Non-members: Click here to review a complimentary excerpt from “Determining Best Practices for Data Dissemination Policies for Global Field Medical Teams”
With the growing emphasis on value-based pricing and evidence-based medicine in the bio-pharmaceutical industry, organizations are turning to their Medical Affairs function to streamline the dissemination of on-label and off-label data to key stakeholders. However, the challenge is to remain vigilant of compliance regulations while formulating guidelines around data discussions for global field medical teams.
Best Practices, LLC conducted benchmarking research to help Medical Affairs leaders better understand how the on-label and off-label data discussions are approached by field medical teams at leading bio-pharmaceutical companies in four major regions across the world including North America, Europe, APAC and Emerging Markets.
- On-Label and Off-Label Field Medical Data Dissemination
- Off-Label Proactive Data Discussions
- Off-Label Data Discussion Restrictions
- Data Dissemination Prior to Label Change
- Data Dissemination Follow-Up
- Please indicate how your field medical teams approach both on-label and off-label data discussions
- Are proactive off-label data discussions with HCPs by your field medical team allowed?
- Please select the restrictions on off-label data discussions
- Do you proactively disseminate major data releases prior to label change?
- Please select the most appropriate response to address how data dissemination is approved
SAMPLE KEY FINDINGS
- Off-label Data Usually Shared on Request While On-label Shared More Proactively: Companies mostly take a reactive approach towards off-label requests across all markets and no company chooses to proactively share information on off-label requests. However, when it comes to on-label data dissemination, 67% of companies in US, and 50% in Europe address off-label requests reactively. Similarly in APAC and in Emerging Markets, 39% and 44% of the participants respectively handle off-label data requests reactively.
Best Practices, LLC engaged 18 leaders from 13 leading bio-pharmaceutical companies through a benchmarking survey instrument. Nearly 70% of participants are at the level of director or above.