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Suggested Citation:"Glossary." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
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Glossary

Adaptive trial designtrials that incorporate one or more decision points into their design. How a trial proceeds following each decision point depends on the data observed up to that point.

Basic researchresearch carried out to understand fundamental principles, generally without a specific use in mind. However, findings from basic research studies can inform clinical research and medical product development.

Biasa systematic as opposed to random distortion of a statistic as a result of a sampling procedure.

Bioinformaticsthe science of using computers, databases, and mathematics to organize and analyze large amounts of biological, medical, and health information. Information may come from many sources, including patient statistics, tissue specimens, genetics research, and clinical trials.

Biomarkera characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.

Suggested Citation:"Glossary." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
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Biomedical imagingthe technique and processes used to create images of the human body for clinical purposes or medical science.

Biospecimensamples of material from a patient, such as urine, blood, tissue, cells, DNA, RNA, and protein.

Commonsdescribes resources that are collectively shared.

Comparative effectiveness researchthe conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat, and monitor health conditions.

Genomicsthe study of the complete genetic material, including genes and their functions, of an organism.

Institutional Review Board (IRB)“An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy” (Department of Health and Human Services IRB Guidebook).

Intellectual property (IP)creations of the mind, creative works, or ideas embodied in a form that can be shared or can enable others to recreate, emulate, or manufacture them.

Investigational new drug (IND)a new molecular, antibiotic, or biological drug that is used in clinical investigation. It also includes a biological product used in vitro for diagnostic purposes.

New drug application (NDA)when the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet Food and Drug Administration (FDA) requirements for marketing approval, the sponsor submits a new drug application to FDA. The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics,

Suggested Citation:"Glossary." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
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and statistics. If the NDA is approved, the product may be marketed in the United States.

New molecular entityan active ingredient that has never before been marketed in the United States in any form.

Orphan diseasea rare disease or a disease for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales of the drug.

Personalized medicinein this report, leveraging scientific advances in fields such as genomics, proteomics, molecular biology, and metabolomics to improve the extent to which medical care is personalized to an individual.

Phase I triala clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed.

Phase II triala clinical trial in which the safety and preliminary efficacy of an intervention are assessed.

Phase III triala large-scale clinical trial in which the safety and efficacy of an intervention are assessed in a large number of patients. The Food and Drug Administration generally requires new drugs to be tested in Phase III trials before they can be put on the market.

Preclinical studyresearch using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies usually take place before clinical trials in humans are conducted.

Precompetitive collaborationcollaboration among competitors to achieve goals that can be more effectively accomplished by a group effort and have the potential to benefit everyone.

Premarket approvalan FDA approval for a new test or device that enables it to be marketed for clinical use. To receive this approval, the manufacturer of the product must submit clinical data showing the product is safe and effective for its intended use.

Suggested Citation:"Glossary." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×

Principal investigator (PI)the lead investigator for a research project, such as a clinical trial, who takes direct responsibility for the completion of a funded project.

Proteomicsthe study of the structure and function of proteins, including the way they work and interact with each other inside cells.

Standard of carein medicine, treatment that experts agree is appropriate, accepted, and widely used. Also called best practice and standard therapy.

Supplemental new drug application—an application submitted to FDA in order to expand the label of a previously approved drug to cover new treatment indications.

Targeted therapya type of treatment that uses drugs or other substances (e.g., monoclonal antibodies) to identify and attack cancer cells without harming normal cells. Targeted therapy may be less harmful to normal cells than other types of cancer treatments.

Trastuzumab (Herceptin)a monoclonal antibody that binds to HER2 (human epidermal growth factor receptor 2), and can kill HER2-positive cancer cells. Herceptin is used to treat breast cancer that is HER2-positive.

Suggested Citation:"Glossary." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×
Page 87
Suggested Citation:"Glossary." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×
Page 88
Suggested Citation:"Glossary." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×
Page 89
Suggested Citation:"Glossary." Institute of Medicine. 2010. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12930.
×
Page 90
Next: Appendix A: Workshop Agenda »
Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary Get This Book
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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.

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