Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world

Since the mid-1990s, investigational sites in the countries of Central and Eastern Europe (CEE) have been increasingly utilized by pharmaceutical companies because of their high productivity in terms of patient enrolment into clinical trials. Based on the FDA’s publicly accessible Clinical Investigator Inspection List, we present an analysis of findings and outcome classifications from FDA inspections during Investigational New Drug (IND) studies and compare the results for the CEE region to those from Western European countries and the USA. Data from all 5531 FDA clinical trials inspections that occurred between 1994 (when the FDA first performed inspections in CEE) and the end of 2010 were entered into the database for comparative analysis. Of these, 4865 routine data audit (DA) inspections were analyzed: 401 from clinical trials performed in Western Europe, 230 in CEE, 3858 in the USA, and 376 in other countries. The average number of deficiencies per inspection ranged between 0.99 for CEE and 1.97 in Western Europe. No deficiencies were noted during 16.6%, 39.0%, and 21.5% of the inspections in Western Europe, CEE and USA, respectively. The percentages of inspections after which no follow-up action was indicated were 36.9% for Western Europe, 55.7% for CEE, and 44.3% for US sites. CEE was also the region with the lowest percentage of inspections that required official or voluntary action. On the basis of FDA inspection data, the high productivity of CEE sites appears to be accompanied by regulatory compliance as well as by data quality standards that are not inferior to those in Western regions

Demographic profile of physician participants in short-term medical missions

BACKGROUND: The US is the leading sending country for short term medical missions (STMMs), an unregulated and unsanctioned, grass roots form of direct medical service aid from richer countries to low and middle income countries. The objective of this study is to profile US physicians who go on such missions by means of a survey sample of the US physician population. METHODS: An online survey solicited information on physician participation in STMMS as well as demographic and professional features. Responses were descriptively tabulated and multivariate regressions were performed to model for physician profiles related to STMM participation. RESULTS: Physician participants in STMMs are more likely to be a surgeon, anesthesiologist or pediatrician, married with few or no children at home, later in their career and have an income of $200–250 K. CONCLUSIONS: Specialty is the strongest predictor of participation. STMM participation does not differ by race, ethnicity nor religion. Descriptive statistics further provide a limited profile of participants. Direct expenses may have less influence on participation than opportunity costs. Potential clues about motivation that may be inferred from the features of the profile are discussed. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12913-016-1929-x) contains supplementary material, which is available to authorized users

Economic assessment of US physician participation in short-term medical missions

BACKGROUND: Short term medical missions (STMMs) are a form of unregulated and unsanctioned, grass roots, direct medical service aid from wealthier countries to low and middle income countries. The US leads the world in STMM activity. The magnitude of monetary and man power inputs towards STMMs is not clear. The objective of this study is to estimate the prevalence of physician participation in STMMs from the US and the related expenditures of cash and resources. METHODS: An online survey solicited information on physician participation in STMMs. Responses regarding costs were aggregated to estimate individual and global expenditures. RESULTS: Sample statistics from 601 respondent physicians indicate an increasing participation by US physicians in STMMs. Including opportunity cost, average total economic inputs for an individual physician pursuing an STMM exceed $11,000. Composite expenditures for STMM deployment from the US are estimated at near$3.7 billion annually and the resource investment equates with nearly 5800 physician fulltime equivalents. CONCLUSIONS: STMM participation and mission numbers have been increasing in the millennium. The aggregate costs are material when benchmarked against formal US aid transfers. Understanding the drivers of physician volunteerism in this activity is thereby worthy of study and relevant to future policy deliberation

Additional file 1: of A systematic review of social, economic and diplomatic aspects of short-term medical missions

PRISMA 2009 Checklist. (DOC 63 kb

Additional file 1: of Demographic profile of physician participants in short-term medical missions

Physician’s Giving Back Survey. (PDF 265 kb