BackgroundWith the globalization of clinical trials, large developing nations have substantially increased their participation in multi-site studies. This participation has raised ethical concerns, among them the fear that local customs, habits and culture are not respected while asking potential participants to take part in study. This knowledge gap is particularly noticeable among Indian subjects, since despite the large number of participants, little is known regarding what factors affect their willingness to participate in clinical trials.MethodsWe conducted a meta-analysis of all studies evaluating the factors and barriers, from the perspective of potential Indian participants, contributing to their participation in clinical trials. We searched both international as well as Indian-specific bibliographic databases, including Pubmed, Cochrane, Openjgate, MedInd, Scirus and Medknow, also performing hand searches and communicating with authors to obtain additional references. We enrolled studies dealing exclusively with the participation of Indians in clinical trials. Data extraction was conducted by three researchers, with disagreement being resolved by consensus.ResultsSix qualitative studies and one survey were found evaluating the main themes affecting the participation of Indian subjects. Themes included Personal health benefits, Altruism, Trust in physicians, Source of extra income, Detailed knowledge, Methods for motivating participants as factors favoring, while Mistrust on trial organizations, Concerns about efficacy and safety of trials, Psychological reasons, Trial burden, Loss of confidentiality, Dependency issues, Language as the barriers.ConclusionWe identified factors that facilitated and barriers that have negative implications on trial participation decisions in Indian subjects. Due consideration and weightage should be assigned to these factors while planning future trials in India.

Objective To determine the effects of high-dose vitamin D on insulin sensitivity in Polycystic Ovary Syndrome (PCOS). Design Randomized placebo-controlled trial. Setting Academic medical center. Patients 28 PCOS women. Interventions Vitamin D3 12,000 International Units or placebo daily for 12 weeks. Main Outcome Measures The primary outcome was quantitative insulin sensitivity check index (QUICKI). Secondary outcomes included glucose and insulin levels during a 75-gram oral glucose tolerance test and blood pressure. Results Twenty-two women completed the study. Compared to placebo, vitamin D significantly increased 25-hydroxyvitamin D (mean (95% confidence interval) in vitamin D group 20.1 (15.7 to 24.5) ng/ml at baseline and 65.7 (52.3 to 79.2) ng/ml at 12 weeks; placebo 22.5 (18.1 to 26.8) ng/ml at baseline and 23.8 (10.4 to 37.2) ng/ml at 12 weeks). There were no significant differences in QUICKI and other measures of insulin sensitivity, however we observed trends towards lower 2-hour insulin and lower 2-hour glucose. We also observed a protective effect of vitamin D on blood pressure. Conclusions In women with PCOS, insulin sensitivity was unchanged with high-dose vitamin D but there was a trend towards decreased 2-hour insulin and a protective effect on blood pressure. Clinical Trial registration number ClinicalTrials.gov Identifier: NCT00907153

Purpose Writing scientific articles is a daunting task for novice researchers. In this qualitative study carried out in 2007, the authors evaluated the experiences of a group of novice researchers engaged in the writing process, to elucidate the main difficulties and sources of encouragement they encountered. Method Sixteen novice researchers were interviewed. Most were women (10), and most were enrolled in programs of medicine (9), followed by nursing (4) and physical therapy (3). These were drawn via convenience sampling from a randomized control trial in which 48 of them were equally assigned to either an online or a face-to-face course of instruction. On completion, interviews were conducted in focus groups of four students each. The interviews were transcribed and read independently by two of the authors, who then encoded the material based on the principles of grounded theory. Initial categories were converted to major emerging themes, which were validated when participants were asked to review the findings. Triangulation of results was carried out by discussing the emerging themes in an online forum with five specialists in college writing education. Results Classifying the diverse responses of participants led to the emergence of four major themes: cognitive burden, group support and mentoring, difficulty in distinguishing between content and structure, and backward design of manuscripts. Conclusions The themes produced by this study provide some insight into the challenges faced by novice researchers in their early attempts at scientific writing. Remedies that address these challenges are needed to substantially improve scientific writing instruction. Writing scientific articles is a daunting task for novice researchers. We carried out the qualitative study described below to evaluate the experiences of a group of novice researchers engaged in the writing process, to elucidate the main difficulties and sources of encouragement they encountered.