A bivariate Bayesian framework for simultaneous evaluation of two candidate companion diagnostic assays in a new drug clinical trial

Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility criteria to include more patients in clinical trials and design options for clinical trials incorporating expanded eligibility criteria. The broadening of clinical trial eligibility criteria can be considered to better reflect the real-world patient population, improve clinical trial participation, and increase patient access to new investigational treatments.

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New Drug Clinical Trial Center, National Taiwan University Hospital

Asia-Pacific Biotech News ◽

10.1142/s0219030302001611 ◽

2002 ◽

Vol 06 (20) ◽

pp. 750-750

Author(s):

Ann-Lii Cheng ◽

Chih-Hsin Yang

Keyword(s):

Clinical Trial ◽

University Hospital ◽

New Drug ◽

Drug Clinical Trial

The article is about the clinical trial center in National Taiwan University Hospital.

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Artemeter-Lumefantrine therapeutic efficacy, safety and plasma levels in patients with uncomplicated falciparum malaria from the Colombian Pacific región

Infectio ◽

10.22354/in.v22i4.738 ◽

2018 ◽

Vol 22 (4) ◽

pp. 199

Author(s):

Alberto Tobón-Castaño ◽

Luisa Garcés-Murillo ◽

Alexandra Ríos-Orrego ◽

Jehidys Montiel-Ramos ◽

Briegel De Las Salas ◽

...

Keyword(s):

Clinical Trial ◽

Falciparum Malaria ◽

Therapeutic Efficacy ◽

Plasma Concentrations ◽

Plasmodium Falciparum Malaria ◽

Therapeutic Failure ◽

World Health ◽

Blood Levels ◽

Drug Clinical Trial ◽

Parasitological Response

Introduction: In Colombia, the published studies for the treatment of uncomplicated Plasmodium falciparum malaria with Artemether-Lumefantrine are scarce. The aim of the study was to evaluate the therapeutic efficacy and safety profile of this combination.Methods: A clinical trial was performed in adults with uncomplicated P. falciparum malaria using the 28-day World Health Organization validated protocol. Patients received supervised antimalarial treatment and the primary efficacy endpoint was the clinical and parasitological response. Safety was assessed through adverse events surveillance and plasmatic levels of antimalarial drugs were measured.Results: 88 patients were included. Adequate clinical and parasitological response rate of 100% on day 28 was achieved in 84 patients, diagnosed by thick blood smear examination. There were four parasitological therapeutic failures (5%) detected by polymerase chain reaction.Discusion: Therapeutic efficacy similar to previous studies was established with a slight increase in therapeutic failure. The serum levels of the antimalarials were adequate and the few cases of therapeutic failure were not related.Conclusion: Treatment of uncomplicated P. falciparum malaria with Artemeter-Lumefantrine was effective and safe in the study population. All patients reached adequate plasma concentrations of the drugs; therapeutic failures were not associated with low blood levels of the drug clinical trial.

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Industry Watch

Asia-Pacific Biotech News ◽

10.1142/s0219030304001673 ◽

2004 ◽

Vol 08 (20) ◽

pp. 1099-1111

Keyword(s):

Clinical Trial ◽

Phase I ◽

Stock Exchange ◽

Medical Industry ◽

Phase I Clinical Trial ◽

New Drug ◽

Global Companies ◽

Japan Tobacco ◽

New Entry

New Entry to Australian Stock Exchange: Acrux. Peplin's Phase I Clinical Trial Completed. Prima BioMed & AstraZeneca in Licensing Agreement. Ultratech India Restrained from Tampering with Pfizer's Viagra Trademarks. India Offers Competitive New Drug Solutions. Rofecoxib Formulation Discontinued after Health Ministry's Ban. GSK Focuses on In-licensing for Other Global Companies in India. Forthcoming Pharmaceutical Hub in Bengal. Upcoming Medical Industry Zone in Japan. Roche and Japan Tobacco in Licensing Collaboration for Potential Dyslipidemia Therapy. Tapping on Nature for Drugs.

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Integrating Companion Diagnostic Assays into Drug Development: Addressing the Challenges from the Diagnostic Perspective

Drug Development Research ◽

10.1002/ddr.21068 ◽

2013 ◽

Vol 74 (2) ◽

pp. 148-154 ◽

Cited By ~ 3

Author(s):

John Beeler

Keyword(s):

Drug Development ◽

Diagnostic Assays ◽

Companion Diagnostic

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Combination Drug Clinical Trial

Encyclopedia of Biopharmaceutical Statistics, Third Edition ◽

10.1201/b14674-52 ◽

2012 ◽

pp. 324-326

Author(s):

H Hung

Keyword(s):

Clinical Trial ◽

Combination Drug ◽

Drug Clinical Trial

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Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study

JMIR Research Protocols ◽

10.2196/14744 ◽

2020 ◽

Vol 9 (1) ◽

pp. e14744

Author(s):

Vishal Vennu ◽

Saurabh Dahiya

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

New Drugs ◽

Survey Study ◽

Multiple Sources ◽

Cross Sectional ◽

Web Based ◽

Google Docs ◽

New Drug ◽

Research Professionals

Background Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. Objective This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. Methods In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. Results The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. Conclusions The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. International Registered Report Identifier (IRRID) PRR1-10.2196/14744

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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

10.21203/rs.3.rs-84171/v1 ◽

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.

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