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02 Oct 2019 Insight Blog

PROs in Early Access - what do you need to know?

PROs in Early Access – what do you need to know?

  • See how your organisation can benefit from patient-reported insight applied to Early Access
  • Keep pace with best practice Managed Access Program design
  • Find potential practical solutions through Early Access provision, to help solve wider Patient Reported Outcomes (PRO) design and collection challenges

Clinigen is pleased to publish some of its thought leadership content from its Unlicensed Medicines division. The topic of the latest work is Patient Reported Outcomes (PROs) in Early Access, which is an emerging area and one in which patient engagement will be crucial.

As a business so inherently focused on patients, this is a natural extension of our work. Led by Clinigen’s Patient Advocacy function and partnering with RWD leaders within the business, Clinigen presents insight sourced through separate panel and workshop discussions, first with patient and then with HCP stakeholder groups respectively. Derived from attendee input from within rarer cancers in Early Access and letting patient groups set the agenda, the exercise brought together both stakeholder perspectives from within a disease area where Clinigen experiences high levels of unmet medical need.

See the below link for a summary of the insight generated, and some key next steps for industry to consider. Clinigen is committed to driving best practice in this area and works with industry partners to ensure that its RWD collection is at the cutting edge within Early Access.

Click here to view the full PDF

If you are an industry or patient group community representative who would be interested to read the wider outcomes of the project, please email and request the full proceedings.