Children’s views on taking medicines and participating in clinical trials

2019 ◽  
Vol 104 (9) ◽  
pp. 900-905 ◽  
Author(s):  
Sofia Nordenmalm ◽  
Elin Kimland ◽  
Franca Ligas ◽  
Birka Lehmann ◽  
Joana Claverol ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Information ◽  
Chronic Health Condition ◽  
Health Condition ◽  
Limited Information ◽  
European Union Countries ◽  
Age Appropriate ◽  
Common Problems ◽  
Children’S Views

IntroductionLimited information is available on the views of children taking medicines and participating in clinical trials. These views may contribute to a better understanding of what can be improved on in the development of medicines from their perspective.ObjectiveTo collect children’s views on taking medicines and participating in clinical trials.Materials and methodsA question-based survey was conducted among children living in European Union countries between January and August 2015.ResultsAlmost 900 children aged 10–17 years from Finland, Germany, Sweden, Spain and Hungary responded. Almost 40% had a chronic health condition. The most commonly used pharmaceutical forms were solid or liquid medicines for oral use and injectable medicines. Bad taste and pain during administration were reported as common problems. Of 785 respondents, 17% had been taking part in a clinical trial. Most respondents would potentially agree to take part in a clinical trial because the investigational medicine might improve their own health or that of other children. Concern that the investigational medicine might be harmful was the main reason to refuse participation, if asked to. Over half of the respondents were willing to learn more about clinical trials, preferably online.ConclusionsIt is necessary to involve children in the development of age-appropriate pharmaceutical forms and in the design of clinical trials. Children and their carers should be provided with age-appropriate medical information in the most suitable channels. We have identified some common problems that children experience when taking medicines, and we conclude that children are interested in learning more and giving their opinions on clinical trials.

scholarly journals How to set up a clinical trial

2020 ◽  
Vol 96 (1139) ◽  
pp. 564-569
Author(s):  
Rachel A B Thomas ◽  
Emma Louise Aitken ◽  
Jean Antonelli ◽  
Lorna Marson
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Design ◽  
Tips And Tricks ◽  
Gold Standard Method ◽  
Randomised Control Trials ◽  
Common Problems ◽  
Healthcare Interventions ◽  
Set Up ◽  
Regulatory Landscape

Clinical trials are considered the gold-standard method for the evaluation of healthcare interventions. However, randomised control trials are complex to perform and many researchers, especially those in the early stages of their career, can find it challenging to know where to start set up, contribute to or lead a trial. This guide provides an introduction to trials and also practical advice to help potential investigators complete their clinical trial to time and to budget by signposting the pathway through the complex regulatory landscape. The authors draw on their own recent experiences of running clinical trials and provide tips and tricks for troubleshooting common problems encountered including trial design and documentation.

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 A step towards equitable clinical trial recruitment: a protocol for the development and preliminary testing of an online prostate cancer health information and clinical trial matching tool

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Hala T. Borno ◽  
Brian M. Bakke ◽  
Celia Kaplan ◽  
Anke Hebig-Prophet ◽  
Jessica Chao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
San Francisco ◽  
Medical Information ◽  
Human Subjects ◽  
Trial Participation ◽  
Recruitment Strategies ◽  
Cancer Clinical Trials ◽  
Clinical Trial Participation ◽  
The Usa

Abstract Background Recruitment of a diverse participant pool to cancer clinical trials is an essential component of clinical research as it improves the generalizability of findings. Investigating and piloting novel recruitment strategies that take advantage of ubiquitous digital technologies has become an important component of facilitating broad recruitment and addressing inequities in clinical trial participation. Equitable and inclusive recruitment improves generalizability of clinical trial outcomes, benefiting patients, clinicians, and the research community. The increasing prevalence of online connectivity in the USA and use of the Internet as a resource for medical information provides an opportunity for digital recruitment strategies in cancer clinical trials. This study aims to measure the acceptability, preliminary estimates of efficacy, and feasibility of the Trial Library intervention, an Internet-based cancer clinical trial matching tool. This study will also examine the extent to which the Trial Library website, designed to address the linguistic and literacy needs of broader patient populations, influences patient-initiated conversations with physicians about clinical trial participation. Methods This is a study protocol for a non-randomized, single-arm pilot study. This is a mixed methods study design that utilizes the statistical analysis of quantitative survey data and the qualitative analysis of interview data to assess the participant experience with the Trial Library intervention. This study will examine (1) acceptability as a measure of participant satisfaction with this intervention, (2) preliminary measure of efficacy as a measure of proportion of participants with documented clinical trial discussion in the electronic medical record, and (3) feasibility of the intervention as a measure of duration of clinical visit. Discussion The principles that informed the design of the Trial Library intervention aim to be generalizable to clinical trials across many disease contexts. From the ground up, this intervention is built to be inclusive of the linguistic, literacy, and technological needs of underrepresented patient populations. This study will collect essential preliminary data prior to a multi-site randomized clinical trial of the Trial Library intervention. Trial registration This study has received institutional approval from the Committee of Human Subjects Research at the University of California, San Francisco.

scholarly journals Impact of the Clinical Trials Act on noncommercial clinical research in Japan: An interrupted time-series analysis

2021 ◽  
Author(s):  
Ikuyo Tsutsumi ◽  
Yusuke Tsutsumi ◽  
Chikashi Yoshida ◽  
Takuya Komeno ◽  
Yuichi Imanaka
Keyword(s):  
Clinical Trial ◽  
Time Series ◽  
Clinical Trials ◽  
Clinical Studies ◽  
Medical Information ◽  
Interrupted Time Series ◽  
University Hospital ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
The Impact

AbstractBackgroundThe number of new noncommercial clinical studies conducted in Japan declined within the first year of the implementation of the Clinical Trials Act (CTA) on April 1, 2018. This study aimed to examine the impact of the CTA’s enforcement on the number of new noncommercial clinical studies registered in the Japanese Clinical Trial Registry.MethodsAn interrupted time-series design was used in the analysis, which was conducted for the period of April 2015 to March 2019. We collected data for trials registered in the Clinical Trial Registry, managed by the University Hospital Medical Information Network.ResultsIn total, 35,811 studies were registered in the registry; of these, 16,455 fulfilled the eligibility criteria. The difference in the trend of monthly number of new trials after CTA enforcement decreased significantly by 15.0 trials (95% CI, −18.7 to −11.3), and the level decreased by 40.8 (95% CI, −68.2 to −13.3) from the pre-enforcement to the post-enforcement period. Multigroup analyses indicated that the act exerted a significant effect on the trend of new clinical trials, particularly those with smaller sample sizes, interventional study designs, and nonprofit funding sponsors.ConclusionsThe number of Japanese noncommercial clinical studies declined significantly following implementation of the CTA. It is necessary to establish a system to promote clinical studies in Japan while ensuring transparency and safety.

scholarly journals A Critical Review on Adaptive Sample Size Re-estimation (SSR) Designs for Superiority Trials with Continuous Endpoints

2019 ◽  
pp. 1-13
Author(s):  
Xiaoyu Cai ◽  
Yi Tsong ◽  
Meiyu Shen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sample Size ◽  
Treatment Effect ◽  
Critical Review ◽  
Adaptive Design ◽  
Sample Size Determination ◽  
Limited Information ◽  
Study Objective ◽  
Superiority Trials

Adaptive sample size re-estimation (SSR) methods have been widely used for designing clinical trials, especially during the past two decades. We give a critical review for several commonly used two-stage adaptive SSR designs for superiority trials with continuous endpoints. The objective, design and some of our suggestions and concerns of each design will be discussed in this paper. Keywords: Adaptive Design; Sample Size Re-estimation; Review Introduction Sample size determination is a key part of designing clinical trials. The objective of a good clinical trial design is to achieve the balance between efficiently spending resources and enrolling enough patients to achieve a desired power. At the designing stage of a clinical trial, there usually only have limited information available about the population, so that the sample size calculated at this stage may not be sufficient to address the study objective. Assumed that the data from two parallel treatment groups (e.g. treatment and control groups) are normally distributed with mean treatment effect μ_1 and μ_2, and equal within-group variance 𝜎2. Let the mean difference (treatment effect) . The efficacy of the treatment will be evaluated by testing the hypothesis.

Planning the Size of Clinical Trials with Allowance for Patient Noncompliance

1990 ◽  
Vol 29 (03) ◽  
pp. 243-246 ◽  
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.

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

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.

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

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
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.

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

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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