Abstract:
:Introduction: An important gap within modern medicine is the lack of enough comparative effectiveness research of marketed medicines. Low-risk pragmatic randomized controlled trials (pRCTs) are those conducted resembling usual clinical practice that poses no or minimal incremental risk compared with normal clinical practice.Areas covered: This review addresses one important hurdle in the conduct of low-risk pRCTs: the need to seek participants' written informed consent.Expert opinion: The CIOMS ethical guidelines consider that any research that (a) would not be feasible or practicable to carry out without the waiver or modification, (b) has important social value, and (c) poses no more than minimal risks to participants, and that is approved by the relevant research ethics committee, could be conducted without participants' consent. It is clear that these provisions are applicable to some low-risk RCTs. Recently a research on the EU-CTR registry showed that only 2% of all ongoing phase 4 RCTs could have fulfilled the CIOMS provisions following the investigators' assessment. The EU clinical trial regulation - and that of other jurisdictions - should be debated on the suitableness of the conduct with an alteration or waiver of participants' consent of those low-risk pRCTs that fulfill the three CIOMS provisions.
journal_name
Expert Rev Clin Pharmacoljournal_title
Expert review of clinical pharmacologyauthors
Dal-Ré Rdoi
10.1080/17512433.2020.1732816subject
Has Abstractpub_date
2020-03-01 00:00:00pages
205-210issue
3eissn
1751-2433issn
1751-2441journal_volume
13pub_type
杂志文章,评审abstract::Introduction: Dementia is the 7th leading cause of death that imposes a significant financial and service burden on the global population. Presently, only symptomatic care exists for cognitive loss, such as Alzheimer's disease.Areas covered: Given the advancing age of the global population, it becomes imperative to de...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2020.1698288
更新日期:2020-01-01 00:00:00
abstract::Chagas disease is the highest impact parasitic disease in the Americas but often goes untreated due to the shortcomings of currently available therapeutics. Thus there is an urgent need for new treatment options and growing interest in drug development for the infection. This review summarizes some of the recent advan...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2014.909282
更新日期:2014-05-01 00:00:00
abstract::The thermo transient receptor potential (TRP) ion channels, a recently discovered family of ion channels activated by temperature, are expressed in primary sensory nerve terminals, where they provide information regarding thermal changes in the environment. Six thermo-TRPs have been characterized to date: TRPV1-4, whi...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/ecp.10.41
更新日期:2010-09-01 00:00:00
abstract::G-quadruplexes are non-Watson-Crick four-stranded nucleic acid structures. Recent evidence points toward their existence in vivo and their implication in various biological processes. Over the past two decades, small molecules have been developed to specifically and selectively target these structures in order to diss...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2014.945909
更新日期:2014-09-01 00:00:00
abstract::Aripiprazole monohydrate (AM) and aripiprazole lauroxil (AL) are two different long-acting injectable formulations of aripiprazole. AM 400 mg administered once monthly demonstrated efficacy in an acute, double-blind, placebo-controlled, randomized clinical trial, as well as in a double-blind, placebo-controlled, rando...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2016.1121809
更新日期:2016-01-01 00:00:00
abstract::The aim of this article was to assess the efficacy and safety of apremilast in treatment of psoriatic arthritis (PsA) with meta-analysis method. We included four randomized clinical trials identified from MEDLINE, EMBASE, Cochrane Library, "ISRCTN Register" and "ClinicalTrials.gov" which compared apremilast with place...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,meta分析,评审
doi:10.1586/17512433.2016.1159130
更新日期:2016-06-01 00:00:00
abstract::Pregnancy represents a major challenge in the management of patients with systemic lupus erythematosus, with substantial risks to both mother and baby. Over the past 40 years there have been major improvements in outcomes. This partly relates to the discovery of the antiphospholipid syndrome, which has transformed man...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/ecp.10.55
更新日期:2010-11-01 00:00:00
abstract::Reducing the burden of falciparum malaria in pregnancy is an urgent international public health priority but one that involves considerable challenges. The rapidly declining effectiveness of agents known to be safe in pregnancy, and the limited efficacy, safety and pharmacokinetic data available for many other antimal...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/17512433.1.1.61
更新日期:2008-01-01 00:00:00
abstract::Bone metastases are associated with a broad spectrum of clinical sequelae. Pain, reduced mobility, skeletal complications and treatment-related events reduce quality of life. Numerous randomized controlled trials have evaluated pharmacological interventions to treat bone metastases. The primary outcomes used have evol...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/ecp.12.21
更新日期:2012-05-01 00:00:00
abstract::Zanamivir is currently not recommended by the WHO for the first-line treatment of human influenza A (H5N1) infections. Zanamivir pharmacokinetics and antiviral efficacy were reviewed to assess the basis for this recommendation. Following inhalation of 10 mg zanamivir in healthy humans, the drug is widely distributed t...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/ecp.09.60
更新日期:2010-01-01 00:00:00
abstract:INTRODUCTION:Allogeneic hematopoietic cell transplants (allo-HCT) recipients are at the high-risk of reactivation of cytomegalovirus (CMV), and reactivation is associated with significant morbidity and mortality. Although available anti-CMV therapies may be effective for the prevention of CMV, they are plagued by unacc...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2018.1500897
更新日期:2018-10-01 00:00:00
abstract::Introduction: Primary endpoints and inclusion/exclusion criteria of biologics and small oral molecules for psoriasis treatment have been evolving due to a better understanding of the pathogenesis and potential risks.Areas covered: We analyzed the designs of key phase 3 pivotal trials of all biologics and small oral mo...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2020.1743175
更新日期:2020-03-01 00:00:00
abstract::Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are effective and widely used antihypertensive drugs. Exposure to these agents is known to be harmful to the fetus in the second and third trimesters of pregnancy. Concerns have also been raised about the risk of congenital malfo...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2015.1005074
更新日期:2015-03-01 00:00:00
abstract::Introduction: Combined antiretroviral therapy (cART) has transformed an inexorably fatal disease into a chronic pathology, shifting the focus of research from the control of viral replication to the possibility of HIV cure. Areas covered: The present review assesses the principal pharmacological strategies that have b...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2019.1561272
更新日期:2019-01-01 00:00:00
abstract::The anti-tumor activity of CpG-containing oligodeoxynucleotides (ODNs) has been well established in numerous animal models and confirmed in a number of early clinical trials. While the use of chemical modifications has effectively reduced the sensitivity of ODNs to nuclease degradation and a number of human trials hav...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/17512433.2.2.181
更新日期:2009-03-01 00:00:00
abstract:INTRODUCTION:The incidence of kidney dysfunction increases with age and is highly prevalent among patients with hypertension. Since many therapeutic compounds are primarily eliminated through the kidneys, impaired renal function can have negative consequences on drug disposition, efficacy and safety. Therefore, regulat...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2017.1274651
更新日期:2017-03-01 00:00:00
abstract::Introduction: With the majority of elderly persons consuming multiple drugs, inappropriate drug use is a major issue in geriatric medicine. Areas covered: We reviewed PubMed, Embase, and Cochrane from inception to 1 May 2019 for potentially inappropriate use of medications, polypharmacy, and age-dependent changes in p...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2019.1632188
更新日期:2019-08-01 00:00:00
abstract::RNAi is a powerful gene silencing process that holds great promise in cancer therapy by the use of siRNA. The aim of this review is to give an outline on different approaches to deliver siRNA and to describe the advantages and disadvantages of these systems. The prospects for siRNA are to be substantially better than ...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/ecp.12.33
更新日期:2012-07-01 00:00:00
abstract::Methotrexate is an antifolate agent used in the treatment of various cancers and some autoimmune diseases. In oncology, methotrexate is frequently administered at a high dose (>1 g/m(2)) and comes with various procedures to reduce the occurrence of toxicity and particularly to ensure optimal renal elimination. Drug-dr...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/ecp.11.57
更新日期:2011-11-01 00:00:00
abstract::Calcineurin inhibitors are widely used as maintenance immunosuppressants in solid-organ transplantation to minimize the risk of allograft rejection. Although the use of these agents has transformed the outcomes for patient and graft survival, this has come at a cost, notably the well-known adverse events of nephrotoxi...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/ecp.12.49
更新日期:2012-09-01 00:00:00
abstract::Introduction: The development of immunotherapies and targeted therapies has changed the treatment approach in resectable, nonresectable, and metastatic melanoma. Because of their different pharmacological profiles, immunotherapies and/or targeted therapies have been studied in various combinations.Areas covered: We re...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1080/17512433.2019.1650641
更新日期:2020-03-19 00:00:00
abstract:INTRODUCTION:More than half of the patients with inflammatory bowel disease (IBD) experience at least one extra-intestinal manifestation (EIM). The most common EIM in patients with IBD is spondyloarthritis (SpA). Microscopic intestinal inflammation is documented in almost 50% of the patients with SpA. Areas covered: We...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2017.1377609
更新日期:2017-12-01 00:00:00
abstract::Alzheimer's disease is the most common cause of dementia and is becoming a global health concern. Despite a well-established understanding of the molecular mechanism involved in its pathogenesis, and millions of dollars of investment in drug discovery and clinical trials, no single molecule has yet been approved for i...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2013.811237
更新日期:2013-07-01 00:00:00
abstract::Chronic diarrhea remains a common condition that affects people infected with human immunodeficiency virus (HIV) despite the widespread use of potent antiretroviral therapy. It is important that providers control this condition, as the persistence of diarrhea affects the quality of life of patients and may contribute ...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2015.1082424
更新日期:2015-01-01 00:00:00
abstract::Introduction: Statins remain among the most frequently prescribed drugs and constitute a cornerstone in the prevention of cardiovascular disease. However, muscle symptoms are often reported from patients on statins. Muscle symptoms are frequently reported as adverse events associated with statin therapy.Areas covered:...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2020.1734451
更新日期:2020-03-01 00:00:00
abstract:INTRODUCTION:Diabetes mellitus is associated with increased cardiovascular disease (CVD) risk. Areas covered: Main goal of hypolipidemic treatment in diabetic patients is low-density lipoprotein cholesterol (LDL-C) lowering with the use of statins. Addition of ezetimibe is useful in diabetic patients who cannot achieve...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2017.1263565
更新日期:2017-02-01 00:00:00
abstract::Sugammadex, a modified γ-cyclodextrin, is the first selective relaxant binding agent. Sugammadex forms very tight complexes in a 1:1 ratio with steroidal neuromuscular blocking agents (rocuronium > vecuronium > pancuronium). This guest-host complex, which exists in equilibrium, is stable because of its very high assoc...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/17512433.2.1.37
更新日期:2009-01-01 00:00:00
abstract:INTRODUCTION:The Pharmacokinetics/pharmacodynamics (PK/PD) relationships with cytotoxics are usually based on a steepening concentration-effect relationship; the greater the drug amount, the greater the effect. The Maximum Tolerated Dose paradigm, finding the balance between efficacy, while keeping toxicities at their ...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2018.1477586
更新日期:2018-06-01 00:00:00
abstract:INTRODUCTION:Joint hypermobility (JH) is the hallmark of many hereditary soft connective tissue disorders, including Ehlers-Danlos syndromes and related disorders, disorders of the TGFβ-pathway, lateral meningocele syndrome, arterial tortuosity syndrome, and cutis laxa syndromes. Contemporary practice separates individ...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2018.1497973
更新日期:2018-07-01 00:00:00
abstract::Data from clinical trials, retrospective and cross-sectional studies have quantified the metabolic changes associated with long-term use of antiepileptic drugs (AEDs). AEDs can be associated with weight gain or weight loss, although most are weight neutral. Weight gain is not only a cosmetic problem but also a risk fo...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2015.991716
更新日期:2015-01-01 00:00:00