Participants' written informed consent in low-risk pragmatic clinical trials with medicines.


: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.


Dal-Ré R




Has Abstract


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  • Levonorgestrel-releasing intrauterine system (LNG-IUS 12) for prevention of pregnancy for up to five years.

    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


    authors: Nelson AL

    更新日期:2017-08-01 00:00:00

  • Tedizolid (torezolid) for the treatment of complicated skin and skin structure infections.

    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


    authors: Carena AA,Stryjewski ME

    更新日期:2020-06-01 00:00:00

  • The adverse pharmacology of calcineurin inhibitors and their impact on hepatitis C recurrence after liver transplantation: implications for clinical practice.

    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


    authors: Garcia-Saenz-de-Sicilia M,Mukherjee S

    更新日期:2012-09-01 00:00:00

  • Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma.

    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


    authors: Ahmed SR,Petersen E,Patel R,Migden MR

    更新日期:2019-10-01 00:00:00

  • Magnetic nanoparticles: an emerging technology for malignant brain tumor imaging and therapy.

    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


    authors: Wankhede M,Bouras A,Kaluzova M,Hadjipanayis CG

    更新日期:2012-03-01 00:00:00

  • Dinutuximab for the treatment of pediatric patients with high-risk neuroblastoma.

    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


    authors: Mora J

    更新日期:2016-01-01 00:00:00

  • Upcoming drugs for the treatment of preeclampsia in pregnant women.

    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


    authors: Ornaghi S,Paidas MJ

    更新日期:2014-09-01 00:00:00

  • Key toxicity issues with the WHO-recommended first-line antiretroviral therapy regimen.

    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


    authors: Mouton JP,Cohen K,Maartens G

    更新日期:2016-11-01 00:00:00

  • Pharmacological treatment of pediatric Gaucher disease.

    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


    authors: Gupta P,Pastores G

    更新日期:2018-12-01 00:00:00

  • Sex and gender influences on pharmacological response: an overview.

    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


    authors: Franconi F,Campesi I

    更新日期:2014-07-01 00:00:00

  • Seek and destroy: improving PK/PD profiles of anticancer agents with nanoparticles.

    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


    authors: Rodallec A,Fanciullino R,Lacarelle B,Ciccolini J

    更新日期:2018-06-01 00:00:00

  • Establishing pharmacovigilance programs in resource-limited settings: the example of treating malaria.

    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


    authors: Mehta U,Allen E,Barnes KI

    更新日期:2010-07-01 00:00:00

  • Aripiprazole long-acting injectable formulations for schizophrenia: aripiprazole monohydrate and aripiprazole lauroxil.

    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


    authors: Citrome L

    更新日期:2016-01-01 00:00:00

  • Novel disease-modifying therapeutics for the treatment of Alzheimer's disease.

    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


    authors: Léger GC,Massoud F

    更新日期:2013-07-01 00:00:00

  • Radical metastasectomy followed by sorafenib versus observation in patients withclear cell renal cell carcinoma: extended follow -up of efficacy results from the randomized phase II RESORT trial.

    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


    authors: Mennitto A,Verzoni E,Cognetti F,Miceli R,Milella M,Mosca A,Chiuri VE,Bearz A,Morelli F,Ortega C,Atzori F,Donini M,Claps M,Guadalupi V,Sepe P,Cappelletti V,de Braud FG,Procopio G

    更新日期:2021-01-31 00:00:00

  • Use of strong opioids for chronic pain in osteoarthritis: an insight into the Latin American reality.

    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


    authors: Ruiz Iban MA,Benavides J,Forero JP,Bittelman S,Martinez R,Mite MA,Diaz Heredia J,Ulloa S,Lizárraga Ferrand MM

    更新日期:2018-01-01 00:00:00

  • Once-daily glycopyrronium via the Breezhaler® device for the treatment of COPD: pharmacological and clinical profile.

    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


    authors: Molimard M,D'Andrea P

    更新日期:2013-09-01 00:00:00

  • MicroRNAs as potential circulating biomarkers of drug-induced liver injury: key current and future issues for translation to humans.

    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


    authors: Hornby RJ,Starkey Lewis P,Dear J,Goldring C,Park BK

    更新日期:2014-05-01 00:00:00

  • Selecting immuno-oncology-based drug combinations - what should we be considering?

    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


    authors: Festino L,Vanella V,Trojaniello C,Ascierto PA

    更新日期:2018-10-01 00:00:00

  • Antiepileptic drugs influences on body weight in people with epilepsy.

    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


    authors: Hamed SA

    更新日期:2015-01-01 00:00:00

  • Comparative efficacy of bevacizumab, ranibizumab, and aflibercept for treatment of macular edema secondary to retinal vein occlusion: a systematic review and network meta-analysis.

    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


    authors: Sangroongruangsri S,Ratanapakorn T,Wu O,Anothaisintawee T,Chaikledkaew U

    更新日期:2018-09-01 00:00:00

  • Inflammation-mediated changes in drug transporter expression/activity: implications for therapeutic drug response.

    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


    authors: Cressman AM,Petrovic V,Piquette-Miller M

    更新日期:2012-01-01 00:00:00

  • What if there were no new antibiotics? A look at alternatives.

    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


    authors: Rello J,Bunsow E,Perez A

    更新日期:2016-12-01 00:00:00

  • Strategies for recombinant production of antimicrobial peptides with pharmacological potential.

    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


    authors: Sampaio de Oliveira KB,Leite ML,Rodrigues GR,Duque HM,da Costa RA,Cunha VA,de Loiola Costa LS,da Cunha NB,Franco OL,Dias SC

    更新日期:2020-04-01 00:00:00

  • Current perspectives on the modulation of thermo-TRP channels: new advances and therapeutic implications.

    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


    authors: Vay L,Gu C,McNaughton PA

    更新日期:2010-09-01 00:00:00

  • VEGF-targeted therapy and beyond: pharmacotherapy and emerging treatments in agerelated macular degeneration.

    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


    authors: McGimpsey SJ,Chakravarthy U

    更新日期:2010-03-01 00:00:00

  • The genetics of vascular incidents associated with second-generation antipsychotic administration.

    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


    authors: Cocchi E,Drago A,de Ronchi D,Serretti A

    更新日期:2014-01-01 00:00:00

  • Pharmacokinetic drug-drug interactions with methotrexate in oncology.

    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


    authors: Levêque D,Santucci R,Gourieux B,Herbrecht R

    更新日期:2011-11-01 00:00:00

  • Efficacy and safety of etoricoxib in the treatment of osteoarthritis.

    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


    authors: Sebba A

    更新日期:2008-05-01 00:00:00

  • Statin intolerance: more questions than answers.

    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


    authors: Guyton JR,Campbell KB,Lakey WC

    更新日期:2014-01-01 00:00:00