CLINICAL TRIALS IN IRKUTSK SCIENTIFIC CENTER OF SURGERY AND TRAUMATOLOGY: RESULTS AND PROSPECTS

2016 ◽  
Vol 1 (4) ◽  
pp. 129-134
Author(s):  
Демкова ◽  
Olga Demkova ◽  
Апарцин ◽  
Konstantin Apartsin ◽  
Горохова ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Trial Protocol ◽  
Scientific Journals ◽  
Clinical Testing ◽  
Drug Trials ◽  
Scientific Center ◽  
Observational Trial ◽  
Multicentre Trials ◽  
Clinical Drug Trials ◽  
Clinical Drug

Clinical drug trials in Irkutsk Scientific Center of Surgery and Traumatology began in 2005. In 2013, the laboratory of clinical trials was established in the science department of clinical surgery. We analyzed the experience of Irkutsk Scientific Center of Surgery and Traumatology in international multicentre trials. Participation in international mul-ticentre trials allows the Irkutsk Scientific Center of Surgery and Traumatology to get affiliated with the publications in first quartile scientific journals. The experience of the laboratory in clinical trials is projected into practical work of other institutes – Hospital of Irkutsk Scientific Center SB RAS and Irkutsk Regional Clinical Hospital. The important objectives of the laboratory of clinical trials are developing the protocols, performing drug clinical trials and medical device clinical trials. The laboratory carries out admission of patients for observational trial PROTOCOL. One of the fields of work of the laboratory is the prospect of clinical testing of developed clinical technologies.

scholarly journals Analysis of Suspension of Clinical Trials for Drug Registration in China

2021 ◽  
Vol 11 ◽  
Author(s):  
Xian Su ◽  
Xiaocong Pang ◽  
Xin Zeng ◽  
Yi Gao ◽  
Yimin Cui ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Trials ◽  
Drug Evaluation ◽  
Control Measure ◽  
Safety Information ◽  
The Elderly ◽  
Drug Trials ◽  
Drug Registration ◽  
Clinical Drug Trials ◽  
Clinical Drug

Suspension is an important risk control measure during clinical trials. We investigated the use of this in China and identified common reasons for suspension by analyzing trends, hold issues, outcomes, background and design characteristics of suspended clinical drug trials from January 1, 2013 to December 1, 2019. A total of 298 clinical trials during the study timeframe were registered, accounting for 3.1% of all clinical drug trials. Numbers and proportion of clinical trials suspended based on benefit/risk factors have been increasing without holds on registrations by Center for Drug Evaluation. Reasons for suspension vary among trial phases, benefit and risk factors, protocol issues etc. 67% of trials that have been on hold for >1 year were still on hold at the time of this analysis. Children and the elderly were enrolled in 4.1% and 41% of the suspended trials, respectively. Strengthening regulation of pre-market pharmacovigilance through optimizing reporting and monitoring of safety information during clinical trial is thus needed. Establishing a closed-loop treatment mechanism for trial suspension is also important. Examination of potential risks, such as the quality of protocols, the ability of the institution to support the trial, and the adequacy of supplies of the investigational product is needed before beginning clinical trials. More careful evaluation at the drug registration phase will reduce the frequency of suspension and protect subjects after suspension occurs.

scholarly journals Cognitive Enhancing Agents: Current Status in the Treatment of Alzheimer's Disease

1988 ◽  
Vol 15 (3) ◽  
pp. 249-256 ◽  
Author(s):  
Cheryl Waters
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cognitive Functioning ◽  
Recent Literature ◽  
Current Status ◽  
Drug Trials ◽  
Variable Success ◽  
Clinical Drug Trials ◽  
Clinical Drug

ABSTRACT:Extensive recent literature on drugs used to enhance cognitive functioning, reflects the growing social problem of dementia. Many clinical trials have been undertaken with variable success. In most cases the disorder studied has been Alzheimer's disease. The pharmacological approach has been designed to rectify the presumed pathophysiological processes characteristic of the condition. Agents tested include cerebral vasodilators, cerebral metabolic enhancers, nootropics, psychostimulants, neuropeptides and neurotransmitters with a special emphasis on drugs used to enhance cholinergic function. Ethical and practical issues concerning clinical drug trials in dementia will be discussed.

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.

The Importance of Non-biological Factors in Influencing the Outcome of Clinical Trials

1993 ◽  
Vol 163 (S22) ◽  
pp. 45-50 ◽  
Author(s):  
W. Gaebel
Keyword(s):  
Clinical Trials ◽  
Treatment Outcome ◽  
Psychosocial Interventions ◽  
Practical Reasons ◽  
Outcome Predictors ◽  
Drug Trials ◽  
Biological Factors ◽  
Mechanism Of Interaction ◽  
Clinical Drug Trials ◽  
Clinical Drug

The outcome of clinical drug trials is influenced both by biological and by non-biological factors. Non-biological factors can be subdivided into methodological factors and non-drug factors. The former are related to the definition and measurement of treatment course, response, and outcome itself; the latter cover characteristics of the patient, the treatment milieu, the patient's milieu apart from treatment, and (planned) psychosocial interventions. Although their mechanism of interaction with treatment outcome is not yet fully understood, these non-drug factors should be routinely monitored in clinical trials for three practical reasons: (a) to control for the heterogeneity of outcome; (b) to develop individualised outcome predictors; and (c) to promote the development of individualised guidelines for treatment indication.

Expanding Prisoners' Access to AIDS-Related Clinical Trials: An Ethical and Clinical Imperative

1995 ◽  
Vol 75 (1) ◽  
pp. 48-68 ◽  
Author(s):  
EILEEN KELLY
Keyword(s):  
Clinical Trials ◽  
Drug Users ◽  
Drug Trials ◽  
State Laws ◽  
Aids Pandemic ◽  
Clinical Drug Trials ◽  
Prison Environment ◽  
Experimental Treatments ◽  
Clinical Drug ◽  
Community Standard

In the AIDS pandemic, access to experimental treatments has become an important element of community-standard medical care. Rates of AIDS and HIV infection are significantly higher in prison and jail populations than in the U.S. population at large; however, prisoners are denied access to AIDS-related clinical trials in all but a handful of jurisdictions. The author argues for expanded prisoner access to AIDS-related clinical trials and demonstrates that such access is ethical and feasible. Enrolling prisoners in AIDS-related trials would stand to benefit not only affected prisoners but also clinical researchers seeking to gather information on the efficacy of treatments in all population groups contained within the larger HIV-infected population, including African Americans, Latinos, and IV drug users. Existing federal regulations, properly enforced, provide prisoners with adequate protection from exploitation conducted in the name of science. Barriers remain, in the form of state laws, correctional policies, and practical obstacles presented by the prison environment. However, as the author describes, research institutions in several states have succeeded in incorporating prisoners into clinical drug trials.

Pharmacoeconomic Research and Clinical Trials: Concepts and Issues

DICP ◽  
1989 ◽  
Vol 23 (9) ◽  
pp. 693-697 ◽  
Author(s):  
J. Lyle Bootman ◽  
Lon N. Larson ◽  
William F. McGhan ◽  
Raymond J. Townsend ◽  
William F. McGhan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pharmacoeconomic Analysis ◽  
Pharmacoeconomic Study ◽  
Health Sciences ◽  
Drug Trials ◽  
High Quality ◽  
Pharmacoeconomic Research ◽  
Clinical Drug Trials ◽  
Appropriate Education ◽  
Clinical Drug

The purpose of this article is to provide an overview of the emerging discipline of pharmacoeconomics. Specific methodologies and terms are defined. Pharmacoeconomic research is described, related to, and contrasted with clinical drug trials. Additionally, we present a brief overview of the general steps taken designing a pharmacoeconomic study. Finally, several issues centering around pharmacoeconomic analysis are presented for discussion and debate. The need for high-quality pharmacoeconomic research is stressed along with the need for appropriate education of individuals trained in the health sciences.

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.

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