Data collection within patient support programs in Canada and implications for real-world evidence generation: the authors' perspective

Allison Wills; Arif Mitha; Winson Y Cheung

doi:10.3389/jpps.2023.11877

Data collection within patient support programs in Canada and implications for real-world evidence generation: the authors' perspective

J Pharm Pharm Sci. 2023 Oct 13:26:11877. doi: 10.3389/jpps.2023.11877. eCollection 2023.

Authors

Allison Wills¹, Arif Mitha¹, Winson Y Cheung²

Affiliations

¹ 20Sense Corp., Toronto, ON, Canada.
² Department of Oncology, University of Calgary, Calgary, AB, Canada.

Abstract

Patient support programs (PSPs) offer a unique opportunity to collect real-world data that can contribute to improving patient care and informing healthcare decision making. In this perspective article, we explore the collection of data through PSPs in Canada, current advances in data collection methods, and the potential for generating acceptable real-world evidence (RWE). With PSP infrastructure already in place for most specialized drugs in Canada, adding and strengthening data collection capacities has been a focus in recent years. However, limitations in PSP data, including challenges related to quality, bias, and trust, need to be acknowledged and addressed. Forward-thinking PSP developers have been taking steps to strengthen the PSP datasphere, such as engaging third parties for data analysis, publishing peer-reviewed studies that utilize PSPs as a data source and incorporating quality controls into data collection processes. This article illustrates the current state of PSP data collection by examining six PSP RWE studies and outlining their data characteristics and the health outcomes collected from the PSP. A framework for collecting real-world data within a PSP and a checklist to address issues of trust and bias in PSP data collection is also provided. Collaboration between drug manufacturers, PSP vendors, and data specialists will be crucial in elevating PSP data to a level acceptable to healthcare decision makers, including health technology assessors and payers, with the ultimate beneficiary being patients.

Keywords: data collection; novel medications; patient support programs; real world data; real world evidence.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Canada
Data Collection
Delivery of Health Care*
Humans

Grants and funding

The authors declare that this study received funding from the Patient Support Program Leaders Forum, which aims to advance Canada’s patient support programs to promote positive health outcomes and timely patient access. At the time of this study, the Forum’s member organizations included AbbVie, Alexion, AstraZeneca, Bayer, EMD Serono, Gilead Sciences, Pfizer and Roche. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.