Trial participants call for drug regulator to ensure study results are published

BMJ ◽  
2013 ◽  
Vol 346 (jan18 1) ◽  
pp. f382-f382
Author(s):  
Z. Kmietowicz
Keyword(s):  
Study Results ◽  
Drug Regulator ◽  
Trial Participants

scholarly journals Disseminating clinical study results to trial participants in Ethiopia: insights and lessons learned

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Tamiru S. Degaga ◽  
Sophie Weston ◽  
Tedla T. Tego ◽  
Dagimawie T. Abate ◽  
Ashenafi Aseffa ◽  
...  
Keyword(s):  
Clinical Study ◽  
Lessons Learned ◽  
Study Results ◽  
Trial Participants

Study participants’ perceptions of the process and impact of receiving results of N9831

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 518-518
Author(s):  
A. H. Partridge ◽  
A. C. Wolff ◽  
P. K. Marcom ◽  
P. A. Kaufman ◽  
C. Moore ◽  
...  
Keyword(s):  
College Graduates ◽  
Psychosocial Support ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Her2 Breast Cancer ◽  
Study Results ◽  
The Media ◽  
Multivariable Analyses ◽  
Study Participants ◽  
Trial Participants

518 Background: There has been growing interest in providing clinical trial participants with study results. We sought to evaluate the process of sharing results from a large cooperative group trial in an effort to guide clinicians and clinical investigators. Methods: We mailed surveys to a subset of women who participated in NCCTG 9831, Phase III Trial of Adjuvant Chemotherapy with or without Trastuzumab for Women with HER2+ Breast Cancer, after the preliminary study results were mailed to participants. Surveys were sent to all trial participants enrolled through 9 CALGB/ECOG institutions. Results: Of 228 surveys sent, 160 (70%) have been returned. Average age of respondents was 51 years (range 26–76); 84% were white; 61% were college graduates; 4% reported recurrent disease. Women reported receiving results by mail (84%), from a health care provider in person or by phone (43%), and/or from the media (47%); 2% reported that they were not informed of the results. 29% heard the results first from the media; 27% first heard by mail. 35% of women might have preferred to be offered results, with the option of not receiving them, but only 4% of women indicated that they would have declined results had they been offered first. 89% of women found the results information easy to understand; 69% correctly interpreted the results of the study; 31% either had an incorrect interpretation or were unsure of the findings. 81% of women were satisfied with how results were shared; 63% of women felt that learning results had an impact on their lives, 24% were more anxious after learning the results; 36% were less anxious. Multivariable analyses evaluating factors associated with greater satisfaction and increased anxiety will be presented. Conclusions: Sharing results is met with overwhelmingly favorable responses from patients, although a substantial proportion of patients may not initially understand the findings. Some patients desire to be offered results first, but few would decline them. The potential for increased anxiety should be considered, and psychosocial support may be required by some. A plan to share results should be routinely and prospectively included in the design of clinical trials. (Supported in part by an ASCO Career Development Award (AHP) No significant financial relationships to disclose.

scholarly journals Factors contributing to fidelity in a pilot trial of individualized resistant starches for pediatric inflammatory bowel disease: a fidelity study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Gisell Castillo ◽  
David R. Mack ◽  
Manoj M. Lalu ◽  
Ruth Singleton ◽  
Dean A. Fergusson ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Data Collection ◽  
Bowel Disease ◽  
Pilot Trial ◽  
Study Results ◽  
Inflammatory Bowel ◽  
Stool Samples ◽  
Resistant Starches ◽  
Trial Intervention ◽  
Trial Participants

Abstract Background The consumption of resistant starches is a promising adjuvant therapy for patients with inflammatory bowel disease. Rigorous evaluation of resistant starches in this setting depends on the intervention being delivered, received, and enacted as intended, that is, with fidelity. As part of a planned pilot trial, participants will be randomized to ingest resistant starches or a placebo. They will also be asked to collect stool samples and keep symptom and dose diaries to inform trial outcomes. We aim to identify potential factors impacting fidelity to the receipt and enactment of trial intervention and data collection activities from the perspective of patients and caregivers in the trial. Identifying fidelity barriers and enablers at the pilot trial phase of a clinical intervention may help to determine optimization processes when expanding to multiple sites in future trials. Methods We will conduct 15-30 semi-structured interviews with pilot trial participants (aged 8-17) and their caregivers. Trial participants will be approached for interviews approximately 6 months after the start of their trial participation. Personal projects analysis, a tool for understanding how individuals manage competing demands in their daily lives, will guide an in-depth exploration of how trial participants engage in activities related to intervention and data collection fidelity (ingesting resistant starches or placebo, collecting stool samples, keeping a symptom and dose diary) amidst the complexities of daily living. Discussion The present study will seek to explore and demonstrate how theory-informed fidelity assessments can be conducted alongside pilot trials to inform future multisite trials. Study results will clarify what factors may affect fidelity to trial intervention and data collection activities. Results may suggest what to modify to optimize the design and conduct, and ensure the integrity, of future multisite trials. Conducting process evaluations alongside clinical trials has the potential to improve our understanding of trial participant experiences. Results will provide a better understanding of how trial participants manage to engage in necessary trial activities along with other priorities.

Informing Clinical Trial Participants About Study Results

JAMA ◽  
2002 ◽  
Vol 288 (3) ◽  
pp. 363 ◽  
Author(s):  
Ann H. Partridge
Keyword(s):  
Clinical Trial ◽  
Study Results ◽  
Trial Participants

Sharing Study Results With Trial Participants: Time for Action

2009 ◽  
Vol 27 (6) ◽  
pp. 838-839 ◽  
Author(s):  
Ann H. Partridge ◽  
Eric P. Winer
Keyword(s):  
Study Results ◽  
Trial Participants

scholarly journals Frequency and format of clinical trial results dissemination to patients: a survey of authors of trials indexed in PubMed

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e032701 ◽  
Author(s):  
Sara Schroter ◽  
Amy Price ◽  
Mario Malički ◽  
Tessa Richards ◽  
Mike Clarke
Keyword(s):  
Research Integrity ◽  
Ethical Review ◽  
Mainstream Media ◽  
Study Results ◽  
Dissemination Of Research ◽  
Research Findings ◽  
Patient Groups ◽  
Human Participants ◽  
Clinical Trial Results ◽  
Trial Participants

ObjectiveDissemination of research findings is central to research integrity and promoting discussion of new knowledge and its potential for translation into practice and policy. We investigated the frequency and format of dissemination to trial participants and patient groups.DesignSurvey of authors of clinical trials indexed in PubMed in 2014–2015.ResultsQuestionnaire emailed to 19 321 authors; 3127 responses received (16%). Of these 3127 trials, 2690 had human participants and 1818 enrolled individual patients. Among the 1818, 498 authors (27%) reported having disseminated results to participants, 238 (13%) planned to do so, 600 (33%) did not plan to, 176 (10%) were unsure and 306 (17%) indicated ‘other’ or did not answer. Of the 498 authors who had disseminated, 198 (40%) shared academic reports, 252 (51%) shared lay reports, 111 (22%) shared both and 164 (33%) provided individualised study results. Of the 1818 trials, 577 authors (32%) shared/planned to share results with patients outside their trial by direct contact with charities/patient groups, 401 (22%) via patient communities, 845 (46%) via presentations at conferences with patient representation, 494 (27%) via mainstream media and 708 (39%) by online lay summaries. Relatively few of the 1818 authors reported dissemination was suggested by institutional bodies: 314 (17%) of funders reportedly suggested dissemination to trial participants, 252 (14%) to patient groups; 333 (18%) of ethical review boards reportedly suggested dissemination to trial participants, 148 (8%) to patient groups. Authors described many barriers to dissemination.ConclusionFewer than half the respondents had disseminated to participants (or planned to) and only half of those who had disseminated shared lay reports. Motivation to disseminate results to participants appears to arise within research teams rather than being incentivised by institutional bodies. Multiple factors need to be considered and various steps taken to facilitate wide dissemination of research to participants.

scholarly journals Imaging Based Spleen Volume Assessments in Myelofibrosis Clinical Trials - Do We Need a Double Read Model?

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4632-4632
Author(s):  
Merryl Lobo ◽  
Alice Motovylyak ◽  
Madhuri Madasu ◽  
Rohit Sood
Keyword(s):  
Image Quality ◽  
Motion Artifacts ◽  
Spleen Size ◽  
Spleen Volume ◽  
Study Results ◽  
Quality Checks ◽  
Independent Review ◽  
Imaging Artifacts ◽  
High Level ◽  
Trial Participants

Abstract Myelofibrosis (MF) is a type of chronic blood cancer characterized by bone marrow fibrosis, extramedullary hematopoiesis and splenomegaly. Approximately 89% of patients present palpable splenomegaly with a compromised quality of life and reduced survival. The International Working Group Myeloproliferative Neoplasm Research and Treatment (IWG-MRT) criteria utilize spleen volume (SV) as part of clinical improvement (CI) response in MF trials. These include evaluation of spleen response as a primary/ secondary endpoint - defined as ≥35% SV reduction from baseline. Progressive disease is defined as ≥25% increase in SV from baseline level. Magnetic resonance imaging (MRI) and Computed tomography (CT) provide a non-invasive way to assess change in spleen size both spatially and temporally in a clinical study. While image acquisition with optimized and harmonized protocols is key, a central independent review of images also plays a critical role in correct patient outcome determination. The aim of this study is to determine if a double read model for central independent review is necessary to maintain a high accuracy of SV estimation. To this effect, alignment among independent readers over review criteria was assessed: inter-reader variability (IRV), in addition to assessment of consistency in review approach: intra-reader variability (ARV). Retrospective analysis was implemented on imaging data across 12 multi-center MF trials-MRI/CT images of two time-points (baseline and 1 follow-up) from 142 trial participants for ARV and 85 trial participants for IRV analysis. All images passed image quality checks and were processed for manual segmentation of the spleen by image analysts, followed by an over-read by trained radiologists. The spleen volume was calculated as the sum of spleen cross-sectional area across all slices multiplied by slice interval. For ARV analysis, the images were presented to the same readers in a blinded fashion at least three weeks after the initial review. For IRV analysis, images read by a primary reader were then presented to the secondary reader. The percent discrepancy for ARV and IRV were calculated as the ratio of difference between primary and secondary spleen volumes, divided by the average of the two. The average ARV discrepancy was 0.37±0.55 % (mean±standard deviation) as shown in Fig 1a. Zero subjects had an ARV discrepancy of more than 5%. As shown in Fig 2a, majority of the cases were under an ARV discrepancy of 1%. These results show excellent consistency in approach of readers over time in comparison to 2.8±3.5% reportedby Harris et al (European Journal of Radiology, 2010). For IRV, the average discrepancy was 0.62±0.85 % as shown in Fig 1b. 1.1% of cases had an IRV discrepancy of more than 5%. As shown in Fig 2b, most of the cases were within an ARV discrepancy of 1%. These results show a high level of alignment between readers in their imaging review approach in comparison to 6.4±9.8% reportedby Harris et al (European Journal of Radiology, 2010). The high level of reliability and repeatability seen across radiological reads suggests that a single read model is sufficient to assess imaging volumetrics-based endpoints. It is important to note that a multi-step approach was used to thoroughly train, test and monitor independent readers throughout the study duration. Readers were chosen based on high level of experience with the indication and analysis application. Reader onboarding involved an accurate overview and clear instruction on the review assessments. Multiple MRI/ CT imaging cases were utilized for reader testing and training. Since image quality can be a significant factor influencing the confidence level of a reader, these cases reflected examples of imaging artifacts expected on such trials, such as motion artifacts, low image resolution, ghosting and low contrast to noise ratio. Routine quality checks and variability assessments were done throughout the trial duration, with prompt corrective action taken to prevent inaccuracy of study results. These actions included issuing training points or re-read of cases that contained established error. Further work is necessary on assessing how variables such as spleen size, imaging artifacts and change in imaging modality affect reader variability. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

Apportionment of Impairment from Meniscal Tears and Knee Arthritis

2013 ◽  
Vol 18 (5) ◽  
pp. 1-10 ◽  
Author(s):  
Charles N. Brooks ◽  
James B. Talmage
Keyword(s):  
Medial Meniscus ◽  
Degenerative Joint Disease ◽  
Joint Disease ◽  
Detailed Knowledge ◽  
Meniscal Tears ◽  
Knee Arthritis ◽  
Degenerative Arthritis ◽  
Study Results ◽  
Physical Findings ◽  
Causation Analysis

Abstract Meniscal tears and osteoarthritis (osteoarthrosis, degenerative arthritis, or degenerative joint disease) are two of the most common conditions involving the knee. This article includes definitions of apportionment and causes; presents a case report of initial and recurrent tears of the medial meniscus plus osteoarthritis (OA) in the medial compartment of the knee; and addresses questions regarding apportionment. The authors, experienced impairment raters who are knowledgeable regarding the AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), show that, when instructions on impairment rating are incomplete, unclear, or inconsistent, interrater reliability diminishes (different physicians may derive different impairment estimates). Accurate apportionment of impairment is a demanding task that requires detailed knowledge of causation for the conditions in question; the mechanisms of injury or extent of exposures; prior and current symptoms, functional status, physical findings, and clinical study results; and use of the appropriate edition of the AMA Guides. Sometimes the available data are incomplete, requiring the rating physician to make assumptions. However, if those assumptions are reasonable and consistent with the medical literature and facts of the case, if the causation analysis is plausible, and if the examiner follows impairment rating instructions in the AMA Guides (or at least uses a rational and hence defensible method when instructions are suboptimal), the resulting apportionment should be credible.

Planned Home Births Safe, Study Results Suggest

Ob Gyn News ◽  
2005 ◽  
Vol 40 (14) ◽  
pp. 11
Author(s):  
MICHELE G. SULLIVAN
Keyword(s):  
Home Births ◽  
Study Results
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