Pharmacology and clinical trials of reversibly-binding P2Y12 inhibitors

2011 ◽  
Vol 105 (S 06) ◽  
pp. S75-S81 ◽  
Author(s):  
Robert Storey
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Platelet Activation ◽  
Clinical Trial Data ◽  
Trial Data ◽  
P2y12 Receptor ◽  
Phase 3 ◽  
P2y12 Inhibitors ◽  
Clopidogrel Therapy

SummaryThe important role of the P2Y12 receptor in amplification of platelet activation and associated responses and the limitations associated with clopidogrel therapy have led to the development of novel inhibitors of this receptor. Three reversibly-binding P2Y12 inhibitors are in phase 3 development, ticagrelor, cangrelor and elinogrel. The pharmacology and clinical trial data for each of these inhibitors are discussed and compared with relevant data for the thienopyridines clopidogrel and prasugrel.

Clinical Trial Data Management Software: A Review of the Technical Features

2019 ◽  
Vol 14 (3) ◽  
pp. 160-172 ◽  
Author(s):  
Aynaz Nourani ◽  
Haleh Ayatollahi ◽  
Masoud Solaymani Dodaran
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Data Management System ◽  
Management Systems ◽  
Data Management Systems ◽  
Technical Features

Background:Data management is an important, complex and multidimensional process in clinical trials. The execution of this process is very difficult and expensive without the use of information technology. A clinical data management system is software that is vastly used for managing the data generated in clinical trials. The objective of this study was to review the technical features of clinical trial data management systems.Methods:Related articles were identified by searching databases, such as Web of Science, Scopus, Science Direct, ProQuest, Ovid and PubMed. All of the research papers related to clinical data management systems which were published between 2007 and 2017 (n=19) were included in the study.Results:Most of the clinical data management systems were web-based systems developed based on the needs of a specific clinical trial in the shortest possible time. The SQL Server and MySQL databases were used in the development of the systems. These systems did not fully support the process of clinical data management. In addition, most of the systems lacked flexibility and extensibility for system development.Conclusion:It seems that most of the systems used in the research centers were weak in terms of supporting the process of data management and managing clinical trial's workflow. Therefore, more attention should be paid to design a more complete, usable, and high quality data management system for clinical trials. More studies are suggested to identify the features of the successful systems used in clinical trials.

Mining Clinical Trial Data

2011 ◽  
pp. 31-47
Author(s):  
Jose Ma. J. Alvir ◽  
Javier Cabrera
Keyword(s):  
Data Mining ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Trial Data ◽  
Treated Group ◽  
Trial Data ◽  
Controlled Trials ◽  
Clinical Trails ◽  
Important Objective

Mining clinical trails is becoming an important tool for extracting information that might help design better clinical trials. One important objective is to identify characteristics of a subset of cases that responds substantially differently than the rest. For example, what are the characteristics of placebo respondents? Who have the best or worst response to a particular treatment? Are there subsets among the treated group who perform particularly well? In this chapter we give an overview of the processes of conducting clinical trials and the places where data mining might be of interest. We also introduce an algorithm for constructing data mining trees that are very useful for answering the above questions by detecting interesting features of the data. We illustrate the ARF method with an analysis of data from four placebo-controlled trials of ziprasidone in schizophrenia.

scholarly journals The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Derek G. Kyte ◽  
Olalekan Lee Aiyegbusi ◽  
Anita L. Slade ◽  
Christel McMullan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Case Studies ◽  
Real World ◽  
Clinical Trial Data ◽  
Research Impact ◽  
Trial Data ◽  
Patient Reported ◽  
The Impact

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.

Role of Radiation Therapy and Fluoropyrimidines in the Treatment of Gastrointestinal Malignancies

1996 ◽  
Vol 3 (4) ◽  
pp. 319-328
Author(s):  
William W. Wong ◽  
Steven E. Schild ◽  
James A. Martenson
Keyword(s):  
Clinical Trial ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Combined Chemotherapy ◽  
Gastrointestinal Malignancies ◽  
Treatment Regimens ◽  
Improved Outcomes ◽  
Clinical Benefits ◽  
Positive Results

Background The use of combined chemotherapy and radiation for gastrointestinal malignancies has several theoretical advantages, and clinical trials to determine the type and extent of clinical benefits have been performed. Methods The basic science and clinical trial data evaluating such combinations are reviewed, with an emphasis on the interactions between fluoropyrimidines and radiation. Results Improved outcomes from chemoradiotherapy have been demonstrated in patients with selected stages of anal, esophageal, rectal, and pancreatic cancer. Conclusion Despite these positive results, further work is needed to demonstrate even more effective and less toxic treatment regimens.

The rate of tumor growth, g, as a biomarker for overall survival (OS) in prostate cancer (PC) in clinical trials as well as in real-world data from the Veterans Administration Medical Centers (VAMCs).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5074-5074
Author(s):  
Harshraj Leuva ◽  
Mengxi Zhou ◽  
Julia Wilkerson ◽  
Keith Sigel ◽  
Ta-Chueh Hsu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Tumor Growth ◽  
Real World ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Real World Data ◽  
World Data

5074 Background: Novel assessments of efficacy are needed to improve determination of treatment outcomes in clinical trials and in real-world settings. Methods: Cancer treatments usually lead to concurrent regression and growth of the drug-sensitive and drug-resistant fractions of a tumor, respectively. We have exploited novel methods of analysis that assess these two simultaneous processes and have estimated rates of tumor growth ( g) and regression ( d) in over 30,000 patients (pts) with diverse tumors. Results: In prostate cancer (PC) we have analyzed both clinical trial and real-world data from Veterans. Using clinical trial data from 6819 pts enrolled in 15 treatment arms we have established separately and by combining all the data that g correlates highly (p<0.0001) with overall survival (OS) – slower g associated with better OS. In PC, abiraterone (ABI) and docetaxel (DOC) are superior to placebo, prednisone and mitoxantrone. ABI (median g =0.0017) is superior to DOC ( g=0.0021) in first line (p=0.0013); and ABI in 2nd line ( g=0.0034) is inferior to ABI in 1st line ( g=0.0017; p<0.0001). Finally, using combined clinical trial data as a benchmark we could assess the efficacy of novel therapies in as few as 30-40 patients. Amongst 7457 Veterans, the median g on a taxane ( g=0.0022) was similar to that from clinical trials ( g=0.0012). Although only 258 Veterans received cabazitaxel (CAB), g values for CAB ( g=0.0018) and DOC ( g=0.0023) were indistinguishable (p=0.3) consistent with their identical mechanism of action. Finally, outcomes with DOC in African American (AA) ( g=0.00212) and Caucasian ( g=0.00205) Veterans were indistinguishable (p=0.9) and comparable across all VAMCs. Conclusions: The rate of tumor growth, g, is an excellent biomarker for OS both in clinical trials and in real-world settings. g allows comparisons between trials and for large trial data sets to be used as benchmarks of efficacy. Real-world outcomes in the VAMCs are similar to those in clinical trials. In the egalitarian VAMCs DOC efficacy in PC is comparable in AA and Caucasian Veterans -- indicating inferior outcomes reported in AAs are likely due to differential health care access, not differences in biology.

scholarly journals Transparency in clinical trials

2021 ◽  
Author(s):  
ChS Pavlov ◽  
DL Varganova ◽  
AA Svistunov ◽  
C Gluud
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Technology Development ◽  
Personal Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Positive Effects ◽  
The World ◽  
Information Technology Development ◽  
Meta Analyses

In the age of information technology development, healthcare professionals around the world have the opportunity to simultaneously access advanced scientific developments, modern achievements, and the results of new clinical trials. The clinical guidelines of the international medical communities are based on the results of meta-analyses of clinical trial data. As new medical challenges emerge, clinical trial data are reviewed and re-analyzed. Unfortunately, to date, the results of not all studies are made public, or are presented selectively, indicating the positive effects of a particular technology (intervention), which makes it difficult to critically evaluate the results of work and makes the task of assessing the true effectiveness of the intervention more difficult. The problem of transparency of research data with the preservation of personal data of participants remains relevant for decades. This article is focused on possible ways of solving this problem and the analysis of the current situation in the world.

Emerging Role of Interleukins for the Assessment and Treatment of Liver Diseases

2021 ◽  
Vol 21 ◽  
Author(s):  
Aaliya L. Ali ◽  
Namrata P. Nailwal ◽  
Gaurav M. Doshi
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Liver Disease ◽  
Alcoholic Liver Disease ◽  
Liver Diseases ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Alcoholic Fatty Liver ◽  
Assessment And Treatment

Background: The most common liver diseases are fibrosis, alcoholic liver disease, non-alcoholic fatty disease, viral hepatitis, and hepatocellular carcinoma. These liver diseases account for approximately 2 million deaths per year worldwide, with cirrhosis accounting for 2.1% of the worldwide burden. The most widely used liver function tests for diagnosis are alanine transaminase, aspartate transaminase, serum proteins, serum albumin, and serum globulins, whereas antivirals and corticosteroids have been proven to be useful for the treatment of liver diseases. A major disadvantage of these diagnostic measures is the lack of specificity to a particular tissue or cell type, as these enzymes are common to one or more tissues. The major adverse effect of current treatment methods is drug resistance. To overcome these issues, interleukins have been investigated. The balance of these interleukins determines the outcome of an immune response. Interleukins are considered interesting therapeutic targets for the treatment of liver diseases. In this review, we summarize the current state of knowledge regarding interleukins in the diagnosis, treatment, and pathogenesis of different acute and chronic liver diseases. Objective: To understand the role of interleukins in the assessment and treatment of different types of liver diseases. Methods: A literature search was conducted using PubMed, Science Direct, and NCBI with the following keywords: Interleukins, Acute Liver Failure, Alcoholic Liver Disease, Non-Alcoholic Fatty Liver Disease, Liver Fibrosis, Hepatocellular Carcinoma, Inflammation, Liver injury, Hepatoprotective effect. Clinical trial data on these interleukins have been searched on Clinicaltrials.gov. Results: Existing literature and preclinical and clinical trial data demonstrate that interleukins play a crucial role in the pathogenesis of liver diseases. Conclusion: Our findings indicate that IL-1, IL-6, IL-10, IL-17, IL-22, IL-35, and IL-37 are involved in the progression and control of various liver conditions via the regulation of cell signaling pathways. However, further investigation on the involvement of these interleukins is necessary for their use as a targeted therapy in liver diseases.

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