Anavex Life Sciences Corp (AVXL)

[nidan7500]

Rubyred...thx, this is important stuff...let's hope they move on these changes right away. If I had a new drug I would wait until these changes were effective. One wonders how long these obvious process flaws were known to exist and how such thinking lead to the flawed Amyloid Thesis thinking...some of this is actually embarrassing to the FDA. IMO.

The second draft guidance, “Adaptive Designs for Clinical Trials of Drugs and Biologics,” discusses principles for designing, conducting and reporting the results from an adaptive clinical trial. An adaptive design is a type of clinical trial design that allows for planned modifications to one or more aspects of the design based on data collected from the study’s subjects while the trial is ongoing. The advantage of an adaptive design is the ability to use information that was not available at the start of the trial to improve efficiency. An adaptive design can provide a greater chance to detect the true effect of a product, often with a smaller sample size or in a shorter timeframe.

An adaptive design can reduce the number of patients exposed to an unnecessary risk of an ineffective investigational treatment. Patients may even be more willing to enroll in these types of trials, as they can increase the probability that subjects will be assigned to the more effective treatment. These guidance documents are part of the FDA’s science-based mission to modernize clinical trials and advance the development of safe and effective drugs and biologics for the American public.

(Related: FDA Takes Renewed Aim at E-Cig Marketing)
“By modernizing our approach to the design of clinical trials, we can make drug development more efficient and less costly while also increasing the amount of information we can learn about a new product’s safety and benefits,” says FDA Commissioner Scott Gottlieb, M.D. “Using more modern approaches to clinical trials, we can lower the cost of developing new drugs and increase the amount of competition in the market.
“This can improve patient access. We’ve found that it’s taking much longer after a new drug is approved to get a second or third drug to the market that’s in the same class as the original medicine. That means that new drugs are enjoying monopolies for longer periods of time, and consumers aren’t benefiting from price competition. Also, patients aren’t getting the benefits from a choice between different drugs in a new class of medicines, where each drug is similar but might have slightly different profiles, and where one drug may work better for an individual patient.”

(Related: Innovations Helping to Grow the Clinical Trial Packaging Market)
Gottlieb continues, “One of the most promising ways to make drug development more efficient—while enabling providers and patients to get better information about how a new medicine works—is through the use of more modern approaches to the design of clinical trials. One such approach are master protocol designs. These are clinical trials that allow the evaluation of more than one investigational drug or biologic, more than one disease type, or more than one patient population in parallel, under a single clinical trial structure.
“The standard approach to generating evidence—a series of clinical trials, each investigating one or two interventions in a single disease—has become more expensive and challenging to execute. As a result, important clinical questions can go unanswered. Instead, well-designed master protocols that look at multiple therapies in a single disease, a single therapy in multiple diseases, or multiple therapies across multiple diseases or disease subtypes, can provide answers more quickly and efficiently than traditional clinical trials.

https://www.healthcarepackaging.com/article/fda-modernizes-its-approach-clinical-trials-drugs-and-biologics