Abstract:
PURPOSES:To describe the kind of the difficulties encountered when seeking research governance approval for a nationwide public health and genetic study-the Drug-Induced Arrhythmia Risk Evaluation study-in England. METHODS:Description of the processes followed when seeking research governance approval for the Drug-Induced Arrhythmia Risk Evaluation study-a case control study with annual follow-up of cases and controls over 5 years, set in the English National Health Service (NHS). RESULTS:The authors describe wide variations in NHS research governance approval procedures in England. CONCLUSION:NHS research governance procedures in England are impeding the process of epidemiological studies; there is the need for a centralised NHS R&D approval of studies, which is analogous to MREC for ethical approval.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Boshier A,Shakir SA,Telfer P,Behr E,Pakrashi T,Camm AJdoi
10.1002/pds.1116keywords:
subject
Has Abstractpub_date
2005-06-01 00:00:00pages
373-6issue
6eissn
1053-8569issn
1099-1557journal_volume
14pub_type
杂志文章,评审abstract::Before a medicine can be recommended for a marketing authorization research must be provided to regulators that convincingly supports the benefit-risk of the product in the claimed indication. The established criteria for such research are usually expressed in terms of evidence from randomized controlled trials (RCT)....
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5005
更新日期:2020-10-01 00:00:00
abstract:PURPOSE:We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveil...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2336
更新日期:2012-01-01 00:00:00
abstract:BACKGROUND:Deferasirox (DFX) is an effective and well-tolerated oral iron chelator elevating the adherence to iron chelating therapy among patients with iron overload. However, the US Food and Drug Administration issued a warning about the potential adverse events associated with DFX in 2010. METHODS:To examine the ri...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3657
更新日期:2014-11-01 00:00:00
abstract:PURPOSE:Opioid analgesic use in chronic non-cancer pain (CNCP) is increasingly prevalent, but the benefits and risks are inadequately understood. In France, tramadol is one of the most used prescription opioids, but studies on its misuse liability in CNCP are still lacking. The aim was to assess the incidence of tramad...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4056
更新日期:2016-09-01 00:00:00
abstract:PURPOSE:We conducted a nested case-control study to evaluate the association between risk of cancer and mirtazapine use in depression patients in Taiwan. METHODS:We obtained data from the Taiwan National Health Insurance Research Database to conduct a population-based nested case-control study. The study cohort includ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3523
更新日期:2013-12-01 00:00:00
abstract:PURPOSE:Although a series of serious adverse events have continually raised concerns about the potential toxicity of traditional Chinese medicine injections (TCM injections), studies on this subject are still sparse. We conducted a descriptive analysis of a spontaneous reporting system in China to describe the safety p...
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pub_type: 杂志文章
doi:10.1002/pds.4805
更新日期:2019-07-01 00:00:00
abstract:PURPOSE:To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial. METHODS:A retrospective multidatabase cohort study using CPRD primary care and linked seconda...
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pub_type: 杂志文章
doi:10.1002/pds.5188
更新日期:2020-12-27 00:00:00
abstract:PURPOSE:This study examined recent trends and correlates of prescription opioid use and long-term use in the United States. METHODS:Data were from 47 356 adult participants of National Health and Nutrition Survey from 1999-2000 to 2013-2014. Participants were asked about prescription medications used in the past 30 da...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4278
更新日期:2018-05-01 00:00:00
abstract:PURPOSE:The objective of this study was to evaluate the validity and completeness of the General Practice Research Database (GPRD) as a tool for research into inflammatory bowel disease epidemiology. METHODS:Patients diagnosed with inflammatory bowel disease were identified from GPRD. Mailed surveys were sent to the g...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.698
更新日期:2002-04-01 00:00:00
abstract:PURPOSE:The use of prescription opioid analgesics has been increasing over the last few decades in Australia. In particular, oxycodone and fentanyl have increased substantially. We examined the gender and age trends in the prescribing of subsidised opioid analgesics in the Australian population for non-palliative care ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3767
更新日期:2015-06-01 00:00:00
abstract:PURPOSE:A recent regulatory warning and case reports have described the development of muscle complications with the use of 5-α reductase inhibitors (5ARIs). We wished to determine if there was a link between rhabdomyolysis and 5ARI usage. METHODS:We used a matched cohort design and linked administrative data from the...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4383
更新日期:2018-03-01 00:00:00
abstract:PURPOSE:Nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with severe renal complications, including acute renal failure, reduced glomerular filtration rate and interstitial nephritis. Caution against NSAIDs is therefore recommended in advanced chronic kidney disease. In this study, we examined NSAID use,...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3227
更新日期:2012-04-01 00:00:00
abstract:PURPOSE:To examine the utility of electronic health records from a routine care setting in assessing comparative effectiveness of fourth-line anti-hypertensive drugs to treat resistant hypertension. METHODS:We conducted a cohort study using the Clinical Practice Research Datalink: a repository of electronic health rec...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4808
更新日期:2019-09-01 00:00:00
abstract:PURPOSE:The Centers for Medicare & Medicaid Services claims comprise an administrative database of beneficiary-specific clinical information. This study evaluates the impacts of (i) claim information updates (claims adjudication) and (ii) delay in claim processing (claims delay) on real-time evaluation of health servic...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2143
更新日期:2011-07-01 00:00:00
abstract:PURPOSE:Stimulant medications used for treating attention deficit hyperactivity disorder (ADHD) can be associated with an increased risk of seizures. Atomoxetine is a non-stimulant medication approved for treating ADHD. This retrospective cohort analysis evaluated risk of seizures among pediatric patients naïve to ADHD...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3390
更新日期:2013-04-01 00:00:00
abstract:PURPOSE:To assess the reason for the relative high risk of local complications for women following cardiac catheterization by evaluating the associations between gender, sheath size, and local adverse outcomes following cardiac catheterization. METHODS:The data used in this study were obtained from a portion of the Am...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究
doi:10.1002/pds.1307
更新日期:2007-02-01 00:00:00
abstract::Denmark has one of the worlds most comprehensive registration of its citizens' use of medical and social services. Most databases are population-based and of very high quality. Virtually all employ a mutual person identifier, which renders it technically possible to link any of them with others. There are two prescrip...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.638
更新日期:2001-12-01 00:00:00
abstract:PURPOSE:Pentaerythrityl tetranitrate (PETN) was the most commonly prescribed long-acting nitrate in Germany. We aimed to assess whether the discontinuation of PETN reimbursability in 2011 resulted in alternative prescriptions of anti-anginal medications or in a discontinuation of anti-anginal therapy. METHODS:This is ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3802
更新日期:2015-08-01 00:00:00
abstract:PURPOSE:To investigate pattern and extent of adverse drug reactions (ADRs) associated with AEDs and to identify safer options for treatment of epilepsy. METHOD:Study was a retrospective, cross-sectional survey. Data from patients with epilepsy at the out-patient and in-patient of Neurology Department was collected in ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1540
更新日期:2008-08-01 00:00:00
abstract:PURPOSE:To determine the effectiveness of quality circles on prescribing patterns of primary care physicians in Germany and to explore the influence of specific factors on changes. METHODS:Three large non-randomised comparative studies were performed in primary care in Germany, with baseline measurements in 2001 and f...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1778
更新日期:2009-09-01 00:00:00
abstract:OBJECTIVE:To update United States steroidal contraceptive use data for the period 1989 to 1994. STUDY DESIGN:Pharmaceutical marketing data were used to examine trends in the utilization and distribution of oral contraceptives, Norplant, and Depo-Provera. RESULTS:There were 56.8 million prescriptions for oral contrace...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199605)5:3<141::AID-PDS221
更新日期:1996-05-01 00:00:00
abstract:OBJECTIVE:This study quantified the overall merit of adjunctive aripiprazole in major depressive disorder (MDD). METHODS:Global benefit-risk (GBR) analysis quantified the benefit and risk differences between adjunctive aripiprazole and antidepressant (ADT) monotherapy. Three hundred and fifty six patients receiving AD...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1805
更新日期:2009-10-01 00:00:00
abstract:PURPOSE:To define periods of acceptable mortality reporting in primary care and to demonstrate through examples the implication for research using automated medical data. METHODS:Annual death counts were obtained for each primary care practice participating in The Health Improvement Network "THIN" (UK). Expected count...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1688
更新日期:2009-01-01 00:00:00
abstract:PURPOSE:To examine and compare the quality of drug prescribing for older patients in nursing homes and home nursing services. METHODS:Cross-sectional study comprising 11,254 patients aged ≥ 65 years in nursing homes (n = 2986) and home nursing services (n = 8268). Potentially inappropriate medications were identified ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2232
更新日期:2012-09-01 00:00:00
abstract::Growth in health information systems presents opportunities to enhance postmarketing safety surveillance of medical products. Spontaneous suspected side effect reports provide the foundation, but we need to 'proactively' improve their quality and our strategies to seek signals. In our more familiar 'reactive' mode, we...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.587
更新日期:2001-05-01 00:00:00
abstract:PURPOSE:The strong male predominance of gastro-oesophageal cancer suggests that sex hormones play an important role. 5α-Reductase (5AR) inhibitors have antiandrogen effects and have been shown to decrease cancer cell proliferation and metastasis. We conducted the first epidemiologic investigation into the association b...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4909
更新日期:2020-01-01 00:00:00
abstract:BACKGROUND:Various strategies have been studied in the literature to address the significant underreporting of adverse drug reactions (ADRs) in healthcare systems worldwide. OBJECTIVES:We conducted a systematic review of the literature that assessed the impact of various strategies to improve ADR reporting published i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4906
更新日期:2020-01-01 00:00:00
abstract:AIM:To study the influence of media attention about statins and ADRs on the level of disproportionality, expressed as the reporting odds ratio (ROR) for statins in the Lareb database, based on patients' reports. METHODS:Patient reports about statins, before and after the broadcast of a consumer programme about statins...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1865
更新日期:2010-01-01 00:00:00
abstract::The cost of drugs represents 10% of the National Health Service (NHS) budget in the UK and this fraction is increasing. Because the NHS is centrally funded and because there is a budgetary limit, prioritization in health care is required. The National Institute for Clinical Excellence in England and Wales and the Heal...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.596
更新日期:2001-08-01 00:00:00
abstract:PURPOSE:The study aimed to evaluate the comparative risk of oral ulcerations among antipsychotic medications. METHODS:We analyzed the National Health Insurance Research Database of Taiwan and included patients newly initiated with a single antipsychotic agent including haloperidol, sulpiride, olanzapine, quetiapine, r...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3903
更新日期:2016-02-01 00:00:00