Disease modifying treatment trials in Parkinson\u2019s disease: how to balance expectations and interests of patients, physicians and industry partners?

D Berg,L Tönges,B Mollenhauer,K Reetz,K Eggert,B Haslinger,A Rogge,E Schaeffer,J Kassubek,K E Zeuner

doi:10.1186/s42466-020-00076-y

Abstract

BackgroundThe advent of therapeutic strategies designed to modify the disease course in Parkinson’s disease has raised great expectations in the currently conducted clinical trials. However, we see ethical challenges in the cooperation of industry and clinical partners, specifically evident in the way recruitment is performed.We here discuss the different positions and challenges of all involved to set the stage for a study and recruitment culture taking into account the expectations of all: (i) patients and their caregivers, ready to take the considerable burden of clinical trials in hope for the development of disease-modifying treatments; (ii) physicians and study nurses, obligated to the patients’ well-being and benefit who accompany and supervise patients closely as basis for the performance of elaborate clinical trials (iii) industrial partners, investing years of efforts and finances to develop new treatments.ConclusionsWe conclude that the current competitive race for enrollment in clinical studies in PD is challenging the primary goal to ensure patients’ benefit and formulate requests to the industrial partners to encounter these concerns.

Highlights

ConclusionsWe conclude that the current competitive race for enrollment in clinical studies in Parkinson’s disease (PD) is challenging the primary goal to ensure patients’ benefit and formulate requests to the industrial partners to encounter these concerns
To improve the situation for the parties involved we here would like to point out one ethical aspect that has already been described almost 15 years ago [2], but has not changed since and seems still of great relevance: Large numbers of centers are initiated with a competitive recruitment or even parallel recruitment to multiple competing studies with immanent concerns of patient safety
Whereas in Alzheimer’s Disease (AD) disease course addressing therapeutic strategies have been tested for many years already, disease modulating clinical trials for Parkinson’s disease (PD) have failed in the past and newer strategies only recently emerged

Summary

Conclusions

The currently performed strategies for competitive recruitment in clinical trials in PD result in considerable ethical concerns, including a great burden for PD patients and a potential impairment of patient-physician relationship. If the formulated requests were fulfilled, the realization and performance of disease modifying therapeutic studies would benefit substantially and thereby accelerate the speed to find a cure for PD

Background

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