Platform Trial Designs in Drug Development

<p>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. </p><p></p><p>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. </p><p></p><p>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. </p><p></p>