PharmaVOICE Blog Post

Access Options for Investigational Products – Key Considerations

Posted By: Dan Limbach
December 13, 2017

In the Fall issue of The Evidence Forum, one of the many informative articles discusses access options for investigational products, comparing and contrasting three key categories. These programs provide an important service in allowing select patient populations to receive access to experimental drugs, and as regulatory agencies place more emphasis on patient access, the need for these programs may increase.

Here is a sample of what you will see in the article…

Patient access to an investigational product (IP) is available not only through the traditional means of clinical trials but also through various pre-approval access programs. These programs exist under a variety of names including extended access, open label extensions, compassionate use, special access, early access, expanded access, and named-patient programs.

Pre-approval access programs come in many forms and the regulations differ from country to country, so it is important to understand the differences between these programs and when they may be appropriate for your products.

Here are some key points covered in the article:

  • Extended Access Programs (XAP)/Compassionate Use Programs (CUP)
  • Expanded Access Programs (EAP)
  • Open Label Extension (OLE)/Long-Term Extension (LTE)
  • Regulatory Issues
  • Ethical Considerations with Pre-approval Access

More details about these areas are included in the full article.

The article also contains four informative charts which help explain the complex issues regarding patient access.

Download the full article pdf at http://bit.ly/access-options

Download the full issue with numerous articles at http://www.evidera.com/why-evidera/the-evidence-forum/

Provided by Evidera

About the Blog Poster: Dan Limbach

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