A course for clinical trial personnel in clinical study designs, randomization, allocation schedules, and interactive response systems

2010 ◽  
Vol 10 (2) ◽  
pp. 175-182 ◽  
Author(s):  
Gregory T. Golm ◽  
Thomas E. Bradstreet ◽  
Laura A. Coffey
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Response Systems ◽  
Study Designs

scholarly journals Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Perrine Créquit ◽  
Isabelle Boutron
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Study ◽  
Primary Source ◽  
European Medicines Agency ◽  
Clinical Trial Registries ◽  
Number Of Patients ◽  
Journal Publications ◽  
Clinical Study Reports ◽  
Completeness Of Reporting

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.

scholarly journals Explaining clinical study designs to patients

2012 ◽  
Vol 18 (3) ◽  
pp. 50
Author(s):  
Maria G. Tanzi
Keyword(s):  
Clinical Study ◽  
Study Designs

Effect of Ark malahara in Vicharchika- A clinical study

2020 ◽  
Vol 6 (2) ◽  
pp. 50-54
Author(s):  
Suman Purohit ◽  
◽  
Shweta Shukla ◽  
Khemchand Sharma ◽  
◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Medical Practice ◽  
Satisfactory Treatment ◽  
Clinical Presentations

Vicharchika (Eczema) is a type of kshudrakustha characterized with symptoms, namely, kandu, Srava, Pidaka and Shyavata and Pidikotpatti. Vicharchika is often correlated to eczema based on the clinical presentations. No satisfactory treatment is available in contemporary medical practice. In Ayurveda variousformulations are mentioned for treatment of Vicharchika. In the present study a clinical trial was done using Ark Malahara in 15 patients of either sex in between the age of 20 to 70 years. Highly significant result is obtained in Kandu, while significant result was obtained in Daha, Srava, Pidika, Rukshta, Vaivarnya.

scholarly journals Infra-Zygomatic Mini Screws Compared to High Pull Headgear for Distalization And Intrusion of Maxillary Molars in Growing Patients with Class II Malocclusion: A Randomized Clinical Trial

2021 ◽  
Vol 2 (1) ◽  
pp. 14-19
Author(s):  
Ahmed K. Afify ◽  
Amr E. El-Dakroury ◽  
Sherif A. El-Kordy ◽  
Mostafa M. El-Dawlatly
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Treatment Duration ◽  
Class Ii ◽  
Class Ii Malocclusion ◽  
Maxillary Molars ◽  
Randomized Clinical Study ◽  
Molar Intrusion ◽  
Before And After ◽  
Patient Cooperation

Objective: The aim of the present randomized clinical study was to evaluate the distalization and intrusion effect of an Infra-zygomatic mini-screws supported appliance and compare it with high pull headgear appliance in treatment of growing patients with class II malocclusion. Methodology: 22 growing boys aged between (10 to 12 years) with class II div 1 malocclusion randomly divided to 2 equal groups. The first group treated with high pull headgear with acrylic splint and the second one treated with an Infra-zygomatic mini-screws supported appliance. The treatment duration was 8 months for both groups. Lateral cephalometric radiographs were taken before and after the treatment for each patient to be analyzed. Results: The maxillary first molar distalization was 2.58±2.31 mm in head gear group and 1.53±2.83 mm in mini-screws group. There was no significant maxillary first molar intrusion in both groups. There were no significant differences between the two groups. Conclusions: the mini-screws supported appliance can be used as the fixed replacement of the removable high pull headgear appliance with no need for patient cooperation.

Combining radiation therapy with anti-PD-1 for patients with advanced hepatocellular carcinoma: An open-label, single-center, single-arm clinical study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16117-e16117
Author(s):  
Jian-Xu Li ◽  
Ting-Shi Su ◽  
Xiao-Feng Lin ◽  
Yi-Tian Chen ◽  
Shi-Xiong Liang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Radiation Therapy ◽  
Clinical Study ◽  
Cancer Staging ◽  
Advanced Hepatocellular Carcinoma ◽  
Single Center ◽  
Open Label ◽  
Grade 3 ◽  
Clinical Trial Information

e16117 Combining radiation therapy with anti-PD-1 for patients with advanced hepatocellular carcinoma: an open-label, single-center, single-arm clinical study Jian-Xu Li, Ting-Shi Su, Xiao-Feng Lin, Yi-Tian Chen, Shi-Xiong Liang, Bang-De Xiang; Guangxi Medical University Cancer Hospital, Nanning, China Abstract Research Funding: Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China. Guangxi Medical and Health Appropriate Technology Development and Application Project (No. S2019039), Guangxi, China. Background: Based on the results of recent studies, the PD-1 monoclonal antibodies have been approved to treat the patients with advanced hepatocellular carcinoma (HCC) by the FDA. Radiation therapy (RT) can enhance responsiveness to PD-1 monoclonal antibody by potential mechanisms. A phase Ⅱa study was conducted to assess the safety and the efficacy of combining RT with anti-PD-1 for patients with advanced hepatocellular carcinoma. Methods: Patients with advanced HCC were eligible. Stereotactic body radiation therapy (SBRT) were adopted, and the dose of radiation were Dt-PGTV 30-50 Gy/10fractions. Camrelizumab (200mg) were given intravenously every 3 weeks since the first day of RT until disease progression, or intolerable toxicity. Adverse events (AEs) and objective response rate (ORR) were summarized to assess the safety and efficacy. Results: From April 2020 to November 2020, 17 patients were enrolled (median age 54, range 32-69). 15 (88%) patients were male. 14 (82%) had ECOG performance score of 0. All the patients had Child-Pugh score A. 16 patients staged as Barcelona Clinic Liver Cancer staging C or China Liver Cancer staging Ⅲ. Extrahepatic metastases were identified in 11 (65%) patients. 13 (77%) patients were Hepatitis B virus infected. 15 (88%) patients had previously 2 lines or more chemotherapy. 9 (53%) patients had Alpha-fetoprotein level≥400 ng/ml. The ORR was 47%. The best response assessed by RECIST 1.1 was partial response (8 patients). Four patients had grade 3 immune-related adverse events (irAEs), including increased aspartate aminotransferase and alanine transaminase (n =1)，decreased hemoglobin (n =1)，decreased platelet count (n =1)，decreased neutrophil count (n =1). All grade 3 irAEs were mitigated with proper treatment. None treatment-related deaths occurred. Conclusions: In this study, RT combined with anti-PD-1 had an acceptable safety profile and indicated an effective treatment option in patients with unresectable HCC. Clinical trial information: NCT04193696. Clinical trial information: NCT04193696.

NCOG-27. STATUS AS A CLINICAL TRIAL PARTICIPANT AND OUTCOME IN IDH-WILDTYPE GLIOBLASTOMA

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi157-vi158
Author(s):  
Peter Pan ◽  
Adela Joanta-Gomez ◽  
Fabio Iwamoto ◽  
Mary Welch ◽  
Aya Haggiagi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Promoter Methylation ◽  
Parietal Lobe ◽  
Strong Predictor ◽  
Standard Of Care ◽  
Mgmt Promoter Methylation ◽  
Study Patient ◽  
Trial Participant ◽  
Mgmt Promoter

Abstract INTRODUCTION Standard of care for glioblastoma consists of surgery, followed by combined chemoradiation and adjuvant chemotherapy, as per the seminal EORTC study from 2005. Clinical trial patients, being a population selected for functional status, hepatic function, renal function, and lack of other malignancies, may have improved outcome over the general treated population. METHOD Single center retrospective analysis of status as a clinical trial patient in the upfront setting and other clinical factors/biomarkers, analyzed for correlation with outcomes (PFS/OS) in IDH-wildtype glioblastomas. RESULTS 82 patients with IDH-wildtype glioblastoma were identified between 2014 and 2020, treated with standard of care or with an upfront clinical study (43% women; median age 66 years, range 35-91 years of age). 22 patients (27%) were treated with upfront clinical study. Status as a patient treated in an upfront clinical study did not correlate with outcome (hazard ratio HR PFS 0.99, CI 0.57-1.7, p=0.97; HR OS 1.09, CI 0.56-2.1, p=0.81). Frontal lobe was most frequently involved (n=36, 44%), followed by parietal lobe (n=33, 40%). Age was not a strong predictor of survival (R2 0.01). No statistically significant correlation was observed between outcome and laterality or location. MGMT promoter methylation was associated with improved PFS (HR 0.56, CI 0.33-0.94, p=0.03) and OS (HR 0.40, CI 0.19-0.85, p=0.02), with mPFS 6 months vs 9 months and mOS 16 months vs 20 months (unmethylated vs methylated respectively). CONCLUSION In this retrospective cohort of IDH-wildtype glioblastomas, age, tumor laterality, and tumor location were not significant predictors of outcome. MGMT promoter methylation predicted for superior PFS/OS. Patient selection for clinical studies are influenced by entry criteria, however at least in this retrospective review, status as a clinical study patient in the upfront setting did not correlate with outcome compared to patients treated with upfront standard of care.

scholarly journals Study Design in Neurosurgical Research: Considerations for Observational and Experimental Cohort Studies

Neurosurgery ◽  
2019 ◽  
Vol 86 (1) ◽  
pp. 14-18
Author(s):  
Christopher E Louie ◽  
Erin D’Agostino ◽  
Alexander Woods ◽  
Timothy Ryken
Keyword(s):  
Cohort Study ◽  
Clinical Study ◽  
Cohort Studies ◽  
Study Design ◽  
Chronic Subdural Hematoma ◽  
Neurosurgical Procedures ◽  
Fundamental Study ◽  
Observational Cohort ◽  
Research Questions ◽  
Study Designs

Abstract There is inadequate neurosurgical literature discussing appropriate clinical study design. Here, we explore considerations for 2 fundamental study designs of epidemiology: experimental and observational cohort studies, through examples of theoretical yet realistic neurosurgical research questions. By examining 2 common neurosurgical procedures—namely, subdural drains for evacuation of chronic subdural hematoma, and the utility of navigation for placing external ventricular drains—we characterize the framework of cohort study models for clinical research applications.

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