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Platform trials test multiple therapies in one indication, one
therapy for multiple indications, or both. These novel clinical
trial designs can dramatically increase the cost-effectiveness of
drug development, leading to life-altering medicines for people
suffering from serious illnesses, possibly at lower cost.
Currently, the cost of drug development is unsustainable.
Furthermore, there are particular problems in rare diseases and
small biomarker defined subsets in oncology, where the required
sample sizes for traditional clinical trial designs may not be
feasible. The editors recruited the key innovators in this domain.
The 20 articles discuss trial designs from perspectives as diverse
as quantum computing, patient's rights to information, and
international health. The book begins with an overview of platform
trials from multiple perspectives. It then describes impacts of
platform trials on the pharmaceutical industry's key stakeholders:
patients, regulators, and payers. Next it provides advanced
statistical methods that address multiple aspects of platform
trials, before concluding with a pharmaceutical executive's
perspective on platform trials. Except for the statistical methods
section, only a basic qualitative knowledge of clinical trials is
needed to appreciate the important concepts and novel ideas
presented.
Platform trials test multiple therapies in one indication, one
therapy for multiple indications, or both. These novel clinical
trial designs can dramatically increase the cost-effectiveness of
drug development, leading to life-altering medicines for people
suffering from serious illnesses, possibly at lower cost.
Currently, the cost of drug development is unsustainable.
Furthermore, there are particular problems in rare diseases and
small biomarker defined subsets in oncology, where the required
sample sizes for traditional clinical trial designs may not be
feasible. The editors recruited the key innovators in this domain.
The 20 articles discuss trial designs from perspectives as diverse
as quantum computing, patient's rights to information, and
international health. The book begins with an overview of platform
trials from multiple perspectives. It then describes impacts of
platform trials on the pharmaceutical industry's key stakeholders:
patients, regulators, and payers. Next it provides advanced
statistical methods that address multiple aspects of platform
trials, before concluding with a pharmaceutical executive's
perspective on platform trials. Except for the statistical methods
section, only a basic qualitative knowledge of clinical trials is
needed to appreciate the important concepts and novel ideas
presented.
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