Abstract
Consistent implementation and measurement of patient engagement initiatives across the industry have remained aspirational and elusive despite strong interest in adopting patient-centric approaches. One factor contributing to this inertia stems from a lack of standardized implementation of patient engagement activities, which varies widely from company to company, making it difficult to track and measure. Further, empirical evidence mapping the impact of patient engagement capabilities on clinical research outcomes has remained sparse. To address this gap, the Drug Information Association (DIA) and Tufts Center for the Study of Drug Development (Tufts CSDD) at the Tufts University School of Medicine developed and administered an assessment tool that companies can use to not only evaluate their organization’s patient engagement capabilities and implementation preparedness but can also measure the impact of such activities on trial outcomes. Results showed that while most organizations are providing logistical support to increase patient engagement in the form of travel stipends, accommodation, and financial incentives, most are not implementing more involved forms of patient engagement such as gathering patient input through patient input panels or patient steering committees. This paper discusses the process for designing and administering this assessment tool, the results of the assessment, and future implications.
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Notes
A total of 34 unique functional areas were represented across the Working Group. For the purpose of analysis, we collapsed the unique functional areas into 4 main function areas: 1) Clinical Operations/Research; 2) Patient Engagement/Patient Centricity; 3) Medical Affairs; and 4) Support, General and Administration (SG&A).
The 3 sponsor companies could not provide survey data due to internal reorganization and realignment efforts and competing internal deadlines that prevented them from participating in data collection.
“Don’t Know’ was treated as a ‘0’ and excluded from data analysis.
To test the appropriateness of a one-way ANOVA, the following tests were performed. The Shapiro–Wilk test showed that the distribution was normally distributed (W = .98, p = .10) and the Bartlett Test for the Homogeneity of Variance revealed that the variances were equal across the groups (K2 = 2.36, p = .50). Further, there was no reason to believe that the levels of the respondents were related to each other.
During the initial round of data collection among the working group sample, participants were unable to generate the minimum number of responses necessary to conduct meaningful sub-analysis. This was largely due to internal timelines within the various organizations that would not allow for many of the outcome measures to be collected during the study’s initial data collection period, representing a common challenge when it comes to collecting data in the real-world rather than among paid survey-takers (i.e., Mturk). In cases such as this, it is common practice to launch a separate survey among a larger, independent professional sample in order to determine whether the study results replicate.12, 13 Thus, the study team decided to launch a global survey separate from the working group data collection efforts that would not only allow us to validate the results of the survey among an independent sample, but also collect self-reported outcome measures that could be used to examine the relationship between patient engagement capabilities and different clinical outcomes.
The global survey was comprised of 44 responders from at least 10 different companies that did not overlap with the working group. We determined that there were at least 10 companies in the following way: the survey was sent out as an anonymous link to our email distribution and network of professionals. Respondents were not asked to provide their company name. However, at the end of the survey, respondents could opt-in to enter a raffle and/or to receive the study results by sharing their email address. Not all respondents chose to share their email address; however, among those that did, we were able to determine the company they represented if they entered their work email address. From this, we gathered that there were at least 10 sponsor companies represented in our dataset.
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Acknowledgements
The authors would like to thank Emily Botto, Maria Florez, Mariana Marañón Laguna, the Working Group members, the Patient Steering Group, and Barbara Kunz for their contributions to this project.
Funding
Tufts CSDD received grant funding from the Drug Information Association. The Drug Information Association received funding from the following organizations: Amicus Therapeutics, Astellas, Biogen, CSL Behring, Daiichi Sankyo Inc, Genentech-Roche, Greenphire, Horizon Therapeutics, Ionis Pharmaceutical, IQVIA, Merck, Otsuka, Syneos Health, UCB, Veeva Systems, and Voz Advisors.
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JK, CSDD, contributed to all four aspects (substantial contribution to conception, design, analysis, interpretation; drafting and revising the work; final approval of the version to be published; agreement to be accountable for all aspects in ensuring accuracy and integrity of the work). MPBA, DIA, contributed to all four aspects. CG, DIA, contributed to all four aspects. KG, Tufts CSDD, contributed to all four aspects.
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Jennifer Y. Kim, Tufts CSDD, has nothing to disclose. Maria Paula Bautista Acelas, DIA, has nothing to disclose. Courtney A. Granville, DIA, has nothing to disclose. Kenneth Getz, Tufts CSDD, has nothing to disclose.
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Kim, J.Y., Acelas, M.P.B., Granville, C.A. et al. Benchmarking Patient Engagement Capabilities and Preparedness of Drug Development Sponsors. Ther Innov Regul Sci 57, 1040–1049 (2023). https://doi.org/10.1007/s43441-023-00545-x
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DOI: https://doi.org/10.1007/s43441-023-00545-x