Quality of phase I clinical drug trials: Influence of organizational management factors.

07:00 EST 13th February 2020 | BioPortfolio

Summary of "Quality of phase I clinical drug trials: Influence of organizational management factors."

Focusing on the tolerance and pharmacokinetics of new drugs, phase I clinical drug trials are characterized by high risk, poor compliance and management difficulties. High-quality clinical drug trials ensure subjects' safety while extending new drug research and development. Many studies have examined micro-level concerns of trial design and implementation rather than macro-level factors. Accordingly, we evaluated the quality of phase I clinical drug trials (trial quality) and analysed the influence of organizational management factors from a macro-level perspective.


Journal Details

This article was published in the following journal.

Name: Journal of clinical pharmacy and therapeutics
ISSN: 1365-2710


DeepDyve research library

PubMed Articles [48471 Associated PubMed Articles listed on BioPortfolio]

Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2.

Drug development in oncology currently is facing a conjunction of an increasing number of antineoplastic agents (ANAs) candidate for phase I clinical trials (P1CTs) and an important attrition rate for...

Data Integrity in Global Clinical Trials: Discussions from Joint US FDA and MHRA UK Good Clinical Practice Workshop.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspection...

Influence of the labor quality of life on the employeeperformance of public hospitals from Mexico: a vision based on the team management.

To assess the relationship between labor quality of life (LQL) and organizational workers performance (OWP) from seven public hospitals, analyzing the influence of the personnel management (PM) as med...

What Is in the Literature.

This installment of what is in the literature is on amyotrophic lateral sclerosis (ALS). The pathophysiology of ALS remains open and the role of genes, a foothold into pathophysiology, but there are >...

Key indicators of phase transition for clinical trials through machine learning.

A significant number of drugs fail during the clinical testing stage. To understand the attrition of drugs through the regulatory process, here we review and advance machine-learning (ML) and natural ...

Clinical Trials [18858 Associated Clinical Trials listed on BioPortfolio]

Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder

This study will evaluate the effectiveness of organizational skills training in improving organizational, time management, and planning difficulties in children with attention deficit hype...

Patient Perceptions and Willingness to Enroll in Clinical Trials

The objective of our study is to determine which factors affect willingness to participate in gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will be...

Brain Plasticity Underlying Acquisition of New Organizational Skills in Children

Organizational, time management and planning (OTMP) skills deficits are impairing features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD), which compromi...

Organizational Skills Training for Children With ADHD

The purpose of this trial is to investigate the effect of organizational skills training, a parent and child training approach on organizational skills, inattentive symptoms and functional...

Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials

The purpose of this study is to compare selective cyclooxygenase-2 (COX-2) and non selective COX inhibitors with respect to the extent to which disease activity is improved without self re...

Medical and Biotech [MESH] Definitions

Comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.

Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.

Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques after phase II trials. A large enough group of patients is studied and closely monitored by physicians for adverse response to long-term exposure, over a period of about three years in either the United States or a foreign country.

Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts.

Works about a study where participants are assigned to a treatment, procedure, or intervention by methods that are not random. Non-randomized clinical trials are sometimes referred to as quasi-experimental clinical trials or non-equivalent control group designs.

Quick Search

DeepDyve research library

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Searches Linking to this Article