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Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.

ABSTRACT: As the number of antibacterial medicines in the pipeline remains low, we anonymously surveyed pharmaceutical industry professionals on challenges and solutions for clinical development of these agents. Challenges were reported primarily as financial and regulatory. For multidrug-resistant organisms, there are needs for rapid diagnostic tests, new regulatory guidance, and adaptation of endpoints/trial designs. Regulators and public/private initiatives are addressing these challenges to help ensure that proposed solutions have the support of all involved stakeholders.

SUBMITTER: Bettiol E

PROVIDER: S-EPMC4468719 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.

Bettiol Esther E Wetherington Jeffrey D JD Schmitt Nicola N Harbarth Stephan S

Antimicrobial agents and chemotherapy 20150427 7

As the number of antibacterial medicines in the pipeline remains low, we anonymously surveyed pharmaceutical industry professionals on challenges and solutions for clinical development of these agents. Challenges were reported primarily as financial and regulatory. For multidrug-resistant organisms, there are needs for rapid diagnostic tests, new regulatory guidance, and adaptation of endpoints/trial designs. Regulators and public/private initiatives are addressing these challenges to help ensur ...[more]

PMID: 25918147

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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.

Dataset Information

Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.

Publications

Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.

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