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.

Incremental Drug Treatment Cost in HIV-Positive Patients in Industry-Sponsored Clinical Trials

2008 ◽  
Vol 42 (11) ◽  
pp. 1586-1591 ◽  
Author(s):  
Rosario Santolaya Perrín ◽  
Fernando J García López
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Therapy ◽  
Cost Savings ◽  
Drug Costs ◽  
Extra Cost ◽  
University Hospital ◽  
Study Entry ◽  
The Cost ◽  
Mean Cost

Background: Drugs used in clinical trials supported by the pharmaceutical industry are supplied free of charge by the companies. However, maintenance of treatment with those drugs when the trials have finished can generate extra cost for patients who participated in the trials. Objective: To assess whether HIV-infected patients' participation in clinical trials results in drug cost savings or increases. Methods: An analysis of alt antiretrovirals dispensed to HIV-infected outpatients prior to, during, and after their participation in clinical trials in a university hospital during a 2-year period was conducted. Only patients who completed the trial during the study period were included. The following outcomes were measured: (1) cost saved (difference between cost per day during the trial and cost per day before study entry), (2) cost generated (difference between cost per day at the end of the trial and cost per day before study entry), (3) balance between cost saved and cost generated, and (4) number of days that a patient received a drug once the trial was finished to generate cost, considering costs saved. All data were extracted from the hospital pharmacy database. A stratified analysis by type of clinical trial (ordinary or expanded use) was undertaken. Results: Data from 61 patients were analyzed. The cost of drug therapy during patient participation in a clinical trial was lower than the cost prior to inclusion. Therefore, mean drug savings of $10.38 (US) per patient day resulted (95% CI –5.9 to 14.84), The mean cost generated was $8.74 per patient day (95% CI 3.95 to 13.52). Conclusions: A patient's participation in a clinical trial or expanded-access clinical trial generated extra cost once the trial had finished because the cost of drug therapy was higher at the end of the study. In our study, the daily drug costs saved during the trial were similar to the daily drug costs generated.

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 Virtual Clinical Trials: Perspectives in Dermatology

Dermatology ◽  
2020 ◽  
Vol 236 (4) ◽  
pp. 375-382 ◽  
Author(s):  
Zarqa Ali ◽  
John Robert Zibert ◽  
Simon Francis Thomsen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Reactions ◽  
Skin Diseases ◽  
Drop Out ◽  
Pharmaceutical Companies ◽  
Home Based ◽  
Life Threatening ◽  
The Cost ◽  
Monitoring Devices

Background: The cost of developing a new drug is approximately USD 2.6 billion, and over two-thirds of the total cost is embedded in the clinical-testing phase. Patient recruitment is the single biggest cause of clinical trial delays, and these delays can result in up to USD 8 million per day in lost revenue for pharmaceutical companies. Further, clinical trials struggle to keep participants engaged in the study and as many as 40% drop out. To overcome these challenges pharmaceutical companies and research institutions (e.g., universities) increasingly use an emerging concept: virtual clinical trials (VCT) based on a remote approach. Summary: VCT (site-less) are a relatively new method of conducting a clinical trial, taking full advantage of technology (apps, monitoring devices, etc.) and inclusion of web platforms (recruitment, informed consent, counselling, measurement of endpoints, and any adverse reactions) to allow the patient to be home-based at every stage of the clinical trial. Studies have shown that VCT are not only operationally feasible, but also successful. They have higher recruitment rates, better compliance, lower drop-out rates, and are conducted faster than traditional clinical trials. The visual nature of dermatological conditions, the relative ease in evaluating skin diseases virtually, and the fact that skin diseases often are not life-threatening and rarely require complex examinations make VCT very attractive for dermatological research. Further, making correct diagnoses based on photographs and patient symptomatology has always been part of the dermatologist’s routine. Thus, VCT are in many ways made for dermatology. Herein we describe VCT and their implications in dermatological research.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

Value-based dentistry: Putting the patient first

2016 ◽  
Vol 7 (3) ◽  
pp. 126-129 ◽  
Author(s):  
Sreenivas Koka ◽  
Galya Raz
Keyword(s):  
Risk Management ◽  
Quality Improvement ◽  
Quality Of Care ◽  
Dental Care ◽  
Time Cost ◽  
Safety Risk ◽  
The Cost ◽  
Over Time

What does ‘value’ mean? In the context of dental care, it can be defined as the quality of care received by a patient divided by the cost to the patient of receiving that care. In other words: V =Q/C, where Q equals the quality improvement over time, which most patients view in the context of the outcome, the service provided and safety/risk management, and C equals the financial, biological and time cost to the patient. Here, the need for, and implications of, value-based density for clinicians and patients alike are explored.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

Heroin-assisted Treatment for drug dependents’ assistance / Los programas experimentales con heroina en la atención de la población drogodependiente

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Alina Danet ◽  
Joan Carles March Cerdá ◽  
Manuel Romero Vallecillos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Literature Review ◽  
Clinical Studies ◽  
Therapeutic Use ◽  
Medical Prescription ◽  
Calidad De Vida ◽  
Survey Results ◽  
Therapeutic Possibilities

Objetivo. Los ensayos clínicos con heroína (diacetilmorfina-DAM) han aportado al arsenal terapeútico disponible una alternativa en la atención a drogodependientes. El objetivo del presente artículo es conocer las experiencias y resultados clínicos de los estudios sobre el uso terapéutico de la heroina.Metodo. Revisión bibliográfica de los diferentes estudios y ensayos clínicos realizados hasta el presente a nivel mundial, sobre la intervención con pacientes dependientes de opioides. Se han consultado las bases de datos: EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid, y los descriptores «heroin», «diacetylmorphine», «clinical trial», «survey».Resultados. Se detectan 42 referencias, 16 presentan los resultados de ensayos clínicos de Suiza, Holanda, Alemania, Canadá, España y Reino Unido, comenzando con 1994. El resto de estudios se refieren a: captación y participación de los drogodependientes, mortalidad, calidad de vida, efectos secundarios y necesidad de nuevas investigaciones y ensayos clínicos.Conclusiones. Los estudios clínicos llevados a cabo hasta la actualidad muestran heterogeneidad en los métodos y variables empleadas, pero los objetivos son comunes (parten de evaluar los efectos del uso terapéutico de la heroina) y los resultados constatan la seguridad y efectividad de la prescripción médica de la diacetilmorfina. AbstractObjective. Clinical trials with heroin (diacetylmorphine) bring an alternative to the available therapeutic possibilities for addict people. The purpose of this article is to describe the experiences and results of clinical studies centered on the therapeutic use of heroin.Method. Literature review of studies and clinical trials, centered on the intervention with opiois- dependent patients. The databases consulted were : EMBASE, ScienceDirect, Wiley-Blackwell, PubMed, Bio-Med Central, Medline, Ovid. The descriptors : «heroin», «diacetylmorphine», «clinical trial», «survey».Results. The literature review revealed the existence of 42 references, of which 16 presented the results of clinical trials in Switzerland, Holland, Germany, Canada, Spain and United Kingdom, starting with 1994. Other references are centered on uptake and involvement of the drug, mortality quality of life/ side effects and need for further research and clinical trials.Conclusions. Clinical studies carried out until the present show heterogeneity in the methods and variables used, but the objectives are the same (based on assessing the effects of the therapeutic use of heroin) and the results confirm the safety and effectiveness of medical prescription of diacetylmorphine.

On Using Monte Carlo Simulations for Project Risk Management

2016 ◽  
pp. 150-173
Author(s):  
Cristiana Tudor ◽  
Maria Tudor
Keyword(s):  
Monte Carlo Simulation ◽  
Risk Management ◽  
Monte Carlo ◽  
Decision Makers ◽  
Project Schedule ◽  
Project Risk ◽  
Monte Carlo Simulation Technique ◽  
Basic Probability ◽  
The Cost

This chapter covers the essentials of using the Monte Carlo Simulation technique (MSC) for project schedule and cost risk analysis. It offers a description of the steps involved in performing a Monte Carlo simulation and provides the basic probability and statistical concepts that MSC is based on. Further, a simple practical spreadsheet example goes through the steps presented before to show how MCS can be used in practice to assess the cost and duration risk of a project and ultimately to enable decision makers to improve the quality of their judgments.

scholarly journals Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025218 ◽  
Author(s):  
Xuan Zhang ◽  
Ran Tian ◽  
Zhen Yang ◽  
Chen Zhao ◽  
Liang Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Reporting Rate ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Data Set

ObjectiveThis study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.MethodsThe ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.ResultsA total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.ConclusionThe registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

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