Abstract:
:Potential conflict between the goals of the investigators and the sponsors of pharmacoeconomic and clinical research has been well documented. Although there have been efforts to formalise relationships between sponsors and investigators in some areas of clinical research, no set of guidelines or standardised contract to govern pharmacoeconomic research relationships is currently in use. In this paper, we discuss a number of provisions that should be included in a sponsored research agreement to define the responsibilities and clarify the rights of the parties in the collaborative research relationship. We also present an example of a sponsored research agreement that we have designed as a model formal contract between sponsors and investigators. The most salient areas in the research agreement include: publication, specification of analysis, data access/ownership, confidentiality, termination and payment to investigators. While this paper focuses on pharmacoeconomic research, many of the principles have relevance to a broader range of research relationships and to other clinical economics and clinical trials research.
journal_name
Pharmacoeconomicsjournal_title
PharmacoEconomicsauthors
Schulman KA,Rubenstein LE,Glick HA,Eisenberg JMdoi
10.2165/00019053-199507030-00004subject
Has Abstractpub_date
1995-03-01 00:00:00pages
206-20issue
3eissn
1170-7690issn
1179-2027journal_volume
7pub_type
杂志文章,评审abstract::Most countries have healthcare resource constraints and it is easy to identify new health technologies as an area in need of resource management, particularly given that new health technologies usually increase rather than save costs. Resource constraints are even more noticeable in Asia than in other regions, with a ...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/11310280-000000000-00000
更新日期:2009-01-01 00:00:00
abstract::A growing body of recent work has identified several problems with economic evaluations undertaken alongside controlled trials that can have potentially serious impacts on the ability of decision makers to draw valid conclusions. At the same time, the use of cost-effectiveness models has been drawn into question, due ...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200017050-00007
更新日期:2000-05-01 00:00:00
abstract::The progressive disability of Parkinson's disease results in substantial burdens for patients, their families and society in terms of increased health resource use, poorer quality of life, caregiver burden, disrupted family relationships, decreases in social and leisure activities, deteriorating emotional well-being, ...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200119070-00003
更新日期:2001-01-01 00:00:00
abstract::Recombinant human erythropoietin (rHuEpo) has been increasingly used in preterm infants in the last 3 to 4 years. Recent studies have indicated a reduction in blood transfusion requirements in infants receiving rHuEpo. No significant adverse effects have emerged, apart from iron deficiency (if iron supplementation is ...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199712040-00002
更新日期:1997-10-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Intensive insulin therapy improves glycosylated haemoglobin (Hb(A1C)) levels and delays the onset of long-term diabetes-related complications. Current treatment guidelines recommend maintaining a glycosylated haemoglobin (Hb(A1C)) of < or = 7% in patients with type 1 and 2 diabetes mellitus. Ho...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200725030-00007
更新日期:2007-01-01 00:00:00
abstract::In the current climate of cost containment and quality control, nosocomial infection is a worrisome adverse event in hospital care. Hospitalised patients require care for increasingly severe illnesses, and are therefore more susceptible to infection, especially by opportunistic micro-organisms. It is thus necessary to...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199507020-00005
更新日期:1995-02-01 00:00:00
abstract:BACKGROUND:Combination therapies with cetuximab (Erbitux®; Merck Serono UK Ltd) and panitumumab (Vectibix®; Amgen UK Ltd) are shown to be less effective in adults with metastatic colorectal cancer who have mutations in exons 2, 3 and 4 of KRAS and NRAS oncogenes from the rat sarcoma (RAS) family. OBJECTIVE:The objecti...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-018-0630-9
更新日期:2018-07-01 00:00:00
abstract::This article examines the twin concepts of the statistical significance and quantitative importance of observed differences in studies comparing medicines in terms of economic parameters such as cost-effectiveness and measures of health-related quality of life (HRQOL). Central to the design and interpretation of any ...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199405050-00005
更新日期:1994-05-01 00:00:00
abstract::To review and critically evaluate published cost-utility analyses (CUAs) pertaining to pharmaceuticals for the past 3 decades. We examined data from the Tufts Medical Center Cost-Effectiveness Analysis Registry (www.cearegistry.org), which contains detailed information on English-language CUAs and their ratios (in $US...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/11312720-000000000-00000
更新日期:2009-01-01 00:00:00
abstract::The use of pharmacoeconomic tools has grown dramatically in the past decade as provision of healthcare throughout the industrialised world has required increased cost consciousness. However, pharmacoeconomic analysis has not yet been fully exploited as a conceptual underpinning for public or private health policy deci...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199916050-00001
更新日期:1999-11-01 00:00:00
abstract:BACKGROUND:Assessment of health state and health-related quality of life (HR-QOL) are limited by a child's age and cognitive ability. Parent-proxy reports are known to differ from children's reports. Simultaneous assessment using a parent-child dyad is an alternative approach. OBJECTIVE:Our objective was to assess the...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/11597890-000000000-00000
更新日期:2012-08-01 00:00:00
abstract:BACKGROUND:Carcinoid syndrome, a rare condition in patients with neuroendocrine tumours, characterised by flushing and diarrhoea, severely affects patients' quality of life. The current carcinoid syndrome standard of care includes somatostatin analogues, but some patients experience uncontrolled symptoms despite somato...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-020-00896-5
更新日期:2020-06-01 00:00:00
abstract:BACKGROUND:Within the framework of economic evaluations, the transferability of utility scores between jurisdictions remains unclear. The EQ-5D is a generic instrument for measuring health-related quality of life in economic evaluations, which can be used for comparing utility scores across countries. At present, the E...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/11314120-000000000-00000
更新日期:2009-01-01 00:00:00
abstract::There are insufficient resources in the UK to fund all new technologies and new indications approved by the National Institute for Health and Clinical Excellence (NICE). Diverting funding from existing sources will have a detrimental effect on the provision of other priority services. The UK Office of Fair Trading (OF...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200826020-00001
更新日期:2008-01-01 00:00:00
abstract::Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders, with an estimated prevalence rate in the general population of 10-15% in industrialised countries. Although IBS is not a life-threatening disease, it contributes significantly to a large segment of healthcare resource consu...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200624010-00002
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:Assessing the societal perspective in economic evaluations of new interventions requires estimates of indirect non-medical costs caused by the disease. Different methods exist for measuring the labor input function as a surrogate for these costs. They rarely specify the effect of health on labor and who gain...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-020-00978-4
更新日期:2020-11-25 00:00:00
abstract::The past few years have seen rapid changes in the methods of decision-analytic modelling of healthcare programmes for the purposes of economic evaluation. This paper focuses on four developments in modelling that have emerged over the past few years or have become more widely used. First, no one optimal method for ext...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200624110-00002
更新日期:2006-01-01 00:00:00
abstract::The pharmaceutical industry's core business is the innovation, development and marketing of new drugs. Pharmacogenetic (PG) testing and technology has the potential to increase a drug's value in many ways. A critical issue for the industry is whether products in development should be teamed with genetic tests that cou...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200624040-00004
更新日期:2006-01-01 00:00:00
abstract::Randomized controlled trials provide unbiased estimates of treatment effect through reducing the attribution of observed differences in outcome to the play of chance or the treatment of interest. Issues in the design of randomized trials may lead to a dilution or magnification of treatment effect when compared with cl...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200927010-00002
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:The apparent decrease in the rate of approval of new molecular entities has provoked extensive discussion and fears that the productivity of biopharmaceutical research and development has severely declined in recent years. OBJECTIVE:To investigate the extent to which traditional measures of innovative outpu...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200624002-00008
更新日期:2006-12-01 00:00:00
abstract::Germany is in a period of transition with regard to healthcare reform. The number and intensity of cost control interventions increased during the last decade in an attempt to contain healthcare expenditure. The German legislature has implemented long term macroeconomic measures such as contribution rate stability and...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199600102-00013
更新日期:1996-01-01 00:00:00
abstract::As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (Sanofi Genzyme) of sarilumab (SAR; Kevzara®) to submit evidence of its clinical effectiveness and cost-effectiveness for previously treated moderate or severe rheumatoid arth...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.1007/s40273-018-0677-7
更新日期:2018-12-01 00:00:00
abstract::Due to a single error in the annual cost of sarilumab the following needs to be corrected in the article. ...
journal_title:PharmacoEconomics
pub_type: 已发布勘误
doi:10.1007/s40273-019-00857-7
更新日期:2020-01-01 00:00:00
abstract::Epilepsy is a chronic condition with numerous social and psychological consequences. This work aimed to review available data on epilepsy and the impact of surgical and pharmaceutical treatments on the quality of life in adults and children. Research on quality of life in epilepsy is characterised by a wide and fragme...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200220150-00002
更新日期:2002-01-01 00:00:00
abstract::Migraine headache is responsible for significantly more healthcare resource and lost labour costs than previously reported. Costs associated with migraine were assessed via a survey conducted in 940 patients, 70% of whom responded. All met the International Headache Society's diagnostic criteria for migraine and had ...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199202010-00008
更新日期:1992-07-01 00:00:00
abstract::The pharmacoeconomics of the low molecular weight heparin (LMWH) enoxaparin in the prophylaxis and treatment of venous thromboembolism have mostly been investigated in cost-effectiveness studies that estimated direct costs associated with treatment, using decision analyses and clinical outcome data from randomised con...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200220040-00002
更新日期:2002-01-01 00:00:00
abstract::As a consequence of its prevalence, early onset and chronicity, schizophrenia imposes clinical and economic impediments to healthcare practitioners and society alike. Among the many antipsychotics available to treat the symptoms of this devastating illness, clozapine has emerged and differentiated itself from the othe...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200321010-00001
更新日期:2003-01-01 00:00:00
abstract::The efficacy of granisetron in preventing acute nausea and vomiting during the 24 hours following chemotherapy in patients with cancer is equivalent to that of other serotonin 5-HT3 receptor antagonists (ondansetron and tropisetron) and similar to or greater than that of conventional antiemetic regimens such as metocl...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199609040-00009
更新日期:1996-04-01 00:00:00
abstract::As part of the Single Technology Appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (AstraZeneca) of durvalumab (IMFINZITM) to submit evidence for the clinical and cost effectiveness of durvalumab for the treatment of patients with locally advanced, unresecta...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.1007/s40273-019-00870-w
更新日期:2020-04-01 00:00:00
abstract::The manufacturer of olaratumab (Lartruvo®), Eli Lilly & Company Limited, submitted evidence for the clinical and cost effectiveness of this drug, in combination with doxorubicin, for untreated advanced soft tissue sarcoma (STS) not amenable to surgery or radiotherapy, as part of the National Institute for Health and C...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.1007/s40273-017-0568-3
更新日期:2018-01-01 00:00:00