scholarly journals Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications

BMJ ◽  
2012 ◽  
Vol 344 (jan03 1) ◽  
pp. d8141-d8141 ◽  
Author(s):  
B. Wieseler ◽  
M. F. Kerekes ◽  
V. Vervoelgyi ◽  
N. McGauran ◽  
T. Kaiser
Keyword(s):  
Clinical Study ◽  
Reporting Quality ◽  
Drug Trials ◽  
Document Type ◽  
Journal Publications ◽  
Clinical Drug Trials ◽  
Clinical Study Reports ◽  
Clinical Drug

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.

scholarly journals Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Perrine Créquit ◽  
Isabelle Boutron
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Study ◽  
Primary Source ◽  
European Medicines Agency ◽  
Clinical Trial Registries ◽  
Number Of Patients ◽  
Journal Publications ◽  
Clinical Study Reports ◽  
Completeness Of Reporting

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.

Methodology of Clinical Drug Trials.

1995 ◽  
Vol 90 (429) ◽  
pp. 390
Author(s):  
Ralph B. D'Agostino ◽  
Alain Spriet ◽  
Therese Dupin-Spriet ◽  
Pierre Simon ◽  
Robert Coluzzi ◽  
...  
Keyword(s):  
Drug Trials ◽  
Clinical Drug Trials ◽  
Clinical Drug

scholarly journals Clinical Drug Trials on Human Beings viz-a-viz Sanctions related to Animal Experimentation: Need to do Introspection?

2012 ◽  
Vol 46 (3) ◽  
pp. 113-116
Author(s):  
Roosy Aulakh ◽  
Chander Shekhar Gautam ◽  
Prabhjot Singh Cheema
Keyword(s):  
Animal Experimentation ◽  
New Drugs ◽  
Drug Trials ◽  
Human Beings ◽  
Animal Protection ◽  
Research Organizations ◽  
Legal Sanctions ◽  
Clinical Drug Trials ◽  
Health Care Law ◽  
Clinical Drug

ABSTRACT Health care law is totally localized in its nature, but research for the development of new drugs has crossed man-made geographical limits. Weaker legal sanctions, poverty, illiteracy and inaccessibility to legal system have all contributed to make India a favored hub for contact research organizations. Many recent clinical drug trials in India have sparked controversy. However, in India today, we are more bothered about animal protection, but show little concern for volunteers in human trials. It is gradually becoming difficult to conduct research on animals; however, research on human beings is far easier. Sanctions against violation of rights of human volunteers in clinical trials are often only a perceived phenomenon. They are not protected as they should be. Regulatory framework needs thorough introspection, debate, reconsideration and strict implementation. These guidelines should not only be recommendatory but mandatory in nature and those who indulge in violations, shall be punished as per the law of the land effectively. How to cite this article Gautam CS, Aulakh R, Cheema PS. Clinical Drug Trials on Human Beings viz-a-viz Sanctions related to Animal Experimentation: Need to do Introspection? J Postgrad Med Edu Res 2012;46(3):113-116.

Clinical Drug Trials in Alzheimer Disease What are Some of the Issues?

1990 ◽  
Vol 4 (4) ◽  
pp. 193-202 ◽  
Author(s):  
Lissy F. Jarvik ◽  
Leonard Berg ◽  
Raymond Bartus ◽  
Leonard Heston ◽  
Nancy Leith ◽  
...  
Keyword(s):  
Alzheimer Disease ◽  
Drug Trials ◽  
Clinical Drug Trials ◽  
Clinical Drug

Methodologic Issues regarding Outcome Measures for Clinical Drug Trials of Psychiatric Complications in Dementia

1995 ◽  
Vol 8 (1_suppl) ◽  
pp. 8-17
Author(s):  
Linda Teri ◽  
Rebecca G. Logsdon
Keyword(s):  
Outcome Measures ◽  
Outcome Research ◽  
Drug Trials ◽  
Psychometric Characteristics ◽  
Content Assessment ◽  
Dementia Patients ◽  
Prior Use ◽  
Clinical Drug Trials ◽  
Psychiatric Complications ◽  
Clinical Drug

Selecting outcome measures that are both psychometrically sound and sensitive to change is a very important aspect of clinical outcome research. A variety of measures have been introduced in recent years to assess behavioral complications in dementia, but few have been adequately tested in clinical trials. This article provides a discussion of factors to consider in selecting measures, including psychometrics, item content, assessment source, and sensitivity to change. A review of behavioral and psychiatric measures for dementia patients is provided, including measures of general behavioral disturbance, and measures specifically developed for agitation and depression. Each measure's psychometric characteristics, prior use with demented patients, and strengths and weaknesses with regard to treatment outcome research is summarized. The importance of linking measures to the investigators’ hypotheses is discussed, along with recommendations for evaluating and selecting outcome measures depending on the needs of the specific investigation. ( J Geriatr Psychiatry Neurol 1995; 8(suppl 1):S8–S17).

Sign in / Sign up

Export Citation Format

Share Document