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

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.

authors

Dal-Ré R

doi

10.1080/17512433.2020.1732816

subject

Has Abstract

pub_date

2020-03-01 00:00:00

pages

205-210

issue

3

eissn

1751-2433

issn

1751-2441

journal_volume

13

pub_type

杂志文章,评审
  • Novel Therapies for Thyroid Autoimmune Diseases.

    abstract::C-X-C chemokine receptor (CXCR)3 and its interferon(IFN)γ-dependent chemokines (CXCL10, CXCL9, CXCL11) are implicated in the immune-pathogenesis of autoimmune thyroiditis (AT), Graves disease (GD) and Graves Ophthalmopathy (GO). In tissue, recruited Th1 lymphocytes produce IFNγ, enhancing the tissue secretion of IFNγ-...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1586/17512433.2016.1157468

    authors: Fallahi P,Ferrari SM,Elia G,Nasini F,Colaci M,Giuggioli D,Vita R,Benvenga S,Ferri C,Antonelli A

    更新日期:2016-06-01 00:00:00

  • Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in women of childbearing age: risks versus benefits.

    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

    authors: Pucci M,Sarween N,Knox E,Lipkin G,Martin U

    更新日期:2015-03-01 00:00:00

  • Phytotherapy as an alternative to conventional antimicrobials: combating microbial resistance.

    abstract:INTRODUCTION:In the modern antimicrobial era, the rapid spread of resistance to antibiotics and introduction of new and mutating viruses is a global concern. Combating antimicrobial resistant microbes (AMR) requires coordinated international efforts that incorporate new conventional antibiotic development as well as de...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1080/17512433.2017.1371591

    authors: Enioutina EY,Teng L,Fateeva TV,Brown JCS,Job KM,Bortnikova VV,Krepkova LV,Gubarev MI,Sherwin CMT

    更新日期:2017-11-01 00:00:00

  • Lipid-based delivery of CpG oligodeoxynucleotides for cancer immunotherapy.

    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

    authors: Wilson KD,Tam YK

    更新日期:2009-03-01 00:00:00

  • An update on repurposed medications for the treatment of drug-resistant tuberculosis.

    abstract:INTRODUCTION:Drug-resistant forms of tuberculosis are a major public health problem with a serious global impact. Although there have recently been two new drugs introduced for the treatment of drug-resistant TB (bedaquiline and delamanid), the current therapeutic armamentarium is limited. Because treatment of drug-res...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1080/17512433.2016.1208562

    authors: Mafukidze A,Harausz E,Furin J

    更新日期:2016-10-01 00:00:00

  • Hydrogen sulfide in the endocrine and reproductive systems.

    abstract::Hydrogen sulfide (H(2)S) is now considered a member of a group of signaling molecules termed 'gasotransmitters'. H(2)S has been shown to be generated in the endocrine and reproductive organs and elicits various actions. H(2)S modulates insulin secretion in pancreatic islets. Adipose tissues have the ability to produce...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1586/ecp.10.125

    authors: Zhu XY,Gu H,Ni X

    更新日期:2011-01-01 00:00:00

  • Secukinumab (AIN-457) for the treatment of Psoriasis.

    abstract::Secukinumab (also known as AIN-457) is a human monoclonal antibody targeting IL-17A, which has been recently FDA-approved for the treatment of moderate to severe psoriasis and psoriatic arthritis with coexistent moderate to severe plaque psoriasis based on clinical trials demonstrating excellent efficacy. This review ...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1586/17512433.2016.1129894

    authors: Jaleel T,Elmets C,Weinkle A,Kassira S,Elewski B

    更新日期:2016-01-01 00:00:00

  • Children in clinical trials: towards evidence-based pediatric pharmacotherapy using pharmacokinetic-pharmacodynamic modeling.

    abstract:INTRODUCTION:In pediatric pharmacotherapy, many drugs are still used off-label, and their efficacy and safety is not well characterized. Different efficacy and safety profiles in children of varying ages may be anticipated, due to developmental changes occurring across pediatric life. AREAS COVERED:Beside pharmacokine...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1080/17512433.2016.1198256

    authors: Brussee JM,Calvier EA,Krekels EH,Välitalo PA,Tibboel D,Allegaert K,Knibbe CA

    更新日期:2016-09-01 00:00:00

  • Gemtuzumab ozogamicin for the treatment of acute myeloid leukemia.

    abstract:INTRODUCTION:Gemtuzumab ozogamicin (GO) is an antibody-drug conjugate consisting of a monoclonal antibody targeting CD33 linked to a cytotoxic derivative of calicheamicin. Despite the known clinical efficacy in relapsed/refractory acute myeloid leukemia (AML), GO was withdrawn from the market in 2010 due to increased e...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1080/17512433.2018.1478725

    authors: Baron J,Wang ES

    更新日期:2018-06-01 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

    doi:10.1080/17512433.2019.1665026

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

    更新日期:2019-10-01 00:00:00

  • Zanamivir for the treatment of avian influenza infections in humans.

    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

    authors: Reece PA

    更新日期:2010-01-01 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

    doi:10.1080/17512433.2016.1241141

    authors: Rello J,Bunsow E,Perez A

    更新日期:2016-12-01 00:00:00

  • Three-month paliperidone palmitate - a new treatment option for schizophrenia.

    abstract:INTRODUCTION:Long-acting injectable antipsychotics (LAIAs) were introduced to improve treatment adherence and tolerability of oral formulations. After risperidone was introduced as the first long-acting injectable second-generation antipsychotic, during the last five years olanzapine pamoate, once-monthly paliperidone ...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1080/17512433.2016.1191945

    authors: Bernardo M,Bioque M

    更新日期:2016-07-01 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

    doi:10.1586/ecp.11.57

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

    更新日期:2011-11-01 00:00:00

  • Lucinactant for the prevention of respiratory distress syndrome in premature infants.

    abstract::Respiratory distress syndrome (RDS) is the leading cause of neonatal morbidity and mortality in premature infants. It is caused by surfactant deficiency and lung immaturity. Lucinactant is a synthetic surfactant containing sinapultide, a bioengineered peptide mimic of surfactant-associated protein B. A meta-analysis o...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1586/ecp.12.80

    authors: Jordan BK,Donn SM

    更新日期:2013-03-01 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

    doi:10.1586/ecp.10.6

    authors: McGimpsey SJ,Chakravarthy U

    更新日期:2010-03-01 00:00:00

  • Evolution of the inclusion/exclusion criteria and primary endpoints in pivotal trials of biologics and small oral molecules for the treatment of psoriasis.

    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

    authors: Hsu SH,Tsai TF

    更新日期:2020-03-01 00:00:00

  • Design and analysis considerations for thorough QT studies employing conventional (10 s, 12-lead) ECG recordings.

    abstract::The QT interval from the ECG cannot be measured precisely. The relationship of the QT interval to the RR interval within individuals across time and different RR values, and across individuals eludes complete understanding. Intrinsic beat-to-beat variability in QT interval corrected for heart rate (QTc interval) is no...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1586/17512433.1.6.815

    authors: Beasley CM Jr,Dmitrienko A,Mitchell MI

    更新日期:2008-11-01 00:00:00

  • The role of the placenta in drug transport and fetal drug exposure.

    abstract:INTRODUCTION:It was assumed for decades that the human placenta serves as a barrier, protecting the fetus from exposure to xenobiotics circulating in the mother. The thalidomide disaster completely reversed this concept. The study of the human placenta is therefore critical to understanding the mechanisms by which xeno...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1080/17512433.2018.1425615

    authors: Koren G,Ornoy A

    更新日期:2018-04-01 00:00:00

  • Bupropion-SR plus naltrexone-SR for the treatment of mild-to-moderate obesity.

    abstract::Naltrexone-bupropion is a recently approved drug combination for chronic weight management. In this article, we discuss the rationale for its use as a combination followed by a comprehensive review of safety and efficacy data from major preclinical, phase II and III clinical trials. ...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1586/17512433.2016.1100072

    authors: Ali KF,Shukla AP,Aronne LJ

    更新日期:2016-01-01 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

    doi:10.1586/ecp.10.37

    authors: Mehta U,Allen E,Barnes KI

    更新日期:2010-07-01 00:00:00

  • Atezolizumab for the treatment of non-small cell lung cancer.

    abstract:INTRODUCTION:The immune system can restrain or promote cancer development and growth. Antibodies targeting immune checkpoints have revolutionized cancer treatment. Among the best responses have been in non-small cell lung cancer (NSCLC) which is largely caused by chronic exposure to carcinogens; associated with high ne...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1080/17512433.2017.1356717

    authors: Santini FC,Rudin CM

    更新日期:2017-09-01 00:00:00

  • Novel pharmaceuticals in the management of postoperative pain.

    abstract::Novel pharmaceutical advances in postoperative pain management include both non-opioid adjuvants as well as opioid analgesics. Optimizing postoperative analgesics includes improving onset of action, matching duration of analgesia to the setting of use, and minimizing adverse events. To improve on the current standard ...

    journal_title:Expert review of clinical pharmacology

    pub_type: 社论

    doi:10.1586/17512433.2015.1072465

    authors: Palmer P

    更新日期:2015-01-01 00:00:00

  • Can a fixed-ratio combination of insulin degludec and liraglutide help Type 2 diabetes patients to optimize glycemic control across the day?

    abstract::'IDegLira' combines insulin degludec (IDeg) with the glucagon-like peptide-1 analog liraglutide (Lira) at a ratio of 1 unit IDeg to 0.036 mg Lira. The two components have complementary therapeutic actions for the treatment of Type 2 diabetes. Studies have shown that combinations of basal insulin with glucagon-like pep...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1586/17512433.2015.1017562

    authors: Simpson R,King A

    更新日期:2015-03-01 00:00:00

  • The pathophysiological and pharmacological basis of current drug treatment of migraine headache.

    abstract::Migraine is a common neurological syndrome that affects approximately 10-20% of the population. The pathophysiology of migraine is unclear. 5-hydroxytriptamine is a key mediator in the pathogenesis of migraine and thus 5-HT1-receptor agonists are the principal drugs for acute migraine therapy. There are three classes ...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1586/ecp.13.14

    authors: Reddy DS

    更新日期:2013-05-01 00:00:00

  • Evidence for a potential protective effect of carnitine-pantothenic acid co-treatment on valproic acid-induced hepatotoxicity.

    abstract::Valproic acid is approved for treatment of seizures and manic episodes of bipolar disorder, and continues to be one of the most commonly prescribed antiepileptic drugs in the world. Hepatotoxicity is a rare but serious side effect resulting from its use, particularly in young patients. This adverse effect does not dis...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1586/17512433.2014.871202

    authors: Felker D,Lynn A,Wang S,Johnson DE

    更新日期:2014-03-01 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

    doi:10.1586/17512433.2015.991716

    authors: Hamed SA

    更新日期:2015-01-01 00:00:00

  • Daunorubicin and cytarabine for certain types of poor-prognosis acute myeloid leukemia: a systematic literature review.

    abstract:INTRODUCTION:Induction chemotherapy based on anthracyclines and cytarabine (Ara-C) combination remains the standard of care for acute myeloid leukemia (AML) patients who are considered candidate for intensive and curative approaches. However, the toxicity of this regimen is high, with disappointing clinical outcomes am...

    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1080/17512433.2019.1573668

    authors: Megías-Vericat JE,Martínez-Cuadrón D,Sanz MÁ,Poveda JL,Montesinos P

    更新日期:2019-03-01 00:00:00

  • 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

    doi:10.1080/17512433.2017.1341308

    authors: Nelson AL

    更新日期:2017-08-01 00:00:00

  • Update and trends on pharmacokinetic studies in patients with impaired renal function: practical insight into application of the FDA and EMA guidelines.

    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

    authors: Paglialunga S,Offman E,Ichhpurani N,Marbury TC,Morimoto BH

    更新日期:2017-03-01 00:00:00