scholarly journals Part 2: Implementing Clinical Trials: A Review of the Attributes of Exemplary Clinical Trial Sites

2011 ◽  
Vol 7 (1) ◽  
pp. 61-64 ◽  
Author(s):  
Robin Zon ◽  
Gary Cohen ◽  
Dee Anna Smith ◽  
Allison R. Baer
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Assurance ◽  
Trial Process ◽  
Awareness Programs

Part two of this series focuses on the remaining three exemplary attributes: quality assurance, multidisciplinary involvement in the clinical trial process, and clinical trials awareness programs.

Transforming the clinical trial process: The I-SPY 2 trial as a model for improving the efficiency of clinical trials and accelerating the drug-screening process.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. TPS2633-TPS2633 ◽  
Author(s):  
Meredith B. Buxton ◽  
Kelsey Natsuhara ◽  
Angela DeMichele ◽  
Jane Perlmutter ◽  
Nola M Hylton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Screening ◽  
Screening Process ◽  
Trial Process

scholarly journals Guidance on the use of MRI for treatment planning in radiotherapy clinical trials

2020 ◽  
Vol 93 (1105) ◽  
pp. 20190161
Author(s):  
Robert I Johnstone ◽  
Teresa Guerrero-Urbano ◽  
Andriana Michaelidou ◽  
Tony Greener ◽  
Elizabeth Miles ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Assurance ◽  
Treatment Planning ◽  
Sufficient Information ◽  
Planning Systems ◽  
Imaging Guidance ◽  
Safety Issues ◽  
Treatment Planning Systems ◽  
Trial Protocols

The aim of this article is to propose meaningful guidance covering the technical and safety issues involved when designing or conducting radiotherapy clinical trials that use MRI for treatment planning. The complexity of imaging requirements will depend on the trial aims, design and MRI methods used. The use of MRI within the RT pathway is becoming more prevalent and clinically appropriate as access to MRI increases, treatment planning systems become more versatile and potential indications for MRI-planning in RT are documented. Novel MRI-planning opportunities are often initiated and validated within clinical trials. The guidance in this document is intended to assist researchers designing RT clinical trials involving MRI, so that they may provide sufficient information about the appropriate methods to be used for image acquisition, post-processing and quality assurance such that participating sites complete MRI to consistent standards. It has been produced in collaboration with the National Radiotherapy Trials Quality Assurance Group (RTTQA). As the use of MRI in RT is developed, it is highly recommended for researchers writing clinical trial protocols to include imaging guidance as part of their clinical trial documentation covering the trial-specific requirements for MRI procedures. Many of the considerations and recommendations in this guidance may well apply to MR-guided treatment machines, where clinical trials will be crucial. Similarly, many of these recommendations will apply to the general use of MRI in RT, outside of clinical trials. This document contains a large number of recommendations, not all of which will be relevant to any particular trial. Designers of RT clinical trials must therefore take this into account. They must also use their own judgement as to the appropriate compromise between accessibility of the trial and its technical rigour.

scholarly journals Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yorokpa Joachim Doua ◽  
Hanneke Dominicus ◽  
Julius Mugwagwa ◽  
Suzelle Magalie Gombe ◽  
Jude Nwokike
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Assurance ◽  
Clinical Trial Registries ◽  
Post Marketing ◽  
Major Clinical Trial

scholarly journals Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review

2020 ◽  
Author(s):  
James R Rogers ◽  
Junghwan Lee ◽  
Ziheng Zhou ◽  
Ying Kuen Cheung ◽  
George Hripcsak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Electronic Health Records ◽  
Scoping Review ◽  
Real World ◽  
Administrative Claims ◽  
Real World Data ◽  
Health Records ◽  
World Data ◽  
Trial Process

Abstract Objective Real-world data (RWD), defined as routinely collected healthcare data, can be a potential catalyst for addressing challenges faced in clinical trials. We performed a scoping review of database-specific RWD applications within clinical trial contexts, synthesizing prominent uses and themes. Materials and Methods Querying 3 biomedical literature databases, research articles using electronic health records, administrative claims databases, or clinical registries either within a clinical trial or in tandem with methodology related to clinical trials were included. Articles were required to use at least 1 US RWD source. All abstract screening, full-text screening, and data extraction was performed by 1 reviewer. Two reviewers independently verified all decisions. Results Of 2020 screened articles, 89 qualified: 59 articles used electronic health records, 29 used administrative claims, and 26 used registries. Our synthesis was driven by the general life cycle of a clinical trial, culminating into 3 major themes: trial process tasks (51 articles); dissemination strategies (6); and generalizability assessments (34). Despite a diverse set of diseases studied, <10% of trials using RWD for trial process tasks evaluated medications or procedures (5/51). All articles highlighted data-related challenges, such as missing values. Discussion Database-specific RWD have been occasionally leveraged for various clinical trial tasks. We observed underuse of RWD within conducted medication or procedure trials, though it is subject to the confounder of implicit report of RWD use. Conclusion Enhanced incorporation of RWD should be further explored for medication or procedure trials, including better understanding of how to handle related data quality issues to facilitate RWD use.

Barriers to clinical trial accrual in a community cancer clinic.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 91-91
Author(s):  
Cheruppolil R. Santhosh-Kumar
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Community Setting ◽  
Care Quality ◽  
Rural Setting ◽  
Trial Participation ◽  
Trial Process ◽  
Clinical Trial Accrual ◽  
Cancer Clinic

91 Background: The availability of and enrollment in clinical trials at an institution may be considered cancer care quality measures. Nationally, most cancer patients are initially diagnosed and treated in the community setting. Data regarding clinical trial accrual of new cancer patients from community-based cancer centers and the barriers they encounter are limited. We sought to identify potential barriers to enrollment in clinical trials at a community cancer clinic. Methods: Data on new cancer patients seen at our comprehensive community cancer clinic were prospectively collected from 2007 through 2010. Factors that potentially affected patient accrual in clinical studies were tracked. Results: During the four-year study period, a total of 662 patients were diagnosed with breast, prostate, colon, lung, gynecological, melanoma and renal cell cancers. No studies were available for 42% of the patients (n=278). Of the remaining patients, 49% (190/384) met protocol eligibility. Of the eligible study patients, 45% (85/190) enrolled, for an overall accrual rate of 13% (85/662), and 55% (105/190) declined participation. Patients declined to participate due to stress of diagnosis, refusal of treatment entirely, issues with randomization and placebo, concerns with side effects of the medications, delay of treatment while awaiting the clinical trial process, patient refusal, transportation concerns and length of treatment. Conclusions: This study demonstrates that above average clinical trial participation can be achieved in community cancer clinics in the rural setting. There are modifiable barriers to clinical trial accrual including study availability, patient eligibility and other patient factors. Improvement of patients’ perceptions and perspectives regarding the clinical trial process could be achieved through patient education. Elimination of barriers to trial accrual could be studied as a quality metric.

scholarly journals How health literacy can enhance the design and conduct of clinical trials from consent to conclusion

2020 ◽  
Vol 40 (1-2) ◽  
pp. 41-49
Author(s):  
Catina O’Leary ◽  
Chris Casey ◽  
Diane Webb ◽  
Deborah Collyar ◽  
Andrew Pleasant
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Health Literacy ◽  
Medical Care ◽  
Standard Medical Care ◽  
Literacy Activities ◽  
Trial Process ◽  
Primary Focus ◽  
Trial Participants ◽  
Literacy Research

Health literacy research and interventions have provided multiple tools to improve communication between professionals and patients in clinical contexts for many years. Despite the reality that many patients participate in clinical trials in conjunction with standard medical care, only recently have efforts extended to address and improve the health literacy of both clinical trial researchers and participants. To date, the primary focus of health literacy activities in clinical trials has centered on communicating trial results to trial participants. This report describes the opportunities and strategies necessary to layer health literacy activities across the clinical trial process from consent to conclusion.

scholarly journals Enrichment Design : Additional Screening Process

2019 ◽  
Vol 9 (4-s) ◽  
pp. 803-805
Author(s):  
Rada Santosh Kumar ◽  
K. Shambhavi
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Early Phase ◽  
Human Subject ◽  
Therapeutic Response ◽  
Target Population ◽  
Therapeutic Agents ◽  
Screening Process ◽  
Trial Process ◽  
Enrichment Design

Identification of a human subject into a study for a clinical trial involves screening and placebo run in periods. In some cases additional screening process is required as some therapeutic agents will be effective in patients with some disorders as they show changes in response. Hence, an additional screening process called Enrichment design is employed in the clinical trials which includes active treatments as it helps in easy identification of patients in whom test agents are found to be beneficial during early phase of trial. They also helps in identification of patients with better therapeutic response. Thus, this additional screening process restricts the target population into a very small selective group during the clinical trial making the trial process easier and effective.

scholarly journals Credentialing Proton Centers for Clinical Trials

2021 ◽  
Author(s):  
Paige A. Taylor
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Assurance ◽  
Patient Outcomes ◽  
Proton Therapy ◽  
Quality Data ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
High Quality ◽  
High Quality Data

This chapter will provide an overview of quality assurance processes to credential proton therapy centers for clinical trial participation. There are a number of credentialing audit steps, including independent output verification, anthropomorphic phantom audits, image guidance credentialing, knowledge assessments, and on-site dosimetry review. The purpose of these credentialing steps is to ensure consistency across proton centers participating in clinical trials, and well as comparability with photon centers for randomized trials. This uniformity ensures high quality data for measuring patient outcomes, which are pivotal at a time when proton therapy is being assessed for superior outcomes.

Planning the Size of Clinical Trials with Allowance for Patient Noncompliance

1990 ◽  
Vol 29 (03) ◽  
pp. 243-246 ◽  
Author(s):  
M. A. A. Moussa
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sample Size ◽  
Event Rate ◽  
Survival Functions ◽  
Time Intervals ◽  
Patient Noncompliance ◽  
Event Rates ◽  
Larger Sample

AbstractVarious approaches are considered for adjustment of clinical trial size for patient noncompliance. Such approaches either model the effect of noncompliance through comparison of two survival distributions or two simple proportions. Models that allow for variation of noncompliance and event rates between time intervals are also considered. The approach that models the noncompliance adjustment on the basis of survival functions is conservative and hence requires larger sample size. The model to be selected for noncompliance adjustment depends upon available estimates of noncompliance and event rate patterns.

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