Addressing the need for standardization of symptomatic medication documentation in Parkinson's disease clinical research: A call to action
- PMID: 39973486
- DOI: 10.1177/1877718X241305711
Addressing the need for standardization of symptomatic medication documentation in Parkinson's disease clinical research: A call to action
Abstract
People with Parkinson's disease (PD) are prescribed a variety of medications to mitigate symptoms and improve their quality of life. These symptomatic therapies cover a range of pharmacological classes, including classical dopaminergic treatments, other antiparkinsonian agents, and pharmacotherapies for non-PD conditions. Often, medications are prescribed for concomitant use and in increasing doses, particularly as the disease progresses. Documentation of these interventions in clinical trials is necessary to accurately capture medication usage, compare medication utilization across different studies, understand factors contributing to experimental therapeutic response, and analyze clinical trial data in a precise manner. At the present time, there is no current international standard for how these medications are documented within clinical trials. As a case example, we will highlight medication use documentation in a large international multicenter observational study commonly used as a reference for design of clinical trials. This review aims to raise awareness within the scientific community of the importance of proper medication documentation and the need for standardization to harmonize prescriptive practices, improve treatment interpretability, and perform consistently robust analyses from clinical trials data.
Keywords: PPMI; antiparkinsonians; collaboration; standards.
Plain language summary
Currently approved medications for the treatment of Parkinson's have been shown to improve motor symptoms, overall disability, and quality of life. There is an urgent need for novel treatments that delay, halt, or reverse the relentless progression of Parkinson's. New disease-modifying treatments are advancing rapidly, and integration of data across different trials is ideally needed to gain insights from every study. It is important to accurately capture the medications that are prescribed to people enrolled in clinical trials. Dopaminergic medications are known to have distinct effects in different patients and at varying stages of disease. This study carefully examines the classification of dopaminergic medications in the PPMI study, a flagship observational study that is used often by sponsors to plan and design clinical trials. The results demonstrate that there are some inconsistencies across sites and study cohorts in terms of classifying medication use in PPMI. There is an urgent need to align on consensus standards to document medications, including both prescribed Parkinson's medications and any other drugs. This would help to accurately identify potential beneficial and/or adverse effects of drugs being evaluated in clinical trials. Several initiatives aimed at standardization are underway with a need for unified consensus and implementation by sponsors of clinical trials.
Conflict of interest statement
Declaration of conflicting interestsTanya Simuni is an Editorial Board Member of this journal but was not involved in the peer- review process of this article nor had access to any information regarding its peer-review.The remaining authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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