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At least 19 recordsLinked to original sources
PubMed1994

Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute.

At the National Cancer Institute, Division of Cancer Prevention and Control, the Chemoprevention Branch and Agent Development Committee develop strategies for efficiently identifying, procuring, and advancing the most promising drugs into clinical trials. Scientific expertise is applied at each phase of development to critically review the testing methods and results, and to establish and apply criteria for evaluating the agents for further development. The Clinical Development Plan, prepared by the Chemoprevention Branch and the Agent Development Committee, is a summary of the status of the agent regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. It also contains the strategy for further development of the drug that addresses pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen Clinical Development Plans are presented here: N-acetyl-l-cysteine (NAC), aspirin, calcium, beta-carotene, 2-difluoromethylornithine (DFMO), DHEA analog 8354, 18 beta-glycyrrhetinic acid, N-(4-hydroxyphenyl)retinamide (4-HPR), ibuprofen, oltipraz, piroxicam, Proscar, sulindac, tamoxifen, vitamin D3 and analogs, and vitamin E. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing chemopreventive drugs.

Clinical Trials as Topic↗
PubMed1996

Strategy and planning for chemopreventive drug development: clinical development plans II.

This is the second publication of Clinical Development Plans from the National Cancer Institute, Division of Cancer Prevention and Control, Chemoprevention Branch and Agent Development Committee. The Clinical Development Plans summarize the status of promising chemopreventive agents regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. They also contain the strategy for further development of these drugs, addressing pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen new Clinical Development Plans are presented here: curcumin, dehydroepiandrosterone, folic acid, genistein, indole-3-carbinol, perillyl alcohol, phenethyl isothiocyanate, 9-cis-retinoic acid, 13-cis-retinoic acid, l-selenomethionine and 1, 4-phenylenebis(methylene)selenocyanate, sulindac sulfone, tea, ursodiol, vitamin A, and (+)-vorozole. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing these and future generations of chemopreventive drugs.

Animals↗
PubMed1977

Issues in health plan development: a critique of the guidelines for plan development under PL 93-641.

The draft guidelines for development of health systems plans and annual implementation plans represent a logical, coherent integration of the best of currently available planning concepts and methods. However, there are at least six major areas in which the current state of the art is clearly inadequate. These are linkages between plan components, synchronization, plan integration, level of detail, cross-impact analyses and policy planning. This article describes each of these issues and identifies some of the projects which seem likely to contribute to their resolution. Finally, it urges each health planning agency to take advantage of the latitude in the guidelines to develop innovative solutions and to share the results with others.

Decision Making↗
PubMed1978

Use of quantitative approaches in plan development.

Health Planning as mandated by P.L. 93-641 requires considerable emphasis on technical procedures, especially during the development of the 5 year Health Systems Plans (HSP) and the one year Annual Implementation Plans (AIP). In addition, the State Health Plans and the State Medical Facilities Plans, which are to be developed in part on the basis of HSPs and AIPs of the Health Systems Agencies (HSAs) in each state, are expected to have solid quantitative documentation. The gap between these expectations and the state of the art reality are reviewed in this article.

Evaluation Studies as Topic↗
PubMedDate not supplied

Prototype antiepileptic drug clinical development plan.

Antiepileptic drug (AED) development has been generally difficult owing to many factors: regulatory requirements for demonstration of efficacy and safety, subject availability, traditional trial designs, and physicians' beliefs about epilepsy and its treatment. The U.S. Food and Drug Administration (FDA) regulations require a new drug to be shown safe and effective for its intended use before it can be marketed. The unambiguous proof required is a formidable hurdle for AED development. We report a recent clinical development plan highlighting innovations in clinical trial design that have addressed these requirements, discuss alternative endpoints, and compare the results of various trial designs at various stages of development. This model clinical development plan includes trials relevant to all three clinically relevant contexts in which an AED might be used: as an adjunct to an existing regimen, as a substitution for much of an existing AED regimen, and as monotherapy.

Anticonvulsants↗
PubMed1987

Need for and approaches to integrated population, human resource and development planning.

The authors discuss the nature of an integrated approach to the treatment of population variables in the socioeconomic planning exercises of developing countries and describe the obstacles that must be overcome in order to achieve meaningful integration. The nature of the system linking demographic and socioeconomic processes is described, and a distinction is made between the roles of population-influencing and population-responsive policies. The types of studies needed to provide an effective analytical framework for integrated population and development planning are set forth and discussed in ascending order, from inventories of demographic and related socioeconomic data to demographic/economic planning models. The need for establishing some form of a population planning unit within the governmental structure is assessed, and the functions which might be undertaken by such a unit are described. Finally, a classification scheme is proposed which would divide countries into broad categories according to their major characteristics and problems, and a scheme for providing each type of country with technical assistance in population and development planning is proposed. In their concluding remarks, the authors note there is a need to promote a transition from simple awareness of the interrelationships and then to integrated planning. This transition, they maintain, will require a continuous and cumulative commitment of countries and an effective co-ordination and collaboration among the agencies which provide technical assistance in this field.

Data Collection↗
PubMed1987

Health Services Development Plan, 1983-1987.

The following are excerpts from this Plan [Health Services Development Plan] relating to family planning: "5. Family Life Development: Emphases must be given to Family Life Development in place of Family Planning. As a result the demographic characteristics of the population must be studied in relation to their impact on health and the quality of life, and programs developed in answer to these needs. This Government interprets Family Planning as much more than reduction of the birthrate. It accepts as its concept a program which includes Family and Family Life Development. The concept fundamentally includes programs for raising the quality of life and social well-being. The basic tenet to be stressed is the return to a greater sense of respect for womanhood and a greater responsibility for men and women in terms of their interpersonal relationships and ultimately the total development of the individual and family in society. The Government sees family life development as the main stay and principal fabric of the society and its heritage. However it accepts that in the short term both traditional and improved procedures of family planning will have to be followed until the message of family life development can bring about the desired results. Further, the Government now firmly intends to develop policies in population planning and to cause the Ministry of Health in conjunction with other Ministries and organizations to develop and introduce new policies in family planning and family life development which will be consonant with the high standard of life and lifestyle now being enjoyed by Barbadians."

Americas↗
PubMed1995

Leadership development plan. A CQI approach to management performance appraisals.

In 1993 managers at St. Mary's Hospital Medical Center established the attributes necessary to be a successful leader in St. Mary's continuous quality improvement culture. These leadership attributes formed the basis of a new performance appraisal system for managers. The medical center adopted its new performance appraisal system at the beginning of fiscal year 1994-1995. The objective of the plan is to develop St. Mary's managers' leadership skills. St. Mary's Leadership Development Plan is an ongoing cycle, with three phases. First, managers and administrative representatives jointly agree on objectives to discuss throughout the fiscal year. The objectives reflect the hospital planning and financial goals and objectives, department goals and objectives, and leadership growth opportunities. Each manager is then responsible for gathering feedback from subordinates on how well he or she is meeting the set objectives. Finally, each manager and administrative representative highlight accomplishments achieved during the fiscal year. St. Mary's decided to discontinue pay-for-performance salary increases beginning with the 1994-1995 fiscal year, coinciding with the initiation of the Leadership Development Plan. Manager's compensation is now a flat percentage increase granted to all managers.

Catholicism↗
PubMed2001

Modelling sustainable development planning: a multicriteria decision conferencing approach.

Development planning is multidimensional in nature. On the one hand, it addresses economic growth, and on the other, it deals with economic development of the whole nation. Sustainable development, on the other hand, emphasizes the need for integration of economics and environment, as well as promoting intra- and intergenerational equity. While the literature deals extensively with the issues of sustainable development, it lacks a prescription of an easy-to-use, yet rigorous, methodology for it. In this paper, we offer a decision conferencing approach to sustainable development planning based on a multicriteria model. The integrated model is presented and applied to a sustainable development planning exercise in a third world country. Sample results are presented and detailed sensitivity analyses show the environmental variables that are of major concern.

Animals↗
PubMed1987

National Development Plan, 1985-1991.

The following are provisions of this Plan [Botswana National Development Plan] relating to maternal-child health care and family planning: "14.73 Maternal Child Health and Family Planning (MCH/FP) tasks during NDP6 will include: the improvement of maternal and child health and family planning promotion, follow up and participation at the home level through strengthening of the family welfare educators in this area and data collection and use; increased knowledge and support of maternal and child family planning in the general population, with special emphasis on the male population and youth; the development of an integrated approach to MCH/FP care which is effective, efficient, and acceptable at the community level; the identification of high-risk groups among pregnant women, mothers, and children and appropriate intervention; the protection of the health of mothers and infants through planning services, so that each family will be of a reasonable size, corresponding to its socioeconomic and health conditions. 14.74 Specific Maternal and Child Health and Family Planning targets are: infant mortality rate - below 50/1000 live births; women of reproductive age using FP - 25%; pregnant women attending antenatal clinics - 98%; supervised deliveries - 70%; newborn babies with birth weight of at least 2500 g - 90%; children under one year of age fully immunized - 75%. 14.75 In order to reduce infant illness and deaths caused by preventable diseases, the Expanded Programme of Immunization has increased its target to vaccination of all eligible children by the year 1990. For this to be achieved, accessibility of the services to the communities should be improved and this can only be done within the context of the overall development of the basic health services."

Africa↗
PubMed1985

A quantitative model of population pressure and its potential use in development planning.

An attempt is made to develop a quantitative model of the concept of population pressure, using the example of population pressure on land resources in agricultural societies. "The model shows that environmental quality is tied to population growth and that population pressure does not bear relationship with population density." The implications of the findings for development planning are considered. (summary in IND)

Agriculture↗
PubMed1978

Population based planning as a tool for health plan development.

Population based planning is an appealing methodology for the development of a people-oriented health systems plan. By focusing on the identification and minimization of the social, behavioral, and environmental risks to ill health, population based planning is compatible with the growing understanding of the social origins of health and disease. Models of both population based and resource based planning are presented and used to define the concepts and contrast the two methodologies. To strengthen the population based planning model, Kessner's tracer methodology is incorporated into the technique. Finally, the benefits (focus on the social origins to disease) and the drawbacks (extensive time and data requirements) of population based planning are highlighted.

Health Planning↗
PubMedDate not supplied

Creating a clinical development plan for acute care nurses.

This article explores the rationale and creation of Clinical Development plans for acute care nursing staff development. The Clinical Development Plan is suggested as a method of determining the learning needs of nurses on various acute care nursing units by identifying required performance. Development is covered from novice to expert levels. Competencies are categorized into technical, interpersonal, and critical thinking skills. Such a plan is helpful for identifying ongoing training needs of nursing personnel.

Education, Nursing, Continuing↗