scholarly journals Randomization of Clinical Trial Participants via an Integrated Web Service

2021 ◽  
Author(s):  
Panos Bonotis ◽  
Achilleas Chytas ◽  
Giorgos Zacharioudakis ◽  
Christina Karamanidou ◽  
Lefteris Koumakis ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Web Service ◽  
Randomized Clinical Trials ◽  
Block Size ◽  
Study Groups ◽  
It Systems ◽  
Block Permutation ◽  
And Control ◽  
Trial Participants ◽  
Inherent Part

Randomization is an inherent part of Randomized Clinical Trials (RCTs), typically requiring the split of participants in intervention and control groups. We present a web service supporting randomized patient distribution, developed in the context of the MyPal project RCT. The randomization process is based on a block permutation approach to mitigate the risk of various kind of biases. The presented service can be used via its web user interface to produce randomized lists of patients distributed in the various study groups, with a variant block size. Alternatively, the presented service can be integrated as part of wider IT systems supporting clinical trials via a REST interface following a micro-service architectural pattern.

scholarly journals Guidelines on how to assess the validity of results presented in subgroup analysis of clinical trials

2002 ◽  
Vol 57 (2) ◽  
pp. 83-88 ◽  
Author(s):  
Edson Duarte Moreira ◽  
Ezra Susser
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Subgroup Analysis ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Usual Method ◽  
Validity Of Results ◽  
Results Of Treatment ◽  
Trial Participants

In observational studies, identification of associations within particular subgroups is the usual method of investigation. As an exploratory method, it is the bread and butter of epidemiological research. Nearly everything that has been learned in epidemiology has been derived from the analysis of subgroups. In a randomized clinical trial, the entire purpose is the comparison of the test subjects and the controls, and when there is particular interest in the results of treatment in a certain section of trial participants, a subgroup analysis is performed. These subgroups are examined to see if they are liable to a greater benefit or risk from treatment. Thus, analyzing patient subsets is a natural part of the process of improving therapeutic knowledge through clinical trials. Nevertheless, the reliability of subgroup analysis can often be poor because of problems of multiplicity and limitations in the numbers of patients studied. The naive interpretation of the results of such examinations is a cause of great confusion in the therapeutic literature. We emphasize the need for readers to be aware that inferences based on comparisons between subgroups in randomized clinical trials should be approached more cautiously than those based on the main comparison. That is, subgroup analysis results derived from a sound clinical trial are not necessarily valid; one must not jump to conclusions and accept the validity of subgroup analysis results without an appropriate judgment.

Conversion to resectability in unresectable metastatic colorectal cancer chemotherapy (mCRC) trials.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 641-641
Author(s):  
Sarah Chrabaszcz ◽  
Rahul Rajeev ◽  
Brittany Klooster ◽  
Ashley Chinn ◽  
T. Clark Gamblin ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Survival Benefit ◽  
Randomized Clinical Trials ◽  
Study Groups ◽  
Dose Effect ◽  
Entire Cohort ◽  
Multiple Observations ◽  
Survival Difference ◽  
Overall Survival Benefit

641 Background: Patients with mCRC undergoing surgical metastasectomy have been shown to derive significant survival benefit with a potential for cure. We hypothesized that conversion to resectability (c2r) is correlated with increased overall survival in patients with unresectable mCRC. Methods: Prospectively registered systematic review (PROSPERO CRD42015024104) was utilized to identify randomized clinical trials published after 2003. Exposure of interest was c2r from unresectable disease, while the outcome was overall survival (OS). Clinical trials were classified into three groups based on difference in c2r between the two study groups ( < 2, 2-2.9, ≥ 3 %). Generalized estimating equations(GEE) were used to measure associations while adjusting for multiple observations from the same trial. The Cochrane risk of bias tool was used to evaluate the methodological quality. Results: Out of 2,902 studies reviewed, 30 satisfied selection criteria (n = 13,618 patients). All studies had two arms only (100%). Median c2r was 7.3% (Interquartile Range 5%-12.9%), with maximum c2r in FOLFOX/FOLFIRI+ cetuximab arm (28.6%). The median difference in c2r between two arms of the same study was 2.3% (IQR 1.3 – 3.4%) and the maximum difference was 15.4% seen in FOLFOX/FOLFIRI+ cetuximab vs. FOLFOX/FOLFIRI (Ye, 2013). Median OS for the entire cohort of patients was 20.7 months (IQR 18.9 – 22.7 months), with a between group difference of 1.3 (IQR -1.2 – 3.6 months). The maximum survival benefit between two study arms was 9.9 months. Median survival difference between the two study arms with a minimal c2r difference ( < 2%) was 0.8 months, as compared to 1.6 months with higher c2r ( ≥ 3%). Incremental dose effect response was noted with an increasing c2r leading to improved overall survival in regression models (p = 0.021, r2= 0.16). Higher response rates also correlated with higher c2r rates (p = 0.003, r2= 0.25). Conclusions: Conversion to resectability is positively correlated with an improvement in survival in trials examining therapies for unresectable mCRC. Patient level data examining the contribution of metastasectomy to the overall survival benefit of systemic chemotherapy needs to be further examined.

ITP in the 21st Century

Hematology ◽  
2006 ◽  
Vol 2006 (1) ◽  
pp. 402-407 ◽  
Author(s):  
Diana S. Beardsley
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Case Series ◽  
The Elderly ◽  
Study Groups ◽  
Therapeutic Modalities ◽  
New Information ◽  
Scientific Results ◽  
Anti Cd20 ◽  
Based Medicine

Abstract Immune (or idiopathic) thrombocytopenic purpura (ITP) is commonly encountered by the practicing hematologist. Clinical management decisions have traditionally been guided by individual training and past experience. Input from the literature has been more from observational reports of case series than from scientific results of hypothesis-driven research. Practice guidelines and several surveys of clinical hematology practice have highlighted important questions in the field, and in the past 5 to 10 years both clinical and laboratory investigations have produced valuable new information. Thrombopoietin levels are normal or only slightly increased in ITP, and stimulation of thrombopoiesis appears to be a promising new therapeutic approach in clinical trials. Chronic, refractory ITP in children or adults remains a challenge for the hematologist. It is this group that has the greatest risk of serious bleeding, particularly among the elderly. The anti-B–cell monoclonal antibody, anti-CD20, has shown benefit in phase I/II clinical trials in patients who had failed a number of previous therapeutic modalities. The standard for clinical research into therapy for ITP has become evidence-based medicine, and more prospective, randomized clinical trials are being completed by multi-institutional study groups.

scholarly journals The Influence of Organizational Climate on the Enrollment of People of Color Into Clinical Trials

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 333-333
Author(s):  
Marcela Blinka ◽  
Karlynn BrintzenhofeSzoc ◽  
James Zabora
Keyword(s):  
Clinical Trial ◽  
Cancer Research ◽  
Clinical Trials ◽  
Organizational Climate ◽  
Randomized Clinical Trials ◽  
Research Management ◽  
People Of Color ◽  
Comprehensive Cancer Center ◽  
Significant Difference ◽  
Trial Participants

Abstract A significant need exists to improve enrollment of people-of-color (POC) in randomized clinical trials as the gold standard for evaluating new therapies so that health disparities can be reduced. Improving representation in clinical trials is expected to improve the applicability of clinical findings more broadly, especially for minority subgroups. This cross-sectional study assessed the perception of organizational climate (OC) among staff in five cancer research groups (CRGs) of a mid-Atlantic NCI-designated comprehensive cancer center. The Organizational Climate Measure (OCM), a measure of four OC models of the Competing Values Framework, was used. Enrollment data were obtained from the 2016 Cancer Research Management System data and 2017 enrollment rates. A statistically significant difference in mean scores was found in the Pressure to Produce Scale (F = 4.21, p &lt; .05). One CRG’s staff reported lower pressure to meet targets than three other CRGs (p &lt; .05) and trending towards significance for the fourth CRG (p &lt; .08). This suggests that organizational priorities considering all patients as potential clinical trial participants increases accrual. A statistically significant negative relationship between the Outward Focus sub-scale and POC enrollment (r = -.228, p &lt; .05) was also found, suggesting that an external organizational focus, alone, is insufficient to increase POC accrual. Implications for future research include 1) does the organizational priority of decreasing the pressure to produce influence accrual of POC? and 2) does an OC that is flexible and externally focused lead to a more effective means of accruing POC as clinical trial participants?

Infections in cancer patients treated with immune checkpoint inhibitors: Data from randomized trials.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2637-2637
Author(s):  
Cinzia Solinas ◽  
Anna Maria Morelli ◽  
Andrea Luciani ◽  
Antonio Ghidini ◽  
Fausto Petrelli
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Solid Tumors ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Randomized Trials ◽  
Randomized Clinical Trials ◽  
Checkpoint Inhibitors ◽  
Cochrane Library ◽  
And Control

2637 Background: Febrile neutropenia and infections are well studied complications of chemotherapy (CT) and some targeted agents employed in oncology. Less is known about the risk of infection associated with the use of immune checkpoint inhibitors (ICIs) in cancer patients. The present systematic review and meta-analysis was performed to address this question in patients diagnosed with solid tumors enrolled in randomized trials employing ICIs as experimental treatment. Methods: The Cochrane Library, EMBASE, and Pubmed databases were searched from inception through December 1st, 2020. Randomized clinical trials comparing any ICI alone, with CT, or with other agents vs CT, placebo, or other agents in patients with solid tumors were included. Two independent reviewers used a standardized data extraction and quality assessment form. Discordant cases were discussed with a third independent investigator. The following information was extracted: baseline study characteristics, including the primary tumor, author, year of publication, type of trial, type of disease, and the type of therapy (experimental and control arms); and the incidence of any-grade (grades [G] 1–5), low-grade (G1–2), and high-grade (G3–4), fatal event (G5) infections, and type of event. Random or fixed-effect models were used according to the statistical heterogeneity. Results: 36 randomized clinical trials were deemed eligible. The total population reached 21451 patients. In the pooled analysis, the use of ICIs was associated with a similar risk of all-grade infections (relative risk, RR = 1.02; 95% CI 0.84–1.24; P = 0.85) compared to non-ICI treatments (G1-5 events: 9.6 vs. 8.3%). When the ICIs alone arms were compared to CT, the experimental arms were associated with a 42% less risk of all-grade infections (RR = 0.58, 95% CI 0.4–0.85; P = 0.01; N = 18 studies). Compared to CT, the combination of ICIs and CT increased the risk of all-grade infections (RR = 1.37, 95% CI 1.23–1.53; P < 0.01; N = 13 studies) and severe infections (RR = 1.52, 95% CI 1.17–1.96; P < 0.01; N = 12 studies). Fatal infections were similar in the experimental and control arms (0.5%). Conclusions: In patients with advanced solid tumors, when ICIs were administered with CT, the risk of all-grade and G3-5 infections was significantly increased. Compared to CT alone, ICIs were safer and their use should be recommended for frail patients. Further studies are required to identify high-risk patients and evaluate the need for CT dose reduction or prophylactic myeloid growth factors use.

The Effects of Qigong for Adults with Chronic Pain: Systematic Review and Meta-Analysis

2015 ◽  
Vol 43 (08) ◽  
pp. 1525-1539 ◽  
Author(s):  
Zhenggang Bai ◽  
Zhen Guan ◽  
Yuan Fan ◽  
Chuan Liu ◽  
Kehu Yang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Waiting List ◽  
Significant Difference ◽  
And Control ◽  
General Care

A systematic review was conducted to evaluate the effectiveness of qigong as a treatment for chronic pain. Five electronic databases were searched from their date of establishment until July 2014. The review included 10 randomized clinical trials (RCTs) that compared the impacts of qigong on chronic pain with waiting list or placebo or general care. Random effect models and standard mean differences were used to present pain scores. A total of 10 RCTs met inclusion criteria. There was a statistically significant difference on reducing chronic pain between internal qigong and control (SMD: [Formula: see text]1.23 95% [Formula: see text], [Formula: see text]), external qigong and general care (SMD: [Formula: see text]1.53 95% [Formula: see text]), external qigong and placebo (SMD: [Formula: see text]0.51 95% [Formula: see text]), and internal qigong for chronic neck pain at 6 months (SMD: [Formula: see text]1.00 95% [Formula: see text]). The differences between external qigong and control, external qigong and waiting list, internal qigong and waiting list, and external for premenstrual syndromes were not significant. This study showed that internal qigong generated benefits on treating some chronic pain with significant differences. External qigong showed nonsignificant differences in treating chronic pain. Higher quality randomized clinical trials with scientific rigor are needed to establish the effectiveness of qigong in reducing chronic pain.

Accrual of Patients to Randomized Clinical Trials: Factors Affecting Cancer Prevention and Control Research

1994 ◽  
Vol 10 (3) ◽  
pp. 506-516 ◽  
Author(s):  
Arnold D. Kaluzny ◽  
Linda M. Lacey ◽  
Richard Warnecke ◽  
Joseph P. Morrissey ◽  
Edward J. Sondik ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Prevention ◽  
Clinical Judgment ◽  
Prevention And Control ◽  
Randomized Clinical Trials ◽  
Cancer Control ◽  
Cancer Prevention And Control ◽  
Factors Affecting ◽  
Control Research ◽  
And Control

AbstractClinical judgment is increasingly being challenged by the need for randomized clinical trials. The 1987 National Cancer Institute mandate—that the Community Clinical Oncology Program (CCOP) accrue patients to cancer control protocols—provided an opportunity to examine the factors that affect accrual performance. An analysis of 52 CCOPs and their research bases participating in the program found that the availability of protocols, involvement with research base activities, a demonstrated link to community physicians (particularly those physicians, such as surgeons, who had access to patients), and the use of personal contacts to inform non-CCOP physicians about CCOP activities were important facilitating factors for accruing patients to cancer prevention and control trials.

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