Carfilzomib

Blood ◽  
2013 ◽  
Vol 121 (6) ◽  
pp. 893-897 ◽  
Author(s):  
K. Martin Kortuem ◽  
A. Keith Stewart
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Disease Progression ◽  
Drug Administration ◽  
Proteasome Inhibitor ◽  
Food And Drug Administration ◽  
Clinical Trial Data ◽  
Drug Approval ◽  
Trial Data ◽  
The Us

Abstract This spotlight review focuses on the second-generation proteasome inhibitor carfilzomib, which was recently approved by the US Food and Drug Administration for treatment of relapsed and refractory multiple myeloma patients who have received at least 2 prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of the completion of the last therapy. This review focuses on clinical trial data leading to drug approval and provides advice for treating physicians who are now accessing this drug for patients.

Pomalidomide

Blood ◽  
2013 ◽  
Vol 122 (14) ◽  
pp. 2305-2309 ◽  
Author(s):  
Martha Q. Lacy ◽  
Arleigh R. McCurdy
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Disease Progression ◽  
Drug Administration ◽  
Second Generation ◽  
Food And Drug Administration ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The Us ◽  
Immunomodulatory Drug

Abstract This spotlight review focuses on the second-generation immunomodulatory drug pomalidomide, which was recently approved by the US Food and Drug Administration. This drug was approved for patients with multiple myeloma who have received at least 2 prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy. This review focuses on the clinical trial data that led to approval and provides advice for treating physicians who are now prescribing this drug for patients.

scholarly journals CLINICAL DATA MANAGEMENT IMPORTANCE IN CLINICAL RESEARCH

2016 ◽  
pp. 59
Author(s):  
Deepa Murugesan ◽  
Ranganath Banerjee ◽  
Gopal Ramesh Kumar
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Clinical Data ◽  
Clinical Trial Data ◽  
Drug Approval ◽  
Trial Data ◽  
Data Capture ◽  
Data Management System ◽  
Pharmaceutical Companies ◽  
Management Tools

<p>ABSTRACT<br />Over the last few decades, most of the pharmaceutical companies and research sponsors are facing a lot of challenges in clinical research for their<br />new drug approval. The sponsor research needs a high-quality data report for getting new drug approval from Food and Drug Administration for their<br />medical products. Clinical trial data are important for the drug and medical device development processing pharmaceutical companies to examine<br />and evaluate the efficacy and safety of the new medical product in human volunteers. The results of the clinical trial studies generate the most<br />valuable data and in recent years; there has been massive development in the field of clinical trials. A good clinical data management system reduces<br />the duration of the study and cost of drug development. Further a well-designed case report form (CRF) assists data collection and make facilitates<br />data management and statistical analysis. Nowadays, the electronic data capture (EDC) is very beneficial in data collection. EDC helps to speed up the<br />clinical trial process and reduces the duration, errors and make the work easy in the data management system. This article highlights the importance<br />of data management processes involved in the clinical trial and provides an overview of the clinical trial data management tools. The study concluded<br />that data management tools play a key role in the clinical trial and well-designed CRFs reduces the errors and save the time of the clinical trials and<br />facilitates the drug discovery and development.<br />Keywords: Pharmaceutical, Clinical trial, Clinical data management, Data capture.</p>

Comparison of oncology drug approval between Health Canada and the US Food and Drug Administration

Cancer ◽  
2015 ◽  
Vol 121 (10) ◽  
pp. 1688-1693 ◽  
Author(s):  
Doreen A. Ezeife ◽  
Tony H. Truong ◽  
Daniel Y. C. Heng ◽  
Sylvie Bourque ◽  
Stephen A. Welch ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Drug Approval ◽  
Oncology Drug ◽  
The Us ◽  
Health Canada

scholarly journals Interpreting clinical trial data in multiple myeloma: translating findings to the real-world setting

2018 ◽  
Vol 8 (11) ◽  
Author(s):  
Paul G. Richardson ◽  
Jesus F. San Miguel ◽  
Philippe Moreau ◽  
Roman Hajek ◽  
Meletios A. Dimopoulos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Real World ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The Real ◽  
Real World Setting

scholarly journals Bendamustine for the treatment of multiple myeloma in first-line and relapsed–refractory settings: a review of clinical trial data

2014 ◽  
Vol 56 (3) ◽  
pp. 559-567 ◽  
Author(s):  
Antonio Palumbo ◽  
Massimo Offidani ◽  
Francesca Patriarca ◽  
Maria Teresa Petrucci ◽  
Michele Cavo
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Clinical Trial Data ◽  
Trial Data ◽  
First Line

scholarly journals Why It Is Important to Develop an Effective and Safe Pediatric COVID-19 Vaccine

Vaccines ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 127
Author(s):  
Nicola Principi ◽  
Susanna Esposito
Keyword(s):  
Clinical Trial ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Rapid Development ◽  
The Elderly ◽  
Pharmaceutical Companies ◽  
Trial Registry ◽  
Huge Number ◽  
Clinical Trial Registry ◽  
The Us

The need to cope with the medical, social, and economic storm due to the new coronavirus 2019 (COVID-19) pandemic as quickly as possible has led to the very rapid development of a huge number of vaccines. All these vaccines have been mainly developed in healthy adults and, in some cases, in the elderly. Children were marginally involved as, according to the clinical trial registry Clinical Trials.gov, only very few studies have included children among subjects to enroll, although just a few weeks after the pandemic declaration, the US Food and Drug Administration had highlighted the importance of vaccine evaluation in pediatrics. Availability of an effective and safe pediatric COVID-19 vaccine appears mandatory for several clinical and epidemiological reasons. However, as the development of an effective and safe pediatric vaccine seems far from easy, strong cooperation among governments, researchers, and pharmaceutical companies is highly desirable.

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