Dublin, Sept. 26, 2013 (GLOBE NEWSWIRE) -- Research and Markets (http://www.researchandmarkets.com/research/fhw2mk/oncology)
has announced the addition of the "Oncology
Development Strategies: Considerable Commercial Potential but
Specific Needs Must be Addressed" report to their
offering.
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.
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
Key Topics Covered:
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
For more information visit http://www.researchandmarkets.com/research/fhw2mk/oncology
Research and Markets
Laura Wood, Senior Manager.
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector:
Oncology