Cross-Border Enrollment of Rare Disease Patients
PRA has written a new white paper on the considerations for planning and conducting global rare disease clinical trials.
Rare disease trials are inherently designed to include fewer patients, are often longer in duration, and more frequently terminated than trials in more common indications. These challenges impact both sponsors and patients. A recent literature review revealed that recruitment and coordination of multinational patients and sites for rare disease clinical trials represents a major barrier to successful study completion.
Crossborder enrollment can provide a solution for some of these challenges. Cross-border enrollment is necessary when a patient enrolls in a clinical trial located at a site in a country other than their permanent residence. Rare disease studies are the most common application of cross-border enrollment. As the number of rare disease studies increases, the need for best practices for cross-border enrollment planning also grows. The majority of the centers that conduct clinical research in rare diseases are in the US and Europe, making these regions the primary focus of cross-border enrollment planning. Crossing borders within Europe is complex but done frequently enough to be fairly commonplace. Transnational studies in Europe are supported by European Parliament Directive 2011/24/EU, which addresses patient rights in cross-border healthcare and notes a need for cooperation to address rare diseases.
The paper also covers
- Site Selection & Patient Identification
- Ethics Committee Review
- Transnational Logistics (including pediatric trials)
- Documentation of Cross-Border Process
More details to be found in the document. Download the white paper now.