The closure of one or more arms of a study to patient entry (either temporarily or permanently) while at least one other study arm remains open to patient accrual.
The Physician Data Query is an online data base which makes state-of-the-art treatment information, directory information, and protocol information available to primary care physicians. This database is maintained by the International Cancer Research Data Base Branch, International Cancer Information Center, NCI.
The decision by a group, institution, or NCI to stop patient entry permanently due to a study reaching accrual, lack of study accrual, or a decision that a study is not efficacious or poses increased risks to patients.
A pharmaceutical company which provides study agents and other clinical support for SWOG trials
Earliest human clinical trial in which a maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and optimal route of administration (e.g. oral or intravenous, etc.) are determined.
These trials continue to test the safety of the treatment and evaluate how well the treatment works. Phase II studies usually evaluate the treatment in a specific condition.
A large clinical trial of a treatment or drug that in Phase I and Phase II has been shown to be efficacious with tolerable side effects. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. After successful conclusion of these clinical trials, it may receive formal approval from the FDA as a new pharmaceutical that can be marketed and sold.
The Protocol and Information Office, CTEP, DCTD; manages the protocol and amendment review process and maintains the official record of all NCI-sponsored protocols and voluntary protocols for PDQ.
Protocol Review Committee. Refers to a group of statisticians at the SWOG statistics and data management center that reviews protocols prior to CTEP submission. CTEP also has a PRC.
Title of physician who has organizational and fiscal responsibility for the use of federal funds to conduct a plan of research which frequently includes several clinical trials, i.e., Contract PI, Group Chairman, RO1/POI PI, etc.
Operations office coordinator who is responsible for the development and maintenance of protocol documents for the group
Free search engine accessing primarily the MEDLINE database of references and abstracts on life sciences and biomedical topics. The National Library of Medicine (NLM) at the NIH maintains the database as part of the Entrez system of information retrieval https://www.ncbi.nlm.nih.gov/pubmed