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.
- 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
- 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
- Executive Summary
- Case Study: Patient Recruitment Specialists
- Regulatory Influence
- Impact of Key Opinion Leaders
- Alternative Tools for Patient Recruitment
- Enrollment Best Practices
- Best Practices and Recommendations
- Current Orphan Drug Clinical Trial Figures
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- Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
- Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries. We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
- Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.
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