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  4. > Oncology Development Strategies - Considerable commercial potential but specific needs must be addressed

The oncology therapeutic area has seen significant development and advances over the last decade. However, oncology has one of the lowest overall clinical success rates of all therapy areas with only a third of oncology drugs that get to Phase III proceeding to approval. There are a number of factors that will affect the likelihood of success in oncology drug development and these must be taken into consideration when designing the clinical development plan. Oncology clinical trials tend to be more complex than those in other therapy areas, largely due to the number of endpoints that can be utilized, the growing need for adaptive trial design and the types of patients that are eligible for the clinical studies. While overall survival is the gold standard endpoint, achieving this is challenging for many oncology trials and other endpoints such as progression-free survival are frequently used as surrogates.

The approval of oncology drugs has been facilitated by regulatory mechanisms that have been put in place to expedite the process for drugs with small patient populations or that address areas of high unmet need. Programs to allow early access to developmental drugs are becoming the norm in oncology, largely driven by the high unmet need and serious nature of the disease, but also due to a desire to obtain real-life data.

The report, “Oncology Development Strategies -Considerable commercial potential but specific needs must be addressed”, was written to provide support and guidance to companies who are both new entrants and long time players in the oncology space. CBR Pharma Insights provides in-depth analysis on the challenges that exist in developing new oncology products and launching them successfully into a challenging health care climate.

Scope

- Oncology clinical trials details including endpoints, trial design, biomarkers, access to patients, and regional data needs
- Regulatory strategies
- oncology launch strategies

Key Reasons to Purchase

- Provides insight into why the development of oncology drugs is different compared to other therapy areas and the implications for the overall process
- Enables you to understand the regulatory mechanisms in place to expedite approval of new oncology drugs and how these should be incorporated into strategic launch planning
- Provides in-depth analysis of key aspects of oncology clinical trial design, examining the merits of different endpoints, alternative trial designs and the importance of biomarkers in oncology clinical trials and drug development
- Better understand the key critical requirements when planning for a successful oncology launch, including the impact of indication sequencing and how to address specific pricing and reimbursement needs
- Gain clear and actionable recommendations on crucial factors to consider when progressing a new oncology drug through clinical testing, the regulatory process and launch

Table Of Contents

Oncology Development Strategies - Considerable commercial potential but specific needs must be addressed
Executive summary
Methodology
Why is oncology different?
Oncology clinical trials
Endpoints
Trial design
Biomarkers
Access to patients
Regional data needs
Regulatory strategies
Mechanisms in place that can facilitate oncology approvals
Critical success factors
Effective oncology launch strategies
Launch sequencing
Pricing and reimbursement considerations
Communication planning
Launching with immature data
Appendix
List of sources

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