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:A new five-year low dose, smaller-framed, levonorgestrel-releasing intrauterine contraceptive system (LNG-IUS 12) has been introduced to complement the currently available systems. Areas Covered: This article will provide an overview of this new intrauterine system - its composition and its mechanisms of a...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2017.1341308
更新日期:2017-08-01 00:00:00
abstract:INTRODUCTION:Acute bacterial skin and skin structure infections (ABSSSI) are among the most frequent infectious diseases. Recently, several new antibiotics with activity against MRSA have been approved. Tedizolid, a second-generation oxazolidinone approved for ABSSSI offers theoretical advantages over first-generation ...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2020.1774362
更新日期:2020-06-01 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: In September of 2018, the United States Federal Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for advanced cutaneous squamous cell carcinoma (CSCC). Cemiplimab is an intravenous human monoclonal antibody directed against programmed cell death-1 receptor (PD-1). Cemiplimab blocks T-cell ina...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2019.1665026
更新日期:2019-10-01 00:00:00
abstract::Magnetic nanoparticles (MNPs) represent a promising nanomaterial for the targeted therapy and imaging of malignant brain tumors. Conjugation of peptides or antibodies to the surface of MNPs allows direct targeting of the tumor cell surface and potential disruption of active signaling pathways present in tumor cells. D...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/ecp.12.1
更新日期:2012-03-01 00:00:00
abstract::Neuroblastoma (NB) is the most common extra cranial solid tumor of childhood, with 60% of patients presenting with high risk (HR) NB by means of clinical, pathological and biological features. The 5-year survival rate for HR-NB remains below 40%, with the majority of patients suffering relapse from chemorefractory tum...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2016.1160775
更新日期:2016-01-01 00:00:00
abstract::Preeclampsia is a pregnancy-specific multisystem disorder, complicating 2 - 8% of pregnancies, and represents a leading cause of maternal and perinatal morbidity and mortality. Recent investigations have elucidated the understanding of its underlying pathogenic mechanisms. However, despite these advances, therapeutic ...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/17512433.2014.944501
更新日期:2014-09-01 00:00:00
abstract:INTRODUCTION:WHO recommends tenofovir, efavirenz, and lamivudine or emtricitabine for first-line antiretroviral therapy (ART) in adults, which replaced more toxic regimens using stavudine, zidovudine or nevirapine. Areas covered: We searched Pubmed to identify observational studies and randomized controlled trials repo...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2016.1221760
更新日期:2016-11-01 00:00:00
abstract:INTRODUCTION:Gaucher disease (GD) is an autosomal recessive disorder resulting from the deficiency of the lysosomal enzyme glucocerebrosidase (b-glucosidase), associated with varying degrees of visceral, bone and central nervous system pathology, leading to wide phenotypic diversity. Response to therapy and clinical ou...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2018.1549486
更新日期:2018-12-01 00:00:00
abstract::Research on the specific effects of sex and gender on pharmacokinetics and pharmacodynamics, as well as safety profile tolerability and drug efficacy, of medications remain meager because female animals and women have only recently been included in the pharmacological domain. To date, the influence of sex and gender o...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2014.922866
更新日期:2014-07-01 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::The unprecedented levels of political, technical and financial support for improved malaria control, and particularly for changes in the malaria treatment policy, have heralded a renewed appreciation of the role of pharmacovigilance, its relationship with other areas of public health and the development of novel appro...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/ecp.10.37
更新日期:2010-07-01 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::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::Background: The RESORT trial showed no longer relapse free survival (RFS) with sorafenib following radical metastasectomy in metastatic renal cell carcinoma. We present the updated 42-month follow-up data. Methods: The phase II RESORT trial randomized patients to sorafenib or observation within 12 weeks from surgery. ...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1080/17512433.2021.1879639
更新日期:2021-01-31 00:00:00
abstract:INTRODUCTION:Osteoarthritis is the most common cause of arthritis and one of the main causes of chronic pain. Although opioids are frequently employed for chronic pain treatment, their usage for osteoarthritis pain remains controversial due to the associated adverse effects. Most guidelines reserve their use for refrac...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2018.1381556
更新日期:2018-01-01 00:00:00
abstract::In the management of chronic obstructive pulmonary disease (COPD), there is an unmet medical need for effective bronchodilator treatments that not only have a fast onset of action, but also a long duration of action and are delivered using a simple, easy-to-use device. Long-acting muscarinic antagonists such as glycop...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2013.828419
更新日期:2013-09-01 00:00:00
abstract::Drug-induced liver injury (DILI) is a common form of adverse drug reaction seen within the clinic. Sensitive, specific and non-invasive biomarkers of liver toxicity are required to help diagnose hepatotoxicity and also to identify safety liabilities during drug development. Limitations exist in the current gold standa...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2014.904201
更新日期:2014-05-01 00:00:00
abstract:INTRODUCTION:Checkpoint inhibitor immunotherapy has revolutionized the treatment of many advanced stage cancers. Preexisting immunity is necessary for a response to these agents, which are most effective in inflamed tumors since they principally act by reinforcing preexisting antitumor T-cell responses. An important go...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2018.1518713
更新日期:2018-10-01 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
abstract:INTRODUCTION:Anti-vascular endothelial growth factor (VEGF) therapy has become the most commonly used treatment for macular edema secondary to retinal vein occlusion (RVO). Although its superior efficacy as compared to other interventions has been proven, there is a lack of evidence for relative efficacy among anti-VEG...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,meta分析,评审
doi:10.1080/17512433.2018.1507735
更新日期:2018-09-01 00:00:00
abstract::Inflammation plays a critical role in host defense, maintaining cellular and tissue integrity following chemical, physical and biological insults. Inflammation presents in a variety of acute and chronic disease states and can contribute to disease resolution or progression depending upon the type, magnitude and durati...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/ecp.11.66
更新日期:2012-01-01 00:00:00
abstract:INTRODUCTION:Bacterial resistance to antibiotics is increasing worldwide, due to the emergence of multidrug-resistant strains. With this panorama, there is a serious danger that we may be entering the 'post-antibiotic era'. Areas covered: We assess why so few new classes of antibiotics have been developed in the past y...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2016.1241141
更新日期:2016-12-01 00:00:00
abstract:INTRODUCTION:The need to develop new drugs for the control of pathogenic microorganisms has redoubled efforts to prospect for antimicrobial peptides (AMPs) from natural sources and to characterize its structure and function. These molecules present a broad spectrum of action against different microorganisms and frequen...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1080/17512433.2020.1764347
更新日期:2020-04-01 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::Treatment of age-related macular degeneration (AMD) has changed dramatically over the last decade. It has evolved from primarily destructive therapies (laser-based treatment strategies) to nondestructive therapies (intravitreal pharmacotherapies that target angiogenesis). Intermittent intravitreal ranibizumab, an inhi...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/ecp.10.6
更新日期:2010-03-01 00:00:00
abstract::Second-generation antipsychotics (SGA) have been associated with risk of stroke in elderly patients, but the molecular and genetic background under this association has been poorly investigated. The aim of the present study was to prioritize a list of genes with an SGA altered expression in order to characterize the g...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1586/17512433.2014.865515
更新日期:2014-01-01 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::Osteoarthritis is a progressive disease that affects millions of people worldwide, but for which there are no curative options and indeed a limited number of medical treatment options. The American College of Rheumatology recommendations suggest administering either a traditional NSAID or a COX-2-selective inhibitor f...
journal_title:Expert review of clinical pharmacology
pub_type: 杂志文章
doi:10.1586/17512433.1.3.345
更新日期:2008-05-01 00:00:00
abstract::The dramatic effectiveness of statins in improving the course of atherosclerotic cardiovascular disease tends to overshadow questions of statin intolerance. Thus after more than 25 years of clinical statin use, intolerance remains a poorly understood, frustrating issue for patients and providers. It has been extraordi...
journal_title:Expert review of clinical pharmacology
pub_type: 社论
doi:10.1586/17512433.2014.857601
更新日期:2014-01-01 00:00:00