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PubMed1995

The NIH consensus development program.

The NIH CDCs are a highly visible, public forum to evaluate controversial medical technologies by synthesizing current medical science data. The consensus statements, although not intended as medical practice guidelines, may form part of the database preceding guideline formulation. It is difficult to assess the effect of the conferences on physician practice, in part reflecting the interference of the many other influences, medical and nonmedical, on physician behavior. Yet the program has had some success in influencing reimbursement policy for some technologies here and abroad and in influencing specialty organization policy, thereby indirectly affecting physician behavior. On the other hand, OMAR's dissemination activities have apparently been so successful that demand for CDC statements has more than doubled over the past five years, prompting OMAR to establish an information service (including fax and the Internet). And finally, the program has spawned consensus conferences throughout the world, including Canada, Western Europe, and Israel (Goodman & Baratz 1990).

Consensus Development Conferences, NIH as Topic↗
PubMed1998

The National Institutes of Health Anticonvulsant Drug Development Program: screening for efficacy.

The procedures employed by the ASP provide detailed information pertaining to the anticonvulsant profile of new candidate substances. In addition, the results obtained from tolerance and liver microsomal studies furnish critical information for predicting whether tolerance and/or serious drug-drug interactions are likely to develop following long-term administration of a candidate substance. Finally, in vitro mechanism-of-action studies supply preliminary information regarding the site of action of promising new anticonvulsant drugs. It is anticipated that the testing protocol outlined above will identify safer and mechanistically novel substances to enhance significantly the quality of life of those epilepsy patients still suffering from uncontrolled seizure disorders and/or experiencing significant adverse drug effects.

Animals↗
PubMedDate not supplied

A systems approach to motivational program development.

The need for heightened motivation among technical staff has long been recognized. Both management and professional radiographers realize a motivated staff has the potential for increasing levels of productivity as well as enhancing the quality of patient care delivered. In accomplishing these highly desirable goals, a knowledge of motivation theory must be systematically integrated into a functional program. Such a program must be based on a flexible design model, sensitive to the personal needs of each radiographer involved.

Employee Incentive Plans↗
PubMed1979

Programs developed from concerns for women in medicine.

Since the Medical College of Pennsylvania, formerly the Woman's Medical College of Pennsylvania, became coeducational in 1969, there has been a continued effort to maintain the commitment of the institution to its heritage of women in medicine. An office has the role of coordinating and stimulating the establishment and maintenance of programs relevant to women in medicine throughout the institution. These programs are now available to men as well but particularly serve women's needs. They include the Summer Premedical Program, the Summer Health Policy Program, a restraining program for inactive physicians, a demonstration child care project, archives and special collections related to women in medicine, a women in medicine oral history project, and a bibliography of the literature on women physicians. The Medical College of Pennsylvania will continue its interests in the present and future needs of women physicians.

Archives↗
PubMed2006

A pharmacokinetic-pharmacodynamic model to optimize the phase IIa development program of maraviroc.

OBJECTIVES: To use a viral dynamics model to compare the effectiveness of in vivo viral inhibition of several doses of maraviroc (MVC;UK-427,857) and to use a modeling approach to support design decisions for a monotherapy study using various dosing regimens of maraviroc given with and without food. DESIGN: The pharmacokinetic-pharmacodynamic model was developed using clinical data from a first monotherapy study (study A4001007). This was a randomized, double-blind, placebo-controlled, multicenter study of maraviroc in 44 asymptomatic HIV-1-infected patients. Patients received maraviroc under food restrictions at 25 mg once daily or 50, 100, or 300 mg twice daily, or placebo for 10 days. METHODS: Antiviral responses were assessed by measuring plasma HIV-1 RNA levels during screening, during randomization, at baseline, and daily during the 10 days of treatment and at days 11 to 15, 19, 22, 25, and 40. An integrated pharmacokinetic-pharmacodynamic model was developed using the mixed effects modeling approach with patients' pharmacokinetic profiles on the last day of treatment, HIV-1 RNA levels over time, and the individual viral susceptibility. The parameters derived from the viral dynamic model were used to calculate average viral inhibition fraction, decay rate of actively infected cells, and basic reproductive ratio for each treatment group. Monte Carlo simulation was then used to determine the distribution of viral load change across simulated patients over time for each regimen to be studied in another monotherapy study, A4001015. RESULTS: The decline rate in the 300 mg twice daily group was comparable to that induced by potent protease inhibitor monotherapy, but was significantly slower than that in patients receiving combination therapy including both protease inhibitor and reverse transcriptase inhibitors. The efficacy of inhibition in vivo was estimated to range from 0.15 to 0.38 for the 25 mg once daily dose group and from 0.88 to 0.96 for the 300 mg twice daily dose group. CONCLUSIONS: The model has aided the analysis and interpretation of the clinical data. The use of a model-based approach for selecting doses can accelerate drug development by replacing some arms or trials with simulations.

Anti-HIV Agents↗
PubMed1988

Usefulness of a local oral health survey in program development.

In 1986, the Columbus (Ohio) Health Department conducted an oral health survey of children in grades 1, 2, 6, and 7. The World Health Organization's Pathfinder methodology served as the basis for survey design. The survey was made possible through collaboration and sharing resources among the local and state health departments and two universities. The findings of the children's portion of the survey proved useful in program planning, marketing (including resource procurement), constituency building, and educating the dental profession and the public. The data were used to support successful grant requests that led to the implementation of a school-based dental sealant program. The local government expanded the health department's dental budget to continue the sealant program beyond the grant period. The state health department considered the survey to be a pilot for a statewide effort.

Adolescent↗