing the immune response enough to prevent rejection while minimizing the risk of infections, organ toxicity, and other complications associated with long-term…

Increasing integrity concerns in medical research have prompted the development of tools to detect untrustworthy studies. Existing tools primarily assess published aggregate data (AD), though scrutiny of individual participant data (IPD) is often required to detect trustworthiness issues. Thus, we developed the IPD Integrity Tool for detecting…

This study explores how qualitative health researchers navigate the demands of medical research ethics committees in Germany where qualitative research is subject to approval only when it is conducted in medical contexts. We present the results of a grounded theory study to investigate qualitative health researchers' experiences with procedural…

This article describes our efforts to screen and enrol clinical trial participants conscientiously in the COVID-19 pandemic setting. We present the standard screening and enrolment process prior to, and our process of adapting to, the pandemic. Our goal was to develop a way to screen and enrol people for clinical trials that was both equitable and…

We examine four important considerations in the development of covariate adjustment methodologies for indirect treatment comparisons. First, we consider potential advantages of weighting versus outcome modeling, placing focus on bias-robustness. Second, we outline why model-based extrapolation may be required and useful, in the specific context of…

Using the method of medical biography, this article challenges some of the more treasured decolonial viewpoints on knowledge production in and from the global South. The biography in question concerns one of the leading cardiovascular scientists in the world with roots in South Africa, but whose breakthrough studies in medicine significantly…

ICH-GCP guidelines have provided international ethical, scientific, quality standards for designing, conducting, recording, and reporting of clinical trials, and are hugely popular in the region. Recent revisions to its guidance; ICH-GCP; E6 (R3) have brought significant changes in both structure and content from its predecessor, affecting every…

The media is crucial in managing public health crises like the COVID-19 pandemic. The pandemic prompts researchers to design and implement fast, efficient research. They cause an infodemic in society by disseminating unprofessional and hasty information. This study examines the practical challenges of publicizing medical research and health data…

Unlike other aspects of Obstetrics and Gynecology (OBGYN) residency training, the research education curriculum and requirements are not standardized. It is unclear what constitutes core curricula in educational research programs, which components are most useful and efficacious, and how to use these findings to adapt existing programs. A…

Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor…

A combination of institutional requirements and research activity means health profession students receive many requests to complete evaluations or participate in research. This study aimed to understand pre-clinical medical students' perceptions and attitudes towards these requests. A prospective audit of evaluation and research requests to…