publication of clinical research Flashcards
sponsorship of published RCTs
half non industry and half industry
types of conflicts: non financial
non financial
- desire to prove hypothesis
- self promotion
- political agenda
- religious beliefs
types of conflicts: financial
must be disclosed on informed consent
- study support
- investigator support to conduct a study
- royalties/patents
- expert witness
- insider information
financial conflicts are?
prevalent in clinical studies
financial conflict of interest
financial consideration may compromise or have appearance of compromising investigators judgement in conducting or reporting research
author’s published opinions were related to ?
their financial arrangments.
more authors were supportive of a drug that had 100% financial tie
how can you make a study design bias?
use known inferior comparison agents or inferior form of administration
industry sponsorship vs study outcome
if drug supported by particular pro-industry instead of anti-industry, outcome generally positive
financial conflicts in research are
pervasive
powerful
clinically hazardous
threat to scientific integrity
many potential problems with industry supported clinical research
financial conflict of interest- thats why company may offer stock after research completion nondisclosure agreements research contract - clauses dealing with publication rithgs, confidentiality, intellectual property (IP), acess to data, conflict resolution development of research protocols comparative groups: inclusion and exclusion criteria - include only favorable groups in the study blind and randomization endpoints - must constitute evidence of efficacy of treatment cost considerations IRB approval data monitoring committtee data analysis interim data release adverse events negative trials delays in publication multiple publications publication committees
university lawyers will not sign ccontract that has
infringment of academic freedom
ability to publish
ability to get toxicity data from other sites
journals must ensure
author independence
publication bias
objective data analysis
if company gives you condensed data, then
journals may refuse to publish it because they need access to data for integrity
consolidated standard of reporting trials (consort)
guidelines for improved and more strucutured reporting of clinical trial results
checklist that editors require as standard for publication
CONSORT E-checklist
