Theme: Planning a research study (June 26, 2007) [Incomplete]
This theme covers important issues in the development of a research study, such as ethical concerns, justification of the sample size, and designing a survey.
Category: Accrual problems in clinical trials. These pages cover some of the issues associated with accrual problems, research studies that accrue patients too slowly. Researchers have the dangerous tendency to provide overly ambitious goals for their clinical trials. They will suggest that they can recruit an unrealistically large number of patients in an unrealistically tight time frame. I am working with a colleague, Byron Gajewski, to develop some Bayesian models for waiting times between successive patients that will allow for more careful planning of the time frame for a clinical trial. These models allow the researchers to track patients accrual rates and react quickly if patient enrollment is suffering.
Category: Adverse events in clinical trials. These pages discuss methods for monitoring the frequency of adverse events in a clinical trial or safety study.
Category: Children in research. Research in children raises special considerations in ethics, medicine, and statistics.
Category: Data management. Data management is the foundation of every good data analysis. You need to consider issues like how your data are entered, documented, and stored. Careful attention to these issues now will help save you time and frustration during your data analysis.
Category: Early stopping. Clinical trials are sometimes stopped because of early evidence of efficacy, early evidence of harm, or early evidence of futility. In general, the rules for stopping a study need to be specified in the research protocol before any data is collected. These pages discuss some of the issues associated with early stopping of clinical trials.
Category: Equipoise in research. In a study where you randomly assign patients to two or more different treatments, you need to provide assurance that none of the patients is being harmed by having a chance at receiving an inferior therapy. This assurance has several different definitions coming from several different research perspectives, but a commonly used term is "equipoise". These pages discuss some of the ethical and practical issues associated with equipoise as well as debate over the proper interpretation of this and other closely related terms.
Category: Ethics in research. These pages describe some of the ethical principles in the conduct of research as well as information on how an Institutional Review Board (IRB) or other research ethics board evaluates research proposals.
Category: Fraud in research. These pages discuss recent examples of fraudulent research, false allegations of fraud, and the research community's efforts to reduce or eliminate fraud.
Category: Grant writing. These pages offer some practical advice I have found on how to write an effective grant.
Category: Observational studies. Observational studies are studies where the experimenter does not choose who gets into the control group and the treatment/exposure group. Rather the patients and/or their physicians make this choice, or the groups were intact prior to the start of the research. Observational studies raise some important methodological challenges, but when they are used carefully, they provide valuable insights that are not possible with other research designs.
Category: Pilot studies. Pilot studies are research studies which derive no direct benefit, but rather which provide benefit through assisting with the planning of a future research study. These pages present some of the issues associated with running a pilot study.
Category: Placebo controlled trials. A placebo is an inert substance that looks and tastes like an active drug, which is used in research studies to provide a blinded comparison group for the active drug. In a study of a medical device or a physical intervention, the placebo takes a different form. Placebo controlled trials raise difficult ethical and logistical concerns.
Category: Privacy in research. These pages discuss the special ethical considerations for research studies that involve the use of private and sensitive information.
Category: Randomization in research. These pages describe the logistics and the ethical issues associated with the use of randomization to allocate patients into the treatment and control groups.
Category: Research designs. These pages describe the variety of designs available to a researcher and contrasts their advantages and disadvantages. Articles are arranged by date with the most recent entries at the top.
Category: Sample size justification. These pages provide formulas and advice for justifying the sample size in a research study. Some of these pages describe the pragmatic and ethical concerns about sample size.
Category: Small sample size issues. These pages outline some of the practical issues and ethical concerns with small sample sizes.
Category: Survey design. These pages discuss how to design a questionnaire or survey. Articles are arranged by date with the most recent entries at the top.
[View all categories] [Return to Stats page] This webpage was written by Steve Simon and was last modified on 07/08/2008.