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Dear all,
I found this paper "Abbreviated Clinical Study Reports with
Investigational Medicinal Products for Human Use: Current Guidelines
and Recommendations"
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2213811
...but still answers to this topic is still not clear ..but anyways
good start.
Here are few of my questions too:
1). BA/BE studies are very short term (only few days)..is it worth to
do data management with oracle clinical/clintrial/PDS express?-this is
consuming lot of time as one has to design the CRFs, design the
database and finally submit report to in the Full ICH format.
2) We have heard some industries do data management of Generic-
bioequivalence studies in excel spreadsheet and submit a abbreviated
report for OGD (the FDA's Office of the Generic Drug)..Is this true?
If yes, do they use the abbreviated report form what you are suggesting?
3). What is the industry standards on Generics-BA/BE datamanagment and
CSR reporting formats? does the Generic-BA/BE CSR reports needs to be
done in the same way as its done in phase II to phase IV studies?
Which tool does the industry use to accomplish BA/BE data management
and CSR reporting done in a non-ICH format?
4). Is it a must to medically code Concomitant medications along with
Adverse events using medical dictionaries in BA/BE studies for CSR
reporting- whether they are a must for statistical analysis?
5) So finally do you suggest/advise that for generic-BA/BE studies(PK
analysis) that the abbreviated format would be sufficient as in cases
where the study is not pivotal for claiming the effectiveness of a
product in a Marketing Authorization Application?
Thanks and Regards,
Mendakki
Trainee researcher
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The following message was posted to: PharmPK
Hi Mendakki,
I have seen some companies go as far as including the synopsis and
then starting at the appendices for abbreviated clinical study reports.
Regarding data management, some companies do CRFs for bioequivalence,
and some companies don't. So I haven't seen any industry standards
regarding data management, only individual company philosophies. To
answer question 4, yes, ideally the AEs should be coded, although
again I've seen some companies do it and others not.
To answer question 5, I would never even think about using an
abbreviated format unless the study failed, or perhaps if it's just a
very small pilot study. Hope this helps,
-Dave
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The following message was posted to: PharmPK
Mendakki,
I can understand how frustrated you must feel considering that the ICH
format is designed for clinical trials and it is difficult to 'fit' a
BA/BE study into this format. We constantly have the same issues. It
is funny how a movement toward harmonization has actually caused such
differences within the industry. Pharma Medica Research Inc. (PMRI)
used to have one report format, now we have a different format for each
sponsor. And it is incredible how different these formats are.
Unfortunately Dave Dubins is correct. Some companies do things one way
and others do them differently. Some companies (e.g. PMRI) do multiple
different methods depending on the request of sponsors.
1) Generally full ICH E3 format reports are required.
2) All reports that are usually submitted to the FDA are full reports
and not abbreviated.
3) There are several electronic data capture tools on the market
designed to help manage BA/BE specific study data (e.g. Alphadas,
Initiator)
4) Yes it is standard to code all AEs, usually with MedDRA.
5) I agree with David. Abbreviated reports are only completed on small
pilots or failed studies. While these may be added to ANDAs for the FDA
they are only supporting documentation.
Robert Lepage, M.Sc., CCRP
Manager, Biopharmaceutics
Pharma Medica Research Inc.
E-mail rlepage.-at-.pharmamedica.com
www.pharmamedica.com
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The following message was posted to: PharmPK
The initial step id to determine whether the common technical document
will be used for submission. If so it might be efficient to prepare
all report following its template.
--
Ed O'Connor, Ph.D.
Laboratory Director
Matrix BioAnalytical Laboratories
25 Science Park at Yale
New Haven, CT 06511
Web: www.matrixbioanalytical.com
Email: eoconnor.aaa.matrixbioanalytical.com
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