Playbook | How to Demonstrate & Discuss the Value & Impact of Patient Impact into Medicines Development

PLAYBOOK | How to Demonstrate & Discuss the Value & Impact of Patient Impact into Medicines Development

How to Demonstrate & Discuss the Value & Impact of Patient Impact into Medicines Development:

Measuring the impact of collaborations between advocacy and industry is a best practice, yet not consistently employed. Collaborations require time, financial and employee resources therefore should be carefully thought about as investments in drug development programs. Each investment should ideally lead to an optimization that can be measured and reported back to the participants so that every individual understands what happened as a result of the investment of their time and other resources.

It is recommended that with each engagement, collaborators establish at the outset, a set of objectives and outcomes expected. Metrics should be linked to these objectives to help determine if the impact was as expected. If the outcomes were less than expected, having quantitative measures in place will help groups identify how to better refine future engagements.

Some examples are:

Number of clinical trial procedures avoided (reduces burden on patients, study teams and trial sites)
Costs savings from reduction in clinical trial procedures
Sub analysis of areas where impact is evidenced (eg, Percentage (%) procedures amended, Percentage (%) eligibility criteria amended, Percentage (%) of remote and digital opportunities applied to visits and procedures, etc)
- Percentage (%) of indications, programs and clinical trial informed by patient communities
- Number of validated novel clinical outcomes measures co-created with advocacy organizations for a specific indication
- Inclusion of patient relevant endpoints and outcomes resulting from input from patient communities
- Percentage (%) of research (pre-clinical) stage programs prioritized for Development based on patient input
- Time saved to recruit a clinical trial vs original baseline due to collaboration with advocacy organization
Change in patients per site/ month during the time of a recruitment campaign
- Percentage (%) of clinical trial achieving diversity goals
- Percentage (%) of clinical development programs with a patient relevant label strategy based on patient insights
- Percentage (%) of programs with a patient-relevant label strategy
- Percentage (%) programs with patient experience data prominently noted in regulatory and HTA dossiers

Up Next:

Best Practices for Initiating Diverse & Inclusive Collaborations

Cultivating a Successful Partnership Throughout the Clinical Trial Continuum

Importance of Sharing Patient Insights

Go Back:

Considerations for Thoughtful & Effective Collaboration

Getting Started: Initiating Collaboration

History & Overview

Introduction & Background

Downloads:

The Value of Collaboration: Suggestions for Effective Collaboration Practices

Top Five Things for PAGs to Keep in Mind About Biopharmaceutical Companies

Top Five Things for Biopharmaceutical Companies to Keep in Mind About PAGs

Industry and PAG Study Considerations for Effective Clinical Trial Execution

Collaborative Approach Roadmap

Assessing the Financial Value of Patient Engagement

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.

Reference:

Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project – Bennett Levitan, Kenneth Getz, Eric L. Eisenstein, Michelle Goldberg, Matthew Harker, Sharon Hesterlee, Bray Patrick-Lake, Jamie N. Roberts, Joseph DiMasi, 2018 (sagepub.com)