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Perspect Clin Res. 2016 Jan-Mar;7(1):4-8. doi: 10.4103/2229-3485.173779.

Early access programs: Benefits, challenges, and key considerations for successful implementation.

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Subject Matter Expert, Risk Based Monitoring, TATA Consultancy Services. Vikhroli (West), Mumbai, Maharashtra, India.


Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant, and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global commercialization strategies. This white paper outlines various circumstances to be considered for the implementation of EAPs named patient programs, the regulatory landscape, the benefits and challenges associated with implementing these programs and the key considerations for their successful implementation.


Early access programs; named patient programs; patients with life-threatening diseases

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