Increasing Global Site Dispersion Source: Tufts CSDD analysis of Industry-Funded Trials Registered on clinicaltrials.gov 2002-2006 (Mean # of Countries) 2006-2010 (Mean # of Countries) Phase I Clinical Trial 2 2 Phase II Clinical Trial 11 18 Phase III Clinical Trial 19 34
A Global Enterprise – Current and Recently Completed Trials Source: ClinicalTrials.gov
Broad social justice issues – testing products for what kinds of diseases and conditions, with what level of transparency, to be made available in what ways to which people, within what kind of health care system?
Ethics – informed consent, undue inducement, vulnerable populations, language and cultural differences, etc.
Quality – in the training of investigators and sites, the conduct of the trial, regulatory oversight, the quality of the data, etc.
Voluntary informed consent is essential, including information regarding benefits, if any, after the study ends
Cultural factors must be considered vis-à-vis informed consent
“ Therapeutic misconception” must be minimized
Participants should have continued access to experimental interventions proven effective
Effective interventions should become available to host country population
Going Beyond Business Considerations and Policy Recommendations
Let’s do some research – in 2010 ACRO undertook a study of global data quality. We gathered data from 25 multi-country phase 3 studies, with more than 63,000 participants
We were interested in determining if market maturity in various regions of the world (defined as “mature”, “developed” , and “emerging”) impacts the quality of clinical research data generated in support of FDA and EMA marketing authorization applications, as measured by data base query rates.
Comparison of Participating Sites and Subjects Across Various Regions
Overall, given the large number of trials, subjects, sites and therapeutic areas included in the analyses, this study represents an attempt at unbiased evaluation of clinical trials data conducted in regions outside mature regions (North America, Western Europe and Japan).
Primary emphasis was placed on comparing data quality (data errors) for each region against those generated for the North American Region.
Our analyses indicates that there are no statistically significant differences in the total query rates or in the number of database changes between various regions or when each region was compared to North America.
Global quality at the investigator/site level, i.e., quality in the conduct of the clinical trial for multi-country projects
Quality of human subject protections: informed consent execution; inclusion/exclusion errors
Investigator/site training and qualifications: GCP compliance; FDA and other agency inspection and audit findings
Performance metrics: e.g., time to first patient in; number of patients per site
Assessing Global Quality at the Investigator/Site Level
Purpose: Gather data from ACRO member managed multi-regional clinical trial programs to assess:1) ‘quality’ of human subject protections; 2) investigator/site training and other qualifications; 3) site/investigator performance metrics
Status : Data gathering complete; analysis beginning
Null Hypothesis : investigator/site quality does not differ significantly between ‘mature’ and ‘non-mature’ countries.