International Clinical Trial Day and clinical trials in Ethiopia and Africa

AbstractREMAP-CAP, a randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia, is an international clinical trial that is rapidly expanding its scope and scale in response to the COVID-19 pandemic. Japan is now joining REMAP-CAP with endorsement from Japanese academic societies. Commitment to REMAP-CAP can significantly contribute to population health through timely identification of optimal COVID-19 therapeutics. Additionally, it will promote the establishment of a national and global network of clinical trials to tackle future pandemics of emerging and re-emerging infectious diseases, in collaboration with multiple stakeholders, including front-line healthcare workers, governmental agencies, regulatory authorities, and academic societies.

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Planning the Size of Clinical Trials with Allowance for Patient Noncompliance

Methods of Information in Medicine ◽

10.1055/s-0038-1634787 ◽

1990 ◽

Vol 29 (03) ◽

pp. 243-246 ◽

Cited By ~ 2

Author(s):

M. A. A. Moussa

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Sample Size ◽

Event Rate ◽

Survival Functions ◽

Time Intervals ◽

Patient Noncompliance ◽

Event Rates ◽

Larger Sample

AbstractVarious approaches are considered for adjustment of clinical trial size for patient noncompliance. Such approaches either model the effect of noncompliance through comparison of two survival distributions or two simple proportions. Models that allow for variation of noncompliance and event rates between time intervals are also considered. The approach that models the noncompliance adjustment on the basis of survival functions is conservative and hence requires larger sample size. The model to be selected for noncompliance adjustment depends upon available estimates of noncompliance and event rate patterns.

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A review of international clinical trial registration

Journal of Chinese Integrative Medicine ◽

10.3736/jcim20070302 ◽

2007 ◽

Vol 5 (3) ◽

pp. 234-242 ◽

Cited By ~ 4

Author(s):

He Yu

Keyword(s):

Clinical Trial ◽

Trial Registration ◽

Clinical Trial Registration ◽

International Clinical Trial

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Inclusion of Minority Patients in Breast Cancer Clinical Trials: The Role of the Clinical Trial Environment

10.21236/ada509888 ◽

2009 ◽

Author(s):

Celia P. Kaplan

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Clinical Trials ◽

Cancer Clinical Trials

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Repurposed Antiviral Drugs for the Treatment of COVID-19: Syntheses, Mechanism of Infection and Clinical Trials

Mini-Reviews in Medicinal Chemistry ◽

10.2174/1389557521666201222145842 ◽

2020 ◽

Vol 21 ◽

Author(s):

Subha Sankar Paul ◽

Goutam Biswas

Keyword(s):

Public Health ◽

Clinical Trial ◽

Clinical Trials ◽

Small Molecule ◽

Mode Of Action ◽

Antiviral Drugs ◽

Public Health Emergency ◽

Advanced Stage ◽

Clinical Trial Results

: COVID-19 is a public health emergency of international concern. Although, considerable knowledge has been acquired with time about the viral mechanism of infection and mode of replication, yet no specific drugs or vaccines have been discovered against SARS-CoV-2, till date. There are few small molecule antiviral drugs like Remdesivir and Favipiravir which have shown promising results in different advanced stage of clinical trials. Chloroquinine, Hydroxychloroquine, and Lopinavir-Ritonavir combination, although initially was hypothesized to be effective against SARS-CoV-2, are now discontinued from the solidarity clinical trials. This review provides a brief description of their chemical syntheses along with their mode of action and clinical trial results available in Google and different peer reviewed journals till 24th October 2020.

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Clinical Trial Data Management Software: A Review of the Technical Features

Reviews on Recent Clinical Trials ◽

10.2174/1574887114666190207151500 ◽

2019 ◽

Vol 14 (3) ◽

pp. 160-172 ◽

Cited By ~ 1

Author(s):

Aynaz Nourani ◽

Haleh Ayatollahi ◽

Masoud Solaymani Dodaran

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Data Management ◽

Clinical Data ◽

Clinical Trial Data ◽

Trial Data ◽

Data Management System ◽

Management Systems ◽

Data Management Systems ◽

Technical Features

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

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The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

10.2196/preprints.17630 ◽

2019 ◽

Author(s):

Allison Hirsch ◽

Mahip Grewal ◽

Anthony James Martorell ◽

Brian Michael Iacoviello

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Scoping Review ◽

Digital Technologies ◽

Good Clinical Practice ◽

The United States ◽

Clinical Trial Research ◽

Digital Methods ◽

Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

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Digital Technology in Clinical Trials for Multiple Sclerosis: a systematic review. (Preprint)

10.2196/preprints.20670 ◽

2020 ◽

Author(s):

Marcello De Angelis ◽

Luigi Lavorgna ◽

Antonio Carotenuto ◽

Martina Petruzzo ◽

Roberta Lanzillo ◽

...

Keyword(s):

Multiple Sclerosis ◽

Clinical Trial ◽

Clinical Trials ◽

Outcome Measures ◽

Digital Technology ◽

Clinical Trial Design ◽

Motor Rehabilitation ◽

Robot Assisted ◽

Future Directions ◽

Treatment Side Effects

BACKGROUND Clinical trials in multiple sclerosis (MS) have leveraged the use of digital technology to overcome limitations in treatment and disease monitoring. OBJECTIVE To review the use of digital technology in concluded and ongoing MS clinical trials. METHODS In March 2020, we searched for “multiple sclerosis” and “trial” on pubmed.gov and clinicaltrials.gov using “app”, “digital”, “electronic”, “internet” and “mobile” as additional search words, separately. Overall, we included thirty-five studies. RESULTS Digital technology is part of clinical trial interventions to deliver psychotherapy and motor rehabilitation, with exergames, e-training, and robot-assisted exercises. Also, digital technology has become increasingly used to standardise previously existing outcome measures, with automatic acquisitions, reduced inconsistencies, and improved detection of symptoms. Some trials have been developing new patient-centred outcome measures for the detection of symptoms and of treatment side effects and adherence. CONCLUSIONS We will discuss how digital technology has been changing MS clinical trial design, and possible future directions for MS and neurology research.

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Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data

Clinical Rheumatology ◽

10.1007/s10067-020-05248-4 ◽

2020 ◽

Author(s):

Chak Sing Lau ◽

Yi-Hsing Chen ◽

Keith Lim ◽

Marc de Longueville ◽

Catherine Arendt ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Viral Hepatitis ◽

Central Europe ◽

Real World ◽

Certolizumab Pegol ◽

Safety Data ◽

Asia Pacific ◽

Hbv Reactivation ◽

Post Marketing

Abstract Introduction/objectives To evaluate the incidence rate (IR) of tuberculosis (TB) and viral hepatitis B and C (HBV/HCV) during certolizumab pegol (CZP) treatment, worldwide and in Asia-Pacific countries, across clinical trials and post-marketing reports (non-interventional studies and real-world practice). Method CZP safety data were pooled across 49 clinical trials from 1998 to June 2017. Post-marketing reports were from initial commercialization until March 2015 (TB)/February 2017 (HBV/HCV). All suspected TB and HBV/HCV cases underwent centralized retrospective review by external experts. Incidence rates (IRs) were calculated per 100 patient-years (PY) of CZP exposure. Results Among 11,317 clinical trial patients (21,695 PY), 62 TB cases were confirmed (IR 0.29/100 PY) including 2 in Japan (0.10/100 PY) and 3 in other Asia-Pacific countries (0.58/100 PY). From > 238,000 PY estimated post-marketing CZP exposure, there were 31 confirmed TB cases (0.01/100 PY): 5 in Japan (0.05/100 PY), 1 in other Asia-Pacific countries (0.03/100 PY). Reported regional TB IRs were highest in eastern Europe (0.17/100 PY), central Europe (0.09/100 PY), and Mexico (0.16/100 PY). Across clinical trials, there was 1 confirmed HBV reactivation and no HCV cases. From > 420,000 PY estimated post-marketing CZP exposure, 5 HBV/HCV cases were confirmed (0.001/100 PY): 2 HCV reactivations; 1 new HCV; plus 2 HBV reactivations in Japan (0.008/100 PY). Conclusions CZP TB risk is aligned with nationwide TB rates, being slightly higher in Asia-Pacific countries excluding Japan. Overall, TB and HBV/HCV risk with CZP treatment is currently relatively low, as risk can be minimized with patient/physician education, screening, and vigilant treatment, according to international guidelines. Key Points:• TB rates were highest in eastern/central Europe, Mexico, and Asia-Pacific regions.• With the implementation of stricter TB screening and risk evaluations in 2007, especially in high TB incidence countries, there was a notable reduction TB occurrence.• Safety profile of biologics in real-world settings complements controlled studies.• TB and hepatitis (HBV/HCV) risk with certolizumab pegol (CZP) treatment is low.

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