PubMed Health⌕ Search

Biomedical subjects

R Temple

Publications and source records attributed to R Temple.

At least 37 records · Page 2Linked to original sources
PubMed1991

Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials.

Expeditious clinical development and approval of new drugs that are beneficial to patients are matters of high priority. There has been a great deal of discussion within the oncology community about what should constitute evidence of effectiveness of new anticancer agents for purposes of drug approval. This commentary is intended to illustrate a variety of end points that can lead to approval of new anticancer agents for specific clinical situations. Although the ultimate hope of antineoplastic therapy is prolongation of life, there are other effects of anticancer drugs that constitute clear clinical benefit and represent evidence of effectiveness. The guiding principle is that the beneficial effects obtained from a new drug should sufficiently outweigh the adverse effects such that the potential risk:benefit ratio achieved by an individual patient is favorable. The assessment of a new drug should flexibly evaluate safety and efficacy in the context of the specific clinical condition being treated. Early discussions with the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) are recommended to identify prospectively the end points and trial designs needed to demonstrate effectiveness of a new drug. The general principles discussed will likely apply to the drug approval process for other medical disciplines as well.

Antineoplastic Agents↗
PubMed1990

Problems in the use of large data sets to assess effectiveness.

Large data sets are an attractive source of information for outcome assessment, but their use involves certain problems and risks. Data base evaluations are retrospective and unblinded; they often represent the result of multiple analyses of multiple endpoints, and it is difficult to identify the procedures used and analytic choices made because critical details are often omitted. While data bases can suggest problems and offer answers, they cannot prove them; data base analyses must be followed by trials.

Humans↗
PubMed1989

Government viewpoint of clinical trials of cardiovascular drugs.

The design of clinical trials affects their usefulness in evaluating the effectiveness and safety of drugs. Problems associated with active control studies are described and methods are given for effective dose-finding. The importance of dose-finding and dose-interval determination is emphasized.

Cardiovascular Agents↗
PubMed1988

The importance of adverse reaction reporting by physicians. Suprofen and the flank pain syndrome.

The role of spontaneous reporting in detecting the suprofen-associated flank pain syndrome was examined, including the specific effect of the "Dear Doctor" letter in accelerating the information-gathering process once the initial signal was generated. We believe this to be a noteworthy example of the ability of spontaneous reporting to produce a timely and unequivocal signal of drug-related risk. It also serves to demonstrate the need for vigilant postmarketing surveillance for all newly marketed drugs in the United States, even though considerable premarketing and postmarketing drug experience may exist from use in countries outside of the United States.

Acute Kidney Injury↗
PubMed1985

Food and Drug Administration requirements for approval of new anticancer drugs.

For approval of new drugs, the law requires a minimum of two independent well-controlled studies for each indication. The preferred study design is prospective, randomized, and comparative. The use of historical controls, while sometimes acceptable, must be justified. A favorable effect on survival and/or quality of life is generally required for approval. The study of cancer drugs in combination presents problems which are discussed. Drug firms are strongly urged to discuss the protocols with the Food and Drug Administration prior to initiating phase III comparative studies to be used for approval of the drug.

Antineoplastic Agents↗
PubMed1973

Stimulation of steroid secretion in adrenal tumor cells by choleragen.

Choleragen, the pure protein from cholera toxin, stimulates steroid secretion by Y-1 adrenal tumor cells in culture. The secreted steroids are the same as seen after addition of adrenocorticotropic hormone. Half-maximal stimulation occurs at 15 pM; stimulation is essentially irreversible by washing and partially reversible (for about 1 hr) by antibody, and there is a latent period of about 60 min before stimulation is seen. Stimulation of adenylate cyclase occurs at about 30-fold higher choleragen concentrations. Gangliosides inhibit choleragen stimulation when added before but not after the toxin. Lipopolysaccharides from Escherichia coli, Salmonella typhosa, and Serratia marcescens also stimulate steroid secretion, but are less potent than choleragen.

Adenylyl Cyclases↗