BioValleyCHINA Ventures
 
Global BioTechnology Incubation
 Western Management and Funding in China Medical Parks

Adaptive Clinical Trial

BioValleyChina will bring US and Global biotechnology products that are in early stages of development and FDA registration to China for further development and sFDA registration.  With China’s large population base and incidence of disease in cardiovascular, diabetes, hypertension, cancer, liver, lung and infectious diseases, this will allow for speedier patient recruitment for clinical studies. 

 

The findings from China clinical studies can streamline the regulatory pathways and allow for gathered clinical data from China registration to be evaluated. With “adaptive changes,” based on this evaluation, it is possible to  improve clinical regulatory pathways in the US and other countries.  This will therefore allow for potentially more successful regulatory outcomes and a more expeditious pathway to commercialization.

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Will Adaptive Design Change The BioPharma World?

Posted: May 13, 2010 09:07 AM by Stephen Simpson
Every so often a good idea comes out way ahead of its time. Fuel cells actually predate the gasoline engine, the Apple (Nasdaq:AAPL) Newton is the almost-forgotten iPad/iPhone predecessor, and Nikola Tesla sketched out plans for concepts like wireless energy transfer and airplanes that could take off vertically in the 1920s.

Adaptive clinical trial design may ultimately belong on this list as well. Although the idea of changing pharmaceutical drug trials in response to data generated within the trial has been around for at least 10 years, the idea may finally be on the cusp of being realized. Should this concept become more commonplace, it could be a major step forward for biotechnology and pharmaceutical companies.

Learn By Doing
The idea behind adaptive design is pretty straightforward - use the information generated within a trial to modify the trial to become even more effective. When biopharmaceutical companies like Amgen (Nasdaq:AMGN) or Gilead (Nasdaq:GILD) launch a study, they are typically locked in to the original design. As a result, companies spend hundreds of millions of dollars (and years of times) muddling through studies even once it becomes clear that the original design is not the best design.

Adaptive design allows for changes to the study while the study is ongoing. If a trial is enrolling too slowly, an adaptive study could allow for a change in the inclusion criterion. If a particular dose looks ineffective, the trial can change to incorporate doses that seem more useful. If a particular combination of drugs seems more effective (or if a drug works better in certain people), the study can be reoriented to focus on that detail.

In short, an adaptive study design can allow a company to maximize the knowledge gained from a study. That, in turn, means lower development costs and a faster path to development. With adaptive design, it is possible that InterMune (Nasdaq:ITMN) could have fine-tuned a dosage or patient subset that would have shown clear therapeutic benefit, or Exelixis (Nasdaq:EXEL) could launch a Phase 2 oncology study with eight potential doses and end the study with the two best candidates for Phase 3.

Will The FDA Go Along?
The problem with adaptive design is not a lack of interest. Companies including Lilly (NYSE:LLY), Novartis, and Merck (NYSE:MRK) have all been publicly supportive of the idea. The biggest issue, apart from the complexity of these studies, is the FDA. Simply put, the FDA takes to new ideas like a vampire takes to garlic fries. That said, the agency did put out some draft guidelines for review in February of this year.

While the FDA has legitimate concerns regarding bias and data interpretation, there appears to be no need for an "all or nothing" approach. After all, Phase 1 studies are already largely adaptive (often starting at a low dose and moving it up as it proves safe), and there is little discussion of using adaptive designs in pivotal Phase 3 studies - the biggest application for adaptive design would be dose-finding Phase 2 studies.  

Progress At Last
After years of hope and talk, the logjam may be breaking. Lilly has been using an adaptive trial design for studies of its potential diabetes drug LY2189265, while the I-SPY2 study is going to investigate whether certain biomarkers can point to the breast patients most likely to benefit from five different drugs offered by Abbott, Amgen, and Pfizer (NYSE:PFE). Assuming that these studies back up the benefits of adaptive design, expect to see more and more companies push for these protocols.

If adaptive clinical trials do become more common, it is not just the biotech and pharma sectors that will benefit. Clinical trials require advanced statistical analysis as is, but adaptive trials are even more complicated. That could prove to be a boon for research service companies like Parexel (Nasdaq:PRXL) and Covance.

The Bottom Line
Adaptive clinical trials could prove to be one of those quiet revolutions that is seldom noticed (let alone appreciated) by those who are not knee-deep in the industry. Nevertheless, if this advance leads to faster development timelines and significant monetary savings, the industry and its shareholders could clearly benefit. (For more, see Measuring The Medicine Makers.)
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