1,222 results match your criteria Clinical Trials[Journal]


Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance.

Clin Trials 2019 Mar 13:1740774519832911. Epub 2019 Mar 13.

5 Health Sciences Institutional Review Boards, University of Wisconsin-Madison, Madison, WI, USA.

Background/aims: Obtaining ethical approval from multiple institutional review boards is a long-standing challenge to multi-site clinical trials and often leads to significant delays in study activation and enrollment. As of 25 January 2018, the National Institutes of Health began requiring use of a single institutional review board for US multi-site trials. To learn more and further inform the research and regulatory communities around aspects of transitioning to single institutional review board review, this study evaluated the efficiency, resource use, and user perceptions of a nascent institutional review board reliance model (Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance). Read More

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http://dx.doi.org/10.1177/1740774519832911DOI Listing

Improving pragmatic clinical trial design using real-world data.

Clin Trials 2019 Mar 13:1740774519833679. Epub 2019 Mar 13.

4 Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.

Background: Pragmatic clinical trials often use automated data sources such as electronic health records, claims, or registries to identify eligible individuals and collect outcome information. A specific advantage that this automated data collection often yields is having data on potential participants when design decisions are being made. We outline how this data can be used to inform trial design. Read More

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http://dx.doi.org/10.1177/1740774519833679DOI Listing
March 2019
1 Read

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration.

Clin Trials 2019 Feb 28:1740774519834257. Epub 2019 Feb 28.

1 Department of Clinical Pharmacology, Royal Adelaide Hospital, Adelaide, SA, Australia.

Aims/background: A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer's autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Read More

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http://dx.doi.org/10.1177/1740774519834257DOI Listing
February 2019

Use of telephone and web interfaces of interactive response technology at clinical investigator sites in clinical trials.

Clin Trials 2019 Feb 28:1740774519832329. Epub 2019 Feb 28.

1 Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, Formulation and Industrial Pharmacy Unit, University of Helsinki, Helsinki, Finland.

Background: Interactive response technologies are used in clinical trials to provide services such as automated randomization and medication logistics management. The objective of this article is to investigate the usage of telephone (Interactive Voice Response) and web (Interactive Web Response) interfaces of interactive response technologies at clinical investigator sites in clinical trials, to obtain information about the preferences of interactive response technology end users between the telephone and web interfaces, and to explore the relevance of the telephone interface in this setting.

Methods: The data consist of an online survey conducted in spring 2016 with clinical investigators, study nurses, and pharmacists in 13 countries. Read More

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http://dx.doi.org/10.1177/1740774519832329DOI Listing
February 2019

Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study.

Clin Trials 2019 Feb 19:1740774519829695. Epub 2019 Feb 19.

1 Duke University School of Medicine, Durham, NC, USA.

Background/aims: Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers. Read More

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http://dx.doi.org/10.1177/1740774519829695DOI Listing
February 2019
2 Reads

Exploring the roots of clinical trial methodology in medieval Islamic medicine.

Clin Trials 2019 Feb 19:1740774519830396. Epub 2019 Feb 19.

2 Nuclear Medicine Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

There is a dominant opinion in the Western sources of history of medicine that the roots of modern clinical trials and methodology of experimental medicine first started in the Renaissance. However, this opinion has been disputed with the thorough study of the rich medical literature of the medieval Islamic era. In the current review, the roots of clinical trial methodology have been traced back to the medieval Islamic tradition and the contribution of Islamic scholars in this field is discussed. Read More

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http://dx.doi.org/10.1177/1740774519830396DOI Listing
February 2019

A review of the impact of utilising electronic medical records for clinical research recruitment.

Clin Trials 2019 Feb 15:1740774519829709. Epub 2019 Feb 15.

1 School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.

Introduction:: Recruitment is an important aspect of clinical research, as poor recruitment could undermine the scientific value of a trial or delay the development process of new treatments. The development of electronic medical records provides a new way to identify potential participants for trials by matching the eligibility criteria with patients' data within electronic medical records.

Methods:: A literature search was performed to examine the effectiveness and efficiency of the electronic medical record recruitment method using MEDLINE, PubMed, PubMed Central, CINAHL Plus with Full Text, ScienceDirect and Cochrane Library databases. Read More

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http://dx.doi.org/10.1177/1740774519829709DOI Listing
February 2019

Defining treatment effects: A regulatory perspective.

Authors:
Thomas Permutt

Clin Trials 2019 Feb 14:1740774519830358. Epub 2019 Feb 14.

Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

The proposed addendum to the International Conference on Harmonization document, Statistical Principles for Clinical Trials, can be read in two ways. There is a new framework for talking about estimands, but is it about fitting present methods into the framework? Or is it about changing methods? My answer: some of each. Where different methods are needed, there are challenging problems in estimating some desirable estimands, but there may also be desirable estimands that can be estimated easily and robustly. Read More

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http://dx.doi.org/10.1177/1740774519830358DOI Listing
February 2019

Merged block randomisation: A novel randomisation procedure for small clinical trials.

Clin Trials 2019 Feb 14:1740774519827957. Epub 2019 Feb 14.

1 Medical Statistics, Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.

Background/aims:: Randomisation in small clinical trials is a delicate matter, due to the tension between the conflicting aims of balanced groups and unpredictable allocations. The commonly used method of permuted block randomisation has been heavily criticised for its high predictability. This article introduces merged block randomisation, a novel and conceptually simple restricted randomisation design for small clinical trials (less than 100 patients per stratum). Read More

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http://dx.doi.org/10.1177/1740774519827957DOI Listing
February 2019

Inference on covariate effect types for treatment effectiveness in a randomized trial with a binary outcome.

Authors:
Yasutaka Chiba

Clin Trials 2019 Feb 13:1740774519828301. Epub 2019 Feb 13.

Clinical Research Center, Kinki University Hospital, Osakasayama, Japan.

Background/aims: Some randomized clinical trials seek to establish covariate effect types that indicate whether a covariate is predictive and/or prognostic, in addition to endpoint evaluation. Here, for a case with a binary outcome, we propose that the covariate effect type should be assessed in terms of four types of potential responses: activated- (always-), inert- (never-), causative-, and preventive-responder.

Methods: We introduce a new concept of covariate effect types differing from the commonly used "prediction" and "prognosis. Read More

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http://dx.doi.org/10.1177/1740774519828301DOI Listing
February 2019
2 Reads

The design and conduct of Project RedDE: A cluster-randomized trial to reduce diagnostic errors in pediatric primary care.

Clin Trials 2019 Feb 5:1740774518820522. Epub 2019 Feb 5.

3 Department of Pediatrics, Albert Einstein College of Medicine and Children's Hospital at Montefiore, Bronx, NY, USA.

Background:: Diagnostic errors contribute to the large burden of healthcare-associated harm experienced by children. Primary care settings involve high diagnostic uncertainty and limited time and information, creating ideal conditions for diagnostic errors. We report on the design and conduct of Project RedDE, a stepped-wedge, cluster-randomized controlled trial of a virtual quality improvement collaborative aimed at reducing diagnostic errors in pediatric primary care. Read More

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http://dx.doi.org/10.1177/1740774518820522DOI Listing
February 2019
1 Read
1.925 Impact Factor

Investigational drug labeling variability.

Clin Trials 2019 Feb 3:1740774519828382. Epub 2019 Feb 3.

1 Unité de Recherche en Pratique Pharmaceutique, Centre Hospitalier Universitaire Sainte-Justine, Montréal, QC, Canada.

Background/aims: In comparison with commercial drugs, there are few regulations concerning the labeling of investigational drugs. This leads to variability in their content and layout. This increases the risk of errors during storage, validation, compounding, dispensing and administration. Read More

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http://dx.doi.org/10.1177/1740774519828382DOI Listing
February 2019
1 Read

Challenges and solutions in the design and execution of the PROSPECT Phase II/III neoadjuvant rectal cancer trial (NCCTG N1048/Alliance).

Clin Trials 2019 Jan 28:1740774518824539. Epub 2019 Jan 28.

8 Alliance Statistics and Data Center, Mayo Clinic Cancer Center, Rochester, MN, USA.

Background: More than half of the 40,000 incident rectal cancer patients in the United States each year are diagnosed at clinical stage II and III (locally advanced stage). For this group, high rates of cure can be achieved with the combination of pelvic radiation and sensitizing 5-fluorouracil (chemoradiation), surgery and chemotherapy, but treatment is long, arduous and toxicities are substantial. The PROSPECT trial (N1048, NCT01515787) was designed to determine whether neoadjuvant chemotherapy with 5-fluorouracil and oxaliplatin (FOLFOX) could be used as an alternative to neoadjuvant chemoradiation without compromising treatment outcomes and to spare these patients excess toxicity. Read More

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http://dx.doi.org/10.1177/1740774518824539DOI Listing
January 2019
5 Reads

Corrigendum.

Authors:

Clin Trials 2019 Jan 17:1740774518820489. Epub 2019 Jan 17.

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http://dx.doi.org/10.1177/1740774518820489DOI Listing
January 2019
1 Read

Assessing the impact of efficacy stopping rules on the error rates under the multi-arm multi-stage framework.

Clin Trials 2019 Jan 16:1740774518823551. Epub 2019 Jan 16.

1 MRC Clinical Trials Unit at UCL, London, UK.

Background: The multi-arm multi-stage framework uses intermediate outcomes to assess lack-of-benefit of research arms at interim stages in randomised trials with time-to-event outcomes. However, the design lacks formal methods to evaluate early evidence of overwhelming efficacy on the definitive outcome measure. We explore the operating characteristics of this extension to the multi-arm multi-stage design and how to control the pairwise and familywise type I error rate. Read More

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http://dx.doi.org/10.1177/1740774518823551DOI Listing
January 2019
2 Reads

Conducting clinical trials-costs, impacts, and the value of clinical trials networks: A scoping review.

Clin Trials 2019 Jan 10:1740774518820060. Epub 2019 Jan 10.

1 Department of Cancer Control Research, BC Cancer, Vancouver, BC, Canada.

Background: A significant barrier to conducting clinical trials is their high cost, which is driven primarily by the time and resources required to activate trials and reach accrual targets. The high cost of running trials has a substantial impact on their long-term feasibility and the type of clinical research undertaken.

Methods: A scoping review of the empirical literature on the costs associated with conducting clinical trials was undertaken for the years 2001-2015. Read More

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http://journals.sagepub.com/doi/10.1177/1740774518820060
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http://dx.doi.org/10.1177/1740774518820060DOI Listing
January 2019
2 Reads

Editorial: We may need large trials to find treatments for neurodegenerative diseases.

Clin Trials 2019 Jan 10:1740774518820814. Epub 2019 Jan 10.

2 Miller School of Medicine, University of Miami, Miami, USA.

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http://dx.doi.org/10.1177/1740774518820814DOI Listing
January 2019
1 Read

Making the case for completion bonuses in clinical trials.

Clin Trials 2018 Dec 20:1740774518820503. Epub 2018 Dec 20.

Department of Medical Ethics and Health Policy, Perelman School of Medicine, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.

Attrition is a serious problem in many clinical trials. The practice of offering completion bonuses-financial incentives offered to participants on the condition that they remain in a trial until they reach a prespecified study endpoint-is one means of addressing attrition. Despite their practical appeal, however, completion bonuses remain ethically controversial due to concern that they will coerce or unduly influence participants to not exercise their right to withdraw from a trial. Read More

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http://dx.doi.org/10.1177/1740774518820503DOI Listing
December 2018
1 Read

Response to Chappell.

Authors:
Andrew J Vickers

Clin Trials 2018 Dec 19:1740774518820530. Epub 2018 Dec 19.

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http://dx.doi.org/10.1177/1740774518820530DOI Listing
December 2018
1 Read

Variance prior specification for a basket trial design using Bayesian hierarchical modeling.

Clin Trials 2018 Dec 7:1740774518812779. Epub 2018 Dec 7.

Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Background:: In the era of targeted therapies, clinical trials in oncology are rapidly evolving, wherein patients from multiple diseases are now enrolled and treated according to their genomic mutation(s). In such trials, known as basket trials, the different disease cohorts form the different baskets for inference. Several approaches have been proposed in the literature to efficiently use information from all baskets while simultaneously screening to find individual baskets where the drug works. Read More

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http://dx.doi.org/10.1177/1740774518812779DOI Listing
December 2018
21 Reads

Commentary on Hay et al.: Can clinical trials data collection be improved by administrative data elements?

Clin Trials 2019 Feb 22;16(1):18-19. Epub 2018 Nov 22.

2 University of Montreal Hospital Research Centre (CRCHUM), Montreal, QC, Canada.

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http://dx.doi.org/10.1177/1740774518815648DOI Listing
February 2019
1 Read

Pilot study of the ability to probabilistically link clinical trial patients to administrative data and determine long-term outcomes.

Clin Trials 2019 Feb 22;16(1):14-17. Epub 2018 Nov 22.

2 Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.

Background: Clinical trials are important but extremely costly. Utilization of routinely collected administrative data may simplify and enhance clinical trial data collection.

Purpose: The aim of this study was to test the feasibility of use of administrative databases in Ontario, Canada, for long-term clinical trial follow-up, specifically (a) to determine whether limited patient identifiers held by the Canadian Cancer Trials Group can be used to probabilistically link with individuals in the Institute for Clinical Evaluative Sciences databases and if so, (b) the level of concordance between the two data sets. Read More

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http://dx.doi.org/10.1177/1740774518815653DOI Listing
February 2019
2 Reads

Automated safety event monitoring using electronic medical records in a clinical trial setting: Validation study using the VA NEPHRON-D trial.

Clin Trials 2019 Feb 16;16(1):81-89. Epub 2018 Nov 16.

1 Cooperative Studies Program Coordinating Center (CSPCC), VA Connecticut Healthcare System, West Haven, CT, USA.

Background/aims:: Electronic medical records are now frequently used for capturing patient-level data in clinical trials. Within the Veterans Affairs health care system, electronic medical record data have been widely used in clinical trials to assess eligibility, facilitate referrals for recruitment, and conduct follow-up and safety monitoring. Despite the potential for increased efficiency in using electronic medical records to capture safety data via a centralized algorithm, it is important to evaluate the integrity and accuracy of electronic medical record-captured data. Read More

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http://dx.doi.org/10.1177/1740774518813121DOI Listing
February 2019
3 Reads

FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.

Clin Trials 2019 Feb 16;16(1):90-97. Epub 2018 Nov 16.

1 Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.

Background:: The US Food and Drug Administration's Sentinel Initiative is well positioned to support pragmatic clinical trials. FDA-Catalyst combines direct contact with health plan members and/or providers with data in the Sentinel infrastructure. Here, we describe the rationale, feasibility analyses, and lessons learned from the planning phase of the first large pragmatic trial conducted using the Sentinel Initiative's delivery system capabilities-IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (the IMPACT-AFib trial). Read More

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http://dx.doi.org/10.1177/1740774518812776DOI Listing
February 2019
11 Reads
1.925 Impact Factor

Beware of on-treatment safety analyses.

Clin Trials 2019 Feb 16;16(1):63-70. Epub 2018 Nov 16.

3 University of Michigan, Ann Arbor, MI, USA.

Introduction:: Assessing safety is important to evaluating new medications. In many randomized clinical trials, assessment of safety relies on so-called on-treatment analysis, where data on adverse events are collected only while the participant is taking study medication and perhaps for a few (7, 14, or 30) days after stopping. This article discusses the consequence of such failure to use intent-to-treat analyses in assessing safety. Read More

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http://journals.sagepub.com/doi/10.1177/1740774518812774
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http://dx.doi.org/10.1177/1740774518812774DOI Listing
February 2019
18 Reads

Strategic inclusion of regions in multiregional clinical trials.

Clin Trials 2019 Feb 16;16(1):98-105. Epub 2018 Nov 16.

1 Department of Health, Social and Clinical Pharmacy, College of Pharmacy, Chung-Ang University, Seoul, Korea.

Background: With the recent publication of the International Conference on Harmonisation E17 guideline and major reforms in China underway, the platform for clinical trial conduct is expected to change. This study aims to assess the strategic inclusion of regions in clinical trials and its change in trends over the past decade.

Methods: The ClinicalTrials. Read More

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http://dx.doi.org/10.1177/1740774518813573DOI Listing
February 2019
18 Reads

Conditional estimation and inference to address observed covariate imbalance in randomized clinical trials.

Clin Trials 2018 Nov 16:1740774518813120. Epub 2018 Nov 16.

3 Division of Cancer Prevention, National Cancer Institute, Rockville, MD, USA.

Background: Baseline covariate imbalance (between treatment groups) is a common problem in randomized clinical trials which often raises questions about the validity of trial results. Answering these questions requires careful consideration of the statistical implications of covariate imbalance. The possibil ity of having covariate imbalance contributes to the marginal variance of an unadjusted treatment difference estimator, which can be reduced by making appropriate adjustments. Read More

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http://dx.doi.org/10.1177/1740774518813120DOI Listing
November 2018
7 Reads

The development of an end-to-end service solution to support lupus patients and improve their experience in clinical trials.

Clin Trials 2019 Feb 14;16(1):71-80. Epub 2018 Nov 14.

2 UCB Pharma, Brussels, Belgium.

Objective: To develop an end-to-end clinical trial service to improve patient experience during trials, reduce the burden of participating in a trial, and increase trial retention.

Methods: A literature search and stakeholder interviews were used to identify current challenges and unmet needs of systemic lupus erythematosus patients and other systemic lupus erythematosus clinical trial stakeholders. The results from the literature search and interviews were used to create a five-phase map describing the current clinical trial experience of all stakeholders. Read More

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http://dx.doi.org/10.1177/1740774518811111DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6364094PMC
February 2019
11 Reads

Developing a risk-based composite neurologic outcome for a trial of hydroxyurea in young children with sickle cell disease.

Clin Trials 2019 Feb 14;16(1):20-31. Epub 2018 Nov 14.

9 Division of Health Sciences Informatics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Background: Studies of interventions to prevent the many neurological complications of sickle cell disease must take into account multiple outcomes of variable severity, with limited sample size. The goals of the studies presented were to use investigator preferences across outcomes to determine an attitude-based weighting of relevant clinical outcomes and to establish a valid composite outcome for a clinical trial.

Methods: In Study 1, investigators were surveyed about their practice regarding hydroxyurea therapy and opinions about outcomes for the "Hydroxyurea to Prevent the Central Nervous System Complications of Sickle Cell Disease Trial" (HU Prevent), and their minimally acceptable relative risk reduction for the two outcome components, motor and neurocognitive deficits. Read More

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http://dx.doi.org/10.1177/1740774518807160DOI Listing
February 2019
4 Reads

The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network-initiated clinical trials.

Clin Trials 2019 Feb 24;16(1):3-10. Epub 2018 Oct 24.

3 Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.

Background/aims:: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network.

Methods:: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Read More

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http://dx.doi.org/10.1177/1740774518807888DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6384136PMC
February 2019
2 Reads

Generalizing the per-protocol treatment effect: The case of ACTG A5095.

Clin Trials 2019 Feb 17;16(1):52-62. Epub 2018 Oct 17.

1 Department of Epidemiology, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: Intention-to-treat comparisons of randomized trials provide asymptotically consistent estimators of the effect of treatment assignment, without regard to compliance. However, decision makers often wish to know the effect of a per-protocol comparison. Moreover, decision makers may also wish to know the effect of treatment assignment or treatment protocol in a user-specified target population other than the sample in which the trial was fielded. Read More

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http://journals.sagepub.com/doi/10.1177/1740774518806311
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http://dx.doi.org/10.1177/1740774518806311DOI Listing
February 2019
11 Reads

Comment on Vickers et al.

Authors:
Rick Chappell

Clin Trials 2018 Oct 13:1740774518806868. Epub 2018 Oct 13.

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http://dx.doi.org/10.1177/1740774518806868DOI Listing
October 2018
1 Read

Shift models for dose-finding in partially ordered groups.

Clin Trials 2019 Feb 11;16(1):32-40. Epub 2018 Oct 11.

Division of Translational Research & Applied Statistics, Department of Public Health Sciences, The University of Virginia Health System, Charlottesville, VA, USA.

Background: Limited options are available for dose-finding clinical trials requiring group-specific dose selection. While conducting parallel trials for groups is an accessible approach to group-specific dose selection, this approach allows for maximum tolerated dose selection that does not align with clinically meaningful group order information.

Methods: The two-stage continual reassessment method is developed for dose-finding in studies involving three or more groups where group frailty order is known between some but not all groups, creating a partial order. Read More

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http://dx.doi.org/10.1177/1740774518801599DOI Listing
February 2019
1 Read

A readily available improvement over method of moments for intra-cluster correlation estimation in the context of cluster randomized trials and fitting a GEE-type marginal model for binary outcomes.

Clin Trials 2019 Feb 8;16(1):41-51. Epub 2018 Oct 8.

Department of Biostatistics, College of Public Health, University of Kentucky, Lexington, KY, USA.

Background/aims: Cluster randomized trials are popular in health-related research due to the need or desire to randomize clusters of subjects to different trial arms as opposed to randomizing each subject individually. As outcomes from subjects within the same cluster tend to be more alike than outcomes from subjects within other clusters, an exchangeable correlation arises that is measured via the intra-cluster correlation coefficient. Intra-cluster correlation coefficient estimation is especially important due to the increasing awareness of the need to publish such values from studies in order to help guide the design of future cluster randomized trials. Read More

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http://journals.sagepub.com/doi/10.1177/1740774518803635
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http://dx.doi.org/10.1177/1740774518803635DOI Listing
February 2019
3 Reads

Developing informed consent materials for non-English-speaking participants: An analysis of four professional firm translations from English to Spanish.

Clin Trials 2018 Dec 8;15(6):557-566. Epub 2018 Oct 8.

1 Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, TN, USA.

Background/aims:: An increasing body of research is being conducted with non-English-speaking subjects. Study-related materials, including those essential for obtaining informed consent, must often be translated from English into other languages. In this study, we sought to examine the types of issues that may arise when consent materials are translated from English to Spanish. Read More

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http://dx.doi.org/10.1177/1740774518801591DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218315PMC
December 2018
1 Read

What gives them the right? Legal privilege and waivers of consent for research.

Clin Trials 2018 Dec 3;15(6):579-586. Epub 2018 Oct 3.

1 Department of Medical Ethics & Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Waivers of informed consent for research participation are permitted in the United States under the Common Rule, the Health Insurance Portability and Accountability Act regulations, and the US Food and Drug Administration's Exception from Informed Consent rule for emergency research. We assess the novel question regarding what legal right researchers have to carry out research procedures on or about another person, be it experimental medical intervention, psychological or social manipulation, or invasion of privacy, without the permission of their subjects. Our analysis frames waivers of consent as a species of presumed consent, and we address the underlying empirical question of whether it is reasonable to believe that subjects from whom no consent is sought would in fact agree, if asked. Read More

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http://dx.doi.org/10.1177/1740774518803122DOI Listing
December 2018
1 Read

Understanding preferences regarding consent for pragmatic trials in acute care.

Clin Trials 2018 Dec 3;15(6):567-578. Epub 2018 Oct 3.

2 Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.

Background: There has been debate about the role of consent in pragmatic trials comparing qualitatively similar interventions. Consent preferences may differ in acute care contexts, given severe illness, time constraints, and other barriers to consent. In addition, studies have not assessed the impact of disclosing financial considerations as a justification for trials. Read More

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http://journals.sagepub.com/doi/10.1177/1740774518801007
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http://dx.doi.org/10.1177/1740774518801007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218277PMC
December 2018
3 Reads

Global pharmacovigilance regulations: Call for re-harmonization.

Clin Trials 2018 Dec 29;15(6):631-632. Epub 2018 Sep 29.

3 Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, USA.

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http://dx.doi.org/10.1177/1740774518801592DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6236640PMC
December 2018
1 Read
1.925 Impact Factor

Effect of two different participant information sheets on recruitment to a falls trial: An embedded randomised recruitment trial.

Clin Trials 2018 Dec 27;15(6):551-556. Epub 2018 Sep 27.

5 NHS Fife, Kirkcaldy, UK.

Background/aims: Recruitment to trials of intervention for older people who fall is challenging. Evidence suggests that the word falls has negative connotations for older people, and this may present a barrier to engaging with trials in this area. We therefore tested whether a participant information sheet that minimised reference to falls could improve recruitment rates. Read More

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http://dx.doi.org/10.1177/1740774518803558DOI Listing
December 2018
1 Read

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials.

Clin Trials 2018 Dec 19;15(6):616-623. Epub 2018 Sep 19.

1 Genentech, South San Francisco, CA, USA.

As new cancer treatment regimens demonstrate increased potential to improve patients' survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment's tolerability. Read More

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http://dx.doi.org/10.1177/1740774518799985DOI Listing
December 2018
8 Reads

Beyond p-values: A phase II dual-criterion design with statistical significance and clinical relevance.

Clin Trials 2018 Oct;15(5):452-461

2 Novartis Pharma AG, Basel, Switzerland.

Background Well-designed phase II trials must have acceptable error rates relative to a pre-specified success criterion, usually a statistically significant p-value. Such standard designs may not always suffice from a clinical perspective because clinical relevance may call for more. For example, proof-of-concept in phase II often requires not only statistical significance but also a sufficiently large effect estimate. Read More

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http://dx.doi.org/10.1177/1740774518770661DOI Listing
October 2018
1 Read

Development of an online resource for recruitment research in clinical trials to organise and map current literature.

Clin Trials 2018 Dec 31;15(6):533-542. Epub 2018 Aug 31.

1 North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.

Background: Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological priority. While there is growing research around recruitment, navigating this literature to support an evidence-based approach remains difficult. The Online resource for Recruitment Research in Clinical triAls project aims to create an online searchable database of recruitment research to improve access to existing evidence and to identify gaps for future research. Read More

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http://dx.doi.org/10.1177/1740774518796156DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6236587PMC
December 2018
11 Reads
1.925 Impact Factor

Contingency management intervention targeting co-addiction of alcohol and drugs among American Indian adults: Design, methodology, and baseline data.

Clin Trials 2018 Dec 29;15(6):587-599. Epub 2018 Aug 29.

2 Program of Excellence in Addictions Research (PEAR), Washington State University, Spokane, WA, USA.

Background/aims: American Indian adults have some of the highest alcohol abstinence rates compared to the overall US population. Despite this, many American Indian people are more likely to concurrently use alcohol and illicit drugs and are less likely to participate and remain in outpatient treatment for alcohol and other drug use compared to the general US population. There is limited knowledge about effective interventions targeting alcohol and drug co-addiction among American Indian adults. Read More

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http://dx.doi.org/10.1177/1740774518796151DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218308PMC
December 2018
7 Reads

Moving forward toward standardizing analysis of quality of life data in randomized cancer clinical trials.

Clin Trials 2018 Dec 24;15(6):624-630. Epub 2018 Aug 24.

1 Quality of Life Department, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.

Background: There is currently a lack of consensus on how health-related quality of life and other patient-reported outcome measures in cancer randomized clinical trials are analyzed and interpreted. This makes it difficult to compare results across randomized controlled trials (RCTs) synthesize scientific research, and use that evidence to inform product labeling, clinical guidelines, and health policy. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials (SISAQOL) Consortium aims to develop guidelines and recommendations to standardize analyses of patient-reported outcome data in cancer RCTs. Read More

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http://dx.doi.org/10.1177/1740774518795637DOI Listing
December 2018
13 Reads

Triggered or routine site monitoring visits for randomised controlled trials: results of TEMPER, a prospective, matched-pair study.

Clin Trials 2018 Dec 22;15(6):600-609. Epub 2018 Aug 22.

MRC Clinical Trials Unit at UCL, University College London, London, UK.

Background/aims: In multi-site clinical trials, where trial data and conduct are scrutinised centrally with pre-specified triggers for visits to sites, targeted monitoring may be an efficient way to prioritise on-site monitoring. This approach is widely used in academic trials, but has never been formally evaluated.

Methods: TEMPER assessed the ability of targeted monitoring, as used in three ongoing phase III randomised multi-site oncology trials, to distinguish sites at which higher and lower rates of protocol and/or Good Clinical Practice violations would be found during site visits. Read More

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http://dx.doi.org/10.1177/1740774518793379DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6236642PMC
December 2018
25 Reads

Abstracts from the SCT 39th Annual Meeting (2018).

Authors:

Clin Trials 2018 Aug;15(2_suppl):S35-S192

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http://dx.doi.org/10.1177/1740774518790846DOI Listing
August 2018
3 Reads

Revisiting isotonic phase I design in the era of model-assisted dose-finding.

Clin Trials 2018 Oct 13;15(5):524-529. Epub 2018 Aug 13.

Division of Translational Research & Applied Statistics, Public Health Sciences, University of Virginia, Charlottesville, VA, USA.

Background/aims In the conduct of phase I trials, the limited use of innovative model-based designs in practice has led to an introduction of a class of "model-assisted" designs with the aim of effectively balancing the trade-off between design simplicity and performance. Prior to the recent surge of these designs, methods that allocated patients to doses based on isotonic toxicity probability estimates were proposed. Like model-assisted methods, isotonic designs allow investigators to avoid difficulties associated with pre-trial parametric specifications of model-based designs. Read More

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http://dx.doi.org/10.1177/1740774518792258DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6133737PMC
October 2018
1 Read

Recruitment and retention of the Hardest-to-Reach families in community-based asthma interventions.

Clin Trials 2018 Dec 13;15(6):543-550. Epub 2018 Aug 13.

1 Department of Pediatrics, School of Medicine & Dentistry, University of Rochester, Rochester, NY, USA.

Background/aims: Engaging underserved populations in research requires substantial effort for recruitment and retention. The objective of this study is to describe the effort needed to recruit and retain urban participants in pediatric asthma studies and to characterize the Hardest-to-Reach group by demographics and asthma severity.

Methods: We included 311 children (3-10 years) with persistent asthma enrolled in two school-based asthma interventions in Rochester, NY. Read More

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http://dx.doi.org/10.1177/1740774518793598DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218290PMC
December 2018
2 Reads