Quality Of Life And Pharmacoeconomics In Clinical Trials Pdf
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- Quality of life and pharmacoeconomics in clinical trials
- Quality of life as patient-reported outcomes: principles of assessment
- Interpreting Pharmacoeconomic and Quality-of-Life Clinical Trial Data for Use in Therapeutics
Modern Pharmacoeconomic and Pharmacoepidemiology. The impact factor of this journal, as shown in the Russian Science Citation Index RSCI is the highest among the periodicals in the areas of pharmacoeconomics, health technology assessment, and epidemiology.
In general, quality of life QoL or QOL is the perceived quality of an individual's daily life, that is, an assessment of their well-being or lack thereof. This includes all emotional , social and physical aspects of the individual's life. In health care , health-related quality of life HRQoL is an assessment of how the individual's well-being may be affected over time by a disease , disability or disorder. Early versions of healthcare-related quality of life measures referred to simple assessments of physical abilities by an external rater for example, the patient is able to get up, eat and drink, and take care of personal hygiene without any help from others or even to a single measurement for example, the angle to which a limb could be flexed. The current concept of health-related quality of life acknowledges that subjects put their actual situation in relation to their personal expectation.
Quality of life and pharmacoeconomics in clinical trials
He is internationally recognised in the area of pharmacoeconomics and outcomes research and is Editor-in- Chief of the newly launched Journal of Pharmacy Finance Economics and Policy and author or co-editor of 19 books, 25 book chapters and more than journal articles. Among many assignments, she has contributed to an analysis of global healthcare systems as well as disease management studies. Ms Chaney spent six years with Eckerd Drugs — , where she spent time in a variety of roles, rising to become head pharmaceutical.
The social science of pharmacoeconomics is quite a new and rapidly changing field. The roots of pharmacoeconomics are in health economics — a specialised aspect of economics developed in the s. The concepts involved in pharmacoeconomics, such as cost-effectiveness and cost-benefit analysis, have been developed from the late s.
Beginning in the s, measurement tools for health and clinical outcomes assessment were created and have subsequently been improved. Pharmacoeconomics emerged in the late s as an independent entity among the varied specialised economic methods.
Over the past 20 years, pharmacoeconomics has become more important due to an increased emphasis on efficient drug therapies for disease, which increase health costs, etc. Pharmacoeconomics is an innovative method that aims to decrease health expenditures, whilst optimising healthcare results. Over the past decade, the importance of pharmacoeconomics has been escalating as a result of numerous factors.
Governments worldwide are spending more money on healthcare than on nearly anything else. These worldwide expenditures increase at a faster rate than the global gross domestic product.
Pharmaceutical expenditures, which constitute a large part of healthcare expenditures, have been increasing much faster than total healthcare expenditures. The increasing cost of healthcare products and services has become a great concern for patients, healthcare professionals, insurers, politicians and the public. This escalation in healthcare spending is due to increased lifeexpectancy, increased technology, increased expectations, increased standards of living and an increased demand in healthcare quality and services.
Pharmacoeconomics strives to guide the utilisation of healthcare resources optimally. The processes by which a drug evolves from an idea to a patented, marketed drug involve a great deal of consideration.
These trials determine whether drugs should be marketed to the public. FDA randomised, controlled trials simply lead to efficacy, which does not provide sufficient information by which to choose a drug product. The outcome of these research studies determines effectiveness. This newly approved drug could be inferior to existing products in the same therapeutic class. Direct comparisons must be carried out with other drug products to truly test this drug.
Today, large buyers of drug products, for example health maintenance organisations HMOs , hospitals, Department of Veterans Affairs, government agencies and the military, have sophisticated staff who analyse and evaluate alternative products. It is these pharmacoeconomic evaluations that can determine which drug is optimal. Pharmacoeconomics addresses both economic and humanistic outcomes.
Pharmacoeconomics includes ideas and methods from a variety of domains including statistics, clinical epidemiology, economics, decision analysis and psychometrics, etc. Pharmacoeconomics and outcomes research are two related disciplines that focus on these areas of investigation. Outcomes research is the scientific study of the effects of medical care on individuals and society.
A variety of disciplines are utilised by outcomes research, including clinical epidemiology, informatics, anthropology, economics, health services research, health policy and biostatistics. Outcomes research has a patient and policy-relevant focus and is essential to the formulation of clinical practice guidelines, assessing the quality of medical care and informing health policy decisions. Traditional clinical research studies the mechanisms of disease through biological mechanisms in the pharmaceutical setting, for example drug versus placebo testing in a randomised clinical trial.
Endpoints studied in. Outcomes research, on the other hand, focuses on the effect of therapeutic treatments on endpoints such as survival, quality of life, satisfaction with care and cost. Pharmacoeconomics is a specific form of health economics that is restricted to pharmaceutical products. Pharmacoeconomics can be described as a social science concerned with the impact of pharmaceutical products and services on individuals, health systems and society, as well as the description and analysis of the costs.
One of the primary goals of pharmacoeconomics is to determine which healthcare alternatives provide the best healthcare outcome per dollar spent. Pharmacoeconomics aims to improve the allocation of resources for pharmaceutical products and services. Numerous methods are utilised to determine the least expensive treatment with the best treatment outcome. Healthcare policies worldwide are focused on increasing efficiency at a lower cost without reducing either the quality of healthcare or access to it.
Pharmacoeconomics involves the utilisation of two major methodologies for health economics analysis: cost analysis and cost outcomes. Cost analysis considers the costs of providing healthcare products or services, but does not consider the outcomes experienced by patients or providers.
Cost-outcomes analysis is the most commonly used of the pharmacoeconomics methodologies. There are four types of cost-outcomes analysis:. The type of analysis used depends on the nature of the problem being studied. Cost-effectiveness analysis is used to compare two or more treatment options for a specific condition. A New European Model? Cost-effectiveness is dependent on the value in nonmonetary terms that is placed on the outcome in relation to the cost.
This analysis compares the unit of effectiveness — i. A treatment can be referred to as being cost-effective if it has an outcome that is worth its corresponding cost in relation to alternative therapies. For example, the diuretic hydrochloro-thiazide may be the most inexpensive treatment for hypertension, but it often requires a potassium supplement.
The additional cost involved in the therapy means that this drug is not always the most cost-effective therapy. This method of cost-outcomes analysis is the most frequently utilised method. Cost minimisation is a type of cost-effectiveness analysis that is used if two alternative therapies are determined to be the same, essentially.
After determining the effectiveness, this method determines which treatment minimises costs. The pharmacoeconomic tool compares all the costs and consequences of two or more therapeutic interventions. The objective of this method is to select the least costly among multiple equivalent interventions. This method is frequently used to compare brands with generics, different routes of administration and different settings of administration, etc.
A cost-benefit analysis compares the costs and outcomes of alternative therapies and the outcome is then expressed in monetary terms. Cost-benefit analysis allows researchers to make comparisons across a wide variety of alternatives. It compares the costs involved in implementing a programme with the value of the outcome. Since the endpoints are measured in monetary terms, different endpoints can be studied, such as a surgical procedure compared with a pharmaceutical intervention.
Cost-utility analysis is performed in the same manner as cost-effectiveness analysis except that the endpoint differs. This allows costutility analysis to compare therapies for different diseases.
Cost-utility analysis integrates both the costs and the consequences of a therapy into its comparison. Cost utility measures the final outcomes in changes of life-expectancy. This method is often used when a programme affects morbidity and mortality. Since pharmacoeconomics is a multidisciplinary field, a group involved in pharmacoeconomics would include pharmacoeconomists, epidemiologists, statisticians, data personnel and research personnel.
There are three types of pharmacoeconomic studies:. Prospective studies are experimental studies that can be an additional part of a randomised clinical trial or strictly an economic evaluation. Prospective studies are the least useful because they require extensive time and money. Retrospective studies are data analyses of clinical trials or cohort studies that were conducted previously.
This type of study involves a comparison of treatment users and non-users that are followed from some point in the past to the present. Retrospective studies are the ideal study method. Model studies are performed as a method of displaying data obtained from a variety of resources if previously studied data is unavailable. Modelling is an inexpensive and effective way of illustrating existing available data regarding the costs and outcomes of alternative therapeutic interventions.
Modelling frameworks include decision trees, influence diagrams, Markov analysis, discrete event simulation and systems dynamics. The goal of these methods of pharmacoeconomic evaluation is to assess the value of pharmaceutical products and services while incorporating clinical, economic and humanistic outcomes. Pharmacoeconomic methods are utilised to assist physicians, hospitals, insurers, patients and healthcare professionals in making important decisions as to what drug therapies should be chosen.
When the FDA or EMEA approves a drug after going through extensive clinical trials focusing on efficacy and safety, numerous drugs that can be used interchangeably are often released into the market.
This leads to difficulty in creating formularies for hospitals and insurance companies. For example, pharmacoeconomic studies. The data obtained from this research can assist HMOs, physicians, health authorities and patients in choosing proper drugs. Pharmacoeconomics is used to determine which drug should be included in the formulary by choosing the most effective treatment at the lowest price.
Drugs can be assessed from a pharmacoeconomic standpoint after the product has been approved. One drug may reduce asthmatic exacerbations, but may not be the best formulary choice. Pharmacoeconomic studies consider the total costs incurred from the disease — both direct and indirect costs. Direct costs consist of pharmaceutical drugs, medical devices, physician visits, emergency room visits, diagnostic testing services, education and research. Indirect costs comprise lost school and work days, lost productivity, travel time and waiting time.
Direct costs have been shown to exceed indirect costs, both in Canada and the US. The greatest portion of direct costs incurred by asthma is medication and those exacerbations that require hospital treatment.
Therefore, pharmacoeconomic analysis must include more than just the costs of drugs. Many costs are not seemingly obvious, for example education and non-compliance costs. For example, an asthma medication with education will. The lower rate of adherence can lead to increased exacerbations and increased hospital visits, therefore increasing costs. For the lowest cost, the formulary should include the educational programme. In addition, many families in the US lack pharmaceutical drug coverage or any healthcare coverage.
This results in decreased adherence, lack of prescription filling, decreased physician visits and increased emergency room care. Physicians need to be aware of effective therapies that minimise costs.
Quality of life as patient-reported outcomes: principles of assessment
Please search here and press enter Indian Journal of Pharmacy and Pharmacology. Journal title :. Online-Issn No :. Print-Issn No :. Indexed - : IPI Value 4. Indexed - : IPI Value 3.
Language: English Spanish French. Assessing quality of life QoL as a patient-reported outcome in adult psychiatry poses challenges in terms of concepts, methods, and applications in research and practice. This review will outline conceptually the construct of QoL, its dimensionality, and its representation across patient groups. Methodological challenges are examined, along with principles of QoL instrument development and testing, as well as across cultures. Application of instruments in epidemiological, clinical health economics, and health services research is reviewed based on pertinent literature. Validated measures for depression, psychosis, and anxiety disorders are available in adult psychiatry, and are increasingly used in research.
Interpretation of quality-of-life QOL and pharmacoeconomic data for therapeutic decision making and therapeutic policy planning requires a basic understanding of the methods, assumptions and limitations of the data and associated methods of analysis. These quality-adjusted effectiveness measures will alter conclusions concerning clinical decisions as well as the cost-effectiveness of the comparative agents under consideration. To provide a conceptual and analytical framework for understanding the relationship between QOL assessment and pharmacoeconomic modelling, interpretations of the quality-adjusted analyses are reviewed, conceptual and analytical models are proposed, and recommendations for using QOL data in pharmacoeconomic models are outlined. Techniques for incorporating QOL measures into pharmacoeconomic models are examined using a hypothetical model involving therapeutic assessments of antiviral treatments for individuals with HIV disease. Adjustments of effectiveness measures based upon QOL-related functions are then globally addressed using stochastic compartmental models. Three specific methods for adjustment used in therapeutic trials are reviewed.
Quality of Life and Pharmacoeconomics in Clinical Trials-Bert Spilker. The Second Edition of this groundbreaking work refines the art and science of quality.
Interpreting Pharmacoeconomic and Quality-of-Life Clinical Trial Data for Use in Therapeutics
Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. Spilker Published Medicine. The Second Edition of this groundbreaking work refines the art and science of quality of life assessment and pharmacoeconomics and redefines the role of these evaluation parameters in clinical trials and health care decision-making.
Interpretation of quality-of-life QOL and pharmacoeconomic data for therapeutic decision making and therapeutic policy planning requires a basic understanding of the methods, assumptions and limitations of the data and associated methods of analysis. These quality-adjusted effectiveness measures will alter conclusions concerning clinical decisions as well as the cost-effectiveness of the comparative agents under consideration. To provide a conceptual and analytical framework for understanding the relationship between QOL assessment and pharmacoeconomic modelling, interpretations of the quality-adjusted analyses are reviewed, conceptual and analytical models are proposed, and recommendations for using QOL data in pharmacoeconomic models are outlined.
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Со смешанным чувством тревоги и любопытства Беккер принял приглашение загадочного агентства. Он проехал тридцать семь миль до их штаб-квартиры, раскинувшейся на участке площадью тридцать шесть акров среди лесистых холмов Форт-Мида в штате Мэриленд. После бесчисленных проверок на контрольно-пропускных пунктах он получил шестичасовой гостевой пропуск с голографическим текстом и был препровожден в роскошное помещение, где ему, как было сказано, предстояло вслепую оказать помощь Отделению криптографии - элитарной группе талантливых математиков, именуемых дешифровщиками. В течение первого часа они, казалось, даже не замечали его присутствия. Обступив громадный стол, они говорили на языке, которого Беккеру прежде никогда не доводилось слышать, - о поточных шифрах, самоуничтожающихся генераторах, ранцевых вариантах, протоколах нулевого понимания, точках единственности. Беккер наблюдал за ними, чувствуя себя здесь лишним.
Происхождение термина вирус всегда казалось Сьюзан весьма забавным. Этот термин возник еще во времена первого в мире компьютера Марк-1 - агрегата размером с комнату, построенного в 1944 году в лаборатории Гарвардского университета. Однажды в компьютере случился сбой, причину которого никто не мог установить. После многочасовых поисков ее обнаружил младший лаборант. То была моль, севшая на одну из плат, в результате чего произошло короткое замыкание. Тогда-то виновников компьютерных сбоев и стали называть вирусами. У меня нет на это времени, - сказала себе Сьюзан.
Агенты сейчас будут. Сьюзан попробовала выскользнуть из его рук, Хейл очнулся и притянул ее к себе за талию.