| Issue Number | 3829 |
|---|---|
| Summary | FOIA Request for Protocols using Drug |
| Created | 2014-11-14 13:11:47 |
| Issue Type | Task |
| Submitted By | Englisch, Volker (NIH/NCI) [C] |
| Assigned To | Englisch, Volker (NIH/NCI) [C] |
| Status | Closed |
| Resolved | 2014-11-21 13:06:38 |
| Resolution | Fixed |
| Path | /home/bkline/backups/jira/ocecdr/issue.141767 |
Email request from Margaret to provide FOIA data:
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From: Beckwith, Margaret (NIH/NCI) [E]
Sent: Wednesday, November 12, 2014 1:47 PM
To: Englisch, Volker (NIH/NCI) [C]
Cc: Henry, Erika (NIH/NCI) [C]
Subject: FW: FOIA Request
Hi Volker,
Erika and I got this request from the FOIA office and I suggested that you might be able to help with it. It looks to me like this person is looking for clinical trials that were active between the time period Jan. 1996 and Jan. 2001 for the three drugs he mentions. Could you take a look at the letter and let me know if that is what you think they are asking for and if there is a way to run a report to get that information? I would be happy to talk to you about this.
Thanks,
Margaret
I'm in the process of downloading the PDQ-C data for the months between Jan-1996 and Jan-2001 in six months increments. (I have not found a CD for Jan-2000 that is readable, though.)
This is what I've found so far:
No information related to protocols (active or closed) using the specified drugs ICI 182,780, Faslodex, or Fulvestrant between Jan-1996 and Jan-1998.
One active protocol (NCI-G98-1412, RPCI-DS-97-29, ZENECA-9238IL/0021) in Jul-98, Jan-99, Jul-99.
The above protocol is closed in Jul-2000.
One approved, not yet active protocol in Jan-2001 (GOG-0188)
Margaret, where do we go from here?
Should we extract the information and send them the ASCII text for these
two protocols for the months I've looked?
I found this European trial but I don't know how useful it is because it is currently withdrawn from PDQ, which means it is no longer on Cancer.gov. However, it is on CTGov as terminated: http://clinicaltrials.gov/ct2/show/NCT00010153?term=NCT00010153&rank=1
CDR0000068451 - NCT00010153
The InScope Version 2 in the CDR indicates that it was Active on "2000-11-30" and Closed on "2001-10-31". Fulvestrant was linked as an Intervention name. The searches I ran indicated that we do not have the other names of the term as drug terms.
Sorry Volker. Yes, I think we should provide what you have found so far and tell them that is the best we can do with the old data. We can talk about this at the meeting today.
The InScope Version 2 in the CDR indicates that it was Active on "2000-11-30" and Closed on "2001-10-31".
That's true. In the CDR it says the protocol start date was November
2000 but the FirstReceivedDate is listed as February 2001. This is in
line with the fact that I can't see the protocol in PDQ-C in January
2001 but it's listed in February.
It looks like that one protocol I've found is the only active one we've
been able to identify (unless a protocol was active for less than 6
months between Jan and Jul or Jan of the following year.
I've provided Margaret with the text dump for the one active protocol we've found (RPCI-DS-97-29) for Jul-1998, Jan-1999, Jul-1999, and Oct-1999. The protocol was first available in Jul-1998 and closed in Nov-1999.
Closed at status meeting. Margaret provided info to FOIA office, and they indicated that what she gave them was satisfactory.
Elapsed: 0:00:00.000601