Identification of the causes that influence recruitment in oncology clinical trials (OCT)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17562-e17562
Author(s):  
L. E. Fein ◽  
A. Romera ◽  
C. M. Micheri ◽  
M. I. Diaz ◽  
R. A. Sala
Keyword(s):  
Clinical Trials ◽  
Data Analysis ◽  
Informed Consent ◽  
Distant Metastases ◽  
Patient Recruitment ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Measurable Disease ◽  
Oncology Clinical Trials ◽  
Clinical Records

e17562 Background: Prediction of patient recruitment in OCT is one of the most important variables to guarantee timely closure of the trial. Earlier data analysis and conclusions define further research or discontinuation of the development of a given drug. Methods: Retrospective analysis of the recruitment and clinical records of all the patients of the COR that were contacted to participate in an OCT from 2006 to 2008 to identify the causes according to which patients did not participate. Results: Total of candidates 346, 175 women (50.6%). Average age 60 years (range 36 to 89). 42 patients (12%) rejected to participate in an OCT. 80 patients (23%) were screening failures (SF). 59 patients (17%) for not fulfilling an inclusion criteria (IC). Non appropriate stage or absence of measurable disease at screening (35%), abnormal labs (14%) and state of receptors or biomarkers (9%). Total of clinically unpredictable IC SF was 57.5%. 21 patients (6%) were SF due to an exclusion criteria (EC). Presence of distant metastases (12,5%), abnormal labs (2.5%) and abnormal EKG (2.5%). Total of clinically unpredictable EC SF was 19%. Conclusions: 35% of candidate patients did not participate. The most frequent cause was SF (23%). 76.5% of these SF were impossible to determine when informed consent was signed. 12% of patients rejected to participate for different reasons. Our results did not identify a predominant modifiable reason to improve recruitment. For future feasibility analyses our estimation of 35% dropout will be considered standard. [Table: see text] No significant financial relationships to disclose.

scholarly journals Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

2021 ◽  
Author(s):  
Paulo Cesar Morales Mayer ◽  
Caroline Amélia Gonçalves ◽  
Franz Porzsolt
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Selection Criteria ◽  
Human Subjects ◽  
Evidence Based ◽  
Inclusion Criteria ◽  
Pragmatic Trials ◽  
Exclusion Criteria ◽  
Policy Makers ◽  
Evidence Based Healthcare

Abstract Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.

Repurposing Ruxolitinib in Combating COVID-19: a mini review

2021 ◽  
Vol 02 ◽  
Author(s):  
Inshia Begum ◽  
Fathima Murthuza ◽  
Juwairiya Syed Iqbaluddin ◽  
Hafsah Fatima Arsal
Keyword(s):  
Clinical Trials ◽  
Severity Of Illness ◽  
Current Evidence ◽  
Public Healthcare ◽  
Inclusion Criteria ◽  
Research Papers ◽  
Exclusion Criteria ◽  
Mixed Treatment ◽  
Marked Selectivity ◽  
Insight Into

Background: The pandemic caused by Coronavirus Disease 2019 (COVID-19), also known as Severe Acute Respiratory Syndrome-Related Coronavirus (SARS-CoV-2), is believed to be one of the greatest threats to global health in the 21st century. Recent collective evidence has warranted Ruxolitinib as a potential agent in recovery. Ruxolitinib is a potent and selective inhibitor of Jack kinase (JAK) 1 and 2 with modest to marked selectivity against tyrosine kinase two and JAK3. Objective: The review aims to outline the current evidence regarding the repurposed treatment for COVID- 19 and give insight into the clinical trials. There has been considerable interest in introducing existing therapeutic agents against COVID-19 to reduce the severity of illness and ease the burden on public healthcare systems. Method: A literature search was conducted using keywords like ‘Ruxolitinib trial’ and ‘COVID-19 Ruxolitinib’ on PubMed, Google Scholar, Science Direct, and Cochrane databases to select research papers and articles on the topic published from January to October 2020. Inclusion criteria were restricted to articles on Ruxolitinib and COVID. In contrast, the exclusion criteria stipulated that any study done on COVID-19 involving a mixed treatment regimen with Ruxolitinib and other drug/s or any studies not pertinent to the purpose of the study would be omitted. Conclusion: Based on the successful outcomes of various researches conducted and clinical trials performed, the use of Ruxolitinib has shown significant improvement and faster clinical recovery among COVID-19 patients of varying severity of infection, advanced age, and multiple comorbidities. This review provides an overview of various such studies with their promising outcomes.

scholarly journals Parental perceptions of the informed consent process in pediatric oncology clinical trials

2013 ◽  
Vol 3 (11) ◽  
Author(s):  
Yvonne D Hastings ◽  
Natalie K Bradford ◽  
Liane R Lockwood ◽  
Robert S Ware ◽  
Jeanine Young
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Pediatric Oncology ◽  
Parental Perceptions ◽  
Informed Consent Process ◽  
Consent Process ◽  
Oncology Clinical Trials

scholarly journals Trial in Progress: Real-World Safety and Effectiveness of Brentuximab Vedotin in Adults with CD30+ Lymphoma in China

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4552-4552
Author(s):  
Pengpeng Xu ◽  
Mingci Cai ◽  
Wendy Zhang ◽  
Wei Li Zhao
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Survival Rate ◽  
Real World ◽  
Brentuximab Vedotin ◽  
Routine Clinical Practice ◽  
Inclusion Criteria ◽  
Real World Data

Abstract Background: Clinical trials have demonstrated the effectiveness of the CD30-targeted antibody-drug conjugate brentuximab vedotin (BV) for the treatment of classical Hodgkin lymphoma (HL) and non-Hodgkin lymphoma(e.g. ALCL, PTCL-NOS, AITL, CTCL and etc.). While clinical trials are critical for establishing efficacy, collection of real-world data outside of the controlled trial setting is important to evaluate how interventions are applied and assess the effectiveness of new treatments in routine clinical practice. Inclusion criteria are often rather restrictive compared with the patient populations seen by physicians in daily practice. There are limited real-world data related to treatment with BV in China. Our study aims to obtain timely real-world knowledge in terms of safety and effectiveness of BV in CD30+ lymphoma patients in China. Study Design and Methods: The study (NCT04837222) is a real-world, prospective, multicenter study to evaluate the safety and effectiveness of BV in patients with CD30+ lymphoma in China. Consecutive CD30+ lymphoma patients treated with BV as a part of standard clinical practice will be enrolled. Key inclusion criteria includes adult patients undergoing treatment with BV or to be received with BV, patient/legal guardian must be able to read, understand, and sign the Informed Consent Form, CD30+ lymphoma by INV (any CD30 expression). Exclusion criteria includes patient who currently participates in or with plan to participate in any interventional clinical trial, any other reason that, in the investigator's opinion, makes the patient unsuitable to participate in this study. As CD30+ lymphoma is not a common disease and the affordability of novel treatment is limited, 1000 patients with CD30+ lymphoma will be recruited from almost 30 hematology centers. The physician will determine the treatment regimen, as well as the frequency of laboratory and clinical assessment according to her/his routine practice. All patients will be followed up per routine clinical practice and data will be documented at baseline/3/6/9/12/18/24 months unless withdrawal of Informed Consent, death or loss of follow-up, whichever comes first. Loss to follow-up will be minimized through active contact with participating patients thereafter to ensure almost all clinically relevant outcomes will be captured. The primary endpoint is serious adverse events. Secondary endpoints include adverse events, adverse drug reaction, dose adjustment, characteristics of patients receiving BV, use of BV, number of BV cycles administered, disease characteristics, time to next treatment, overall response rate, duration of response, progression free survival rate, overall survival rate, quality of life and cost-effectiveness ratio. Descriptive analysis will be performed for data analysis. Disclosures Zhang: Takeda Pharmaceuticals: Current Employment.

The quality of informed consent forms for oncology clinical trials

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 6544-6544
Author(s):  
W. Y. Cheung ◽  
G. R. Pond ◽  
R. J. Heslegrave ◽  
L. Potanina ◽  
L. L. Siu
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Consent Forms ◽  
Oncology Clinical Trials

The Contents and Readability of Informed Consent Forms for Oncology Clinical Trials

2010 ◽  
Vol 33 (4) ◽  
pp. 387-392 ◽  
Author(s):  
Winson Y. Cheung ◽  
Gregory R. Pond ◽  
Ronald J. Heslegrave ◽  
Katherine Enright ◽  
Larissa Potanina ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Consent Forms ◽  
Oncology Clinical Trials

scholarly journals Konseling Indigenous Pesantren (Gaya Kepimpinan Kyai dalam Mendidik Santri)

2020 ◽  
Vol 6 (3) ◽  
pp. 441
Author(s):  
Ujang Khiyarusoleh
Keyword(s):  
Systematic Review ◽  
Data Analysis ◽  
Leadership Style ◽  
Google Scholar ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Review Articles ◽  
Education Data ◽  
Internet Searches

This study aims to find the surrounding indigenous pesantren through the kyai leadership style in educating students. The method used is a systematic review through review articles using inclusion criteria and exclusion criteria. Article searches were accessed from internet searches in the database, namely: proquest.com, Scincedirect and google scholar with the keywords leadership style, Kyai leadership, and santri education. Data analysis was done by collecting articles that met the inclusion criteria collected and examined systematically. Search for literature published from 2015 to 2020. The results of the study showed that the kyai's leadership style in educating students was a leader who had unique characteristics and became an example for his students and had a duty to carry out the task of developing this nation and country. The figure of a kyai who was sincere, simple and tenacious in educating and disciplined in carrying out his duties, this was all reflected in the characteristics of a teacher in Islam, namely, as Murabbi, Muallim, Muaddib and Mudaris. Therefore, the kyai is an exemplary and charismatic figure who is able to influence both within the pesantren and outside the pesantren or in society, so that the students will be similar to the leader of the pesantren, namely the kyai when they have graduated.

Comparison of the Informed Consent Process for Randomized Clinical Trials in Pediatric and Adult Oncology

2004 ◽  
Vol 22 (13) ◽  
pp. 2708-2717 ◽  
Author(s):  
Christian M. Simon ◽  
Laura A. Siminoff ◽  
Eric D. Kodish ◽  
Christopher Burant
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Randomized Clinical Trials ◽  
Human Subjects ◽  
Decision Makers ◽  
Phase Iii ◽  
Ethical Framework ◽  
Clinical Cancer Research ◽  
Oncology Research ◽  
Oncology Clinical Trials

Purpose To compare the informed consent processes for phase III pediatric and adult oncology clinical trials in view of the critical importance of human subjects protection in both pediatric and adult cancer care. Findings are discussed in terms of the opportunities for improving pediatric and adult oncology informed consent. Patients and Methods A total of 219 subjects are reported on. Adult oncology patients made up 36.1% (n = 79) of the sample. Pediatric surrogates made up the remaining 63.9% (n = 140). Subjects in both studies were observed and audiotaped in conversation with their oncologists, and interviewed afterwards. Comparisons between the adult and pediatric subjects were done using χ2 statistics and t tests. Results Differences between the pediatric and adult informed consent processes were found. Adult oncology decision makers were, on average, more fully informed and more actively engaged by their oncologists. Pediatric decision makers were, however, given more information about survival/cure, randomization, and voluntariness. Comprehension difficulties were more frequent among pediatric decision makers. Suggestions for improvement are made in view of the differences between adult and pediatric oncology research environments. Conclusion Ongoing efforts to improve the ethical framework of clinical cancer research need to take into account the key differences between pediatric and adult oncology informed consent. More research needs to be done to explore the differences between adult and pediatric informed consent processes in oncology.

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