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Applying the best of oncology drug development paradigms to the non-malignant space
Indranil Bhattacharya1, Anne Heatherington1, Jeremy Barton2
1Quantitative Clinical Sciences, Pharmatherapeutics, Pfizer Inc., 300 Technology Square, Cambridge, MA 02139, USA.
Abstract:
With 80-90% of drugs entering the clinic not meeting regulatory approval (a high cost of failure), there is a major need for innovation in the clinical development space. Features of the new era of practice-changing innovation in oncology have included novel clinical trial designs incorporating multiple new molecular entities and/or multiple patient types, patient selection strategies (which allow detection of early signs of efficacy), and use of surrogate endpoints to achieve speedy regulatory approval. Disease areas beyond oncology could benefit from the application of specific aspects of these approaches. Here, we describe several such potential adaptations of the approaches, with scenarios and prerequisites, which could help reduce the costs of, and accelerate, clinical drug development with confidence.
Insights
Drug development faces high failure rates, costing billions. This study explores innovative oncology trial designs, like novel endpoints and patient selection, to accelerate drug approval and reduce costs in other disease areas.
Area of Science:
- Drug development and clinical trial innovation
- Oncology and translational medicine
- Regulatory science
Background:
- High failure rates (80-90%) in clinical drug development lead to significant financial losses.
- Current clinical development paradigms require innovation to improve efficiency and success rates.
- Oncology has pioneered innovative trial designs and patient selection strategies.
Purpose of the Study:
- To identify and describe innovative approaches from oncology clinical trials.
- To explore the potential adaptation of these approaches to other disease areas.
- To propose methods for reducing costs and accelerating drug development.
Main Methods:
- Review of novel clinical trial designs in oncology.
- Analysis of patient selection strategies and surrogate endpoints.
- Conceptualization of adaptations for non-oncology drug development.
Main Results:
- Novel trial designs, patient stratification, and surrogate endpoints can improve drug development efficiency.
- These oncology-derived strategies show promise for accelerating development in other therapeutic areas.
- Specific scenarios and prerequisites for adaptation are outlined.
Conclusions:
- Adapting oncology's innovative trial strategies can significantly reduce drug development costs and timelines.
- Implementing these approaches requires careful consideration of disease-specific factors and prerequisites.
- This strategy offers a pathway to more confident and accelerated drug development across diverse fields.
