Bureaucratic overheating is a parasite hampering modern clinical research – a viewpoint from the ‘belly of the beast’

Abstract

Clinical researchers in Europe are experiencing an increasing amount of bureaucracy, which in our eyes has now reached surrealistic heights, hampering the future of research, and thus, the development of new treatment regimens and advances in clinical research. In the long term, the current approval and control processes will negatively impact patient care, education, academia and the health economy of our countries. Thus, a debate is necessary including not only healthcare workers, but also politicians and patients.

Building an evidence base for IVF ‘add-ons’

“…Why? Firstly, RCTs have become very hard to do (Humaidan and Haahr, 2019). Study proposals are subject to intense and prolonged regulatory scrutiny from multiple stakeholders, costing both time and money.…”

The Efficacy of Hyaluronic Acid Binding (HAB) in the Treatment of Male Infertility: A Systematic Review of the Literature

“…This led to the introduction of the "Traffic Light System". However, due to the regulatory scrutiny and financial burden of undertaking large studies [93], there is a paucity of high-quality RCTs reporting benefits of any such treatment, and thus far no add-ons have been given the green light for routine practice. While this does not represent a ban on the use of this technique, and may create a more ethical approach and reduce the potential financial exploitation of desperate patients, it also poses a massive obstacle to treatment innovation and the development of individu-alised care, as for patients with specific infertility aetiologies, e.g., recurrent pregnancy loss and severe teratozoospermia, such treatment supplementation may represent a "last resort" to achieve and maintain a healthy pregnancy, however they will not be routinely offered.…”

May the colleague who truly has no conflict of interest now please stand up!

“…Given the vast potential for conflict of interest to shape scientific discourse, it is not surprising that many formal bodies have attempted to address this by imposing an ever increasing number of regulations, rendering clinical research more and more difficult, time consuming and costly to perform (Humaidan, 2019)…”