Featured Articles
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Patient Reported Outcomes And The Common Terminology Criteria For Adverse Events (CTCAE)
8/5/2019
The Common Terminology Criteria for Adverse Events (CTCAE) was developed to standardize reporting of adverse events (AEs). Originally developed for oncology trials by the National Cancer Institute (NCI), the CTCAE is now used widely across all types of clinical trials, and as a result has become an essential tool for evaluating trial safety. The CTCAE provides a library of over 800 AEs with guidelines for grading event severity. However, it fails to capture the day to day effects a patient might experience. In order to integrate the patient’s perspective into AE reporting, the NCI developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
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Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access Programs
8/5/2019
Programs providing seriously ill patients with early access to investigational products are of great interest to the public, but what are the implications to pharmaceutical and biotechnology product companies? This article examines Right-to-Try legislation as well as FDA’s existing expanded access programs from the perspective of companies who are considering providing investigational products to patients with serious or life threatening diseases that have exhausted all other treatment options.
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Master Protocols And The New FDA Guidance
8/5/2019
In September of 2018, FDA released a new FDA guidance on master protocols. So, what are master protocols, how can they benefit sponsors and patients, and what are the challenges?
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Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S.
8/5/2019
The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.
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Seven Essentials For Successful Drug Development
8/5/2019
In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors consistently emerge as essential components of success and failure. This article reminds of the essentials so that effective therapies have a greater likelihood of reaching patients in need.
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505 (b)(2) vs. ANDA: How Complex Drugs Fit In
2/7/2019
Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.
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Cellular Therapy Studies: 7 Common Challenges
8/1/2018
Cellular therapy is a form of treatment where patients are injected with cellular material. Different types of cells can be utilized such as stem cells (such as mesenchymal stem cells) and cells from the immune system (such as regulatory T cells (Tregs)) from either the patient or a donor.
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Age Diversity In Clinical Trials: Addressing The Unmet Need
7/10/2018
In a recent New York Times article, Paula Span raises the concern that elderly subjects are frequently omitted from clinical trials. Consequently, physicians know very little about how a given treatment may affect their older patients. Is a medication effective for the elderly? Is it safe? Without data, how is a physician to know?
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Implementing Patient-Centric Principles in Asthma Research
3/21/2018
Change the perception of clinical trials by making them less burdensome for patients overall.
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10-Step Commercial Clinical Protocol Authoring Guide
9/13/2017
Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.