Transparent collaboration between industry and academia can serve unmet patient need and contribute to reproductive public health

Abstract

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 ...

Management of Endometriosis: Toward Value-Based, Cost-Effective, Affordable Care

“…21 The time has come to address this topic also when appraising the available evidence on endometriosis management, as it has been done with general gynecology 22 and reproductive medicine. [23][24][25] Several definitions of COIs have been suggested. According to Bekelman et al, 26 "COI is a set of conditions in which a professional judgement concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)".…”

“…As an example, strong convictions regarding specific pathogenic theories or treatment modalities may well influence the information disseminated in narrative reviews and opinion papers. 24 As an example, if an investigator is persuaded that ovulation is crucial in the development of ovarian endometriomas, she/he is at risk of favoring the long-term use of oral contraceptives (OCs), consciously or unconsciously highlighting the evidence in support of the above hypothesis and dismissing the evidence contrary to it. The same is true for advocates of medical versus surgical treatment for pelvic pain, or of surgery versus IVF for infertility.…”

Human sperm ion channel (dys)function: implications for fertilization

“…This is a major challenge, not least because of our dearth of current understanding (see, for example, De Jonge, 2017). Arguably, significant acceleration and advancement of male reproductive medical research necessitates a concerted international collaborative effort involving all relevant stake holders (D’Hooghe, 2017; Barratt et al., 2018; Brown et al., 2018). This is a huge challenge and perhaps more difficult owing to the fact that our discipline is unique in that diametrically opposed success outcomes are sought for sperm by those seeking assisted conception and those requiring contraception (see Barratt et al., 2018 for an argument for the case for development of a male contraceptive).…”

A SWOT Analysis of Human- and Machine Learning- Based Embryo Assessment

“…The collaborative research programs have been developed to shorten the timeline between innovation and application. Furthermore, collaboration helps us achieve better diagnostics, drugs, and devices for patients and society [83]. In recent years, a clinician-led healthcare artificial intelligence company known as Harrison AI was established to continuously innovate and commercialize more efficient and affordable healthcare products and solutions in the IVF market [84].…”