scholarly journals A104 PREVALENCE OF GHOST-AUTHORSHIP IN INDUSTRY-SPONSORED CLINICAL TRIALS

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 80-81
Author(s):  
J Li ◽  
M Hu ◽  
M A Scaffidi ◽  
N Gimpaya ◽  
R Bansal ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled ◽  
Study Protocols ◽  
Fda Approval ◽  
Drug Agency ◽  
Funding Agencies ◽  
Study Results ◽  
High Prevalence ◽  
Inflammatory Bowel ◽  
Medical Writers

Abstract Background Ghost-authorship involves the exclusion of individuals who have made substantial contributions to the article from the author byline. Previous studies have found that ghost-authorship is highly prevalent in industry-sponsored clinical trials. Its prevalence, however, has yet to be investigated in trials of biologics in the management of inflammatory bowel disease (IBD). Aims To determine the prevalence of ghost-authorship in IBD biologic industry-sponsored clinical randomized controlled trials (RCTs). Methods Biologic medications indicated for ulcerative colitis (UC) or for Crohn’s disease (CD) were identified using the Food and Drug Agency (FDA) database. We identified the clinical trials on clinicaltrials.gov corresponding to the data presented at the time of FDA approval. Specifically, we included the first publication for each trial to report study results for our analysis. Two authors independently identified the presence of ghost-authorship, which we defined as the exclusion on the author byline of the included RCT publication of any individuals who assisted in the writing of the trial manuscript and/or performed the data analyses. Results We identified a total of 28 relevant RCTs on biologic medications (10 for UC and 18 for CD), which were matched to 20 publications. We found ghost-authorship in 70% of publications (n=14); 40% (n=8) involved manuscript and protocol writing assistance from sponsor staff; 35% (n=7) involved medical writers from external companies; 15% (n=3) involved both sponsor staff and medical writers assisting in manuscript writing; and 20% (n=4) involved individuals performing data analysis or interpretation. Conclusions We found that ghost-authorship in industry-sponsored IBD biologic clinical trials has a moderately high prevalence, with the most common being manuscript or protocol writing assistance. A lack of transparency regarding sponsor-affiliated and/or external contributors may negatively affect the trust placed in medical research. One limitation is that data was only extracted from publications. Further evidence on ghost-authorship may be found in study protocols and registrations, which will be investigated in the future. Funding Agencies None

P070 TRENDS AND CHARACTERISTICS OF CLINICAL TRIALS PARTICIPATION IN THE IBD PARTNERS COHORT

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S11-S12
Author(s):  
Cole Johnson ◽  
Edward Barnes ◽  
Xian Zhang ◽  
Millie Long
Keyword(s):  
Clinical Trials ◽  
Controlled Trial ◽  
Severe Disease ◽  
Drug Approval ◽  
Cross Sectional Study ◽  
Participation Rates ◽  
Cross Sectional ◽  
Mild Disease ◽  
Randomized Controlled ◽  
Study Results

Abstract Background and Aims There are currently several recruitment challenges in randomized controlled trials (RCT) for inflammatory bowel disease (IBD) which prolong the drug approval process and affect the generalizability of study results. The purpose of this study is to characterize individuals who participate in IBD RCTs and identify factors which could influence future recruitment strategies. Methods We performed a cross-sectional study within the IBD Partners cohort comparing patients with current or prior participation in an interventional randomized controlled trial (RCT) of a medical therapy for IBD to those without any RCT participation. Bivariate statistics were used to compare RCT participation by IBD subtype and by other demographic and disease characteristics, and predictive modeling was used to identify factors predictive of RCT participation. We calculated the percent of the cohort that participated an in RCT during each calendar year from 2011–2018 and Clinicaltrials.gov was accessed to determine the number of active RCTs for IBD therapies per year during that same period. Results A total of 14,747 patients with IBD were included in the analysis and 1,116 (7.6%) reported RCT participation at any time. Demographic factors predictive of RCT participation (Table 1) included following at an academic institution (OR=1.8; 95%CI: 1.51–2.04) and age 36–75 (OR=1.6; 95%CI: 1.43–1.87). Patients with Crohn’s disease (CD) were more likely to participate than those with ulcerative colitis (UC) (OR=1.5; 95%CI: 1.35–1.77). Patients with more severe disease were more likely to participate, including those with prior IBD-related hospitalization (OR=2.6; 95%CI: 2.19–2.99), IBD-related surgery (OR=2.5; 95%CI: 2.24–2.87), biologic exposure (OR=3.2; 95%CI: 2.76–3.65), and “Poor” or worse quality of life (OR=1.7; 95%CI: 1.45–1.93). Steroid-free remission was associated with lower likelihood of RCT participation (OR=0.6; 95%CI: 0.53–0.70). While the number of active RCTs for IBD more than doubled between 2011 and 2018, RCT participation rates during that same time period decreased from 1.1% to 0.7% of the cohort (Figure 1). Conclusions RCT participation rates declined within this cohort between 2011–2018. Groups underrepresented in RCTs for IBD included younger patients, patients followed in community settings, and patients with more mild disease. The non-RCT group had mean sCDAI and SCCAI scores that did not meet remission thresholds, demonstrating populations in need of alternate therapies for whom clinical trials could be an option. Given anti-TNF exposure rates in this national cohort, studies should focus on anti-TNF failure populations. Investigators should make every effort to offer RCTs to all patients and network with community providers to increase awareness of RCTs.

Professional medical writing assistance in oncology clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14088-e14088
Author(s):  
Joseph Abi Jaoude ◽  
Ramez Kouzy ◽  
Walker Mainwaring ◽  
Timothy Lin ◽  
Austin B. Miller ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Scientific Communication ◽  
Phase Iii ◽  
Professional Writing ◽  
Academic Publishing ◽  
Cancer Clinical Trials ◽  
Fda Approval ◽  
English Speaking ◽  
Medical Writers

e14088 Background: Academic publishing remains the cornerstone of biomedical research and scientific communication. Researchers often assign professional medical writers (PMWs) to craft publications, as these individuals may improve the overall writing quality and/or reduce time to publication. We sought to characterize the landscape of PMW utilization in phase III cancer clinical trials. Methods: We searched ClinicalTrials.gov for phase III randomized clinical trials between the years 2003 and 2018. Randomized multi-arm trials assessing a therapeutic intervention in cancer patients were included. After identifying the corresponding publications, we identified whether a PMW was involved in writing the manuscript based on author disclosures, along with any related funding information. Results: Six-hundred oncology RCTs with corresponding manuscripts were identified. In total, 260 (43.3%) trials used a PMW. Financial support to medical writers was largely provided by the industry (247/260, 95.0%). In multivariate analyses, PMW utilization was higher among industry-funded trials compared to non-industry-funded trials (OR: 14.2, p= 0.001). PMWs were used more frequently to report successful trials that met their primary endpoint (OR: 1.8, p= 0.03) but did not differ between English-speaking and non-English-speaking countries ( p= 0.19). Cooperative group trials used PMWs with less frequency compared to non-cooperative groups (OR 0.68, p < 0.001). PMWs were used more often in trials that led to subsequent drug FDA approval (69.6% vs 40.6% in trials that did not lead to subsequent FDA approval), but this association did not reach statistical significance in multivariate analysis ( p = 0.744). The use of PMWs has increased significantly over time (OR: 1.11/year, p =0.001). Conclusions: In this analysis, we show a strikingly high prevalence of PMW utilization in phase III oncology trials, with a vast majority of industry-supported studies using PMWs. We believe that professional writing assistance plays an important role in clear and efficient scientific communication. However, the disproportionate role of PMWs in reporting positive, industry-funded trials may represent a conflict of interest. We urge continued and increased reporting of utilization and funding of professional writing assistance in cancer clinical trials.

scholarly journals Maintenance Therapy for Inflammatory Bowel Disease: What Really Works

1997 ◽  
Vol 11 (3) ◽  
pp. 261-264 ◽  
Author(s):  
Lloyd R Sutherland
Keyword(s):  
Quality Of Life ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Maintenance Therapy ◽  
Bowel Disease ◽  
Time Interval ◽  
Double Blind ◽  
Randomized Controlled ◽  
Inflammatory Bowel

The propensity of inflammatory bowel disease sufferers to experience recurrent episodes or disease flares is well documented. Until a cure can be found, strategies to lengthen the period of remission offer the greatest opportunity to reduce morbidity and enhance patient quality of life. Therapies that have been shown in randomized, controlled, double-blind clinical trials to either lengthen the time of remission or improve the odds of staying in remission during a set time interval are required.

The Consolidated Standards of Reporting Trials (CONSORT): Better Presentation of Surgical Trials in the Journal of Hand Surgery

2004 ◽  
Vol 29 (6) ◽  
pp. 621-624 ◽  
Author(s):  
S. SAUERLAND ◽  
T. R. C. DAVIS
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Hand Surgery ◽  
Controlled Trials ◽  
Scientific Validity ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Study Results ◽  
Methodological Aspects ◽  
Treat Analysis

To assure readers that study results are scientifically valid, the methods of a clinical trial should be described adequately. Since randomization, blinding, and intention-to-treat-analysis are major bias-reducing techniques, these aspects should be reported most accurately. The Consolidated standards of reporting trials (CONSORT) are recommendations to improve the reporting of trials. CONSORT requires that trial authors describe basic methodological aspects that readers need to appraise the strengths of report ed clinical trials. This article presents the CONSORT recommendations and explains some of their main aspects. From now on, the Journal of Hand Surgery will use CONSORT to assist authors of randomized controlled trials in improving the description of their studies. We believe that this decision increases the scientific validity of study reports and helps readers when critically appraising articles.

scholarly journals Efficacy of Behavioral Experiments in Cognitive Therapy for Social Anxiety Disorder: Study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Celina Clément ◽  
Jihong Lin ◽  
Ulrich Stangier
Keyword(s):  
Clinical Trials ◽  
Anxiety Disorder ◽  
Social Anxiety ◽  
Cognitive Therapy ◽  
Social Anxiety Disorder ◽  
Self Report ◽  
Secondary Outcome ◽  
Behavioral Experiments ◽  
Randomized Controlled ◽  
Study Results

Abstract Background While the efficacy of cognitive therapy (CT) has been well established for social anxiety disorder (SAD) in several randomized controlled trials, there are still large differences between trials with respect to effect sizes. The present study investigates the question of whether enhanced training and the use of behavioral experiments (BEs) increases the efficacy of traditional CT, based on verbal methods of cognitive restructuring. Methods/design A mixed within/between conditions design will be applied, with therapists and patients being randomly allocated to one of two conditions: (1) training of CT plus BEs, (2) training of CT “as usual”. Sixty patients with the primary diagnosis of SAD will be recruited and treated in the outpatient clinic of the Department of Psychology, University of Frankfurt. To ensure adherence to therapist protocols, all therapists will be trained and supervised by the project coordinators. In addition, videotaped treatment sessions will be independently evaluated to guarantee both adherence to protocols and the quality of the intervention. Treatment effects will be assessed by independent SAD symptom ratings using the Liebowitz Social Anxiety Scale as the primary outcome measure and self-report measures as secondary outcome measures. Discussion The present cognitive behavioral therapy (CBT) trial will be the first to clarify the contribution of BEs to the efficacy of CT in a randomized controlled design. Study results are relevant to clinical training and implementation of evidence-based treatments. Trial registration German Clinical Trials Register International Clinical Trials Registry Platform (ICTRP) identifier: DRKS00014349. Trial status: recruiting.

scholarly journals Trends and Characteristics of Clinical Trials Participation for Inflammatory Bowel Disease in the United States: A Report From IBD Partners

2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Cole Johnson ◽  
Edward L Barnes ◽  
Xian Zhang ◽  
Millie D Long
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Bowel Disease ◽  
Severe Disease ◽  
Drug Approval ◽  
The United States ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Study Results ◽  
Inflammatory Bowel

Abstract Background and Aims There are currently several recruitment challenges in randomized controlled trials (RCTs) for inflammatory bowel disease (IBD), which prolong the drug approval process and affect the generalizability of study results. The purpose of this study is to characterize individuals who participate in IBD RCTs and identify factors that could influence future recruitment strategies. Methods We performed a cross-sectional study within the IBD Partners cohort comparing patients with current or prior participation in an RCT of medical therapy for IBD to those without any RCT participation. Bivariate statistics were used to compare RCT participation by IBD subtype and by other demographic and disease characteristics, and predictive modeling was used to identify factors predictive of RCT participation. We calculated the percent of the cohort that participated in an RCT during each calendar year from 2011 to 2018 and accessed Clinicaltrials.gov to determine the number of active RCTs for IBD therapies per year during that same period. Results A total of 14,747 patients with IBD were included in the analysis and 1116 (7.6%) reported RCT participation at any time. Demographic factors predictive of RCT participation included following at an academic institution [odds ratio (OR) = 1.8; 95% confidence interval (CI) 1.51–2.04) and age 36–75 (OR = 1.7; 95% CI 1.46–1.92). Patients with Crohn’s disease were more likely to participate than those with ulcerative colitis (OR = 1.5; 95% CI 1.35–1.77). Patients with more severe disease were more likely to participate, including those with prior IBD-related hospitalization (OR = 2.6; 95% CI 2.19–2.99), IBD-related surgery (OR = 2.5; 95% CI 2.24–2.87), biologic exposure (OR = 3.2; 95% CI 2.76–3.65), and “Poor” or worse quality of life (OR = 1.7; 95% CI 1.45–1.93). Steroid-free remission was associated with a lower likelihood of RCT participation (OR = 0.6; 95% CI 0.53–0.70). Although the number of active RCTs for IBD more than doubled between 2011 and 2018, RCT participation rates during that same time period decreased from 1.1% to 0.7% of the cohort. Conclusions RCT participation declined within this cohort. Groups underrepresented in RCTs for IBD included younger patients, patients followed in community settings, and patients with more mild disease. The non-RCT group had mean disease activity scores that did not meet remission thresholds, demonstrating populations in need of alternate therapies for whom clinical trials could be an option. Given anti-tumor necrosis factor (TNF) exposure rates in this national cohort, studies should focus on anti-TNF failure populations. Investigators should make every effort to offer RCTs to all patients and network with community providers to increase awareness of RCTs.

Trends in PRO reporting in clinical trials leading to cancer immunotherapy drug approvals from 2011 to 2019.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 105-105
Author(s):  
Houssein Safa ◽  
Monica Tamil ◽  
Adi Diab ◽  
Adele Semaan ◽  
Jad Chahoud
Keyword(s):  
Clinical Trials ◽  
Cancer Immunotherapy ◽  
Current Trend ◽  
Type I ◽  
Patient Centeredness ◽  
Quality Reporting ◽  
Study Protocols ◽  
Fda Approval ◽  
Patient Reported ◽  
Drug Approvals

105 Background: Patient-reported outcomes (PROs) are a primary tool to evaluate the effect of a given drug on the health-related quality of life from a patient’s perspective and to maximize the value of patient-centeredness in drug development and approval. In this study, we aimed to evaluate the current trend in reporting, analysis and interpretation of PRO data. Methods: We conducted a systematic review of the FDA archives, identifying all cancer immunotherapy drug approvals between the years 2011 and 2019. We then retrieved the clinical trials that respectively led to these drug approvals from PubMed and ClinicalTrials.gov. We systematically screened for PROs and assessed their analytic tools and interpretation methods that were collected from the published journal articles and their study protocols. If one FDA approval was supported by more than one clinical trial, we included all studies in our review. An FDA approval was considered to include PROs if they were reported in at least one of the supporting trials. Results: Thirty-seven clinical trials leading to 35 immunotherapy drug approvals were identified. More than half (54%) did not publish any PROs. While PROs were reported in the primary clinical outcomes manuscript of 4 trials (11%) and in a secondary separately published paper for 13 trials (35%). The median time between the primary and secondary papers was 22 months (range: 5 - 40). In the 17 published PROs, the hypothesis was broad in 12 (71%), not reported in 4 (24%) and specific in only 1 (6%). Ten (59%) were reported as exploratory endpoints, five (29%) as secondary endpoints, and two (12%) did not specify the PRO reporting in their endpoints. The most common PRO instruments were EQ-5D (71%) and QLQ-C30 (65%). Control for type I error was needed but not done in 15 (88%). Fourteen (82%) described an approach for dealing with missing PRO assessments. None reported on significant differences based on race and ethnicity of participants. Conclusions: Suboptimal reporting and delays in publication of PROs occur regularly in cancer immunotherapy trials. Increased efforts are needed to enhance standardization and quality reporting of PROs to maximize the value of this data in cancer immunotherapy drug approval.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

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