Call for Speaker Proposals
第2回
Oncology Clinical Trials
-癌治療薬臨床試験学会-
臨床試験の改善による癌治療薬開発の促進
2月21日〜23日
癌分子生物学研究における近年の目覚しい成果により、癌治療薬開発の分野では、かつてないほど多くの新たな標的が生まれています。こうした標的に対応する薬剤の多くは、すでに臨床段階に進んでおり、さまざまな療法に対応する癌治療薬の臨床試験が盛んに行われています。癌治療薬の臨床試験を成功に導くための要因は数多くありますが、最も重要なのは、臨床前データの質が検証可能な仮説を導き出すことができるだけの水準に達しているかどうかという点です。また、生物統計学、科学、組織、規制、倫理、経済などにまつわる要因も、医薬品の臨床開発を進めるうえで重要な意味を持っています。
Who should attend: Scientists, biostatisticians, project managers, research investigators and other specialists involved in oncology clinical trials
Topics will include, but are not limited to:
- Translational clinical trials in oncology
- Evaluating pre-clinical evidence to avoid clinical development failures
- Molecular imaging in cancer clinical trials
- Prescreening patients for somatic mutations before randomization
- Biomarker-driven clinical trials
- Companion diagnostics in oncology clinical trials
- Advanced methodology for dose-finding clinical trials
- Dose finding for “nontoxic” drug
- Pharmacodynamic biomarkers and their use in clinical trials
- Role of randomization in middle development
- How to use surrogate outcomes in the light of lack of biomarker validation
- Regulatory and legal challenges and solutions
- Safety issues in cancer clinical trials
- Ways to increase patient enrollment
- Ethical issues related to biomarker use for patient selection (what is the threshold?)
- Cost effectiveness of clinical trials in the US and abroad
- Joint development: Industry-academic collaboration (identification (who takes responsibility), shared intellectual property, etc.)
The deadline for submission is July 29, 2011.
All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are
offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
