Tackling challenges of global health electives: Resident experiences of a structured and supervised medicine elective within an existing global health partnership

Background: The Toronto-Addis Ababa Academic Collaboration in Emergency Medicine (TAAAC-EM) deploys teaching teams of Canadian EM faculty to Addis Ababa to deliver a longitudinal residency curriculum. Canadian trainees participate in these teams as a formally structured and supervised elective in global health (GH) and EM, which has been designed to enhance the strength of GH electives and address key challenges highlighted in the literature.Methods: The purpose of this qualitative study was to identify, describe, and evaluate strengths and weaknesses of this elective in relation to its purposeful structure. Residents who completed the elective were invited to participate in face-to-face interviews to discuss their experiences.Results: The findings show that the residents both chose this elective because of its purposefully designed features, and that these same features increased their enjoyment and the educational benefit of the elective. Supervised bedside teaching, relationships shared with Ethiopian residents, and the positive impact the experience had on their clinical practice in Canada were identified as the primary strengthsConclusion: Purposeful and thoughtful design of global health electives can enhance the resident learning experience and mitigate challenges for trainees seeking global health training opportunities

Poor Reporting of Scientific Leadership Information in Clinical Trial Registers

BACKGROUND: In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information. METHODOLOGY/PRINCIPAL FINDINGS: We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95-701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6-14) than were solely industry funded trials. CONCLUSIONS/SIGNIFICANCE: Despite the requirements set by WHO and ICMJE, data on scientific leadership and contact e-mail addresses are frequently omitted from clinical trials registered in the two leading public clinical trial registers. To promote accountability and transparency in clinical trials research, public clinical trials registers should ensure adequate monitoring of trial registration to ensure completion of mandatory contact information fields identifying scientific leadership

Investigator experiences with financial conflicts of interest in clinical trials

<p>Abstract</p> <p>Background</p> <p>Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.</p> <p>Methods</p> <p>Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.</p> <p>Results</p> <p>844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.</p> <p>Conclusion</p> <p>Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.</p