scholarly journals Do all services provided as part of a clinical trial require research ethics and governance review?

2017 ◽  
Vol 47 (10) ◽  
pp. 1197-1199
Author(s):  
Jeremy Kenner ◽  
John R. Zalcberg
Keyword(s):  
Clinical Trial ◽  
Research Ethics

Can research ethics committees enable clinical trial data sharing?

2017 ◽  
Vol 3 (1) ◽  
pp. 56-63 ◽  
Author(s):  
A. Thorogood ◽  
B.M. Knoppers
Keyword(s):  
Clinical Trial ◽  
Research Ethics ◽  
Data Sharing ◽  
Clinical Trial Data ◽  
Ethics Committees ◽  
Trial Data ◽  
Research Ethics Committees

scholarly journals Accuracy and consequences of usingtrial-of-antibioticsfor TB diagnosis (ACT-TB study): protocol for a randomised controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e033999
Author(s):  
Titus Henry Divala ◽  
Katherine L Fielding ◽  
Derek J Sloan ◽  
Neil French ◽  
Marriott Nliwasa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mycobacterium Tuberculosis ◽  
Research Ethics ◽  
Primary Outcome ◽  
Standard Of Care ◽  
Ethics Committee ◽  
Absolute Difference ◽  
Controlled Clinical Trial ◽  
London School ◽  
Randomised Controlled

IntroductionOver 40% of global tuberculosis case notifications are diagnosed clinically without mycobacteriological confirmation. Standard diagnostic algorithms include ‘trial-of-antibiotics’—empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a ‘rule-out’ diagnostic test for tuberculosis. Potentially 26.5 million such antibiotic courses/year are prescribed globally for the 5.3 million/year mycobacteriology-negative patients, making trial-of-antibiotics the most common tuberculosis diagnostic, and a global-scale risk for antimicrobial resistance (AMR). Our systematic review found no randomised controlled trial (RCT) to support use of trial-of-antibiotic. The RCT aims to determine the diagnostic and clinical value and AMR consequences of trial-of-antibiotics.Methods and analysisA three-arm, open-label, RCT randomising (1:1:1) Malawian adults (≥18 years) seeking primary care for cough into: (a) azithromycin 500 mg one time per day for 3 days or (b) amoxicillin 1 g three times per day for 5 days or (c) standard-of-care (no immediate antibiotic). We will perform mycobacteriology tests (microscopy, Xpert MTB/RIF (Mycobacterium tuberculosis/rifampicin) andMycobacterium tuberculosisculture) at baseline. We will use audiocomputer-assisted self-interview to assess clinical improvement at day 8. First primary outcome will be proportion of patients reporting day 8 improvement out of those with negative mycobacteriology (specificity). Second primary outcome will be day 29 incidence of a composite endpoint of either death or hospitalisation or missed tuberculosis diagnosis. To determine AMR impact we compare proportion of resistant nasopharyngealStreptococcus pneumoniaeisolates on day 29. 400 mycobacteriology-negative participants/arm will be required to detect a ≥10% absolute difference in diagnostic specificity with 80% power. We will estimate measures of effect by comparing outcomes in antibiotic arms (combined and individually) to standard-of-care.Ethics and disseminationThe study has been reviewed and approved by Malawi College of Medicine Research and Ethics Committee, London School of Hygiene & Tropical Medicine (LSHTM) Research Ethics Committee and Regional Committee for Health and Research Ethics – Norway, and Malawi Pharmacy, Medicines and Poisons Board. We will present abstracts at relevant conferences, and prepare a manuscript for publication in a peer-reviewed journal.Trial registration numberThe clinical trial is registered with ClinicalTrials.gov,NCT03545373

Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards

2020 ◽  
pp. medethics-2020-106757
Author(s):  
Vilma Lukaseviciene ◽  
Joerg Hasford ◽  
Dirk Lanzerath ◽  
Eugenijus Gefenas
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Negative Consequences ◽  
Ethics Review ◽  
Clinical Trial Directive ◽  
Favourable Environment ◽  
The Eu

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

scholarly journals Availability of post-trial access in clinical trials: a review of clinical trial protocols submitted to the research ethics board of the University of the Philippines Manila

2019 ◽  
Vol 35 (11) ◽  
pp. 1849-1855
Author(s):  
Edlyn B. Jimenez ◽  
Jessa Mae P. Virtudazo ◽  
Cristina E. Torres ◽  
Rosemarie dlC Bernabe
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
The Philippines ◽  
Trial Protocols ◽  
Research Ethics Board ◽  
Post Trial ◽  
The University

scholarly journals Comparison of COVID‐19 studies registered in the clinical trial platforms: A research ethics analysis perspective

2021 ◽  
Author(s):  
Banu Buruk ◽  
Muberra Devrim Guner ◽  
Perihan Elif Ekmekci ◽  
Aksuyek Savas Celebi
Keyword(s):  
Clinical Trial ◽  
Research Ethics

scholarly journals The ORVAC trial protocol: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032549 ◽  
Author(s):  
Bianca Fleur Middleton ◽  
Mark A Jones ◽  
Claire S Waddington ◽  
Margaret Danchin ◽  
Carly McCallum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Ethics ◽  
Ethics Committee ◽  
Northern Territory ◽  
Rotavirus Vaccine ◽  
Additional Dose ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Indigenous Children

IntroductionRotavirus vaccines were introduced into the Australian National Immunisation Program in 2007. Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life. We hypothesised that scheduling an additional (third) dose of oral human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to <12 months would improve protection against clinically significant all-cause gastroenteritis.Methods and analysisThis Bayesian adaptive clinical trial will investigate whether routinely scheduling an additional dose of Rotarix for Australian Indigenous children aged 6 to <12 months old confers significantly better protection against clinically important all-cause gastroenteritis than the current two-dose schedule at 2 and 4 months old. There are two coprimary endpoints: (1) seroconversion from baseline serum anti-rotavirus immunoglobulin A (IgA) titre <20 U/mL prior to an additional dose of Rotarix/placebo to serum anti-rotavirus IgA titre >20 U/mL following the administration of the additional dose of Rotarix/placebo and (2) time from randomisation to medical attendance (up to age 36 months old) for which the primary reason is acute gastroenteritis/diarrhoea. Secondary endpoints include the change in anti-rotavirus IgA log titre, time to hospitalisation for all-cause diarrhoea and for rotavirus-confirmed gastroenteritis/diarrhoea, and rotavirus notification. Analysis will be based on Bayesian inference with adaptive sample size.Ethics, registration and disseminationEthics approval has been granted by Central Australian Human Research Ethics Committee (HREC-16-426) and Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC-2016-2658). Study investigators will ensure the trial is conducted in accordance with the principles of the Declaration of Helsinki and with the ICH Guidelines for Good Clinical Practice. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication. The trial is registered with Clinicaltrials.gov (NCT02941107) and important modifications to this protocol will be updated.Trial registration numberNCT02941107; Pre-results.

scholarly journals Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017550
Author(s):  
Hang Ding ◽  
Rajiv Jayasena ◽  
Andrew Maiorana ◽  
Alison Dowling ◽  
Sheau Huey Chen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Research Ethics ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Care Programme ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Randomised Controlled

IntroductionChronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients’ compliance, and associated health and economic outcomes.Methods and analysisAn open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits.Ethics and disseminationThe clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees.Trial registration numberRegistered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640).

scholarly journals Packed Cell Transfusion and Feeding Tolerance in Well Preterm Infants: A Randomized Clinical Trial

2020 ◽  
Author(s):  
Mohammad Kazemian ◽  
Minoo Fallahi ◽  
Saeed Hojjat Kashani ◽  
Saleheh Tajalli ◽  
Naeeme Taslimi Taleghani
Keyword(s):  
Clinical Trial ◽  
Research Ethics ◽  
Preterm Infants ◽  
Gestational Age ◽  
Intervention Group ◽  
Ethics Committee ◽  
Research Ethics Committee ◽  
Significant Difference ◽  
Packed Cell Transfusion ◽  
Feeding Tolerance

Abstract Background: The correlation between necrotizing enteroculitis (NEC) and packed cell transfusion (PCT) has recently been identified. Based on some research, 25–35% of NEC has been linked to transfusion, we planned this study to determine, the association between PCT and feeding tolerance in well preterm newborns.Method: Our study was a clinical trial study in preterm infants admitted to NICU of Mofid Children's Hospital from April 2017 to May 2018.Seventy well premature babies with a birth weight of <1500 grams and gestational age <32 weeks with enteral feeding, who need PCT were enrolled. The eligible patients divided by simple randomization to two groups, in the intervention group (35 patients) the baby's breastfeeding withholding just during the time of PCT and continue as usual after that, but in control groups (35 patients) feeding of neonates is given as usual regardless of PCT. The feeding tolerance during the first 72 hours after transfusion was compared between the two groups. Sick neonates exclude from the study. Data analysis was performed in SPSS version 20.Results: The mean gestational age, birth weights, and postnatal age in the intervention group were 30.13 weeks, 1245.71grams, and 17 days respectively and in the control group were 29.97weeks, 1169.43grams and 15.46 days respectively without any statistically significant difference between them. Except for hemoglobin and hematocrit pre-transfusion, other characteristics of patients were similar. In the evaluation of feeding tolerance after transfusion during 24, 48 and 72 hours, 32(91.2%), 33(94.73%), 34(97.1%) of both groups, had feeding tolerance with no significant difference There were no statistically significant differences between neonates with and without the feeding tolerance in the patients of each group.Conclusion: Our research showed that in well preterm neonates with a good general condition, during PCT, withholding of feeding, isn’t necessary and continued breastfeeding seems to be safe.Trial registration: All ethical considerations of the study were approved by the institutional review board and the research ethics committee at Shahid Beheshti University of Medical Sciences, Tehran, Iran (IR. SBMU.RETECH.1395.1010) and granted ethical approval and the Iranian Registry of Clinical Trial code are IRCT20200419047136N1.Approved by Iranian Registry of Clinical TrialsTrial Id: 47347IRCT Id: IRCT20200419047136N1Registration date: 2020-05-04, 1399/02/15(The link directly for trial registration: https://en.irct.ir/trial/47347)Approved by Research Ethics Committee: IR. SBMU.RETECH.1395.1010

Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy

2019 ◽  
Vol 49 (4) ◽  
pp. 31-41 ◽  
Author(s):  
Alex John London ◽  
Jonathan Kimmelman
Keyword(s):  
Clinical Trial ◽  
Research Ethics ◽  
Drug Regulation ◽  
Human Research ◽  
Human Research Ethics
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