+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project

Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project

Therapeutic Innovation and Regulatory Science 52(2): 220-229

While patient groups, regulators, and sponsors are increasingly considering engaging with patients in the design and conduct of clinical development programs, sponsors are often reluctant to go beyond pilot programs because of uncertainty in the return on investment. We developed an approach to estimate the financial value of patient engagement. Expected net present value (ENPV) is a common technique that integrates the key business drivers of cost, time, revenue, and risk into a summary metric for project strategy and portfolio decisions. We assessed the impact of patient engagement on ENPV for a typical oncology development program entering phase 2 or phase 3. For a pre-phase 2 project, the cumulative impact of a patient engagement activity that avoids one protocol amendment and improves enrollment, adherence, and retention is an increase in net present value (NPV) of $62MM ($65MM for pre-phase 3) and an increase in ENPV of $35MM ($75MM for pre-phase 3). Compared with an investment of $100,000 in patient engagement, the NPV and ENPV increases can exceed 500-fold the investment. This ENPV increase is the equivalent of accelerating a pre-phase 2 product launch by 2½ years (1½ years for pre-phase 3). Risk-adjusted financial models can assess the impact of patient engagement. A combination of empirical data and subjective parameter estimates shows that engagement activities with the potential to avoid protocol amendments and/or improve enrollment, adherence, and retention may add considerable financial value. This approach can help sponsors assess patient engagement investment decisions.

Please choose payment method:

(PDF emailed within 0-6 h: $19.90)

Accession: 050242041

Download citation: RISBibTeXText

PMID: 29714515

DOI: 10.1177/2168479017716715

Related references

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials. Therapeutic Innovation and Regulatory Science 52(2): 206-213, 2018

A Novel Collaborative Approach to Building Better Clinical Trials: New Insights From a Patient Engagement Workshop to Propel Patient-Centricity Forward. Therapeutic Innovation and Regulatory Science 2019: 2168479019849875, 2019

Assessing the Effects of Financial Literacy on Patient Engagement. American Journal of Health Behavior 40(4): 523-533, 2016

The importance of consistent use of denominators across patient groups in assessing responses in clinical trials. British Journal of Haematology 132(6): 794, 2006

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey. Plos one 10(10): E0140232, 2015

Models Of Patient Engagement In AlzheimerS Disease (Mopead): A European Multinational Project To Develop And Test Innovative Patient Engagement Strategies. Alzheimer's and Dementia 14(7): P1197-P1198, 2018

Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation. Clinical Trials 15(1_suppl): 19-22, 2018

Multi-Method Patient-Engagement Approach: A Case Example from a PCORI-Funded Training Project. Patient 12(2): 277-280, 2019

Assessing Patient and Provider Perceptions of Factors Associated with Patient Engagement in Asthma Care. Annals of the American Thoracic Society 14(5): 659-666, 2017

Patient and public engagement in health-related quality of life and patient-reported outcomes research: what is important and why should we care? Findings from the first ISOQOL patient engagement symposium. Quality of Life Research 24(5): 1069-1076, 2015

Patient Engagement in Randomized Controlled Tai Chi Clinical Trials among the Chronically Ill. Reviews on Recent Clinical Trials 12(1): 24-33, 2017

Patient Engagement in Neurological Clinical Trials Design: A Conference Summary. Clinical and Translational Science 8(6): 776-778, 2016

Exploring Meaningful Patient Engagement in ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness). Medical Care 56 Suppl 10(Suppl. 1): S11, 2018

A New Framework for Patient Engagement in Cancer Clinical Trials Cooperative Group Studies. Journal of the National Cancer Institute 110(6): 553-559, 2018

The MACTAR Patient Preference Disability Questionnaire--an individualized functional priority approach for assessing improvement in physical disability in clinical trials in rheumatoid arthritis. Journal of Rheumatology 14(3): 446-451, 1987