Global Medical Affairs Fertility, Merck KGaA, Frankfurter Str. 250, Post Code F135/002, 64293 Darmstadt, Germany.
Department of Development and Regeneration, Laboratory of Reproductive Medicine, Endometrium and Endometriosis, p/a Dept Obstetrics Gynecology, University Hospital Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium.
Hum Reprod. 2017 Aug 1;32(8):1549-1555. doi: 10.1093/humrep/dex230.
The pharmaceutical and device industry has greatly contributed to diagnostic and therapeutic approaches in reproductive medicine in a very highly regulated environment, ensuring that development and manufacturing follow the highest standards. In spite of these achievements, collaboration between industry and physicians/academia is often presented in a negative context. However, today more than ever, partnership between industry and academia is needed to shorten the timeline between innovation and application, and to achieve faster access to better diagnostics, drugs and devices for the benefit of patients and society, based on complementary knowledge, skills and expertise. Such partnerships can include joined preclinical/clinical and post-marketing research and development, joint intellectual property, and joint revenue. In Europe, the transparency of this collaboration between pharmaceutical industry and medical doctors has been made possible by the Compliance and Disclosure Policy published by the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the major pharmaceutical companies operating in Europe, and includes as members some but not all companies active in infertility and women's health. Under the EFPIA Disclosure Code of conduct, companies need to disclose transfers of value including amounts, activity type and the names of the recipient Health Care Professionals and Organizations. EFPIA member companies have also implemented very strict internal quality control processes and procedures in the design, statistical analysis, reporting, publication and communication of clinical research, according to Good Clinical Practice and other regulations, and are regularly inspected by competent authorities such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) for all trials used in marketing authorization applications. The risk of scientific bias exists not only in the pharmaceutical industry but also in the academic world. When academics believe in a hypothesis, they may build their case by emphasizing the arguments supporting their case, and either refute, refuse, oppose or ignore arguments that challenge their assumptions. A possible solution to reduce this bias is international consensus on study design, data collection, statistical analysis and reporting of outcomes, especially in the area of personalized reproductive medicine, e.g. to demonstrate superiority or non-inferiority of personalized ovarian stimulation using biomarkers. Equally important is that declarations of interest are reported transparently and completely in scientific abstracts and publications, and that ghost authorship is replaced by proactive and clear co-authorship for experts from industry where such co-authorship is required based on the prevailing ICMJE criteria. In that context, however, reviewers should stop believing that publications by industry authors only, or by mixed groups of co-authors from industry and academia, are more prone to bias than papers from academic groups only. Instead, the scientific quality of the work should be the only relevant criterion for acceptance of papers or abstracts, regardless of the environment where the work was done. In the end, neutrality does not exist and different beliefs and biases exist within and between healthcare professionals and organizations and pharmaceutical industries. The challenge is to be transparent about this reality at all times, and to behave in an informed, balanced and ethical way as medical and scientific experts, taking into account compliance and legal regulations of both industry and academic employers, in the best interest of patients and society.
制药和医疗器械行业在高度监管的环境中为生殖医学的诊断和治疗方法做出了巨大贡献,确保了开发和制造符合最高标准。尽管取得了这些成就,但业界与医生/学术界之间的合作往往被描绘成负面的。然而,今天比以往任何时候都更需要行业和学术界之间的合作,以缩短创新和应用之间的时间线,并基于互补的知识、技能和专业知识,更快地为患者和社会获得更好的诊断、药物和设备。这种合作可以包括联合临床前/临床和上市后研发、联合知识产权以及联合收入。在欧洲,制药行业与医生之间合作的透明度是通过欧洲制药工业和协会联合会 (EFPIA) 发布的合规和披露政策实现的,该政策代表了在欧洲运营的主要制药公司,并包括一些但不是全部活跃在不孕症和妇女健康领域的公司。根据 EFPIA 行为准则,公司需要披露包括金额、活动类型和受援医疗保健专业人员和组织名称在内的价值转移。EFPIA 成员公司还根据良好临床实践和其他法规,在临床研究的设计、统计分析、报告、发表和交流方面实施了非常严格的内部质量控制流程和程序,并定期接受美国食品和药物管理局 (FDA) 或欧洲药品管理局 (EMA) 等主管部门对用于营销授权申请的所有试验的检查。科学偏见的风险不仅存在于制药行业,也存在于学术界。当学者相信一个假设时,他们可能会通过强调支持他们观点的论据来构建自己的案例,而对挑战他们假设的论据进行反驳、拒绝、反对或忽略。减少这种偏见的一个可能方法是就研究设计、数据收集、统计分析和结果报告达成国际共识,特别是在个性化生殖医学领域,例如,使用生物标志物证明个性化卵巢刺激的优越性或非劣效性。同样重要的是,在科学摘要和出版物中透明和完整地报告利益声明,并以积极和明确的合著者取代工业界专家的幽灵作者身份,如果根据现行的 ICMJE 标准需要这种合著者身份。在这种情况下,评审员不应再认为仅由行业作者或由行业和学术界的合著者混合小组撰写的出版物比仅由学术团体撰写的论文更容易出现偏见。相反,接受论文或摘要的唯一相关标准应该是工作的科学质量,而不论工作是在何处完成的。最终,中立并不存在,医疗保健专业人员和组织以及制药行业内部和之间存在不同的信念和偏见。挑战是始终如一地透明地了解这一现实,并作为医学和科学专家以知情、平衡和合乎道德的方式行事,同时考虑到行业和学术雇主的合规和法律规定,以患者和社会的最佳利益为出发点。