scholarly journals Publication bias in clinical trials

2009 ◽  
Author(s):  
Martin Fenner
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
England Journal ◽  
New England ◽  
Cancer Patients ◽  
Publication Bias ◽  
Secondary Outcome ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

Last week the New England Journal of Medicine (NEJM) published a paper on selective outcome reporting in clinical trials (Vedula et al. 2009). The primary and secondary outcome(s) of a clinical trial could for example be survival in cancer patients or ...

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

Selective outcome reporting in root coverage randomized clinical trials

2021 ◽  
Author(s):  
Daniel Isaac Sendyk ◽  
Nathalia Vilela Souza ◽  
João Batista César Neto ◽  
Dimitris N. Tatakis ◽  
Cláudio Mendes Pannuti
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Root Coverage ◽  
Selective Outcome Reporting ◽  
Outcome Reporting

Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.

1996 ◽  
Vol 14 (3) ◽  
pp. 984-996 ◽  
Author(s):  
N K Aaronson ◽  
E Visser-Pol ◽  
G H Leenhouts ◽  
M J Muller ◽  
A C van der Schot ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Cancer Patients ◽  
Intervention Group ◽  
Nursing Intervention ◽  
Informed Consent Process ◽  
Consent Process ◽  
Trial Participation ◽  
Oncology Nurse

PURPOSE Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed. RESULTS The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P < .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention. CONCLUSION The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.

scholarly journals Returning aggregate results of clinical trials: Empirical data of patient preferences

2018 ◽  
Vol 2 (6) ◽  
pp. 356-362 ◽  
Author(s):  
Carmen E. Aldinger ◽  
Jennifer Ligibel ◽  
Im Hee Shin ◽  
John W. Denninger ◽  
Barbara E. Bierer
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Integrative Medicine ◽  
Patient Preferences ◽  
Empirical Data ◽  
Online Survey ◽  
Plain Language ◽  
Research Participants ◽  
Study Results

AbstractIntroduction:The purpose of this research was to understand the preferences of patients receiving integrative medicine services for return of aggregate study results.Methods:A brief online survey (survey 1) was sent to 341 cancer patients receiving integrative medicine interventions; subsequently, a minimally revised survey (survey 2) was sent to 812 individuals with various medical conditions who had been either research participants in integrative medicine studies (n = 446) or patients (n = 346) of mind–body medicine.Results:Feedback to a model plain language summary was elicited from survey 1 and survey 2 respondents. Seventy-seven survey recipients (23%) responded to survey 1, and 134 survey recipients (17%) responded to survey 2. The majority of respondents to the surveys were female and 51–70 years of age. Ninety percent of responders to survey 1 and 89% of responders to survey 2 indicated that researchers should share overall results of a study with participants. In terms of the means of result distribution, 37%–47% preferred email, while 22%–27% indicated that, as long as the results are shared, it did not matter how this occurred. Of 38 survey 1 respondents who had previously participated in a clinical trial, 37% had received the results of their study. In survey 2, 63 individuals indicated that they previously participated in clinical trials, but only 16% recalled receiving results.Conclusions:These results confirm that the majority (89%–90%) of integrative medicine patients are interested in receiving the results of clinical trials. The majority (82%–94%) of respondents felt the model plain language summary of results provided was helpful.

scholarly journals Human Embryonic Stem Cell Research, Abortion, and Publication Bias in the New England Journal of Medicine

2019 ◽  
Vol 86 (1) ◽  
pp. 103-114
Author(s):  
Fritz Baumgartner
Keyword(s):  
Stem Cell ◽  
England Journal ◽  
New England ◽  
Embryonic Stem Cell ◽  
Publication Bias ◽  
Stem Cell Research ◽  
Human Embryonic Stem Cell ◽  
Embryonic Stem ◽  
Embryonic Stem Cell Research ◽  
Controversial Issues

Publication bias in medical journals depends on outside influences and the particular ideological bent of the editorial board. The New England Journal of Medicine ( NEJM) is a premier medical scientific publication having among the highest impact rankings of any research journal. The Vioxx question and industry ties it highlighted have led to legitimate questions of whether significant conflicts of interest have arisen within NEJM that compromise the free exchange of scientific information and ideas. Over the past two decades, several socially charged areas have been treated with considerable bias in the editorial policy of NEJM, including the issues of human embryonic stem cell research and abortion. From 2000 to 2017, NEJM published over twenty pieces favorable toward human embryonic stem cell research and over fifty pieces favorable to abortion, with virtually no publication of contrary opinion. An aggressive editorial defense of Planned Parenthood Federation most recently seems particularly striking. A secular journal which is meant to represent the entire spectrum of physician opinion in controversial issues has a practical, if not also an ethical, responsibility to provide an unbiased forum for intelligible discussion for evaluation of the merits of particular issues. To do otherwise is publication bias that suppresses legitimate contrary viewpoints having merit and validity. Nontechnical Summary: Publication bias in medical journals is detrimental to the free exchange of ideas regarding controversial issues. From 2000 to 2017, a premier publication, the New England Journal of Medicine ( NEJM), has shown considerable bias in only publishing articles and editorials highly favorable toward human embryonic stem cell research and abortion, without permitting valid discussion and publication of contrary opinion. The recent strong editorial defense by NEJM of Planned Parenthood Federation in their sale of aborted fetal body parts seems particularly striking and disproportionate. Publication bias suppresses legitimate contrary viewpoints with merit and validity, suppressing fair debate in controversial issues.

Cancer clinical trials available in the community setting: A 5-year analysis from 1999–2004

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6056-6056
Author(s):  
J. K. Keller ◽  
J. Bowman ◽  
J. A. Lee ◽  
M. A. Mathiason ◽  
K. A. Frisby ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Community Setting ◽  
Disease Stage ◽  
Cancer Center ◽  
Newly Diagnosed ◽  
Community Based ◽  
Eligibility Criteria ◽  
Major Barrier

6056 Background: Less than 5% of newly diagnosed cancer patients are accrued into clinical trials. In the community setting, the lack of appropriate clinical trials is a major barrier. Our prospective study in 2004 determined that 58% of newly diagnosed adult cancer patients at our community-based cancer center didn’t have a clinical trial available appropriate for their disease stage. Among those with clinical trials, 23% were subsequently found to be ineligible (Go RS, et al. Cancer 2006, in press). However, the availability of clinical trials may vary from year to year. Methods: A retrospective study was conducted to determine what clinical trials were available for newly diagnosed adult cancer patients at our institution from June 1999-July 2004. The study also investigated the proportions of newly diagnosed patients who had a clinical trial available appropriate for type and stage of disease and patients accrued. Results: Over the 5-year period, 207 (82, 87, 99, 102, 117, years 1–5, respectively) trials were available. Most (50.7%) trials were for the following cancers: breast (15.5%), lung (13.5%), head and neck (7.7%), colorectal (7.2%) and lymphoma (6.8%). ECOG (53%), RTOG (26%), and CTSU (9%) provided the majority of the trials. A total of 5,776 new adult cancer patients were seen during this period. Overall, 60% of the patients had a trial available appropriate for type and stage of their cancer, but only 103 (3%) were enrolled. There was a significant upward trend in the proportions of patients with available trials over the years (60.2%, 55.9%, 59.2%, 60.7%, 63.9%, years 1–5, respectively; Mantel-Haenszel P=.008). The proportion of patients with a trial available was highest for prostate (97.3%), lung (90.9%), and breast (73.9%), and lowest for melanoma (17.1%), renal (11.6%), and bladder (7.2%). The majority of patients accrued to trials had the following cancers: breast (32%), lung (17%), lymphoma (9%), colon (7%), and prostate (5%). Conclusions: Nearly half of the newly diagnosed adult patients at our center had no trials available appropriate for type and stage of their cancers. It is likely that if strict clinical trial eligibility criteria were applied, approximately 2/3 of our patients would not be eligible for a clinical trial. No significant financial relationships to disclose.

Screening cancer patients for clinical trial eligibility: A randomized study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6529-6529
Author(s):  
J. Wright ◽  
T. Whelan ◽  
J. Julian ◽  
M. Simunovic ◽  
M. Levine
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Primary Outcome ◽  
Randomized Study ◽  
Secondary Analysis ◽  
Chi Square ◽  
Ongoing Research ◽  
Number Of Patients ◽  
The Difference

6529 Background: The overall proportion of cancer patients enrolled into clinical trials is undesirably low. Research suggests many aspects of the recruitment process can be improved. The present study was undertaken to evaluate the benefit of identifying potentially eligible (PE) clinical trial patients for physicians. Methods: Consenting physicians were randomized to 26 weeks of screening support or not, and were then crossed-over to the other strategy for a second 26-week time period. A computer program reviewed new patient consultations to identify PE clinical trial patients. Physicians receiving support were provided with written individualized details of patient eligibility for trials prior to their medical consultation. The primary outcome of interest was the difference, by physician, in the number of patients who were approached for consent to enter a clinical trial. Results: Thirty-six physicians participated in the 52-week study. 5051 consultations were screened in a blinded fashion, 2,376 when physicians had support and 2,675 when they did not. 939 of 2,376 (39.5%) consultations were identified as involving PE patients when physicians were receiving support, and 1,061 of 2,675 (39.7%) when without. The primary outcome of the study, by physician, did not demonstrate a statistically significant improvement, with 4.1 patients per physician without vs. 4.7 patients with screening support (p>0.05). Secondary analysis demonstrated that the overall proportion of patients approached with the clinical trial option increased from 149/2,675 (5.6%) to 169/2,376 (7.1%) with screening support (Chi-square, p=0.024) and that the number of patients that entered a clinical trial also increased from 60/2,675 (2.2%) to 83/2,376 (3.5%) (Chi-square, p=0.007). Conclusions: This study suggests that individualized patient screening for clinical trial eligibility may be useful to improve the numbers of patients approached to consider clinical trials. The number of new patients that entered clinical trials remained low, and ongoing research to facilitate improvements is required. No significant financial relationships to disclose.

Barriers to participation in breast cancer trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6593-6593
Author(s):  
O. Herasme ◽  
J. Goldberg ◽  
R. Sandoval ◽  
C. Harris ◽  
Y. Ortiz-Pride ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Child Care ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Demographic Factors ◽  
Trial Participation ◽  
Barriers To Participation ◽  
Cancer Trials

6593 Background: Clinical cancer trials allow investigators to test the effectiveness and safety of new cancer drugs and treatments. Historically, fewer that 5% of cancer patients have participated in clinical trials. The purpose of this study was to assess attitudes, beliefs, and practical barriers to clinical trial recruitment. Methods: Women were recruited in the Herbert Irving Comprehensive Cancer Center while waiting for routine breast screening or for oncology care in connection with a diagnosis of breast cancer. The 29-item survey questionnaire covered demographic factors, prior cancer diagnosis or risk factors, past experience with clinical trials if any, willingness to participate in different types of trials, and attitudinal and practical barriers to participation. Results: Of 329 respondents, 48.9% were non- Hispanic white, 10.9% non-Hispanic black, 34.9% Hispanic, and 5.30% other/unknown. The mean age of participants was 52.5 (SD=12.1). Of 131 (39.8%) participants reporting that they had been asked to participate in clinical trial, 82 were white, 17 black and 32 Hispanic. Of those who enrolled, 64 were white, 14 were black, and 19 Hispanic. Of those asked to participate 56/63 breast cancer patients (88.9%) and 44/68 others (64.7%) enrolled (P=0.002). Of 48 who reported that they had child care responsibilities, 33 enrolled (68.8) compared to 67/83 (80.7%) of those without such responsibilities (P=0.07). Of the total sample, 88/220 (40.0%) of those without childcare responsibilities but only 32/109 (29.4) said they would be willing to participate in a placebo-controlled trial. Respondents were twice as likely to say they would participate in a trial comparing two active agents as a placebo-controlled trial. Conclusion: Our findings suggest that being asked to participate in a clinical trial may be associated with demographic factors, and that specific circumstances, such as child care responsibilities, may also affect trial participation. Awareness of these barriers may help investigators to develop effective strategies for overcoming them and for improving trial participation overall. No significant financial relationships to disclose.

Providing oncologic care with access to clinical trials to an underserved and minority population: The Mayo Clinic/Indian Health Service experience.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 79-79
Author(s):  
Donald W. Northfelt ◽  
Chara Chamie ◽  
Farhia Omar ◽  
Janet Okamoto ◽  
Timothy Mathews ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Health Service ◽  
Cancer Patients ◽  
Mayo Clinic ◽  
Clinical Care ◽  
Indian Health Service ◽  
Cancer Clinical Trials ◽  
High Quality ◽  
Indian Health

79 Background: Novel mechanisms are needed to provide high quality oncologic clinical care and clinical trial access to underserved and minority populations (UMP). UMP are underrepresented in cancer clinical trials, thus limiting the generalizability of the research. As a National Cancer Institute-Comprehensive Cancer Center, Mayo Clinic has the responsibility to ensure that its cancer care reaches a diverse patient population. Mayo Clinic in Arizona developed a clinical oncology practice in collaboration with the US Indian Health Service at Phoenix Indian Medical Center (PIMC), in part to address these needs. The relationship between Mayo and PIMC is invaluable and serves a crucial need in the community. The Mayo consultants serve as staff physicians in the “Oncology Center of Excellence” at PIMC and see 100 – 200 tribal members annually with new diagnoses of cancer or blood disorders. Being onsite at PIMC allows Mayo consultants to integrate seamlessly into the wider PIMC practice. Methods: Descriptive demographic data from the MCA-PIMC clinical practice were obtained from the PIMC practice database 2008 - 2017. Enrollment of MCA-PIMC patients into MCA cancer clinical trials were prospectively enumerated. Results: Between the time period of 2008-2017, 356 breast cancer patients and 259 colorectal cancer patients were seen by Mayo Clinic oncologists and the PIMC nurse practitioner. During the period of 2016-2017, there were 13 clinical trial referrals from PIMC with 8 of those patients being enrolled in Mayo cancer clinical trials. Conclusions: High quality oncologic clinical care can be provided via unique collaborations between academic oncology program and UMP-focused care provider. This mechanism allows access to cancer clinical trial opportunities for UMP. Prior to the established partnership, there were no Native American patients referred to clinical trials from PIMC, showing the critical pathway that has been forged. Importantly, this is the only known program of its kind in the country. By imbedding the cancer provider in the community, we are able to build trust with the underserved community and create a pathway to a quality care and clinical research.

Comparison of attitudes and beliefs about cancer clinical trial enrollment between physicians, research staff, and cancer patients.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 170-170
Author(s):  
Grace Hillyer ◽  
Melissa Beauchemin ◽  
Dawn L. Hershman ◽  
Moshe A. Kelsen ◽  
Frances L Brogan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Online Survey ◽  
Cancer Clinical Trial ◽  
Cultural Barriers ◽  
Attitudes And Beliefs ◽  
Research Staff ◽  
Hispanic Patients ◽  
Clinical Trial Enrollment

170 Background: Essential to bringing innovative cancer treatments to patients is voluntary participation in clinical trials but fewer than 10% of cancer patients are enrolled onto a trial. We used a domain-oriented framework to assess barriers to cancer clinical trial enrollment (CTE). Methods: Physicians and research staff completed an online survey in 2017; adult cancer patients not currently enrolled in a trial were interviewed in 2018. Perceived structural, provider- and patient-level barriers to CTE were assessed. Differences in perceptions, attitudes and beliefs toward CTE between physicians and staff, patients by ethnicity, and physicians/staff and patients were examined. Results: In total, 120 physician/staff (64.4% response rate) and 150 cancer patient completed surveys. Interacting with the patients’ family was seen as a CTE barrier by nearly one-third of physicians/staff overall, however, staff much more often stated this barrier than did physicians (44.0% vs. 18.2%, p= 0.007). Hispanic patients more often stated they would join a trial, even if standard therapy was an option compared to non-Hispanic patients ( p= 0.004). Overall, patients, more often than physicians/staff, believed that clinical trials are only offered to people whose disease is hopeless (27.3% vs. 8.7%, p < 0.001) and that CTE does not help patients personally (32.9% vs. 1.8%, p < 0.001). More often physicians/staff believed that patients decline CTE due to language or cultural barriers (57.5% vs. 27.3%, p < 0.001), lack of understanding about clinical trials (63.3% vs. 9.1%, p = 0.001), and mistrust of the medical system (69.2% vs. 36.4%, p= 0.043) than was reported by patients. Patients less often reported declining CTE because of concerns about invasive procedures (9.1% vs. 41.7%, p = 0.02), toxicity (18.2% vs. 60.0%, p= 0.006) or reluctance to be randomized/receive a placebo (27.3% vs. 70.8%, p= 0.005). Conclusions: Our findings indicate a wide gap between provider and patient attitudes and beliefs about CTE. Reconciling these differences will require tailored education to dispel misperceptions and strategies to improve the quality of patient-provider communication.

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