- Site selection considerations specific to Radiopharmaceutical Therapy (RPT) clinical trials
- A sponsor’s perspective of the technical knowledge and expertise required to deliver RPT studies
- Country specific RPT clinical trial requirements and regulations
- Challenges with just-in-time supply for RPT investigational products
- Geographic feasibility for country selection
- Benchmarking timelines, trial costs and recruitment rates
- DCT complications
- Site selection process including e-feasibility questionnaires
- Evaluating, predicting and understanding of the Innovator:
- Product value, medical potential, product profile
- Ongoing studies, IP intelligence
- Defining the details of the generic development:
- Competition level
- Markets, generic pricing
- Paediatric oncology trials pose unique challenges
- International clinical trial networks have traditionally driven the clinical development of new agents for pediatric patients
- Partnership opportunities for study protocol preparation and patient selection: the case for basket trials
- Regulatory implications and the case for “fit-for-filing” studies
- Examples of collaborative approaches
