scholarly journals Safety and Effectiveness of Favipiravir for Novel Coronavirus (COVID-19): A Rapid Review of Available Evidence

2021 ◽  
Author(s):  
Mohammadreza Mobinizadeh ◽  
Morteza Arab-Zozani
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Therapeutic Potential ◽  
Data Extraction ◽  
Rapid Review ◽  
Eligibility Criteria ◽  
Clinical Trial Registration ◽  
Registration System ◽  
Novel Coronavirus ◽  
First Time

Context: Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) appeared for the first time in December 2019 in Wuhan, China. Due to the lack of unified and integrated evidence for Favipiravir, this study was conducted to rapidly review the existing evidence to help evidence-based decision-making on the therapeutic potential of this drug in the treatment of COVID-19 patients. Evidence Acquisition: This study is a rapid Health Technology Assessment (HTA). By searching pertinent databases, the research team collected relevant articles and tried to create a policy guide through a thematic approach. This rapid review was done in four steps: (1) Searching for evidence through databases; (2) screening the evidence considering eligibility criteria; (3) data extraction; and (4) analyzing the data through thematic analysis. Results: After applying the inclusion criteria, four studies were finally found, including three review studies and a clinical trial that was temporarily removed by its publisher from the journal’s website. After searching the sources mentioned in the articles, two ongoing clinical trials were found in China. Also, by searching the clinical trial website, www.clinicaltrials.gov, five clinical trials were found in the search. The result of the search in the clinical trial registration system in Iran showed a study that is in the process of patient recruitment. A limited number of other articles were found, mostly in the form of reflections from physicians or researchers and letters to editors who have predicted the drug’s performance on SARS-CoV-2, which needs further clinical study to be approved. Conclusions: With the available evidence, it is not possible to make a definite conclusion about the safety and efficacy of Favipiravir in the treatment of patients with COVID-19.

scholarly journals Safety and Efficacy of Remdesivir for the Treatment of Covid-19: A Rapid Review of Available Evidence

2021 ◽  
Author(s):  
Zahra Gharibnaseri ◽  
Alireza Olyaeemanesh
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Registration ◽  
Rapid Review ◽  
Cochrane Library ◽  
Compassionate Use ◽  
Clinical Trial Registration ◽  
Registration System ◽  
Safety And Efficacy ◽  
Number Of Patients

Context: Remdesivir is an antiviral drug manufactured by Gilead Sciences, Inc., in which in-vitro studies have been shown to work in COVID-19 patients. Although it’s not approved by pharmaceutical authorities and has not passed the first and second phases of clinical trials, it is prescribed on a trial basis for patients with Covid-19. In more than 20 countries, researchers are monitoring the results of using Remdesivir in clinical settings to see if it can be prescribed for larger populations if patients respond positively. Methods: This is a rapid review of the evidence for the potential effects of Remdesivir, which intended to create a policy guide. To do so, health technology assessment studies indexed in MEDLINE and Cochrane Library databases were searched using the keywords, including drug name and disease name, on April 21, 2020. In addition, references of retrieved studies were checked to ensure throughout the capture of the literature. Studies on the safety and efficacy of Remdesivir in Covid-19 patients, both in Persian or English, were included. To identify ongoing clinical trials in Iran and some countries, clinical trial registration systems were also searched. Results: In total 90 titles were identified, which after removing duplicates and applying inclusion criteria, 32 were included, all of which were published in 2020. 25 of them were review studies, mostly on treating Covid-19 disease, and some of them were dedicated to the effects of Remdesivir in treating the disease. However, no systematic review was found. Of the remaining studies, three were finished clinical trials, two of which evaluated the safety and efficacy of Remdesivir on mild, moderate, and severe Covid-19 compared to a placebo, and the third study compared Remdesivir with routine treatment. A cohort study on the efficacy of Remdesivir in compassionate use was also found. Also, two case reports of patients receiving Remdesivir and a letter-to- editor describing Remdesivir as an appropriate treatment for Covid-19 were identified. Moreover, registered clinical trials with different designs intended to investigate the safety and efficacy of Remdesivir in treating Covid-19 were extracted from clinical trial registration systems (Table 3). In total 15 protocols were found, which 13 were in primary stages. The other two were in phase three of clinical trials and aimed to investigate the effect of Remdesivir in treating patients with severe, moderate, or mild Covid-19. In the clinical trial registration system, it is mentioned that the first study is stopped prematurely due to the lack of a sufficient number of patients, and the second study is also suspended. Conclusions: Evidence on the safety and efficacy of Remdesivir in treating Covid-19 are very limited to make a decision. However, if registered trials are completed, enough evidence would be available to decide whether to accept or reject the Remdesivir. Since the effectiveness of Remdesivir is not clear yet, its prescription for Covid-19 patients has so far been limited to clinical trials, compassionate use, or emergency use.

scholarly journals Measuring frailty in younger populations: a rapid review of evidence

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e047051
Author(s):  
Gemma F Spiers ◽  
Tafadzwa Patience Kunonga ◽  
Alex Hall ◽  
Fiona Beyer ◽  
Elisabeth Boulton ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Predictive Validity ◽  
Data Extraction ◽  
Grey Literature ◽  
Frailty Index ◽  
Study Data ◽  
Rapid Review ◽  
Eligibility Criteria ◽  
Adult Age ◽  
The Impact

ObjectivesFrailty is typically assessed in older populations. Identifying frailty in adults aged under 60 years may also have value, if it supports the delivery of timely care. We sought to identify how frailty is measured in younger populations, including evidence of the impact on patient outcomes and care.DesignA rapid review of primary studies was conducted.Data sourcesFour databases, three sources of grey literature and reference lists of systematic reviews were searched in March 2020.Eligibility criteriaEligible studies measured frailty in populations aged under 60 years using experimental or observational designs, published after 2000 in English.Data extraction and synthesisRecords were screened against review criteria. Study data were extracted with 20% of records checked for accuracy by a second researcher. Data were synthesised using a narrative approach.ResultsWe identified 268 studies that measured frailty in samples that included people aged under 60 years. Of these, 85 studies reported evidence about measure validity. No measures were identified that were designed and validated to identify frailty exclusively in younger groups. However, in populations that included people aged over and under 60 years, cumulative deficit frailty indices, phenotype measures, the FRAIL Scale, the Liver Frailty Index and the Short Physical Performance Battery all demonstrated predictive validity for mortality and/or hospital admission. Evidence of criterion validity was rare. The extent to which measures possess validity across the younger adult age (18–59 years) spectrum was unclear. There was no evidence about the impact of measuring frailty in younger populations on patient outcomes and care.ConclusionsLimited evidence suggests that frailty measures have predictive validity in younger populations. Further research is needed to clarify the validity of measures across the adult age spectrum, and explore the utility of measuring frailty in younger groups.

scholarly journals Identifying enablers and barriers to referral, uptake and completion of lifestyle modification programmes: a rapid literature review

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e045094
Author(s):  
Yvonne Zurynski ◽  
Carolynn Smith ◽  
Joyce Siette ◽  
Bróna Nic Giolla Easpaig ◽  
Mary Simons ◽  
...  
Keyword(s):  
Chronic Disease ◽  
Lifestyle Modification ◽  
Data Extraction ◽  
Empirical Studies ◽  
Grey Literature ◽  
International Health ◽  
Rapid Review ◽  
Eligibility Criteria ◽  
Relevant Evidence ◽  
Literature Reviews

ObjectiveTo identify current, policy-relevant evidence about barriers and enablers associated with referral, uptake and completion of lifestyle modification programmes (LMPs) for secondary prevention of chronic disease in adults.DesignA rapid review, co-designed with policymakers, of peer-reviewed and grey literature using a modified Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework.Data sourcesMedline, Embase, Scopus, PsycINFO and CINAHL were searched for relevant studies and literature reviews. Grey literature was identified through Advanced Google searching and targeted searching of international health departments’ and non-government organisations’ websites.Eligibility criteria for selecting studiesDocuments published 2010–2020, from high-income countries, reporting on programmes that included referral of adults with chronic disease to an LMP by a health professional (HP).Data extraction and synthesisData from grey and peer-reviewed literature were extracted by two different reviewers. Extracted data were inductively coded around emergent themes. Regular meetings of the review group ensured consistency of study selection and synthesis.ResultsTwenty-nine documents were included: 14 grey literature, 11 empirical studies and four literature reviews. Key barriers to HPs referring patients included inadequate HP knowledge about LMPs, perceptions of poor effectiveness of LMPs and perceptions that referral to LMPs was not part of their role. Patient barriers to uptake and completion included poor accessibility and lack of support to engage with the LMPs. Enablers to HP referral included training/education, effective interdisciplinary communication and influential programme advocates. Support to engage with LMPs after HP referral, educational resources for family members and easy accessibility were key enablers to patient engagement with LMPs.ConclusionsFactors related to HPs’ ability and willingness to make referrals are important for the implementation of LMPs, and need to be coupled with support for patients to engage with programmes after referral. These factors should be addressed when implementing LMPs to maximise their impact.

A Framework for Systematic Assessment of Clinical Trial Population Representativeness Using Electronic Health Records Data

2021 ◽  
Vol 12 (04) ◽  
pp. 816-825
Author(s):  
Yingcheng Sun ◽  
Alex Butler ◽  
Ibrahim Diallo ◽  
Jae Hyun Kim ◽  
Casey Ta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Electronic Health Records ◽  
The United States ◽  
Design Stage ◽  
Common Data Model ◽  
Free Text ◽  
Eligibility Criteria ◽  
Health Records ◽  
Electronic Health

Abstract Background Clinical trials are the gold standard for generating robust medical evidence, but clinical trial results often raise generalizability concerns, which can be attributed to the lack of population representativeness. The electronic health records (EHRs) data are useful for estimating the population representativeness of clinical trial study population. Objectives This research aims to estimate the population representativeness of clinical trials systematically using EHR data during the early design stage. Methods We present an end-to-end analytical framework for transforming free-text clinical trial eligibility criteria into executable database queries conformant with the Observational Medical Outcomes Partnership Common Data Model and for systematically quantifying the population representativeness for each clinical trial. Results We calculated the population representativeness of 782 novel coronavirus disease 2019 (COVID-19) trials and 3,827 type 2 diabetes mellitus (T2DM) trials in the United States respectively using this framework. With the use of overly restrictive eligibility criteria, 85.7% of the COVID-19 trials and 30.1% of T2DM trials had poor population representativeness. Conclusion This research demonstrates the potential of using the EHR data to assess the clinical trials population representativeness, providing data-driven metrics to inform the selection and optimization of eligibility criteria.

scholarly journals Are clinical trial eligibility criteria an accurate reflection of a real-world population of advanced non-small-cell lung cancer patients?

2018 ◽  
Vol 25 (4) ◽  
Author(s):  
K. Al-Baimani ◽  
H. Jonker ◽  
T. Zhang ◽  
G.D. Goss ◽  
S.A. Laurie ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Small Cell Lung ◽  
Eligibility Criteria ◽  
Ecog Ps

Background Advanced non-small-cell lung cancer (nsclc) represents a major health issue globally. Systemic treatment decisions are informed by clinical trials, which, over years, have improved the survival of patients with advanced nsclc. The applicability of clinical trial results to the broad lung cancer population is unclear because strict eligibility criteria in trials generally select for optimal patients.Methods We performed a retrospective chart review of all consecutive patients with advanced nsclc seen in outpatient consultation at our academic institution between September 2009 and September 2012, collecting data about patient demographics and cancer characteristics, treatment, and survival from hospital and pharmacy records. Two sets of arbitrary trial eligibility criteria were applied to the cohort. Scenario A stipulated Eastern Cooperative Oncology Group performance status (ecog ps) 0–1, no brain metastasis, creatinine less than 120 μmol/L, and no second malignancy. Less-strict scenario B stipulated ecog ps 0–2 and creatinine less than 120 μmol/L. We then used the two scenarios to analyze treatment and survival of patients by trial eligibility status.Results The 528 included patients had a median age of 67 years, with 55% being men and 58% having adenocarcinoma. Of those 528 patients, 291 received at least 1 line of palliative systemic therapy. Using the scenario A eligibility criteria, 73% were trial-ineligible. However, 46% of “ineligible” patients actually received therapy and experienced survival similar to that of the “eligible” treated patients (10.2 months vs. 11.6 months, p = 0.10). Using the scenario B criteria, only 35% were ineligible, but again, the survival of treated patients was similar in the ineligible and eligible groups (10.1 months vs. 10.9 months, p = 0.57).Conclusions Current trial eligibility criteria are often strict and limit the enrolment of patients in clinical trials. Our results suggest that, depending on the chosen drug, its toxicities and tolerability, eligibility criteria could be carefully reviewed and relaxed.

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

scholarly journals Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals

2013 ◽  
Vol 29 (6) ◽  
pp. 1095-1100 ◽  
Author(s):  
Ludovic Reveiz ◽  
Eleana Villanueva ◽  
Chimaraoke Iko ◽  
Iveta Simera
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Latin American ◽  
Randomized Clinical Trials ◽  
Reporting Guidelines ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Biomedical Journals ◽  
The Caribbean ◽  
Latin American And Caribbean

The objective of this study was to determine to what extent Latin American and Caribbean biomedical journals have endorsed and complied with clinical trial registration and reporting guidelines. A search of randomized clinical trials was carried out using the LILACS database. The randomized clinical trials identified through the search were assessed to determine whether trial registration and CONSORT guidance was mentioned. Information regarding endorsement of the ICMJE, trial registration and other reporting guidelines was extracted from the online instructions for authors of the journals included in the study. The search identified 477 references. We assessed a random sample of 240 titles of which 101 were randomized clinical trials published in 56 journals. Trial registration was reported in 19.8% of the randomized clinical trials, 6.9% were prospectively registered and 3% mentioned CONSORT. The ICMJE was mentioned by 68% of the journals and 36% of journals required trial registration. Fewer journals provided advice on reporting guidelines: CONSORT (13%), PRISMA (1.8%), STROBE (1.8%), and the EQUATOR network (3.6%). Wider endorsement of trial registration and adherence to reporting guidelines is necessary in clinical trials conducted in Latin America and the Caribbean.

scholarly journals 2166

2017 ◽  
Vol 1 (S1) ◽  
pp. 12-12
Author(s):  
Jianyin Shao ◽  
Ram Gouripeddi ◽  
Julio C. Facelli
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Power Distribution ◽  
Large Scale ◽  
Search Space ◽  
Free Text ◽  
Eligibility Criteria ◽  
Clinical Notes ◽  
Semantic Concepts ◽  
Mimic Iii

OBJECTIVES/SPECIFIC AIMS: This poster presents a detailed characterization of the distribution of semantic concepts used in the text describing eligibility criteria of clinical trials reported to ClincalTrials.gov and patient notes from MIMIC-III. The final goal of this study is to find a minimal set of semantic concepts that can describe clinical trials and patients for efficient computational matching of clinical trial descriptions to potential participants at large scale. METHODS/STUDY POPULATION: We downloaded the free text describing the eligibility criteria of all clinical trials reported to ClinicalTrials.gov as of July 28, 2015, ~195,000 trials and ~2,000,000 clinical notes from MIMIC-III. Using MetaMap 2014 we extracted UMLS concepts (CUIs) from the collected text. We calculated the frequency of presence of the semantic concepts in the texts describing the clinical trials eligibility criteria and patient notes. RESULTS/ANTICIPATED RESULTS: The results show a classical power distribution, Y=210X(−2.043), R2=0.9599, for clinical trial eligibility criteria and Y=513X(−2.684), R2=0.9477 for MIMIC patient notes, where Y represents the number of documents in which a concept appears and X is the cardinal order the concept ordered from more to less frequent. From this distribution, it is possible to realize that from the over, 100,000 concepts in UMLS, there are only ~60,000 and 50,000 concepts that appear in less than 10 clinical trial eligibility descriptions and MIMIC-III patient clinical notes, respectively. This indicates that it would be possible to describe clinical trials and patient notes with a relatively small number of concepts, making the search space for matching patients to clinical trials a relatively small sub-space of the overall UMLS search space. DISCUSSION/SIGNIFICANCE OF IMPACT: Our results showing that the concepts used to describe clinical trial eligibility criteria and patient clinical notes follow a power distribution can lead to tractable computational approaches to automatically match patients to clinical trials at large scale by considerably reducing the search space. While automatic patient matching is not the panacea for improving clinical trial recruitment, better low cost computational preselection processes can allow the limited human resources assigned to patient recruitment to be redirected to the most promising targets for recruitment.

scholarly journals Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025218 ◽  
Author(s):  
Xuan Zhang ◽  
Ran Tian ◽  
Zhen Yang ◽  
Chen Zhao ◽  
Liang Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Reporting Rate ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Data Set

ObjectiveThis study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.MethodsThe ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.ResultsA total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.ConclusionThe registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

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