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 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 ◽  
Clinical Trial Data ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Drug Clinical Trial ◽  
The Cost ◽  
Self Examination ◽  
The Impact

Abstract Background: China Food and Drug Administration issued Announcement of Self-examination and Inspection of Drug Clinical Trial Data on July 22, 2015. Great change have taken place since the most stringent drug registration self-examination and inspection in history was launched, among those variety, the cost of clinical trials is one of the important changes. Methods ：The paper compare the changes in the cost of drug clinical trials on both amount and structures between 3 years before and after self-examination and inspection initiated by the CFDA ,Identify the increase number and composition, analyze the impact of the cost of new CRC, the labor service of researchers, the audit company, the institutional drug management and quality control on the quality improvement of drug clinical trials. Conclusions ： According to the article, the emergence and rise in most clinical trials costs are conducive to the quality enhancement of drug clinical trial, the occurrence and continuous increase of CRC costs improve the quality, at the same time, It implies a barriers factor to improve the drug clinical trial quality. To improve the quality of clinical trials, China must regulate the booming SMO market and formulate actively industry standards and qualification certification for CRC.

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 Current aspects of risk management in clinical trials

2020 ◽  
pp. 45-52
Author(s):  
E. A. Polozova
Keyword(s):  
Clinical Trial ◽  
Risk Management ◽  
Clinical Trials ◽  
Cost Savings ◽  
Pharmaceutical Companies ◽  
Main Task ◽  
Legal Requirements ◽  
Financial Cost ◽  
The Cost

Improving the quality of drugs is the main task of the pharmaceutical industry as a whole. Getting safe and eff ective medications is directly related to minimizing the risks of conducting clinical trials. Maintaining the quality of clinical research based on risk management is a continuous, constant and dynamic process ensuring the success of the study, which in turn leads to the integrity of the data collected, the safety of subjects and compliance with legal requirements, as well as to the financial cost savings of pharmaceutical companies. The cost of research is growing inexorably, and the quality of their research is rapidly declining, so it is important to use a risk-based approach when developing the upcoming clinical trial project.

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 &gt;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.

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.

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.

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