Objectives
To provide eligible patients with free access to a new biologically targeted drug which had shown provisionally beneficial results in phase 2 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.