Orphan Drug Market Dynamics and Patient Recruitment Best Practices

Report Overview

The recruitment of patients for orphan drug trials adds levels of complexity to the already difficult process of patient recruitment. ISR sought the opinions of individuals with extensive experience with orphan drug trial recruitment in order to understand the most and least effective practices in orphan drug trial patient recruitment, how orphan drug trials are organized, the regulatory guidelines surrounding orphan drug trial recruitment, and ultimately what to expect for the future in terms of orphan drug trials.

ISR also analyzes key trial metrics, such as number and phase of orphan drug trials, outsourcing trends, study type, source of funding, projected vs. actual trial lengths, and enrollment figures for ongoing orphan drug/rare disease trials to provide a comprehensive look at the orphan drug market.

What you will learn:

• The most and least effective practices in orphan drug trial patient recruitment
• How orphan drug trials are typically organized within a company’s structure
• The regulatory guidelines surrounding orphan drug trial recruitment
• What to expect for the future in terms of orphan drug trials
• How individual companies perceive and handle orphan drug trials (number of orphan drug trials, outsourcing trends, deadlines met, etc.)
• Current orphan drug trial metrics, such as the phase, source of funding, study type, length of trial, projected vs. actual trial lengths, and enrollment figures
• Best practices for:
  • Marketing CRO orphan drug services
  • Direct recruiting practices
  • Involving Key Opinion Leaders
  • Patient advocacy groups and social media
  • Sponsor methods for CRO selection

How you can use this report:

• Anticipate potential problems in orphan disease patient recruitment in order to reduce trial delays
• Understand regulatory guidelines for orphan drug trials and the difficulties these guidelines pose
• Benchmark your company’s orphan drug trial recruiting structure to those of other companies outlined in the report
• Understand the bigger picture of the orphan drug recruitment process and what to expect in the future

Report Contents:

1. Executive Summary
2. Case Study: Patient Recruitment Specialists
3. Regulatory Influence
4. Impact of Key Opinion Leaders
5. Alternative Tools for Patient Recruitment
6. Enrollment Best Practices
7. Best Practices and Recommendations
8. Current Orphan Drug Clinical Trial Figures