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At least 685 records · Page 38Linked to original sources
PubMed2007

A clinical development paradigm for cancer vaccines and related biologics.

Therapeutic cancer vaccines are a heterogeneous group of complex biologics with distinctly different clinical characteristics than cytotoxic agents. The current clinical development paradigm used for oncology drug development is based on criteria developed for cytotoxic agents. More flexible and focused developmental guidelines are needed to address the unique characteristics of therapeutic cancer vaccines. Over the course of 1 year, the Cancer Vaccine Clinical Trial Working Group, representing academia and the pharmaceutical and biotechnology industries with participation from the US Food and Drug Administration, defined in a consensus process the cornerstones of a new clinical development paradigm for cancer vaccines and related biologics. Four major topics were addressed: (1) end points for clinical trials, (2) trial designs and statistical methods, (3) technical and developmental challenges, and (4) combination therapy. The proposed paradigm suggests therapeutic cancer vaccines to be investigated in 2 general types of clinical studies: proof-of-principle trials and efficacy trials. Proof-of-principle trials, which introduce a novel cancer vaccine into humans, should include a minimum of 20 or more patients in a homogenous, well-defined population in an adjuvant setting or without rapidly progressive disease in a metastatic setting to allow vaccines adequate time to induce biologic activity and should incorporate immune and molecular markers. Objectives should include initiation of a safety database, determination of dose and schedule, and demonstration of biologic activity as proof-of-principle. Biologic activity is defined as any effect of the vaccine on the target disease or host immune system using biologic markers as study end points, for example, clinical, molecular, or immune response. Immune response is demonstrated if determined in 2 separate, established and reproducible assays at 2 consecutive follow-up time points after the baseline assessment. If proof-of-principle trials show such immune response, or other biologic or clinical activity, efficacy trials may be initiated. If none of these end points is met, the clinical development plan should be reevaluated to decide if further development is warranted. Efficacy trials formally establish clinical benefit either directly or through a surrogate and are encouraged to be randomized studies. This is in contrast to single-arm phase 2 trials used for cytotoxic agents, which often use tumor response rate as the primary end point and historical controls as a comparator. Efficacy trials may use prospectively planned adaptive designs to expand from randomized phase 2 into phase 3 studies if well-defined trigger-point criteria are met, but the cost of incorporating such design elements should be carefully evaluated. Efficacy trials can also be exploratory randomized phase 2 trials or conventional phase 3 trials. In addition, conventional clinical end points can be adjusted to account for biologic features of cancer vaccines. The concept of efficacy trials allows for an early assessment of vaccine efficacy based on credible prospective data. This 2-phase developmental paradigm supports a more flexible, expeditious, and focused clinical developmental process with early and informed decision making. In addition, this report addresses clinical development challenges and issues for combination therapies.

Cancer Vaccines↗
PubMed2002

Integrated watershed approach for combating drought in a semi-arid region of India: the case of Jhabua watershed.

The integrated watershed management approach for the semi-arid regions of India is considered to be very important due to the inadequate availability of water resources. The drought experienced in recent years has brought on an environmental and socio-economic crisis in these regions. The role of the watershed management has been crucial and development of alternative water resources has been critically important. To overcome the isolated sectoral development planning and implementation, as was done in many of the previous land based programs in India, an integrated concept of watershed development through participatory planning and actions has been followed for combating drought in Jhabua watershed in Madhya Pradesh state, India. This research paper will look into the successful watershed management experience of our on-going research project, and appropriate watershed strategies for the Jhabua watershed.

Agriculture↗
PubMed2006

Succession planning and individual development.

The authors present a framework for a succession planning and individual development initiative implemented in a Veterans Health Administration facility. Foundational strategic goals and a conceptual framework in the Veterans Affairs system provide the structure for the 3 facility-level succession planning and individual development programs. Outcomes of the programs are promising with 2 of 3 programs demonstrating clear succession planning outcomes and the other one showing positive preliminary results.

Career Mobility↗
PubMed1979

Socio-economic development, environmental and health perspectives in Malaysia.

With Malaysia independence in 1957, development in the country changed from system maintenance to development planning. Environmental and health perspectives are discussed in relation to current development as reflected in the Second Malaysia Plan 1971--1975 and the Third Malaysia Plan 1976--1980.

Environmental Health↗
PubMed1986

Measurement of theophylline absorption from different regions of the gastro-intestinal tract using a remote controlled drug delivery device.

The absorption of a theophylline solution containing 80-120 mg doses delivered to different sites in the gastro-intestinal tract has been determined in 3 male volunteers using a remote controlled drug release system (HF-capsule). There was no difference between the stomach, ileum and the colon in the amount of theophylline absorbed (AUC). The T 1/2abs of theophylline absorbed via the colon was prolonged when compared with that entering via the upper gastro-intestinal tract. The results provide a rational basis for the further development of theophylline formulations and are indispensable for planned development and to account for variation in the bioavailability of retarded release drug preparations.

Absorption↗
PubMedDate not supplied

Task complexity and nursing expertise as factors in decision making.

This study used an information-processing approach and verbal protocol methodology to describe the initial and overall approaches to planning used by six expert and five novice nurses for three patient cases of varying complexity. Subjects did not change their initial approaches significantly across the cases. Most experts consistently used broad initial approaches, but no clear pattern was evident in novices' use of initial approaches. Experts varied their overall approaches as a function of case complexity; novices did not. Most experts used opportunistic overall approaches in the more complex cases; that is, they jumped about, pursuing whatever was opportune at a given point in the planning process. However, they used systematic overall approaches in the least complex case. In contrast, most novices used opportunistic overall approaches in all cases. No relationship was found between overall approaches used and quality of plans developed. The findings support the cognitive model of planning proposed by Hayes-Roth and Hayes-Roth (1979) and the conclusion found in information-processing literature that the task itself is a major determinant of decision-making behavior.

Decision Making↗
PubMed1988

A dilemma in national population policy: evidence from Nigeria.

The population policies followed by the several governments of Nigeria since 1970 are discussed vis-a-vis the national development plans. The respective governments have not shown the political will to formulate policies that could be enforced to reduce fertility with the result that the population problem has become acute in the country. Even the little economic progress made has not resulted in the acceptance of contraception to a level that can produce an effective decline in fertility. Suggestions, taken into account the peculiar cultural problems of Nigeria, are made to have a successful conception control program for Nigeria.

Africa↗
PubMedDate not supplied

Developing a marketing plan for a residency practice.

Competition for patients is becoming a hallmark of the health care system. Family medicine centers must increasingly think about marketing if they are to attract and retain adequate numbers of patients for resident education. As we have learned from direct experience, marketing is best done in the context of a comprehensive plan. We believe residency faculty can develop and successfully implement marketing plans. Since 1982, we have developed and implemented a marketing plan for the Mercy Family Medicine Center located in Denver, Colorado. We describe the planning process we employed and briefly discuss the successful results due to the plan's implementation.

Family Practice↗
PubMedDate not supplied

The practice characterization model: the importance of organizational life cycles and targeted interventions in general medical practice.

In response to a climate of constant change and increasing demand for services, general practice in the UK has undergone significant modification over the last 10 years. It has become a multi-disciplinary organisation encouraged by funding bodies to plan for service delivery using a more structured team based approach. In Tayside in 1996, practices were charged with producing formal Practice Development Plans (PDPs) which would focus on priority areas aligned with the Health Boards own strategic plan--those were teamwork, information management and technology, and clinical service delivery. The University of Dundee's Department of General Practice successfully applied for funding to develop ways of facilitating practices so that they could a) identify their own development priorities, and b) plan and implement action and learning to see these priorities through. Using action research methodology, the project attempted to create a climate for change, provide support and training to see the changes implemented, and ensure commitment to the changes from all members of the practice team. The Facilitator adopted a flexible style varying her role between expert, guide and support. Analysis of progress made by different practices, coupled with the Facilitator's in depth knowledge of them, suggested the importance of certain key aspects of practice organisation and culture. A practice characterisation model identified practices which were stable, currently coping, proactive and ready to face the challenge of change as best placed to engage in a full scale development programme. Other profiles suggested a range of alternative interventions as more likely to be acceptable and productive.

Data Collection↗
PubMed1996

Public empowerment through accessible health information.

The Public Library Association (PLA) is developing plans for cooperative consumer health information services. Foremost for developing this program is the need for partnerships with health agencies and mechanisms to attract grant funding. The proposed project will expand the role of public librarians to address the health information queries they receive effectively. The project plans include the use of new technologies for delivery of health information, and the provision of tools, training, and resources.

Cooperative Behavior↗
PubMed1992

Illegal migration in Taiwan: a preliminary overview.

Since 1986, there have been indications that Taiwan (the Republic of China) has been experiencing an increase in illegal migration. Despite a lack of data describing the number, origins, and demographic characteristics of the illegal migrants, an open policy debate has been carried out by economic and social planners, entrepreneurs, and labor leaders. Interviews with representatives of these 3 groups suggest that, contrary to expectations, planners favor the legalization of foreign workers; individual entrepreneurs also consider legalization a wise option. Labor leaders, as expected, are opposed to the use of imported labor. In January 1990, the Executive Yuan (Assembly) adopted regulations permitting limited use of foreign labor. The increase in illegal migrants and the decision to regularize their status suggests the need to review carefully the implications of all planning initiatives as far in advance as possible, and preferably when development plans are being initially implemented.

Administrative Personnel↗
PubMed1995

[Demography perspectives and forecasts of the demand for electricity].

"Demographic perspectives form an integral part in the development of electric load forecasts. These forecasts in turn are used to justify the addition and repair of generating facilities that will supply power in the coming decades. The goal of this article is to present how demographic perspectives are incorporated into the electric load forecasting in Quebec. The first part presents the methods, hypotheses and results of population and household projections used by Hydro-Quebec in updating its latest development plan. The second section demonstrates applications of such demographic projections for forecasting the electric load, with a focus on the residential sector." (SUMMARY IN ENG AND SPA)

Americas↗
PubMedDate not supplied

Strategic planning activities of the American Medical Informatics Association.

The American Medical Informatics Association (AMIA) has begun the process of long-range strategic plan development. The AMIA Board of Directors established an Ad Hoc Strategic Planning Task Force, with the goal of initiating such planning in November 1992. In January 1993, the Task Force convened a group of AMIA members in order to develop an initial set of goals and objectives. The group consisted of past and present AMIA Board members, AMIA Committee chairpersons, representative AMIA Working Group chairpersons, the AMIA Executive Director and members of the AMIA office staff, and a number of AMIA members-at-large. The group created a draft strategic plan, which was refined by the Task Force after circulation among two focus groups and through a mailing to the AMIA membership. This report of the AMIA strategic planning process is intended to create a historical record and to stimulate further discussion of a working plan that will evolve over time. AMIA will continue the strategic planning process through its Ad Hoc Strategic Planning Committee as it begins to implement aspects of the strategic plan over the next several years.

Association↗
PubMedDate not supplied

Development of a unique decentralized rapid-response capability and contingency mass-casualty field hospital for the 1996 Democratic National Convention.

This article describes the planning, development, and execution of a unique, decentralized, and flexible medical response capability that was developed for the 1996 Democratic National Convention in Chicago. Concerns for coordinated acts of violence, terrorism, toxicologic exposures, and logistic problems posed by the United Center prompted the development of a decentralized and flexible rapid-response plan. Contingency planning for the remote possibility of a full-scale disaster led to the additional development of a contingency mass-casualty field hospital on site. The plans for this mass-gathering response are described in considerable detail. Forty-four patient encounters across the four days of the convention were recorded, with a combination of minor injuries and potentially serious medical presentations. The 1.46 EMS encounters per 1,000 attendees at the Democratic National Convention is comparable to other utilization rates for mass gatherings in the literature. Proactive attention to comprehensive contingency planning for equipment, supplies, personnel, and organizational needs, especially when multiagency response and cooperation are required, is essential.

Chicago↗