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

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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?