June 3, 2002

Docket Management Branch

HFA-305

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. 01N-0322

> Institutional Review Boards: Requiring Sponsors and Investigators to
> Inform IRBs of any Prior IRB Reviews

Dear Sir or Madam:

I am writing on behalf of a clinical trial sponsor, Northwest
Biotherapeutics, Inc. (NWBT). We are involved in a multi-site Phase III
clinical trial and are ready to initiate a multi-site Phase II study as
well.

NWBT cautiously supports FDA's consideration of a proposed rule
requiring sponsors and investigators to inform IRBs of any prior IRB
reviews. From the sponsor's perspective, dissemination of previous IRB
reviews will help alleviate the repetitive responses to IRB questions
and concerns, as well as help to standardize the informed consent form.
Currently, clinical sites involved in the same study may have vastly
different consent forms. There should be a way to coordinate IRBs at
each participating clinical site so that all research subjects will sign
an informed consent that is closely related to the other informed
consents at different sites.

While NWBT supports FDA's efforts to facilitate IRB review, we also
recognize that there are a few caveats, mainly related to the practical
nature of this rule. Is it realistic for sponsors of larger trials, such
as those with 100 clinical sites, to disclose everything? Does this mean
that the IRB for site number 100 would need to review 99 consent forms
and IRB questions?

Perhaps one solution to this question would be to have sponsors
summarize the activities with other clinical sites on a secured company
web page. This could include questions that the sponsor has answered
frequently for other IRBs, and could also include a list of which
clinical sites have IRB approval.

NWBT would also propose that FDA consider a working group on the issue
of consistent guidelines for IRBs. It seems appropriate that a working
group consisting of participants from FDA, clinical sites, and industry,
as well as involving an organization such as the Food and Drug Law
Institute (FDLI), could work together towards development and
implementation of IRB regulations that would help each group. For
example, FDA could require a standardized consent form where the format
of the consent form is consistent, making it easier to verify that the
procedures and investigational drug or device is adequately explained to
the subject. This type of standardized consent form would make is easier
for FDA to audit these consents, and it would lessen the amount of time
that IRBs use to review consent forms as well.

As mentioned earlier in this letter, NWBT supports FDA's efforts on
determining the need for proposed rule making that requires sponsors and
investigators to inform IRBs of any prior IRB reviews. This type of
disclosure may expedite the initiation of a clinical trial that may
benefit patients in the long run. However, it must be recognized that
the burden of disclosing this information becomes an even bigger issue
with studies that involve numerous clinical sites. Thus, NWBT supports,
and would enthusiastically participate in, the formation of a working
group. This working group could address IRB regulations, and how to make
the entire process easier for IRBs, FDA, and industry.

Should you have any questions regarding these comments, or would like to
discuss them further, please feel free to contact me at
vbowes@nwbio.com.

Respectfully submitted by,

Victoria (Tory) Bowes

Associate Director, Regulatory Affairs

Northwest Biotherapeutics, Inc.

21720 23^rd^ Drive SE, Suite 100

Bothell, WA 98021

\(425\) 608-3000