scholarly journals Identifying Core Outcome Sets in COVID-19 Clinical Trials Using ClinicalTrials.gov

2021 ◽  
Author(s):  
Irena Parvanova ◽  
Joseph Finkelstein
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Evidence Synthesis ◽  
Initial Assessment ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Trial Outcomes ◽  
Secondary Outcomes ◽  
Structured Representation ◽  
Expensive Process

Introduction of core outcome sets (COS) facilitates evidence synthesis, transparency in outcome reporting, and standardization in clinical research. However, development of COS may be a time consuming and expensive process. Publicly available repositories, such as ClinicalTrials.gov (CTG), provide access to a vast collection of clinical trial characteristics including primary and secondary outcomes, which can be analyzed using a comprehensive set of tools. With growing number of COVID-19 clinical trials, COS development may provide crucial means to standardize, aggregate, share, and analyze diverse research results in a harmonized way. This study was aimed at initial assessment of utility of CTG analytics for identifying COVID-19 COS. At the time of this study, January, 2021, we analyzed 120 ongoing NIH-funded COVID-19 clinical trials initiated in 2020 to inform COVID-19 COS development by evaluating and ranking clinical trial outcomes based on their structured representation in CTG. Using this approach, COS comprised of 25 major clinical outcomes has been identified with mortality, mental health status, and COVID-19 antibodies at the top of the list. We concluded that CTG analytics can be instrumental for COVID-19 COS development and that further analysis is warranted including broader number of international trials combined with more granular approach and ontology-driven pipelines for outcome extraction and curation.

scholarly journals Patient involvement to inform the design of a clinical trial in postbariatric hypoglycaemia

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Matthias Hepprich ◽  
Marc Y. Donath ◽  
Lars G. Hemkens
Keyword(s):  
Quality Of Life ◽  
Bariatric Surgery ◽  
Clinical Trial ◽  
Primary Outcome ◽  
Evidence Based ◽  
Core Outcome ◽  
Online Questionnaire ◽  
Core Outcome Sets ◽  
German Speaking

Abstract Background Bariatric surgery may lead to symptomatic postprandial hypoglycaemia as a major side effect without established therapy so far. We aimed to develop an evidence-based study design of a clinical trial that tests treatment options and can provide useful patient-relevant evidence. Methods We searched systematically for guidance of core outcome sets to determine the most relevant types of outcomes and duration of such a trial. Our search comprised literature databases, a database of core outcome sets and self-help organizations. We then developed a simple online questionnaire based on interviews with German-speaking patients with postprandial hypoglycaemia after bariatric surgery. We recruited participants by reaching out to all German speaking endocrinologists in Switzerland and large Swiss bariatric centres. We asked for preferences regarding outcome types and acceptable duration of being included in a corresponding clinical trial. Results The literature search did not identify evidence-based guidance for informing our study design. Experience of clinical and research routine as well as patient interviews helped in identifying potential outcomes and the design of an online questionnaire. Therein, a total of 29 persons started the questionnaire and 22 answered questions related to the primary outcome. Of these, 17 (77.3%) deemed quality of life more relevant as primary outcome than the rate of hypoglycaemic episodes. A trial length of four weeks or longer was regarded as acceptable for 19 of 21 respondents to this question (91.4%) and of six months or longer for 12 respondents (56%). Conclusions In situations with no other guidance, a simple questionnaire may help to inform trial design decisions. This study identifies a patient preference for “quality of life” as a primary outcome and supports the evidence-based conception of a patient-centred clinical trial in postbariatric hypoglycaemia.

scholarly journals Integrated deep learned transcriptomic and structure-based predictor of clinical trials outcomes

2016 ◽  
Author(s):  
Artem V. Artemov ◽  
Evgeny Putin ◽  
Quentin Vanhaelen ◽  
Alexander Aliper ◽  
Ivan V. Ozerov ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Systems Biology ◽  
Phase I ◽  
Biological Data ◽  
Drug Induced ◽  
Multi Stage ◽  
Pathway Activation ◽  
Trial Outcomes ◽  
Analytical Tools

AbstractDespite many recent advances in systems biology and a marked increase in the availability of high-throughput biological data, the productivity of research and development in the pharmaceutical industry is on the decline. This is primarily due to clinical trial failure rates reaching up to 95% in oncology and other disease areas. We have developed a comprehensive analytical and computational pipeline utilizing deep learning techniques and novel systems biology analytical tools to predict the outcomes of phase I/II clinical trials. The pipeline predicts the side effects of a drug using deep neural networks and estimates drug-induced pathway activation. It then uses the predicted side effect probabilities and pathway activation scores as an input to train a classifier which predicts clinical trial outcomes. This classifier was trained on 577 transcriptomic datasets and has achieved a cross-validated accuracy of 0.83. When compared to a direct gene-based classifier, our multi-stage approach dramatically improves the accuracy of the predictions. The classifier was applied to a set of compounds currently present in the pipelines of several major pharmaceutical companies to highlight potential risks in their portfolios and estimate the fraction of clinical trials that were likely to fail in phase I and II.

scholarly journals Development of Core Outcome Sets for Clinical Trials in Temporomandibular Disorders 

2022 ◽  
Author(s):  
Natália dos Reis Ferreira ◽  
Carlos Miguel Marto ◽  
Aleli Tôrres Oliveira ◽  
Maria João Rodrigues ◽  
Marcos Fabio DosSantos
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Temporomandibular Disorder ◽  
Masticatory Muscles ◽  
Delphi Survey ◽  
Limiting Factor ◽  
Core Outcome ◽  
Masticatory Muscle ◽  
Core Outcome Sets ◽  
Muscle Disorders

Abstract Background Temporomandibular Disorder (TMD) is a generic term applied to describe musculoskeletal disorders that affect the temporomandibular joint (TMJ), the masticatory muscles and the related structures. TMD comprises two groups of disorders, namely intra-articular TMD and masticatory muscle disorders. There is still difficulty in establishing the effectiveness of different therapeutic modalities for TMD with robust evidence, despite the large volume of publications in the area. The lack of outcomes standardization may represent a limiting factor in the search for scientific evidence. Objective This study aims to develop a core outcome sets (COS) for clinical trials in intra-articular TMD and masticatory muscle disorders. Methods The protocol for determining the COS-TMD will consist of three phases: 1. Synthesis of TMD Management Intervention Outcomes. The identification of outcomes will be carried out through a systematic review, which will include randomized clinical trials that evaluated the effectiveness of interventions used in TMD management. 2. Through a two-round international Delphi survey, the list of outcomes will be scored by three panels of stakeholders. 3. A representative sample of key stakeholders will be invited to participate in a face-to-face meeting where they can discuss the results of the Delphi survey and determine the final core set. Conclusions The implementation of this protocol will determine the COS-TMD, which will be made available for use in all TMD clinical studies. The use of COS when planning and reporting TMD clinical trials will reduce the risk of publication bias and enable proper comparison of results found by different studies.

Core Outcome Sets for Clinical Trials in Dry Eye Disease

2018 ◽  
Vol 136 (10) ◽  
pp. 1180 ◽  
Author(s):  
Michael T. M. Wang ◽  
Jennifer P. Craig
Keyword(s):  
Clinical Trials ◽  
Dry Eye ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Core Outcome ◽  
Core Outcome Sets

Core Outcome Sets for Psoriasis Clinical Trials

2018 ◽  
Vol 154 (10) ◽  
pp. 1135
Author(s):  
Bruce E. Strober ◽  
Kenneth B. Gordon
Keyword(s):  
Clinical Trials ◽  
Core Outcome ◽  
Core Outcome Sets

Impact of direct physician-to-physician contact on accelerating oncology clinical trial accrual

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6613-6613
Author(s):  
J. R. Eckardt ◽  
N. Ku ◽  
A. DeMaggio ◽  
M. Reese ◽  
M. Levonyak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Current Model ◽  
Phase Iii ◽  
Initial Assessment ◽  
Phase Ii Trials ◽  
Physician Intervention ◽  
Physician Contact ◽  
Clinical Trial Accrual ◽  
Physician Awareness

6613 Background: The development of more effective oncology agents is critically dependent on the completion of clinical trials; currently, >4000 oncology trials listed in www.clinicaltrials.gov are accruing pts in the US. Unfortunately, only 3–5% of new cancer pts participate in clinical trials and most trials do not meet their projected accrual timelines. Barriers to pt accrual include physician awareness & attitudes, access to protocols, administrative burdens to conduct clinical trials, cost to physicians and pts, and pt concerns about participation in research trials. To overcome at least some of these barriers, we investigated a strategy to improve clinical trial accrual that optimizes trial placement and awareness through a direct physician to physician intervention. Methods: For each site, a customized enrollment plan is established after initial assessment of interest and accrual potential. Implementation of the enrollment plan includes clinical communications and medical support delivered through direct physician to physician interactions. From Feb 2008 to December 2008, we implemented this strategy to increase accrual to 5 oncology trials (2 placebo controlled randomized trials and 3 phase II trials in breast cancer, non-Hodgkin's lymphoma and soft tissue sarcoma). Results: The implementation of direct physician to physician intervention resulted in a measurable improvement of between 50 - 300% in the monthly accrual to each of these 5 trials. Despite being significantly behind projections, 2 of the trials have now completed accrual on schedule. In the ongoing phase III study, accrual has improved from an average of 3.8 pts/mo to 13.5 pts/mo. Conclusions: The use of our current model of optimizing trial placement and awareness through a direct physician to physician intervention has been successful in significantly accelerating clinical trial accrual in 5/5 trials initiated to date. [Table: see text] [Table: see text]

Outcome domains and measures for pain in psoriasis used in registered trials: analysis of studies on ClinicalTrials.gov

2021 ◽  
Author(s):  
Ana Sanader Vucemilovic ◽  
Livia Puljak
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Future Studies ◽  
Psoriasis Treatment ◽  
Trial Protocols ◽  
Secondary Outcomes ◽  
Study Designs

Aim: Psoriasis includes unpleasant symptoms such as pain. This study aimed to investigate whether clinical trials have domains related to pain in their study designs. Materials and methods: We analyzed all clinical trials about interventions for psoriasis treatment registered on ClinicalTrials.gov and the frequency of pain-related outcomes. Results: Our analysis included 1033 registered clinical trials. They had 1329 primary outcomes and 5457 secondary outcomes. The pain was used in six (0.6%) protocols as a primary outcome and 68 (6.5%) protocols as a secondary outcome. Conclusion: Pain as an outcome was used in few registered clinical trial protocols for the treatment of psoriatic conditions. Future studies should investigate why the trialists do not include pain among primary or secondary outcomes.

scholarly journals Clinical Trials in Precision Oncology

2016 ◽  
Vol 62 (3) ◽  
pp. 442-448 ◽  
Author(s):  
Susan M Mockus ◽  
Sara E Patterson ◽  
Cara Statz ◽  
Carol J Bult ◽  
Gregory J Tsongalis
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Egfr Mutation ◽  
Bioinformatics Analysis ◽  
Precision Oncology ◽  
Reporting Standards ◽  
Clinical Trial Registries ◽  
Genomics Research ◽  
Trial Outcomes ◽  
Programmatic Access

Abstract BACKGROUND Availability of genomic information used in the management of cancer treatment has outpaced both regulatory and reimbursement efforts. Many types of clinical trials are underway to validate the utility of emerging genome-based biomarkers for diagnostic, prognostic, and predictive applications. Clinical trials are a key source of evidence required for US Food and Drug Administration approval of therapies and companion diagnostics and for establishing the acceptance criteria for reimbursement. CONTENT Determining the eligibility of patients for molecular-based clinical trials and the interpretation of data emerging from clinical trials is significantly hampered by 2 primary factors: the lack of specific reporting standards for biomarkers in clinical trials and the lack of adherence to official gene and variant naming standards. Clinical trial registries need specifics on the mutation required for enrollment as opposed to allowing a generic mutation entry such as, “EGFR mutation.” The use of clinical trials data in bioinformatics analysis and reporting is also gated by the lack of robust, state of the art programmatic access support. An initiative is needed to develop community standards for clinical trial descriptions and outcome reporting that are modeled after similar efforts in the genomics research community. SUMMARY Systematic implementation of reporting standards is needed to insure consistency and specificity of biomarker data, which will in turn enable better comparison and assessment of clinical trial outcomes across multiple studies. Reporting standards will facilitate improved identification of relevant clinical trials, aggregation and comparison of information across independent trials, and programmatic access to clinical trials databases.

scholarly journals Developing core outcome sets for clinical trials: issues to consider

Trials ◽  
2012 ◽  
Vol 13 (1) ◽  
Author(s):  
Paula R Williamson ◽  
Douglas G Altman ◽  
Jane M Blazeby ◽  
Mike Clarke ◽  
Declan Devane ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Core Outcome ◽  
Core Outcome Sets
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