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 Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Somayeh Makaremnia ◽  
Marieh Dehghan Manshadi ◽  
Zahra Khademian
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Training Program ◽  
Randomized Clinical Trial ◽  
Thalassemia Major ◽  
Trial Registration ◽  
Control Group ◽  
Positive Thinking ◽  
Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

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.

Clinical trial designs in anaesthesia

2017 ◽  
Author(s):  
Simon J. Howell
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Control Group ◽  
Or Groups ◽  
Related Quality ◽  
Health Related ◽  
Economic Analyses ◽  
Surrogate Measures ◽  
The Impact

A clinical trial is a research study that assigns people or groups to different interventions and compares the impact of these on health outcomes. This chapter examines the design and delivery of clinical trials in anaesthesia and perioperative medicine covering the issues outlined below. The features of a high-quality clinical trial include well-defined inclusion and exclusion criteria, a control group, randomization, and blinding. Outcome measures may be broadly divided into counting the number of people who experience an outcome and taking measurements on people. The outcome measures selected for a clinical trial reflect the purpose of the study and may include ‘true’ clinical measures such as major postoperative complications or surrogate measures such as the results of a biochemical test. Outcome measures may be combined in a composite outcome. Assessment of health-related quality of life using a tool such as the SF-36 questionnaire is an important aspect of many clinical trials in its own right and also informs the economic analyses that may be embedded in a trial. Determining the number for recruits needed for a clinical trial requires both clinical and statistical insight and judgement. The analysis of a clinical trial requires a similarly sophisticated approach that takes into account the objectives of the study and balances the need for appropriate subgroup analyses with the risk of false-positive results. The safe and effective management of a clinical trial requires rigorous organizational discipline and an understanding of the ethical and regulatory structures that govern clinical research.

scholarly journals Analysis on the influence of the proportion and growth rate of different categories of drug clinical trial research funds on quality improvement in China recently six years

2019 ◽  
Author(s):  
Liran Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Improvement ◽  
Drug Trials ◽  
Clinical Drug Trials ◽  
The Cost ◽  
Self Examination ◽  
The Impact ◽  
Clinical Drug

Abstract Background: The China food and drug administration (CFDA) issued the Announcement of Self-examination and Inspection of Clinical Drug Trial Data on July 22, 2015. Great changes have taken place since the launch of the most stringent drug registration self-examination and inspection in history; the cost of clinical trials is one of the important changes. Methods: The paper compares the changes in the cost of clinical drug trials on both the number and the structure of the trials 3 years before and 3 years after self-examination and inspection were initiated by the CFDA,analyzes the impact on the cost of the clinical research coordinator ( CRC ), the labor service of researchers, audit companies, institutional drug management and quality control on the quality improvement of clinical drug trials. Conclusions: According to the article, the emergence and increase in most clinical trial costs are conducive to the quality enhancement of clinical drug trials,However, the emergence and continued increase of CRC costs can improve the quality of clinical drug trials in some ways and hinder it in others..To improve the quality of clinical trials, China must regulate the booming site management organization ( SMO ) market and actively formulate industry standards and qualification certifications for CRCs.

Health economic evaluations alongside clinical trials: A review of study protocols at the Swedish Medical Products Agency

2007 ◽  
Vol 23 (3) ◽  
pp. 392-396 ◽  
Author(s):  
Anne Lindfors ◽  
Nils Feltelius ◽  
Jonas Lundkvist
Keyword(s):  
Clinical Trial ◽  
Health Economic ◽  
Clinical Trials ◽  
Economic Evaluation ◽  
Economic Evaluations ◽  
Limited Information ◽  
Medical Products ◽  
Study Protocols ◽  
Trial Protocols

Objectives: Conducting economic evaluation in the context of clinical studies is common but has been the subject of extensive discussion due to its limitations. Various standard approaches and guidelines how such studies should be conducted have been proposed, but there is very limited information available about how common these studies are, what type of data that is collected, and how the quality of the protocols compares to the suggested standards. This study examines the prevalence and study design of health economic evaluations conducted alongside clinical trials in Sweden between 1995 and 2005.Methods: A systematic assessment of clinical trial protocols that had arrived as applications to the Medical Products Agency between 1995 and 2005 was performed. Only protocols arriving during the first half of odd years within the time period were included.Results: A total number of 680 protocols from 1995 to 2005 were examined, and among them, 14.4 percent included a health economic part. With the exception of year 2001, a trend toward an increased prevalence of economic evaluations next to clinical trials can be seen.Conclusions: This study shows that economic evaluations alongside clinical trials are becoming more common, although most trials still lack a health economic part of the protocol. The information about the economic evaluation provided in the protocols is in many cases scarce, possibly due to the fact that there currently are no generally accepted and applied guidelines for economic evaluations in clinical trial protocols. Introducing requirements for detailed study plans also for the economic evaluation should improve the quality of economic evaluations alongside clinical trials.

scholarly journals The impact of COVID-19 on the clinical trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251410
Author(s):  
Zhimin Chen ◽  
Liran Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Remote Monitoring ◽  
Structured Interviews ◽  
Trial Staff ◽  
The Impact ◽  
Express Delivery

The objective of this study was to explore the impact of the coronavirus disease 2019 epidemic on ongoing and upcoming drug clinical trials. Qualitative semi-structured interviews were conducted with clinical trial staff and clinical trial subjects were surveyed by questionnaire in this study. The results of interviews and questionnaire showed that coronavirus disease 2019 pandemic has led to many changes in the implementation of drug clinical trials, including: a variety of meetings being held online webinars using various platforms, telemedicine and follow-up by video, A large number of deviations from protocol and losses of follow-up, delivery of clinical trial drugs by express, additional workload caused by screening for coronavirus, and anxiety of subjects. These results suggest that the coronavirus disease 2019 outbreak has hindered the progress and damaged the quality of clinical trials. The online meeting, remote follow-up, express delivery of drugs and remote monitoring in the epidemic environment can ensure the progress of clinical trials to a certain extent, but they cannot fully guarantee the quality as before.

scholarly journals Study on efficacy and safety of Tong-luo Qu-yu plaster treatment for knee osteoarthritis: study protocol for a randomised, double-blind, parallel positive control, multi-center clinical trial

2019 ◽  
Author(s):  
Bao-ping Xu ◽  
Min Yao ◽  
Zi-rui Tian ◽  
Long-yun Zhou ◽  
Long Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Knee Osteoarthritis ◽  
Clinical Symptoms ◽  
Positive Control ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Experimental Group

Abstract Background: Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affect quality of life. Patients with KOA frequently develop one or more of the typically following symptoms: joint pain, stiffness, joint friction noise, impaired functionality. Traditional Chinese medicines (TCM) have showed a superior effect and peculiar advantage on the treatment of KOA, among TCMs, the Tong-luo Qu-yu plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high quality of clinical evidences to support the therapeutic effect that Chinese adhesive plaster can relieve pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-yu plaster in patients with KOA. Methods: This study will be a randomised, double-blind, parallel positive control, multi-center clinical trial. A total of 2000 participants older than 40 years with KOA, will be randomly allocated into a experimental group (n=1500) and a control group (n=500). All participants will receive a conventional conservative treatment lasted for 14 days as two courses, daily 1 time. Tong-luo Qu-yu plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score, visual analog scale scores will be measured during the assessment visits (baseline and 1-, 2-week follow-up). In addition, adverse events concerning clinical symptoms and signs as well as laboratory tests will be documented during clinical trials. Discussion: This study will be a randomized, double-blind, parallel positive control trial to further evaluate the effectiveness and safety of Tong-luo Qu-yu plaster for patients with KOA in nine medical centers compared with control group, it is expected that the patients with KOA will benefit from this study. Trial Registration: ClinicalTrials.gov, NCT03309501. Registered on 08 November 2017. Keywords: Clinical trials, Knee osteoarthritis, Tong-luo Qu-yu plaster, Randomized, Protocol

scholarly journals Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review

2018 ◽  
Author(s):  
Obaro Evuarherhe ◽  
William Gattrell ◽  
Richard White ◽  
Christopher Charles Winchester
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Writing ◽  
Quality Of Reporting ◽  
Medical Publication ◽  
Number Of Citations ◽  
The Impact ◽  
The Relationship

Background: Many authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials. Methods: Using terms related to medical writer and observational study, we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014-2017). We also hand-searched the journals Medical Writing and The Write Stuff (2014-2017), and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS. Results: Our searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with: increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed); publication in journals with an impact factor (one study); a higher quality of written English (one study); and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies). Conclusions: This systematic review of eight observational studies suggests that PMWS increases the overall quality of reporting of clinical trials and may improve the timeliness of publication.

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 Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xin Ye ◽  
Dawei Zhu ◽  
Siyuan Chen ◽  
Xuefeng Shi ◽  
Rui Gong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hearing Loss ◽  
Cost Effectiveness ◽  
Treatment Group ◽  
Hearing Aids ◽  
Control Group ◽  
Chinese Adults ◽  
Community Based ◽  
The Impact

Abstract Background Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. Methods/design In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. Discussion The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. Trial registration Chinese Clinical Trial Registry ChiCTR1900024739. Registered on 26 July 2019.

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