In addition to the general admission requirements of the VCU Graduate School, students applying to the clinical research and biostatistics concentration must hold the M.D., D.D.S., Ph.D., D.P.H., D.O., Pharm.D. or an equivalent health professional terminal degree from an accredited college or university. Applicants with international M.D. degrees are considered on an individual basis. The applicant must have a minimum undergraduate GPA of 3.00. Applicants must also submit a letter detailing career goals and how the M.S. in Biostatistics with a concentration in clinical research and biostatistics applies to those goals, as well as at least three letters of recommendation.
There is evidently an overlap between the tasks and responsibilities of medical biostatisticians and neighbouring professions. However, all disciplines have different focuses. Important application fields of biostatistics are clinical studies, systematic reviews / meta-analysis, observational and complex interventional studies, and statistical genetics.
Translational research is a key area of focus of the National Institutes of Health (NIH), as demonstrated by the substantial investment in the Clinical and Translational Science Award (CTSA) program. The goal of the CTSA program is to accelerate the translation of discoveries from the bench to the bedside and into communities. Different classification systems have been used to capture the spectrum of basic to clinical to population health research, with substantial differences in the number of categories and their definitions. Evaluation of the effectiveness of the CTSA program and of translational research in general is hampered by the lack of rigor in these definitions and their application. This study adds rigor to the classification process by creating a checklist to evaluate publications across the translational spectrum and operationalizes these classifications by building machine learning-based text classifiers to categorize these publications.
To train the classifiers, the five categories of translational research were grouped into three categories, roughly corresponding to basic, clinical, and post-clinical research. T3 and T4 articles were grouped into one set, due to the low frequency of T4 articles during initial piloting of classification schemes. Similarly, T1 and T2 articles were grouped into one set due to the low frequency of both types of articles in the training set. An additional category was designated as TX, denoting articles that did not fall along the translational research spectrum, although they cited a CTSA hub. The training set for each classifier would then consist of articles that were coded as being in a particular category and those that were coded as not being in that category, the latter set including TX for each of the categories.
We believe that even if the planning and analysis of a trial is undertaken by an expert statistician, it is essential that the investigators understand the implications of using an adaptive design, for example, what the practical challenges are, what can (and cannot) be inferred from the results of such a trial, and how to report and communicate the results. This tutorial paper provides guidance on key aspects of adaptive designs that are relevant to clinical triallists. We explain the basic rationale behind adaptive designs, clarify ambiguous terminology and summarise the utility and pitfalls of adaptive designs. We discuss practical aspects around funding, ethical approval, treatment supply and communication with stakeholders and trial participants. Our focus, however, is on the interpretation and reporting of results from adaptive design trials, which we consider vital for anyone involved in medical research. We emphasise the general principles of transparency and reproducibility and suggest how best to put them into practice.
Our M.D./Ph.D. program is an institutional partnership between Robert Wood Johnson Medical School, Rutgers University-New Brunswick campus, and Princeton University. In addition to clinical and basic science proficiency, the M.D./Ph.D. program includes opportunities for professional development, global health work, and the study of health policy and management. Our goal is to ensure that graduates of the M.D./Ph.D. program at RWJMS are uniquely prepared to become leaders in biomedical research, academic medicine, and the prevention of disease. 2b1af7f3a8