Dataset Information

Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany.

ABSTRACT: In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center.

SUBMITTER: Ruppert T

PROVIDER: S-EPMC3278977 | biostudies-other | 2012

REPOSITORIES: biostudies-other

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Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany.

Ruppert Thorsten T Hahn Michael M Hundt Ferdinand F

German medical science : GMS e-journal 20120207

In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 20 ...[more]

PMID: 22355280

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Project description:BackgroundIncreasingly, medical school policies limit pharmaceutical representatives' access to students and gifts from drugmakers, but little is known about how these policies affect student attitudes toward industry.ObjectiveTo assess interactions between trainees and the pharmaceutical industry, and to determine whether learning environment characteristics influence students' practices and attitudes.Design, participantsWe conducted a cross-sectional survey with a nationally-representative sample of first- and fourth-year medical students and third-year residents, stratified by medical school, including ? 14 randomly selected trainees at each level per school.Main measuresWe measured frequency of industry interactions and attitudes regarding how such interactions affect medical training and the profession. Chi-squared tests assessed bivariate linear trend, and hierarchical logistic regression models were fitted to assess associations between trainees' attitudes and their schools' National Institutes of Health (NIH) funding levels and American Medical Student Association (AMSA) PharmFree Scorecard grades reflecting industry-related conflict of interest policies.Key resultsAmong 1,610 student (49.3 % response rate) and 739 resident (43.1 %) respondents, industry-sponsored gifts were common, rising from 33.0 % (first-year students) to 56.8 % (fourth-year students) and 54 % (residents) (p?<?0.001). These gifts included meals outside the hospital (reported by 5 % first-year students, 13.4 % fourth-year students, 27.5 % residents (p?<?0.001)) and free drug samples (reported by 7.4 % first-year students, 14.1 % fourth-year students, 14.3 % residents (p?<?0.001)). The perception that industry interactions lead to bias was prevalent, but the belief that physicians receive valuable education through these interactions increased (64.1 % to 67.5 % to 79.8 %, p?<?0.001). Students in schools receiving more NIH funding reported industry gifts less often (OR?=?0.51, 95 % CI: 0.38-0.68, p?<?0.001), but the strength of institutional conflict of interest policies was not associated with this variable.ConclusionsDespite recent policy changes, a substantial number of trainees continue to receive gifts from pharmaceutical representatives. We found no relation between these outcomes and a school's policies concerning interactions with industry.

Project description:BackgroundClinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the pharmaceutical industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the pharmaceutical industry 2 years after publication of the primary results.Main textPubMed and ClinicalTrials.gov were searched to identify clinical trials of medicines sponsored by the pharmaceutical industry and first published between 1 July 2015 and 31 December 2015 in the top 10 general and internal medical journals by impact factor. For each clinical trial, the eligibility of independent researchers to request participant-level data was identified via the sponsor having a data sharing policy/process and a positive response to an enquiry. Fifty-six publications reporting on 61 industry-sponsored clinical trials were identified, of which 32 (52%) had a public data sharing policy/process and 9 (15%) were confirmed eligible for data sharing. Industry sponsors within the top 25 by global sales were more likely to have a data sharing policy (93% vs 10%), and there was a trend towards increased data sharing eligibility (23% vs 4%). Twenty-six studies were explicitly confirmed as ineligible for data sharing. The two most common data sharing policy conditions that prevented sharing of data for published results were the exclusion of studies that had ongoing follow-up of the published results and the exclusion of studies of medicines that have not yet achieved regulatory approval in the USA and the European Union.ConclusionsFifteen percent of the sampled clinical trials were available for data sharing 2 years after publication of primary results of the trial. Key issues limiting data sharing include a large proportion of industry sponsors who do not have a data sharing policy/process, and data sharing policy conditions that exclude access on the basis of ongoing follow-up and regulatory activity.

Dataset Information

Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany.

Publications

Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany.

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