DAVID GRANOVSKY

THE CLINICAL TRIAL MUSE SPOUTS OFF

In BUSINESS OF STEM CELLS on May 25, 2010 at 3:56 pm

My new friend, Dan just posted –

Can Web 2.0 Really Save Clinical Trial Participation Rates?

It never ceases to amaze me that people think that technology alone can improve clinical trial participation rates. What they need to understand is that potential study participants want to actually LEARN more about clinical trials before they sign up for a study. Having an app that can find open studies available for your phone is not going to encourage anyone to actually join a study. What is missing is the human touch, and research professionals doing more education themselves and not outsourcing study participant recruitment to third party vendors.  Via: Save Clinical Trial

-Dan

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Dan poses an interesting question that got me thinking. In support and response, here are a few of my thoughts…

THE CLINICAL TRIAL MUSE SPOUTS OFF


A few thoughts…

  • ***I fully support and applaud Dan’s movement/efforts to re-evaluate and reform the clinical trial parameters and process so it is more patient friendly.
  • ***Changing the trial process to help those within the trial is a great step in the right direction.
  • ***I would further like to see the process changed to help those patients outside of the trials who are sick, desperate and with no available options ‘to get better’ within our current medical practices.

A few facts…

  • ***1938 – the Federal Food, Drug, and Cosmetic Act was the first attempt to regulate cosmetics and medical devices requiring that drugs be proven safe prior to marketing.
  • ***It typically costs 500-700 million dollars and 7-10 years to bring a drug public, including the clinical trial process.
  • ***The current clinical trial process severely limits the available treatments for thousands of disorders because there just is no hope of recouping the expenditure to study them properly.  For ex: A very effective drug for treating a rare form of glioblastoma drug was abandoned because there was only 23,000 people in the US with the disease [ $500mil/$23k = ~$22k per patient just to break even on the expenditure!! ]
  • ***The clinical trial process is based on an outdated and “broken” paradigm that has let many drugs pass only to be pulled off of the market when patients started developing serious complications or dying from the “safe and approved” drugs.
  • ***New technologies like stem cells are now available all over the world except in the US because the FDA is trying to force stem cells to be a “clinical trial drug” which they are not.


A few conclusions…

  • 1.  The clinical trial process from soup to nuts MUST be revamped…perhaps with many of the ideas Dan proposed.
  • 2.  The clinical trial process must be reformed based on the goal of “treating more patients and more diseases safely and well”…not the goal of “recouping expenditures for the trials.”
  • 3.  The clinical trial process must be torn down and rebuilt anew for those procedures that exist outside of the historic and pre-conceived notions of medicine…those that are not “DRUGS,” like adult or repair stem cell treatments.
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