scholarly journals Towards Interoperable Clinical Trial Registries: Design and Implementation of a Prototypical Registry based on Fast Healthcare Interoperability Resources (FHIR) (Preprint)

2020 ◽  
Author(s):  
Christian Gulden ◽  
Romina Blasini ◽  
Azadeh Nassirian ◽  
Alexandra Stein ◽  
Fatma Betül Altun ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Storage ◽  
Data Exchange ◽  
Data Entry ◽  
University Hospitals ◽  
Local Study ◽  
Manual Task ◽  
Clinical Trial Registries ◽  
Health Level 7

BACKGROUND Clinical trial registries increase transparency in medical research by making information and results of planned, ongoing, and completed studies publicly available. However, the registration of clinical trials remains a time-consuming manual task complicated by the fact that often the same studies need to be registered in different registries with different data entry requirements and interfaces. OBJECTIVE Investigate how Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) may be used as a standardized format for exchanging and storing clinical trial records. METHODS We designed and prototypically implemented an open-source central trial registry containing records from university hospitals which are automatically exported and updated by local study management systems. RESULTS We provide an architecture and implementation of a multi-site clinical trials registry based on HL7 FHIR as a data storage and exchange format. CONCLUSIONS The results show that FHIR resources establish a harmonized view of study information from heterogeneous sources by enabling automated data exchange between trial centers and central study registries.

scholarly journals Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Perrine Créquit ◽  
Isabelle Boutron
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Study ◽  
Primary Source ◽  
European Medicines Agency ◽  
Clinical Trial Registries ◽  
Number Of Patients ◽  
Journal Publications ◽  
Clinical Study Reports ◽  
Completeness Of Reporting

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.

scholarly journals Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053096
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

ObjectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.DesignCross-sectional study.SettingThe COVID-19 clinical trial landscape.Participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.Main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.ResultsFollowing automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n=25) followed by journal articles (n=18), and results on a registry (n=2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%.ConclusionCOVID-19 trials completed during the first 6 months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.

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 Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yorokpa Joachim Doua ◽  
Hanneke Dominicus ◽  
Julius Mugwagwa ◽  
Suzelle Magalie Gombe ◽  
Jude Nwokike
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Assurance ◽  
Clinical Trial Registries ◽  
Post Marketing ◽  
Major Clinical Trial

scholarly journals Rare use of patient-reported outcomes in childhood cancer clinical trials – a systematic review of clinical trial registries

2021 ◽  
Vol 152 ◽  
pp. 90-99
Author(s):  
David Riedl ◽  
Maria Rothmund ◽  
Anne-Sophie Darlington ◽  
Samantha Sodergren ◽  
Roman Crazzolara ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Childhood Cancer ◽  
Patient Reported Outcomes ◽  
Cancer Clinical Trials ◽  
Clinical Trial Registries ◽  
Patient Reported

scholarly journals Clinical trials history & trends in Qatar

2021 ◽  
Vol 2021 (2) ◽  
Author(s):  
Ahmed Soliman Mohamed ◽  
Ralph Christian Cosme Villar ◽  
Abdulqadir Jeprel Nashwan
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Contribution Rate ◽  
Mena Region ◽  
Microsoft Excel ◽  
Noticeable Increase ◽  
Clinical Trial Registries ◽  
Advanced Search ◽  
Number Of Publications ◽  
Economical Growth

Background: Clinical trial registries ensure the transparency and accountability of clinical trials (CTs) internationally. It is important to safeguard the public's safety through the delivery of quality clinical research. Since the start of the COVID-19 pandemic there has been a tremendous increase in the number of CTs globally. The MENA region has an opportunity to increase its overall contribution to CTs, which is less than 1%, in particular, through Qatar given its substantial economical growth and healthcare advancements. This review aims to explore the characteristics of clinical trials performed in Qatar, registered on ClinicalTrials.gov. Methods: The ClinicalTrials.gov registry was searched for trials conducted in Qatar using the appropriate keywords and advanced search options. Data retrieved was downloaded and sorted within Microsoft Excel then reviewed by two independent co-investigators. Results: The preliminary search yielded 143 entries with 32.1% (46) registered as multisite trials. The first trial in Qatar was registered in 2005. There has been a noticeable increase in CTs with its peak in 2020 , with currently 39.1% (9) of registered CTs on COVID-19; 83% of the completed studies were published, with the highest number of publications (8) in 2020 . Several specialties contributed to the CTs, with the highest participation and contribution rate of 31 CTs being in the field of pediatrics. Furthermore, some variations were found in recruitment status as reflected in with ∼65% (93) of studies being interventional and ∼35% being observational. Conclusion: The CTs conducted in Qatar are still relatively low despite the rapidly evolving healthcare system. Immediate updates and follow-ups could be considered by research investigators in Qatar with regards to CTs registration and updating. Further analysis is needed to elucidate the discrepancy of CTs reporting and to increase the contribution of CTs from Qatar to improve the health of its people.

Global drug development in cancer: A cross-sectional study of clinical trial registries

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2520-2520
Author(s):  
P. Hertz ◽  
B. Seruga ◽  
L. W. Le ◽  
I. F. Tannock
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Development ◽  
Phase Ii ◽  
New Drugs ◽  
Phase Iii ◽  
Cancer Site ◽  
Cancer Type ◽  
Clinical Trial Registries ◽  
Global Drug Development

2520 Background: Clinical trials are increasingly funded by industry. High costs of drug development may lead to attempts to develop new drugs in more ‘profitable’ (i.e., more prevalent) as compared to ‘less profitable’ (i.e., more deadly) cancers. Here we determine the focus of current global drug development. Methods: We determined characteristics of phase II and III clinical trials evaluating new drugs in oncology, which were registered with WHO International Clinical Trial Registries between 01/2008 and 06/2008. Estimates of incidence, mortality, and prevalence in the more- and less-developed world (MDW, LDW) were obtained from GLOBOCAN 2002. Simple correlation analysis was performed between the number of clinical trials and incidence, mortality and prevalence per cancer site after log transformation of variables. Results: We identified 399 newly registered trials. Of 374 trials with information about recruitment, 322 (86.1%) and 39 (10.4%) recruited patients only from the MDW and LDW, respectively, while 13 (3.5%) had worldwide recruitment. 229 (58%) of trials were sponsored by industry and 324 trials were phase II (81%). Most trials (and most phase III trials) evaluated treatments for globally prevalent cancers: breast, lung, prostate, and colorectal cancer (Table). Prevalence of a particular cancer type in both the MDW and LDW correlated significantly with the number of clinical trials (Pearson r = 0.63 and 0.55; p = 0.01 and 0.03, respectively). In contrast, mortality in the MDW (Pearson r = 0.73; p= 0.002), but not in the LDW (Pearson r = 0.38; p= 0.17), correlated significantly with the number of clinical trials. Conclusions: Global drug development in cancer predominates in globally prevalent cancers, which are a more important cause of mortality in the MDW than in the LDW. Cancer sites that are major killers globally, and especially in the LDW (e.g., stomach, liver, and esophageal cancer) should receive priority for clinical research. [Table: see text] No significant financial relationships to disclose.

scholarly journals Therapeutic Application of Chloroquine and Hydroxychloroquine in Clinical Trials for COVID-19: A systematic review

2020 ◽  
Author(s):  
Divya RSJB Rana ◽  
Santosh Dulal
Keyword(s):  
Public Health ◽  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Virus Disease ◽  
Global Public Health ◽  
Therapeutic Application ◽  
Clinical Trial Registries ◽  
Corona Virus

AbstractThe corona virus disease -2019 (COVID-19) pandemic has caused a massive global public health havoc. Recent published clinical trials show conflicting data for use of chloroquine/hydroxychloroquine for COVID-19. This study meticulously evaluated the various dosages of chloroquine and hydroxychloroquine utilized in clinical trials registered in Chinese and US clinical trial registries for the treatment of pneumonia caused by SARS-CoV-2. Moreover, the results of published clinical trials and in vitro studies using chloroquine and hydroxychloroquine relevant to the disease are discussed.

Clintrial Refer- a Mobile App To Connect Patients With Local Clinical Trials

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5600-5600
Author(s):  
Judith Trotman ◽  
Xavier Badoux ◽  
Admir Huseincehajic ◽  
Michele Gambrill ◽  
Anais LeGall ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Data Entry ◽  
Smart Phone ◽  
Mobile App ◽  
Research Network ◽  
Trial Participation ◽  
Time Data ◽  
App Development

Abstract Background Readily accessible, smart-phone applications (Apps) have the potential to revolutionise and improve the delivery of patient care. Significant challenges associated with recruiting patients to haematology clinical trials include the rarity of diseases, complexity of trials, limited site locations, and maintaining knowledge of current trials in the context of rapid therapeutic developments. The Haematology Clinical Research Network, of New South Wales and the Australian Capital Territory (NSW/ACT) aimed to develop an App to facilitate clinician and patient access to current information on local clinical trials and improve trial participation by increasing referrals. Methods Key objectives were to develop an App that was free to download, simple to use and effective. Only publically listed data was to be included. Endpoints were rates of App usage, and cross-site and internal clinical trial referrals. Through liaison between the end-users (clinicians, trial managers and patients), and the contracted software developer, App specifications were refined through successive iterations. With the key search filters of Disease, Location, Sponsor and Study Status, the App has an easy to navigate listing of currently recruiting haematology trials. Useful features include: listing of inclusion and exclusion criteria; direct links to ClinTrials.gov; a lay summary; and direct contacts from the mobile device to participating study sites. Real-time data entry into the database app manager ensures currency of trial information. Results ClinTrial Refer went live in May 2013, on both iOS and Android platforms. As at 10th August, ClinTrial Refer has 654 users, over 4358 sessions and 13924 screen views.91% of current users are repeat users. Despite its local application the App has been accessed in 46 countries. Among the target audience in NSW 290 repeat users returned for an average 11 sessions each indicating a high user acceptance. It is being endorsed on the websites of Australian blood cancer consumer groups. A survey has confirmed that since its launch, through having readily accessible data on their smart-phones, ClinTrial Refer has increased clinician awareness of the NSW trial portfolio. In just twelve weeks it has resulted in the cross-referral of an additional 30+ patients for clinical trials, representing a >300% increase over previous referral patterns. This improvement in trials knowledge management has also increased within-site recruitment; however it is harder to quantify the exact short-term impact of ClinTrial Refer within hospitals. The App has already been duplicated for other Australian state-wide haematology networks and the Adolescent & Young Adult Research Network, NSW. Conclusion ClinTrial Refer is an innovative but simple, readily accessible mobile Application. Its widespread adoption across 18 Haematology Clinical Research sites in NSW Australia is facilitating increased patient recruitment to trials. Only recently available on iTunes and Google Play, it has attracted national and international attention as a template for any clinical trial network portfolio. Disclosures: Trotman: Celgene: Grant for App development Other. Huseincehajic:Celgene: Grant for App development Other.

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