Chris, All,

I guess Eastern Research Group is still collecting data then to
document the cost of CDISC use. I know that Rho and the DCRI
provided some data to them last summer/fall, but I believe the
researchers were having trouble getting companies to cough up
production metrics. "Trade secrets" I guess.... sigh.

If anyone else can provide hard numbers for these researchers then
that would be great. The more data they get, the better the FDA
rulemaking estimates will be.

- Jack


I wonder if this is a new FDA contract
--- In rtp_cdisc@yahoogroups.com, "Chris Decker" <Chris.Decker@...>
wrote:
>
> All,
>
> This has recently come from the CDISC Global User Network. I know
> some of the question are open ended but I am simply passing along
the
> message. This is regard to the new rule by the FDA to require
CDISC
> models. If you have feedback please pass along to me at
> cdecker@...
>
> Chris
>
> ------------------------------------------------------------
>
> Eastern Research Group is working with FDA's Office of the
> Commissioner to provide an economic analysis of the possible
proposed
> regulation that will require electronic submission of clinical
trial
> data using CDISC formats. Our objectives are to estimate the costs
and
> possible cost savings to biopharmaceutical companies related to
> implementing and using CDISC standards. These estimates are
required
> for any proposed regulation, in order to gauge whether the
regulation
> will be a burden on the industry.
>
> The general questions we need to answer are:
> 1. How are companies planning to implement standards, and how
long
> will implementation take?
> a. Are you already in process of implementing? why/why not?
> b. What type of implementation are you planning/carrying out?
(e.g.,
> collecting data in SDTM or near-SDTM formats; using a data
repository
> to produce SDTM data; etc.)
> c. Are you implementing ADaM and define.xml as well as SDTM?
> d. How long do you anticipate your implementation will take?
> 2. What are the estimated total initial costs to implement
standards
> for your company?
> 3. Do you anticipate incremental costs for the first few years?
(e.g.,
> do you expect that data handling will be more cumbersome for a
while,
> or that costs will be higher for other reasons?) Please elaborate
on
> the reasons and magnitude.
> 4. Do you expect cost savings once standards are in place? How
soon?
> What level of savings do you anticipate?
> 5. How do you expect to address ongoing evolution of the
standards?
>