scholarly journals Magyar klinikai vizsgálatok sajátosságai egy nemzetközi adatbázis elemzése alapján

2017 ◽  
Vol 158 (9) ◽  
pp. 345-351
Author(s):  
Tamás Tóth ◽  
Péter Pollner ◽  
Gergely Palla ◽  
Elek Dinya
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Data Cleaning ◽  
Free Text ◽  
Research Organizations ◽  
The Us ◽  
Us Government ◽  
International View ◽  
Significant Data

Abstract: Intorduction: The ClinicalTrials.gov website, which is operated by the US government, collects data about clinical trials. Aim: We have processed data related to Hungary by downloading from the website as XML files. Method: Most of the data describe trials performed after 2000, so we got an overview about the clinical research of the last 10 to 15 years. As the majority of the data fields are collected as free text, significant data cleaning was needed. Results: The database contained 2863 trials related to Hungary from 189 settlements. Only 20 per cent of the actual research organizations could have been identified as many times only an “id” number or a general name was given, thus this information was anonymised in many cases. Conclusion: Besides the analysis of the information obtained from this database, our study points out the relevant issues that may influence the international view of the Hungarian clinical research. Orv. Hetil., 2017, 158(9), 345–351.

scholarly journals FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results

2018 ◽  
Author(s):  
Nicholas J. DeVito ◽  
Seb Bacon ◽  
Ben Goldacre
Keyword(s):  
Clinical Trials ◽  
Relevant Information ◽  
Reporting Requirements ◽  
Practical Support ◽  
The Us ◽  
Us Government ◽  
Results Reporting ◽  
And Performance ◽  
Legal Frameworks ◽  
Clinical Trial Results

AbstractIntroductionNon-publication of clinical trials results is an ongoing issue. In 2016 the US government updated the results reporting requirements to ClinicalTrials.gov for trials covered under the FDA Amendments Act 2007. We set out to develop and deliver an online tool which publicly monitors compliance with these reporting requirements, facilitates open public audit, and promotes accountability.MethodsWe conducted a review of the relevant legislation to extract the requirements on reporting results. Specific areas of the statutes were operationalized in code based on the results of our policy review, publicly available data from ClinicalTrials.gov, and communications with ClinicalTrials.gov staff. We developed methods to identify trials required to report results, using publicly available registry data; to incorporate additional relevant information such as key dates and trial sponsors; and to determine when each trial became due. This data was then used to construct a live tracking website.ResultsThere were a number of administrative and technical hurdles to successful operationalization of our tracker. Decisions and assumptions related to overcoming these issues are detailed along with clarifications directly from ClinicalTrials.gov. The FDAAA TrialsTracker was successfully launched in February 2018 and provides users with an overview of results reporting compliance.DiscussionClinical trials continue to go unreported despite numerous guidelines, commitments, and legal frameworks intended to address this issue. In the absence of formal sanctions from the FDA and others, we argue tools such as ours - providing live data on trial reporting - can improve accountability and performance. In addition, our service helps sponsors identify their own individual trials that have not yet reported results: we therefore offer positive practical support for sponsors who wish to ensure that all their completed trials have reported.

scholarly journals Trends in US pediatric mental health clinical trials: An analysis of ClinicalTrials.gov from 2007–2018

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0248898
Author(s):  
Joshua R. Wortzel ◽  
Brandon E. Turner ◽  
Brannon T. Weeks ◽  
Christopher Fragassi ◽  
Virginia Ramos ◽  
...  
Keyword(s):  
Mental Health ◽  
Clinical Trials ◽  
Clinical Research ◽  
Mental Health Research ◽  
Funding Source ◽  
Annual Growth Rate ◽  
Compound Annual Growth Rate ◽  
The Past ◽  
Us Government ◽  
Pediatric Mental Health

Whereas time trends in the epidemiologic burden of US pediatric mental health disorders are well described, little is known about trends in how these disorders are studied through clinical research. We identified how funding source, disorders studied, treatments studied, and trial design changed over the past decade in US pediatric mental health clinical trials. We identified all US pediatric interventional mental health trials submitted to ClinicalTrials.gov between October 1, 2007 and April 30, 2018 (n = 1,019) and manually characterized disorders and treatments studied. We assessed trial growth and design characteristics by funding source, treatments, and disorders. US pediatric mental health trials grew over the past decade (compound annual growth rate [CAGR] 4.1%). The number of studies funded by industry and US government remained unchanged, whereas studies funded by other sources (e.g., academic medical centers) grew (CAGR 11.3%). Neurodevelopmental disorders comprised the largest proportion of disorders studied, and Non-DSM-5 (Diagnostic and Statistical Manual-5) conditions was the only disorder category to grow (14.5% to 24.6%; first half to second half of decade). There was significant growth of trials studying non-psycho/pharmacotherapy treatments (33.8% to 49.0%) and a decline in trials studying pharmacotherapies (31.7% to 20.6%), though these trends differed by funding source. There were also notable differences in funding sources and treatments studied within each disorder category. Trials using double blinding declined (26.2% to 18.0%). Limitations include that ClinicalTrials.gov is not an exhaustive list of US clinical trials, and trends identified may in part reflect changes in trial registration rather than changes in clinical research. Nevertheless, ClinicalTrials.gov is among the largest databases available for evaluating trends and patterns in pediatric mental health research that might otherwise remain unassessable. Understanding these trends can guide researchers and funding bodies when considering the trajectory of the field.

scholarly journals Clinical research in developing countries: recent moral arguments

2002 ◽  
Vol 18 (5) ◽  
pp. 1455-1461 ◽  
Author(s):  
Douglas P. Lackey
Keyword(s):  
Developing Countries ◽  
Clinical Trials ◽  
Clinical Research ◽  
Ethical Problems ◽  
Declaration Of Helsinki ◽  
The Us ◽  
Advisory Commission ◽  
Moral Arguments

During the 1990s, bioethicists raised questions about certain clinical trials conducted in developing countries. These inquiries led to revisions in the Declaration of Helsinki and recommendations from the US National Bioethics Advisory Commission. This article raises doubts about the original questions and subsequent recommendations. It is possible that impractical solutions have been proposed for nonexistent ethical problems.

scholarly journals Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research

2017 ◽  
Vol 49 (6) ◽  
pp. 1700051 ◽  
Author(s):  
Adam T. Hill ◽  
Charles S. Haworth ◽  
Stefano Aliberti ◽  
Alan Barker ◽  
Francesco Blasi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Working Group ◽  
Exercise Tolerance ◽  
Research Collaboration ◽  
Round Table ◽  
Consensus Definition ◽  
The Us ◽  
Sputum Volume ◽  
Definition Of

There is a need for a clear definition of exacerbations used in clinical trials in patients with bronchiectasis. An expert conference was convened to develop a consensus definition of an exacerbation for use in clinical research.A systematic review of exacerbation definitions used in clinical trials from January 2000 until December 2015 and involving adults with bronchiectasis was conducted. A Delphi process followed by a round-table meeting involving bronchiectasis experts was organised to reach a consensus definition. These experts came from Europe (representing the European Multicentre Bronchiectasis Research Collaboration), North America (representing the US Bronchiectasis Research Registry/COPD Foundation), Australasia and South Africa.The definition was unanimously approved by the working group as: a person with bronchiectasis with a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required.The working group proposes the use of this consensus-based definition for bronchiectasis exacerbation in future clinical research involving adults with bronchiectasis.

Clinical Research From Proposal to Implementation

2008 ◽  
Vol 56 (8) ◽  
pp. 975-984 ◽  
Author(s):  
Suzanne M. Rivera
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Human Subject ◽  
Institutional Review Boards ◽  
Human Subject Protection ◽  
Institutional Review ◽  
The Us ◽  
Complicated Process ◽  
Study Participants ◽  
Review Boards

ABSTRACTThe conduct of clinical trials is a complicated process involving a myriad of regulations and enforcement entities. To protect the rights and welfare of study participants, a system of oversight bodies called institutional review boards has been established in the US. This article describes how institutional review boards work and explains what clinical researchers need to know about federally mandated human subject protection requirements.

scholarly journals Barriers, adoption, technology, impact and benefits of risk based monitoring

2016 ◽  
Vol 3 (1) ◽  
pp. 9 ◽  
Author(s):  
Bharat Kumar Shukla ◽  
Mohammed Saleem Khan ◽  
Veerabhadra Nayak
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Data Quality ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Source Information ◽  
The Us ◽  
Previous Decade

The expense and unpredictability of clinical trials have increased drastically as of late. Up to third of a clinical trials expense can now be credited to the customary on location audit of trial information. While powerful observing is basic to ensuring the prosperity of trial members and keeping up the respectability of definite results, it is presently by and large acknowledged that the procedure for clinical trial checking needs to change. A more brought together, hazard based methodology is currently the favoured technique for monitoring clinical trials, as per a few administrative offices, including the US Food and Drug Administration (FDA). The movement has demonstrated overwhelming to numerous associations, nonetheless, and it is now and again not clear where to start. Over the previous decade, the clinical research industry's standard to meet regulators monitoring commitments has included continuous and normal onsite monitoring visits with 100% source information confirmation (SDV). The conviction that "more is better" proceeds with new proof that onsite monitoring practices don't inexorably ensure persistent wellbeing and data quality.

Frequency Analysis of Medical Concepts in Clinical Trials and their Coverage in MeSH and SNOMED-CT

2015 ◽  
Vol 54 (01) ◽  
pp. 83-92 ◽  
Author(s):  
M. Dugas ◽  
J. Varghese
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Significance Test ◽  
University Hospital ◽  
Free Text ◽  
Snomed Ct ◽  
Eligibility Criteria ◽  
Unified Medical Language System ◽  
Data Elements ◽  
Medical Concepts

Summary Background: Eligibility criteria (EC) of clinical trials play a key role in selecting appropriate study candidates and the validity of the outcome of a clinical trial. However, in most cases EC are provided in unstandardised ways such as free text, which raises significant challenges for machine-readability. Objectives: To establish a list of most frequent medical concepts in clinical trials with semantic annotations. This concept list contributes to standardisation of EC and identifies relevant data items in electronic health records (EHRs) for clinical research. The coverage of the list in two major clinical vocabularies, MeSH and SNOMED-CT, will be assessed. Methods: Four hundred and twenty-fivec linical trials conducted between 2000 and 2011 at a German university hospital were analysed. 6671 EC were manually annotated by a medical coder using Concept Unique Identifiers (CUIs) provided by the Unified Medical Language System. Two physicians performed a semi-automatic CUI code revision. Concept frequency was analysed and clusters of concepts were manually identified.A binomial significance test was applied to quantify coverage differences of the most frequent concepts in MeSH and SNOMED-CT. Results: Based on manual medical coding of 425 clinical trials, 7588 concepts were identified, of which 5236 were distinct. A top 100 list containing 101 most frequent medical concepts was established. The concepts of this list cover 25 % of all concept occur-rences in all analysed clinical trials. This list reveals six missing entries in SNOMED-CT, 12 in MeSH. The median of EC frequency per trial has increased throughout the trial years (2000 –2005: 8 EC/trial, 2011: 14 EC/ trial). Conclusions: Relatively few concepts cover one quarter of concept occurrences that represent EC in recent studies. Therefore, these concepts can serve as candidate data elements for integration into EHRs to optimise patient recruitment in clinical research.

scholarly journals Criteria for site selection in industry-sponsored clinical trials: a survey among decision-makers in biopharmaceutical companies and clinical research organizations

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Tilde Dombernowsky ◽  
Merete Haedersdal ◽  
Ulrik Lassen ◽  
Simon Francis Thomsen
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clinical Research ◽  
Site Selection ◽  
Decision Makers ◽  
Relative Importance ◽  
Related Factors ◽  
Trial Site ◽  
Large Patient ◽  
Research Organizations

Abstract Background Knowledge of what the pharmaceutical industry emphasizes when assessing trial sites during site selection is sparse. A better understanding of this issue can improve the collaboration on clinical trials and increase knowledge of how to attract and retain industry-sponsored trials. Accordingly, we investigated which site-related qualities multinational biopharmaceutical companies and clinical research organizations (CROs) find most important during site selection. Methods An online survey among decision-makers for trial site selection in the Nordic countries employed at multinational biopharmaceutical companies and CROs was conducted. The respondents’ experiences with and perceptions of site selection were addressed to evaluate the relative importance of site-related qualities. We included up to four respondents per company, representing different geographic regions. Descriptive statistics were used to summarize findings. Results Of 49 eligible companies, 20 biopharmaceutical companies and 23 CROs participated. In total, 83 responses were analyzed (estimated response rate 78%). A relative importance of site-related qualities was identified: For example, 88% (binomial 95% confidence interval [CI] ±7%) preferred reaching enrollment goals at trial sites in their region 10% quicker rather than cutting the costs at all sites by 20%. Likewise, 42% (CI ±11%) of the respondents preferred that trial sites were best at having the first patients ready for inclusion right after site initiation visit compared to having good data entry, documentation, and reporting practice (25% [CI ±9%]), easily reachable site personnel and backup (23% [CI ±9%]), fast contractual procedure times (6% [CI ±5%]), a key opinion leader associated with the site (3% [CI ±4%]), and updated equipment and facilities (1% [CI ±2%]). In total, 75% [CI ±9%] agreed that their company would be interested in cooperating with an inexperienced trial site if the site had access to a large patient population and 52% [CI ±11%] had experienced that their company selected an inexperienced trial site in favor of an experienced site due to a higher level of interest and commitment. Conclusions This study indicates that recruitment-related factors are pivotal to the pharmaceutical industry when assessing trial sites during site selection. Data quality-related factors seem highly valued especially in early phase trials whereas costs and investigator’s publication track record are less important. Experience in conducting clinical trials is not imperative. However, this applies primarily to late phase trials.

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