scholarly journals Archival and management of clinical trial documents

2021 ◽  
Vol 8 (1) ◽  
pp. 101
Author(s):  
Mehnaaz Alam ◽  
D. Yamini Sai Nikitha ◽  
Sai Sugun Jala ◽  
Gulam Khaleel Ahmed
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Specialty ◽  
Ethics Committee ◽  
X Rays ◽  
Clinical Knowledge ◽  
Secure Systems ◽  
Post Trial ◽  
Recovery Procedure

<p class="abstract">Clinical trial documents are all records, in any type which incorporates written, electronic, magnetic, optical records, scans, x-rays and electrocardiograms that describe or record the strategy, conduct and results of an effort, the factors poignant an effort and the actions taken. Such a record is thought as document and method is documentation. The documents collected before, throughout and once clinical trials give proof that the study was conducted, the information collected is correct and valid which the investigator and sponsor conducted the trial in line with ICH GCP tips is thought as Trial master file. because of exaggerated quality of studies, particularly medical specialty studies, and therefore the issue managing paper TMF’s for various departments, most organizations have moved to eTMF. Archiving may be a key demand to guage post trial observance and analysis and to facilitate any analysis before initiation of an effort and deposit strategy should be developed. It includes the subsequent parts documents to be archived, amount of archiving, location, retrieval or access of archived documents, disaster recovery, procedure of clinical knowledge archiving, archiving by an ethics committee, archiving by the investigator. Archiving of trial documents helps to store knowledge safely and firmly for future use with facilities like secure systems and e-back up.</p>

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

Heroin-assisted Treatment for drug dependents’ assistance / Los programas experimentales con heroina en la atención de la población drogodependiente

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Alina Danet ◽  
Joan Carles March Cerdá ◽  
Manuel Romero Vallecillos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Literature Review ◽  
Clinical Studies ◽  
Therapeutic Use ◽  
Medical Prescription ◽  
Calidad De Vida ◽  
Survey Results ◽  
Therapeutic Possibilities

Objetivo. Los ensayos clínicos con heroína (diacetilmorfina-DAM) han aportado al arsenal terapeútico disponible una alternativa en la atención a drogodependientes. El objetivo del presente artículo es conocer las experiencias y resultados clínicos de los estudios sobre el uso terapéutico de la heroina.Metodo. Revisión bibliográfica de los diferentes estudios y ensayos clínicos realizados hasta el presente a nivel mundial, sobre la intervención con pacientes dependientes de opioides. Se han consultado las bases de datos: EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid, y los descriptores «heroin», «diacetylmorphine», «clinical trial», «survey».Resultados. Se detectan 42 referencias, 16 presentan los resultados de ensayos clínicos de Suiza, Holanda, Alemania, Canadá, España y Reino Unido, comenzando con 1994. El resto de estudios se refieren a: captación y participación de los drogodependientes, mortalidad, calidad de vida, efectos secundarios y necesidad de nuevas investigaciones y ensayos clínicos.Conclusiones. Los estudios clínicos llevados a cabo hasta la actualidad muestran heterogeneidad en los métodos y variables empleadas, pero los objetivos son comunes (parten de evaluar los efectos del uso terapéutico de la heroina) y los resultados constatan la seguridad y efectividad de la prescripción médica de la diacetilmorfina. AbstractObjective. Clinical trials with heroin (diacetylmorphine) bring an alternative to the available therapeutic possibilities for addict people. The purpose of this article is to describe the experiences and results of clinical studies centered on the therapeutic use of heroin.Method. Literature review of studies and clinical trials, centered on the intervention with opiois- dependent patients. The databases consulted were : EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid. The descriptors : «heroin», «diacetylmorphine», «clinical trial», «survey».Results. The literature review revealed the existence of 42 references, of which 16 presented the results of clinical trials in Switzerland, Holland, Germany, Canada, Spain and United Kingdom, starting with 1994. Other references are centered on uptake and involvement of the drug, mortality quality of life/ side effects and need for further research and clinical trials.Conclusions. Clinical studies carried out until the present show heterogeneity in the methods and variables used, but the objectives are the same (based on assessing the effects of the therapeutic use of heroin) and the results confirm the safety and effectiveness of medical prescription of diacetylmorphine.

scholarly journals Can prospective systematic reviews of animal studies improve clinical translation?

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Pandora Pound ◽  
Merel Ritskes-Hoitinga
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Animal Studies ◽  
Poor Quality ◽  
Human Studies ◽  
Clinical Knowledge ◽  
Safety And Efficacy ◽  
High Quality Evidence ◽  
Animal Data

AbstractSystematic reviews are powerful tools with the potential to generate high quality evidence. Their application to animal studies has been instrumental in exposing the poor quality of these studies, as well as a catalyst for improvements in study design, conduct and reporting. It has been suggested that prospective systematic reviews of animal studies (i.e. systematic reviews conducted prior to clinical trials) would allow scrutiny of the preclinical evidence, providing valuable information on safety and efficacy, and helping to determine whether clinical trials should proceed. However, while prospective systematic reviews allow valuable scrutiny of the preclinical animal data, they are not necessarily able to reliably predict the safety and efficacy of an intervention when trialled in humans. Consequently, they may not reliably safeguard humans participating in clinical trials and might potentially result in lost opportunities for beneficial clinical treatments. Furthermore, animal and human studies are often conducted concurrently, which not only makes prospective systematic reviews of animal studies impossible, but suggests that animal studies do not inform human studies in the manner presumed. We suggest that this points to a confused attitude regarding animal studies, whereby tradition demands that they precede human studies but practice indicates that their findings are often ignored. We argue that it is time to assess the relative contributions of animal and human research in order to better understand how clinical knowledge is actually produced.

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.

scholarly journals Methodological Characteristics of Clinical Trials: Impact of Mandatory Trial Registration

2019 ◽  
Vol 22 ◽  
pp. 131-141
Author(s):  
Ashish Kumar Kakkar ◽  
Biswa Mohan Padhy ◽  
Sudhir Chandra Sarangi ◽  
Yogendra Kumar Gupta
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Statistical Methods ◽  
Quality Characteristics ◽  
Allocation Concealment ◽  
Trial Registration ◽  
Control Group ◽  
Study Protocols ◽  
The Impact

Purpose: Numerous studies across multiple specialties have evaluated the impact of trial registration on quality of study reports and found significant improvements over several domains. However, the impact of mandatory trial registration on the quality of clinical trial protocols remains hitherto unexplored. Methods: We carried out a retrospective cohort study of clinical trial applications submitted to drug regulatory authority of India for initial review with the objective of comparing methodological characteristics of their protocols. Since trial registration was made mandatory in the country in June 2009, we selected two study periods as between January 2007 to May 2009 (Period I) and July 2009 to December 2011 (Period II). Seventy-five protocols were randomly selected using a computer-generated list for each study period, making a total of 150 protocols. Data on twelve key methodological characteristics were collected including clearly defined primary outcomes, randomization, blinding, use of control group, statistical methods, handling of withdrawals amongst others. Results: More than 3/4th of the trial applications in the two study periods were for new chemical entities and nearly 90% were pharmaceutical industry sponsored studies. Comparing the period before and after implementation of mandatory trial registration, description of clearly defined trial outcomes improved from nearly 42% to 80% (p<0.001), sample size justifications increased from 38% to 70% (p<0.001) and use of allocation concealment improved from 24% to 49% (p=0.001). Marked improvement was also noted for blinding, description of statistical methods and handling of withdrawals and dropouts. Remaining characteristics did not change significantly between the two study periods. The mean cumulative scores for the study protocols improved significantly from 7± 0.296 in the first period to 8.93± 0.346 (p<0.001) in the second period. Conclusions: Our study found a significant improvement in the methodological quality characteristics of the protocols particularly in elements related to minimization of bias and statistical methods, which could be attributed to mandatory trial registration. Overall, the significant improvement was limited to global clinical trials, and room for improvement was noted for two quality characteristics – proportion of randomized studies and trials adequately describing the generation of allocation sequence.

scholarly journals Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension

BMJ ◽  
2020 ◽  
pp. m3164 ◽  
Author(s):  
Xiaoxuan Liu ◽  
Samantha Cruz Rivera ◽  
David Moher ◽  
Melanie J Calvert ◽  
Alastair K Denniston
Keyword(s):  
Artificial Intelligence ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Trial Design ◽  
Trial Protocols ◽  
General Readership ◽  
Peer Reviewers ◽  
Multi Stakeholder ◽  
Analysis Of Error

Abstract The CONSORT 2010 (Consolidated Standards of Reporting Trials) statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency when evaluating new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI. Both guidelines were developed through a staged consensus process, involving a literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed on in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items, which were considered sufficiently important for AI interventions, that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human-AI interaction and providing analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer-reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

The Implementation of Directive 2001/20/EC into Belgian Law and the Specific Provisions on Pediatric Research

2008 ◽  
Vol 15 (2) ◽  
pp. 153-161 ◽  
Author(s):  
Herman Nys ◽  
Kris Dierickx ◽  
Wim Pinxten
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Legal System ◽  
Human Person ◽  
Ethics Committee ◽  
Pediatric Research ◽  
European Directive ◽  
Clinical Trial Directive ◽  
Medical Experiments ◽  
Protocol Review

AbstractThe European Clinical Trial Directive (2001/20/EC) was implemented into the Belgian legal system by the Law of 7 May 2004 concerning experiments on the human person (LEH). Apart from implementing the European Directive, this law also broadens the scope of the Directive from interventional clinical trials to all medical experiments involving human persons. This article offers an overview of the requirements for involving minors in medical experiments that are captured in the LEH, illustrates the process of protocol review by an ethics committee, and discusses the dissimilarities between the LEH and the European Directive.

scholarly journals Analysis of costs and strategies for using academic research in a private dental college to develop commercially viable products

2020 ◽  
Author(s):  
Rampalli Viswa Chandra ◽  
Devaraju Rama Raju
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Product Development ◽  
Negative Impact ◽  
Academic Research ◽  
Research Projects ◽  
Trial Duration ◽  
Cycle Times ◽  
Surgical Devices

ABSTRACTBackground & objectivesThe study had two aims. 1) Analysis of research projects done in our institution from 2014-2019 to identify products with a potential for commercialization and 2) To understand the effect of product-development variables on research projects to improve the quality of future commercialization-oriented trials.Methods338 clinical trials were grouped into 188 projects under the headings irrigants, diagnostic devices, surgical devices, biomaterials and gels. Trials per project, capital, material costs, labour and the cycle times per trial were calculated. To understand the effect these variables, five hypotheses were generated to test whether greater number of trials, successes, higher capital, more investigators per trial and a longer trial duration will result in a product worthy of commercialization.Results22 projects had products with a potential for commercialization. Except labour and cycle time (p>0.05), all variables showed significant differences across all projects. Three products were identified as having potential for actual commercialization. It was observed that greater number of trials (χ2=4.6793; p=0.030528) and successes (χ2=20.8134; p<0.00001) in a project along with a higher capital (χ2=12.2662; p=0.000461) will generate a product worthy of commercialization.Interpretation & conclusionsThe results seem to suggest that in trials for commercialization, emphasis must be placed on implementing multiple, well-designed clinical trials on a device or product to successfully identify whether it is commercialization-worthy or not. Due attention must be given to the financial aspects of the projects as deficiencies may result in negative impact on the flow and outcomes of a clinical trial.

Sign in / Sign up

Export Citation Format

Share Document