Case Study: Expanded Access Program

Objectives

To provide eligible patients with free access to a new biologically targeted drug which had shown provisionally beneficial results in Phase II trials.

Scope

Nearly 33,000 patients in 75 countries and almost 3,000 sites addressing Site Registration, Patient Registration, Medical Review of Patient Registration Pack, Processing of drug re-supply requests, Data Management, SAE Management (with the client), Interaction with Client Local Marketing Companies, Web-tracking System, Project Management Oversight.

Challenges

• Managing the open nature of the EAP in terms of size, geographic spread and site and patient recruitment.
• To manage the client's objectives for the program
  • providing expanded access under pressure from patient/clinicians/lobby groups;
  • giving hands on experience to prescribers;
  • keeping interest while tightly controlling access to the product.

Solutions

• Close interaction established and maintained with client Local Marketing Companies; different communication strategies in different countries.
• Call / Coordination centres set-up to handle clinical activities and drug re-supply admin.
• Use of single data entry for Named Patient Program (NPP) patients.
• Robust web tracking system / CTMS to handle large number of sites / patients plus automatic monitoring fax to sites.