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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.



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Glossary Adaptive trial design—trials 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 research—research carried out to understand fundamental prin- ciples, generally without a specific use in mind. However, findings from basic research studies can inform clinical research and medical product development. Bias—a systematic as opposed to random distortion of a statistic as a result of a sampling procedure. Bioinformatics—the science of using computers, databases, and math- ematics 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. Biomarker—a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or phar- macologic responses to a therapeutic intervention. 

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 PRECOMPETITIVE COLLABORATION IN ONCOLOGY RESEARCH Biomedical imaging—the technique and processes used to create images of the human body for clinical purposes or medical science. Biospecimen—samples of material from a patient, such as urine, blood, tissue, cells, DNA, RNA, and protein. Commons—describes resources that are collectively shared. Comparative effectiveness research—the conduct and synthesis of system- atic research comparing different interventions and strategies to prevent, diagnose, treat, and monitor health conditions. Genomics—the 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 bio- logical 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,

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 GLOSSARY and statistics. If the NDA is approved, the product may be marketed in the United States. New molecular entity—an active ingredient that has never before been marketed in the United States in any form. Orphan disease—a 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 medicine—in this report, leveraging scientific advances in fields such as genomics, proteomics, molecular biology, and metabolo - mics to improve the extent to which medical care is personalized to an individual. Phase I trial—a clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed. Phase II trial—a clinical trial in which the safety and preliminary efficacy of an intervention are assessed. Phase III trial—a 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 study—research 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 collaboration—collaboration among competitors to achieve goals that can be more effectively accomplished by a group effort and have the potential to benefit everyone. Premarket approval—an 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.

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0 PRECOMPETITIVE COLLABORATION IN ONCOLOGY RESEARCH 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. Proteomics—the study of the structure and function of proteins, including the way they work and interact with each other inside cells. Standard of care—in 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 therapy—a 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.