[Ip-health] Size, cost of trials

Gregg Gonsalves gregg.gonsalves at yale.edu
Sat Mar 12 05:53:10 PST 2016

I’d also like to see how long these trials ran, the clinical trials results summaries, to see “what we’re paying for”. Joe Ross and others have written about how studies for FDA approval have gotten smaller, shorter in duration over the past several years, particularly as companies seek some sort of fast-track, breakthrough expedited consideration.
What we “buy” when we invest in clinical trials is a set of answers—are we getting less bang for the buck nowadays? That is, are these high price tags getting us reliable clinical evidence on the effects of these drugs for the populations and indications for which they’ll be marketed? My fear is that, we are seeing inflated cost estimates for clinical trials and we’re getting less information now than we did in the past—a hypothesis, but having some info on the results of the studies Joe DiMasi looked at, the number of people in the studies, their length etc, would be very helpful too.
Gregg Gonsalves
Global Health Justice Partnership <http://www.yaleghjp.org/>
Yale Law School <http://law.yale.edu/>-Yale School of Public Health <http://publichealth.yale.edu/>
P.O. Box 208215
New Haven, CT 06520-8215
Email: gregg.gonsalves at yale.edu
Skype: gregggonsalves

> On Mar 12, 2016, at 8:12 AM, Jamie Love <james.love at keionline.org> wrote:
> ​Dear Joe,
> I meant to share this with the list.
> Now that your paper on drug development costs has been published, and gIven
> how central are the costs of clinical trials to your analysis, and the fact
> that in your previous estimate you disclosed to the average number of
> patients in the trials (which allowed one to calculate the average cost per
> patient, and that UACT and others have asked for data on the number of
> patients and the cost per patient in the trials, and because these are
> numbers that can be used to verify the reasonableness of your your
> estimates, can you provide the following information
> 1.  The average number of patient in the trials, by Phase.
> 2.   The average cost per patient in the trials, by Phase.
> 3.  The same information for oncology products, and non-oncology products
> 4   The same information for drugs approved for Orphan designation, and
> non-orphans?
> Once we see the numbers for the number of patients in the trials, we can
> compare them to the numbers of patients that are reported to the FDA in the
> medical reviews.
> Once we have per patient cost estimates, we can compare them to the
> estimated published by PhRMA in a report prepared by Battelle Technology
> Partnership Practice Prepared for Pharmaceutical Research and Manufacturers
> of America (PhRMA), in  March 2015
> https://urldefense.proofpoint.com/v2/url?u=http-3A__www.phrma.org_sites_default_files_pdf_biopharmaceutical-2Dindustry-2Dsponsored-2Dclinical-2Dtrials-2Dimpact-2Don-2Dstate-2Deconomies.pdf&d=AwIGaQ&c=-dg2m7zWuuDZ0MUcV7Sdqw&r=EFBdf8ADVYl9WOYd5csvOk9tGGo9Pipgvllbk-Q4SDo&m=0Q7DNM7ioK1vHQbHLxqQJSFYVrL07lk0X_SOkS_ehLM&s=8rIgWgozwQk8TZcN1S3AjxxutXVVSgBX_ENmO9foh7U&e= 
> Also, can your sponsors find a way to make the paper public, so it is not
> behind a paywall?
> -- 
> James Love.  Knowledge Ecology International
> https://urldefense.proofpoint.com/v2/url?u=http-3A__www.keionline.org_donate.html&d=AwIGaQ&c=-dg2m7zWuuDZ0MUcV7Sdqw&r=EFBdf8ADVYl9WOYd5csvOk9tGGo9Pipgvllbk-Q4SDo&m=0Q7DNM7ioK1vHQbHLxqQJSFYVrL07lk0X_SOkS_ehLM&s=gbL75_zhwxFlBVZp75AH-qT1wdMb3LTWPn3_aiUOdLA&e= 
> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
> +41.76.413.6584, twitter.com/jamie_love
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