Despite spending more time and money in developing novel therapeutics, the success rate for new pharmacologic treatments has been poor. Although the research and development expenditures have grown 13 percent each year since 1970 (a 50-fold increase), the number of new drugs approved annually is no greater now than it was 50 years ago. Over the past decade, skyrocketing costs and the complexity of the scientific knowledge upon which to develop new agents have provided incentives for alternative approaches to drug development, if we are to continue to improve clinical care and reduce mortality. These challenges create opportunities for improved collaboration between industry, academia, government, and philanthropic organizations at each stage in new drug development, marketing, and implementation. Perhaps the most appropriate initial step in addressing the need for collaboration is to consider more precompetitive relationships that allow sharing of scientific information to foster drug development. While these collaborative relationships in basic and preclinical research on drug targets and the early stages of clinical testing are acknowledged to be potentially important drivers for innovation and more rapid marketing of new agents, they also raise a number of concerns that must be addressed. For example, acknowledgment of academic productivity and independence and economic competitiveness must be considered and these challenges managed to foster a culture of collaboration. At the same time, regulatory issues, the need for standardization, and intellectual property concerns must be confronted if the current models for drug development are to be refined to encourage robust participation in precompetitive collaborations. Recognizing the growing importance of precompetitive collaborations in oncology drug development, as well as the challenges these innovative collaborations pose, the National Cancer Policy Forum of the Institute of Medicine held a workshop on February 9 and 10, 2010. This book is a summary of the workshop proceedings.

Despite spending more time and money in developing novel therapeutics, the success rate for new pharmacologic treatments has been poor. Although the research and development expenditures have grown 13 percent each year since 1970 (a 50-fold increase), the number of new drugs approved annually is no greater now than it was 50 years ago. Over the past decade, skyrocketing costs and the complexity of the scientific knowledge upon which to develop new agents have provided incentives for alternative approaches to drug development, if we are to continue to improve clinical care and reduce mortality. These challenges create opportunities for improved collaboration between industry, academia, government, and philanthropic organizations at each stage in new drug development, marketing, and implementation. Perhaps the most appropriate initial step in addressing the need for collaboration is to consider more precompetitive relationships that allow sharing of scientific information to foster drug development. While these collaborative relationships in basic and preclinical research on drug targets and the early stages of clinical testing are acknowledged to be potentially important drivers for innovation and more rapid marketing of new agents, they also raise a number of concerns that must be addressed. For example, acknowledgment of academic productivity and independence and economic competitiveness must be considered and these challenges managed to foster a culture of collaboration. At the same time, regulatory issues, the need for standardization, and intellectual property concerns must be confronted if the current models for drug development are to be refined to encourage robust participation in precompetitive collaborations. Recognizing the growing importance of precompetitive collaborations in oncology drug development, as well as the challenges these innovative collaborations pose, the National Cancer Policy Forum of the Institute of Medicine held a workshop on February 9 and 10, 2010. This book is a summary of the workshop proceedings.

Despite the many basic research discoveries in genetics, relatively few gene-based treatments, drugs, or preventative measures have been developed. One way to bridge this gap may be for industry, academia, and government to develop partnerships that share resources while distributing risk. However, intellectual property protections and other barriers can inhibit collaborative efforts. The Institute of Medicine held a workshop on July 22, 2010, to explore these issues and develop solutions.

Advances in biomedical research have increased our understanding of the complex nature of disease and the interaction of multiple molecular pathways involved in cancer. Combining investigational products early in their development is thought to be a promising strategy for identifying effective therapies. The IOM's National Cancer Policy Forum held a workshop to discuss challenges and identify potential solutions to improve collaboration and advance the development of combination investigational cancer therapies.

The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research Delves into data management and addresses how to collect data and use it for discovery Contains valuable, up-to-date information on how to obtain funding from the federal government

Many ongoing changes are likely to have an impact on cancer research and care. For example, technological advances are rapidly changing the way cancer research is conducted, and the recently passed healthcare reform legislation has many implications for cancer care. Technological advances are altering the way cancer research is conducted and cancer care is delivered, and the recently passed healthcare reform legislation has many implications for cancer care. There is a growing emphasis on molecularly targeted therapies, information technology (IT), and patient-centered care, and clinical cancer research has become a global endeavor. At the same time, there are concerns about shrinking research budgets and escalating costs of cancer care. Considering such changes, the National Cancer Policy Forum (NCPF) of the Institute of Medicine held a National Cancer Policy Summit on October 25, 2010. The Summit convened key leaders in the cancer community to identify and discuss the most pressing policy issues in cancer research and cancer care. The National Cancer Policy Summit: Opportunities and Challenges in Cancer Research and Care is a summary of the summit. The report explores policy issues related to cancer research, the implementation of healthcare reform, delivery of cancer care, and cancer control and public health needs. Expert participants suggested many potential actions to provide patient-centered cancer care, to foster more collaboration, and to achieve other goals to improve research and care.

Covering fundamentals and new developments in phytotherapy, this book combines pharmaceutical sciences and chemistry with clinical issues. • Helps readers better understand phytotherapy and learn the fundamentals of and how to analyze phytotherapeutic agents • Discusses phytotherapy in modern medicine, chemoprevention of disease, and alternatives to western medicines for specific diseases • Chapters summarizes the uses and applications of phytomedicines, by type like Chinese, Greco-Arab, Indian, European, and Ayurvedic • Includes international regulatory perspectives and discusses emerging regulations for various established and emerging markets