[Dysphagia] VitalStim conference

[eripley at yahoo.com (Irene Campbell-Taylor)]

There are many guidelines for regulation of financial aspects of research.  Two prominent ones in the US are;
   
  http://www.hhs.gov/ohrp/humansubjects/finreltn/finalguid.pdf
   
  DEPARTMENT OF HEALTH AND
  HUMAN SERVICES
  Financial Relationships and Interests
  in Research Involving Human
  Subjects: Guidance for Human Subject
  Protection
  and
  http://www.fda.gov/oc/guidance/financialdis.html
   
  Concern about the condut of research has grown over the past ten years probably because of several scandals involving major researchers to the point that registration of trials will be mandatory as financial disclosure currently is. 
  
Speech Pathology <slpdysphagia@yahoo.com> wrote:
  Your position would apply to a company that had come up with a product independently.  That isn't the case with Vitalstim.  An old technology (once the rage in the PT community but now pretty much abandoned) was applied to swallowing by an slp.  The SLP patented the technique.  The company bought the idea and ran with it in advance of research.  They claim a 97% success rate in curing dysphagia in advance of efficacy studies.  Gerry, in this case I don't understand your position.  If development is not complete until efficacy is demonstrated (your words) how can Vitalstim make these claims and sleep well at night?  (unless they're just in it for the money?) 

HAL9600@aol.com wrote:   

But with respect, that was not my question. I asked about the company not 
the researcher. Clinical trials are part of product development. Development 
is not complete until efficacy is demonstrated. 

If the company cannot conduct its own trials, then what are the options? 
Must they simply wait until a third party researcher comes up with funding of 
their own?


Gerry Brooks
Brain Injury Program Director
Northeast Center for Special Care
Lake Katrine, NY 12449
www.northeastcenter.com
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Dr I Campbell-Taylor
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