You can not select more than 25 topics
Topics must start with a letter or number, can include dashes ('-') and can be up to 35 characters long.
812 lines
31 KiB
812 lines
31 KiB
WEBVTT
|
|
|
|
00:00.000 --> 00:25.980
|
|
I think we're going to start again because my wife took the kids to the gym and I missed
|
|
|
|
00:25.980 --> 00:31.260
|
|
the ride by about 30 seconds that's why actually the stream was still on and I was still doodling
|
|
|
|
00:31.260 --> 00:36.060
|
|
because I was trying to figure out where the car went and then I think I just realized
|
|
|
|
00:36.060 --> 00:43.380
|
|
that what happened was my wife took the kids to the gym which means that I can finish this
|
|
|
|
00:43.380 --> 00:50.340
|
|
stream now as a second edition and then do something else after dinner to earn my bread.
|
|
|
|
00:50.340 --> 00:55.860
|
|
So I'm going to go right away back to this and that means that I'll cut over here, I'll
|
|
|
|
00:55.860 --> 01:10.380
|
|
put this one up, I'll get over to this one.
|
|
|
|
01:10.380 --> 01:14.220
|
|
And I will head to the gym after this is over with and meet them after they're done shooting.
|
|
|
|
01:14.220 --> 01:20.580
|
|
So they have this thing, you can look it up on the internet, it's called shoot 360 and
|
|
|
|
01:20.580 --> 01:25.320
|
|
it's a little like workout place just for basketball and they get a half an hour of
|
|
|
|
01:25.320 --> 01:30.140
|
|
shooting on like a rebounding machine and they also get like a half an hour of ball handling
|
|
|
|
01:30.140 --> 01:35.300
|
|
and so they do that by themselves and then after that we play and so usually during that
|
|
|
|
01:35.300 --> 01:40.060
|
|
hour I have a podcast in my ears or something like that and I'm shooting around on the big
|
|
|
|
01:40.140 --> 01:46.340
|
|
gym. So it's a pretty nice place to go because it's also in this giant building that has
|
|
|
|
01:46.340 --> 01:52.180
|
|
a full-size soccer field inside of it and so you just get this kind of very spacious
|
|
|
|
01:52.180 --> 01:58.860
|
|
feeling, it's a giant gym with a giant place to shoot buckets and also it has soccer going
|
|
|
|
01:58.860 --> 02:02.420
|
|
on and stuff so it's kind of like a little funny temple of sport. So that's where they
|
|
|
|
02:02.420 --> 02:06.740
|
|
are now, I've got about 45 more minutes, I think that's all I need to finish this.
|
|
|
|
02:06.740 --> 02:12.460
|
|
So I will escape out of here and we'll just let Uve continue to explain the subtleties
|
|
|
|
02:12.460 --> 02:19.260
|
|
of getting an EUA from the FDA in February of 2020.
|
|
|
|
02:19.260 --> 02:25.260
|
|
The guidance describes FDA's current thinking on this topic and should be reviewed as a
|
|
|
|
02:25.260 --> 02:33.300
|
|
recommendation unless specific regulatory or statutory requirements are cited. The guidance
|
|
|
|
02:33.300 --> 02:42.740
|
|
is applicable to all devices as defined under Section 201 of the Act. As you've seen earlier
|
|
|
|
02:42.740 --> 02:50.580
|
|
in Dr. Tense's presentation, for the purpose of the guidance, real-world evidence is defined
|
|
|
|
02:50.580 --> 02:59.100
|
|
as data relating to patient health status and or delivery of healthcare routinely collected
|
|
|
|
02:59.100 --> 03:05.420
|
|
from a variety of sources. For example, real-world data include data derived from electronic
|
|
|
|
03:05.420 --> 03:13.300
|
|
health records, claims and billing, data from products and disease registries and data gathered
|
|
|
|
03:13.300 --> 03:19.100
|
|
from other sources such as mobile devices. For the purpose of the guidance, real-world
|
|
|
|
03:19.100 --> 03:26.100
|
|
evidence is defined as a clinical evidence regarding the usage and potential benefit
|
|
|
|
03:26.100 --> 03:31.500
|
|
or risk of a medical product derived from analysis of real-world data.
|
|
|
|
03:31.500 --> 03:41.980
|
|
The regulatory context in which real-world evidence may be used, FDA will consider the use of real-world
|
|
|
|
03:41.980 --> 03:48.780
|
|
evidence to support regulatory decision-making for merit devices when it concludes that the data
|
|
|
|
03:48.780 --> 03:57.020
|
|
used to generate the evidence are sufficient quality to inform a supportive, support a particular
|
|
|
|
03:57.020 --> 04:05.420
|
|
decision. Real-world data may potentially be used as some or all of the evidence necessary to
|
|
|
|
04:05.420 --> 04:12.820
|
|
understand medical device performance at different points of the total product life cycle. For
|
|
|
|
04:12.820 --> 04:20.460
|
|
example, real-world data may be used to generate hypothesis to be tested in appropriate clinical
|
|
|
|
04:20.460 --> 04:29.260
|
|
study or be used as evidence for expanding the labeling or to include additional indications for
|
|
|
|
04:29.260 --> 04:36.100
|
|
use. I would like to mention the guidance does not change FDA's standards for regulatory decision
|
|
|
|
04:36.100 --> 04:43.300
|
|
making and in each context we will evaluate whether the available evidence is of sufficient
|
|
|
|
04:43.300 --> 04:48.660
|
|
quality to address the specific. So I assume that he's going to be evaluating it when it comes to
|
|
|
|
04:48.660 --> 04:54.820
|
|
EUAs that he himself has granted and that's where I think this regulatory scheme starts to become
|
|
|
|
04:54.820 --> 05:00.700
|
|
incredibly sketchy because you might think that there might be an ACIP equivalent here but there
|
|
|
|
05:00.700 --> 05:06.860
|
|
isn't there's just this one guy who they sheriff and a maybe a couple equivalents that are able to
|
|
|
|
05:06.860 --> 05:13.900
|
|
give EUAs they make the decision and the context in which that decision could be made is solely
|
|
|
|
05:13.900 --> 05:21.820
|
|
dependent on what he considers good and if it's all real-world data that he makes that decision on
|
|
|
|
05:21.820 --> 05:27.180
|
|
all the better clinical studies can now be based on real-world data that includes data from medical
|
|
|
|
05:27.180 --> 05:38.780
|
|
devices, mobile devices, disease registries and electronic health records. Do you see how a national
|
|
|
|
05:38.780 --> 05:48.780
|
|
security priority could really streamline the use of an electronic health record to cross-reference
|
|
|
|
05:48.780 --> 05:57.100
|
|
and verify a disease registry or cross-reference or verify mobile device data? Do you see where
|
|
|
|
05:57.100 --> 06:04.220
|
|
a national security priority event could put a German-speaking American guy in front of you
|
|
|
|
06:04.220 --> 06:11.420
|
|
telling you that he is the firewall between you and a wholly fraudulent set of diagnostics being
|
|
|
|
06:11.420 --> 06:15.980
|
|
used to create the illusion of a pandemic? This is our firewall right here, this guy
|
|
|
|
06:18.540 --> 06:23.580
|
|
and his angry presentation that he's being seems to be forced to being given right now. It's
|
|
|
|
06:23.580 --> 06:27.820
|
|
extraordinary regulatory decision being made.
|
|
|
|
06:36.860 --> 06:43.020
|
|
So what are the characteristics for real-world data to support particular regulatory decisions?
|
|
|
|
06:43.740 --> 06:50.620
|
|
Please note that the FDA does not endorse one type of real-world data over another.
|
|
|
|
06:51.180 --> 06:58.300
|
|
They're all the same. They're all great. Assess the reliability and relevance of the source
|
|
|
|
06:58.300 --> 07:04.780
|
|
and the specific elements to determine whether real-world data sources and the proposed analysis
|
|
|
|
07:04.780 --> 07:11.340
|
|
can generate evidence that is sufficiently robust to be used for a given regulatory purpose.
|
|
|
|
07:12.300 --> 07:21.420
|
|
The primary factors FDA considers are assessing the reliability of data include data approval
|
|
|
|
07:22.380 --> 07:31.740
|
|
that is how the data were collected and data assurance that is whether the people and processes
|
|
|
|
07:31.740 --> 07:40.700
|
|
in place doing data collection and analysis provide adequate assurance that errors are minimized
|
|
|
|
07:40.700 --> 07:44.060
|
|
and that the data quality and integrity are sufficient.
|
|
|
|
07:48.060 --> 07:53.340
|
|
Real-world evidence might be used in support of regulatory decision-making in several situations
|
|
|
|
07:53.900 --> 08:02.140
|
|
as listed here. For more detail in all of the
|
|
|
|
08:02.940 --> 08:07.900
|
|
sections, I refer to section six of the guidance.
|
|
|
|
08:18.140 --> 08:23.900
|
|
So before I end, I have two slides where I want to address a couple of questions,
|
|
|
|
08:23.900 --> 08:30.940
|
|
common questions from sponsors which plan to transition an EUA IBD product to a full market
|
|
|
|
08:30.940 --> 08:38.620
|
|
application. The first question is, can I use the analytical and clinical data obtained for an
|
|
|
|
08:38.620 --> 08:46.060
|
|
EUA authorization? The answer is yes, if new modification to the device has been made since
|
|
|
|
08:46.060 --> 08:52.940
|
|
the authorization. However, if modifications have been made, then the risk assessment of the
|
|
|
|
08:52.940 --> 08:59.020
|
|
modification will be required to determine to which extent the changes to the device would
|
|
|
|
08:59.100 --> 09:05.980
|
|
influence its performance. For clinical data, it's important to assure that the comparator
|
|
|
|
09:05.980 --> 09:11.420
|
|
method used to determine the truth of the specimen is still viewed as an acceptable
|
|
|
|
09:11.420 --> 09:20.380
|
|
preference method. And the second question, can I use generated the data outside of the US
|
|
|
|
09:20.380 --> 09:28.220
|
|
for my FDA submission? The answer here is yes as well provided that the test procedure and
|
|
|
|
09:28.220 --> 09:35.100
|
|
performance, the test procedure was performed according to the package insert with no deviations.
|
|
|
|
09:36.060 --> 09:42.060
|
|
We encourage sponsors to contact early, as early in the development for questions
|
|
|
|
09:42.060 --> 09:46.700
|
|
concerning the use of EUA data to support marketing submissions.
|
|
|
|
09:48.620 --> 09:55.900
|
|
The last question, can real data be used to help support the advancement of EUIBD products
|
|
|
|
09:55.980 --> 10:00.860
|
|
through full marketing status? As stated in the guidance, I just reviewed
|
|
|
|
10:01.580 --> 10:07.180
|
|
under the right conditions, yes. Data derived from real-world sources
|
|
|
|
10:07.180 --> 10:13.260
|
|
that potentially be used to support regulatory decisions. And under the right conditions,
|
|
|
|
10:13.260 --> 10:19.500
|
|
real-world data and associated real-world evidence, they constitute valid scientific evidence
|
|
|
|
10:19.500 --> 10:25.340
|
|
depending on the characteristics of the data. As I mentioned earlier several times,
|
|
|
|
10:25.340 --> 10:32.380
|
|
we encourage sponsors to contact us early in the development for questions concerning data to support.
|
|
|
|
10:32.380 --> 10:42.380
|
|
So data derived from real-world sources becomes validation. That's what we're doing here now.
|
|
|
|
10:42.380 --> 10:48.700
|
|
We're allowing these EUA devices to be rolled out and then for them to collect their own data,
|
|
|
|
10:48.700 --> 10:57.340
|
|
report their own results, call it real-world data and be a source of validation for a market
|
|
|
|
10:57.340 --> 11:04.060
|
|
approval submission. And it's as simple as that. He's telling you exactly how it's done. Yes,
|
|
|
|
11:04.060 --> 11:09.660
|
|
it can happen. This is the way it's done. This is where the reliability has to be feigned.
|
|
|
|
11:09.660 --> 11:15.420
|
|
This is where these are the benchmarks that you need to meet. That's what he's saying.
|
|
|
|
11:15.420 --> 11:16.460
|
|
It's extraordinary.
|
|
|
|
11:18.460 --> 11:22.220
|
|
Marketing market applications. This is my last material slide.
|
|
|
|
11:24.140 --> 11:30.940
|
|
I want to thank my division, the whole staff of my division of the Division of Microbiology
|
|
|
|
11:30.940 --> 11:38.220
|
|
Devices. Everybody is one way or the other involved in EUAs. And I would like to especially
|
|
|
|
11:39.100 --> 11:45.340
|
|
acknowledge the individuals listed here because they have performed the heavy lifting in most of
|
|
|
|
11:45.340 --> 11:55.340
|
|
the EUAs that we have seen. All those thanks to OC and OCC for their continuous help as well as
|
|
|
|
11:55.340 --> 12:01.020
|
|
to our colleagues from SIBO who have helped us with standards which you will develop.
|
|
|
|
12:01.980 --> 12:09.900
|
|
These are the individuals who make EUA happen. They have stand up to any call of an emergency
|
|
|
|
12:09.900 --> 12:16.940
|
|
and they have worked tirelessly over weekends to make these devices available to the public as
|
|
|
|
12:16.940 --> 12:19.100
|
|
fast as possible. Thank you.
|
|
|
|
12:19.100 --> 12:20.860
|
|
Tirelessly over the weekend.
|
|
|
|
12:20.860 --> 12:33.020
|
|
And so that guy was essentially what he said was that he is the head of all the EUA because
|
|
|
|
12:33.020 --> 12:40.780
|
|
this whole division of microbiology devices is EUAs, this whole department. So the division
|
|
|
|
12:40.780 --> 12:46.860
|
|
of microbiology devices, isn't that an interesting division to be the head of for 20 years?
|
|
|
|
12:47.500 --> 12:53.740
|
|
To get three houses for heading to not lose your accent?
|
|
|
|
12:53.740 --> 12:56.540
|
|
Really wanted to thank everybody. It's good that we've got incredibly good time
|
|
|
|
12:56.540 --> 13:00.220
|
|
for making out your critical positions, isn't it?
|
|
|
|
13:00.220 --> 13:04.860
|
|
As a note to the Office of the Chief Scientist for actually being able to help facilitate a lot
|
|
|
|
13:04.860 --> 13:11.420
|
|
of this work in the medical device innovation consortium where we could actually get a conference
|
|
|
|
13:11.500 --> 13:18.460
|
|
together in very short time. So Frank Whitehold in particular has been in short time.
|
|
|
|
13:18.460 --> 13:22.380
|
|
The ladies that started the conference said that they've been organizing this for months.
|
|
|
|
13:23.820 --> 13:26.700
|
|
What is he talking about? Is that a short time to him?
|
|
|
|
13:26.700 --> 13:32.300
|
|
Incredibly important in actually helping do a lot of the background work that is
|
|
|
|
13:32.300 --> 13:36.940
|
|
helping facilitate hopefully the future for the collection of rural evidence.
|
|
|
|
13:36.940 --> 13:43.500
|
|
And so to go on with Dr. Shur and Dr. Stenzel we're actually talking about
|
|
|
|
13:46.060 --> 13:50.860
|
|
just let's drill down just a little bit more in the rural evidence and fundamentally
|
|
|
|
13:51.820 --> 13:54.460
|
|
while he wants to drill down the real world evidence.
|
|
|
|
13:54.460 --> 13:58.300
|
|
There was a 21st Century Cures initiative and we had the FDA reauthorization act
|
|
|
|
14:00.540 --> 14:06.620
|
|
which led to Meduva for commitments actually to help get pre-imposed market information
|
|
|
|
14:07.180 --> 14:10.540
|
|
to support regulatory decisions across the breadth of which.
|
|
|
|
14:10.540 --> 14:12.460
|
|
That was a mention of something very important.
|
|
|
|
14:12.460 --> 14:13.740
|
|
The 21st Century Cures initiative.
|
|
|
|
14:13.740 --> 14:23.900
|
|
21st Century which led to Meduva for commitments actually to help get pre-imposed market information
|
|
|
|
14:24.460 --> 14:28.060
|
|
to support regulatory decisions across the breadth of which it could pop.
|
|
|
|
14:28.060 --> 14:36.860
|
|
A huge amount of real important legislation that underlies the possibility of pandemics.
|
|
|
|
14:37.420 --> 14:43.820
|
|
Being executed in the way that they were executed this time is found in the 21st Century Cures
|
|
|
|
14:43.820 --> 14:49.980
|
|
Act and initiative. And I strongly recommend that everybody look into that if you've never
|
|
|
|
14:49.980 --> 14:57.020
|
|
heard of it before. I am a little bit less informed about this one that I am about prep
|
|
|
|
14:57.020 --> 15:05.580
|
|
and about the National Vaccines Act but this one is essential and it's a part of this stepwise
|
|
|
|
15:05.580 --> 15:12.300
|
|
move toward the prep act. And so I need to read into this as well but it's interesting
|
|
|
|
15:12.300 --> 15:14.540
|
|
that he mentions that one as being pivotal.
|
|
|
|
15:14.540 --> 15:19.420
|
|
Completely used. And underneath that the medical device innovation consortium has the
|
|
|
|
15:19.420 --> 15:27.980
|
|
national evaluations system for health technology to help develop a space where real
|
|
|
|
15:27.980 --> 15:33.660
|
|
evidence could actually fundamentally be used. Now in the Center for Devices and Real Logic Health
|
|
|
|
15:33.660 --> 15:38.860
|
|
we actually have a strategic priority to do this and part of the strategic priority was
|
|
|
|
15:38.860 --> 15:45.260
|
|
this guidance that that Uva just talked about which is a cross-center harmonized effort.
|
|
|
|
15:45.900 --> 15:50.860
|
|
Now again you're probably going to see this many times throughout the day but
|
|
|
|
15:51.580 --> 15:56.860
|
|
that context of collecting information from a real clean health care setting.
|
|
|
|
15:57.420 --> 16:02.620
|
|
Obviously that information if it's going to be collected it's going to have to be analyzed to
|
|
|
|
16:02.620 --> 16:09.020
|
|
be able to be used in the context of valid scientific evidence. Now what are we talking about?
|
|
|
|
16:09.020 --> 16:14.540
|
|
In the traditional setting you know obviously many of you are familiar with the fact that
|
|
|
|
16:14.540 --> 16:19.660
|
|
studies are designed and they're conducted and analyzed. And then when those devices go out to
|
|
|
|
16:19.660 --> 16:26.940
|
|
market I please note the context here that an ID is probably not necessary in every single
|
|
|
|
16:26.940 --> 16:31.820
|
|
situation. In some cases it might be and I would refer to the Rural Evidence Guidance
|
|
|
|
16:31.820 --> 16:39.020
|
|
to actually provide the context for that but when those devices actually get to market
|
|
|
|
16:39.900 --> 16:45.180
|
|
or get to actual use in a health care setting they begin to help generate data.
|
|
|
|
16:45.900 --> 16:51.100
|
|
Then that data when it's generated is done in a natural health care setting and then the question
|
|
|
|
16:51.100 --> 16:58.860
|
|
is how can we collect and analyze that information so it can actually be useful. And so this is an
|
|
|
|
16:58.860 --> 17:03.740
|
|
unprecedented shift in the way we think about medical records and medical data and they are
|
|
|
|
17:03.740 --> 17:09.660
|
|
shifting it at a very opportune time right before the pandemic starts when we're going to grant 200
|
|
|
|
17:09.660 --> 17:16.540
|
|
plus EUAs for diagnostics that could actually be the data collection that could be reflected back
|
|
|
|
17:16.540 --> 17:24.300
|
|
on the nationwide electronic medical records etc. They are talking about a national
|
|
|
|
17:25.100 --> 17:38.540
|
|
security priority here right this is a national security priority and so all of this talk about
|
|
|
|
17:38.540 --> 17:45.420
|
|
what to do with the data and how to collect it has built into it these national security priorities
|
|
|
|
17:45.420 --> 17:51.340
|
|
which may actually lead to them doing things that they wouldn't otherwise do collecting data that
|
|
|
|
17:51.340 --> 17:58.300
|
|
they wouldn't otherwise do and interfacing with electronic medical records in a way that they
|
|
|
|
17:58.300 --> 18:09.580
|
|
wouldn't otherwise do in order to facilitate a national security priority of moving more EUA products
|
|
|
|
18:09.580 --> 18:22.060
|
|
to full market approval I can't write worth a damn when I'm actually talking while I write and
|
|
|
|
18:22.060 --> 18:29.100
|
|
trying to write what I'm saying because then I try to write too fast so what does this say moving
|
|
|
|
18:29.660 --> 18:37.420
|
|
more EUA products to full market approval I should write that without so such scribble scratch here
|
|
|
|
18:37.500 --> 18:43.100
|
|
but that's the national security priority that has been ascribed to the entire seminar
|
|
|
|
18:45.020 --> 18:49.820
|
|
I'm so glad I got to close this out with a little bit of a of a closer here because it's really
|
|
|
|
18:49.820 --> 18:57.580
|
|
this is really summarizing the last three the last three so well as we looked at this seminar from
|
|
|
|
18:57.580 --> 19:04.380
|
|
February 3rd 2020 what we are seeing is that the national security priority is not the safe and
|
|
|
|
19:04.380 --> 19:09.660
|
|
effective products that are rolled out but it is getting more EUA products to successfully get
|
|
|
|
19:09.660 --> 19:16.380
|
|
to full market approval using this shift from having to go through a pre-market submission system
|
|
|
|
19:16.380 --> 19:23.500
|
|
to being able to use real world evidence gathered during the EUA stage to get through the approval
|
|
|
|
19:23.500 --> 19:27.100
|
|
process without having to go through all this pre-market submission stuff
|
|
|
|
19:28.060 --> 19:37.340
|
|
replacing what was required in a pre-market submission as outlined by Louvay sheriff that includes things like
|
|
|
|
19:40.940 --> 19:47.660
|
|
that includes quality control that includes precision that and now can instead be substituted
|
|
|
|
19:47.660 --> 19:54.620
|
|
within silico evaluation and no full validation is required and and that means that all of these
|
|
|
|
19:54.700 --> 20:00.300
|
|
things can in theory get through with real world evidence that has been misconstrued as validating
|
|
|
|
20:00.300 --> 20:10.380
|
|
their effectiveness and that is a very dangerous place to be had February 3rd 2020 February 3rd
|
|
|
|
20:11.340 --> 20:17.100
|
|
it hasn't even started yet and we're already throwing all regulatory systems out of the out of the
|
|
|
|
20:17.740 --> 20:25.580
|
|
out of the window and having a german national with a thick accent explained to us how we can
|
|
|
|
20:25.580 --> 20:32.620
|
|
circumvent the traditional methods of pre-market approval before full market approval of the FDA
|
|
|
|
20:32.620 --> 20:39.020
|
|
by getting an EUA and doing everything with real world data that can even include things as mundane
|
|
|
|
20:39.580 --> 20:48.140
|
|
mobile device data never mind data from other EUA products right which could also be used to
|
|
|
|
20:48.140 --> 20:53.420
|
|
evaluate whether or not the virus was there and so then one EUA product is validating the
|
|
|
|
20:53.420 --> 21:01.180
|
|
effectiveness of another EUA product don't you see it holy cow it's amazing in that space
|
|
|
|
21:02.140 --> 21:08.620
|
|
fundamentally we need data quality data quality is a very important key yeah it's all processed
|
|
|
|
21:08.620 --> 21:14.300
|
|
data quality understand what the information is inside of a health care system exactly how
|
|
|
|
21:14.300 --> 21:18.620
|
|
are you going to be able to use it now this question is the common question
|
|
|
|
21:20.140 --> 21:26.220
|
|
that really drives the next statement of what is valid scientific it's fundamentally so per
|
|
|
|
21:26.220 --> 21:33.180
|
|
our regulations you can submit anything you want to but fundamentally we can only rely on
|
|
|
|
21:33.180 --> 21:38.300
|
|
valid scientific evidence and to be a little more clear about what valid scientific evidence could
|
|
|
|
21:38.300 --> 21:44.940
|
|
be it really is a very broad breadth and range um well controlled investigation parcel controlled
|
|
|
|
21:44.940 --> 21:50.300
|
|
studies objective trials and even reports of significant human experience if it can actually
|
|
|
|
21:50.300 --> 21:57.100
|
|
be determined that you know by qualified experts that there's reasonable assurance
|
|
|
|
21:57.100 --> 22:04.860
|
|
of safety and effectiveness that are real world personal experience can also be used to evaluate
|
|
|
|
22:04.860 --> 22:11.260
|
|
the effectiveness of an FDA device here he just said those words you want to hear him say him again
|
|
|
|
22:11.740 --> 22:14.620
|
|
I'll roll it back half a second now information
|
|
|
|
22:17.580 --> 22:22.460
|
|
objective trials and even reports of significant human experience if it can actually be determined
|
|
|
|
22:23.260 --> 22:28.700
|
|
that you know by qualified experts that's impressive there's reasonable assurance
|
|
|
|
22:28.700 --> 22:35.260
|
|
to say from the fact that information that's impressive that's impressive and has been used
|
|
|
|
22:35.260 --> 22:41.420
|
|
support regulatory decisions it doesn't always follow the traditional space but certainly
|
|
|
|
22:42.300 --> 22:50.300
|
|
it's noted that things that are weird really can't be used as valid scientific evidence is it's not
|
|
|
|
22:50.300 --> 22:56.460
|
|
logical a rationality section kind of be taken into place so what is not regarded as valid
|
|
|
|
22:56.460 --> 23:03.100
|
|
scientific evidence is your isolated case reports are random experiences um if you don't have enough
|
|
|
|
23:03.100 --> 23:08.620
|
|
detail around it how do you actually use utilize that information this is where the key comes in
|
|
|
|
23:09.180 --> 23:13.740
|
|
so all we care about the end of the day is information that's fit for purpose and the appropriate
|
|
|
|
23:14.380 --> 23:20.540
|
|
yes he did of a particular setting so we're talking he did he said weird things we don't use
|
|
|
|
23:20.540 --> 23:25.420
|
|
weird things weird things are not generally scientific but you know it's a individual evaluation
|
|
|
|
23:25.420 --> 23:31.180
|
|
basis talking about information that's relevant and reliable we have to be able to make a determination
|
|
|
|
23:31.180 --> 23:35.980
|
|
fundamentally that the benefits outweigh the risks and that we can actually utilize that
|
|
|
|
23:35.980 --> 23:43.500
|
|
information and throwing in a little extra complexity into that setting of course is that we try to
|
|
|
|
23:43.500 --> 23:48.700
|
|
make sure that patients information is properly protected so we have harmonization for that
|
|
|
|
23:48.700 --> 23:56.300
|
|
information it does become a little more understandable at how you can actually navigate patient
|
|
|
|
23:56.300 --> 24:01.980
|
|
protection information and get high quality information out so in the rural evidence space
|
|
|
|
24:03.980 --> 24:09.260
|
|
now he's using very big words to describe how they are going to try to protect people's personal
|
|
|
|
24:09.260 --> 24:15.820
|
|
data while using it to evaluate EUA devices I don't think you can hear it any other way he
|
|
|
|
24:15.820 --> 24:22.300
|
|
used the phrase here at the bottom information harmonization do you know what that is that's got
|
|
|
|
24:22.300 --> 24:29.180
|
|
to be the the interface between an electronic medical record database and the database of a
|
|
|
|
24:29.180 --> 24:37.820
|
|
pharmaceutical company the database of a social media company interfacing with the data from a
|
|
|
|
24:38.940 --> 24:44.380
|
|
electronic medical medical record database would be information harmonization and talking about
|
|
|
|
24:44.380 --> 24:50.300
|
|
how to anonymize make all anonymous the data or to protect people's personal data
|
|
|
|
24:50.300 --> 24:55.900
|
|
is precisely what you would talk about if you intended to use a national security priority
|
|
|
|
24:55.900 --> 25:02.780
|
|
to allow people to create information harmonization when that would no way shape or form be allowed
|
|
|
|
25:03.420 --> 25:06.860
|
|
under the normal laws governing medical data and its use
|
|
|
|
25:09.900 --> 25:15.180
|
|
that's why he has to use these big words and talk with such obfuscating sentences because
|
|
|
|
25:15.180 --> 25:22.860
|
|
he doesn't tell you want everyone to understand it does become a little more understandable
|
|
|
|
25:22.860 --> 25:27.500
|
|
at how you can actually navigate patient protection information and get high quality
|
|
|
|
25:27.500 --> 25:36.780
|
|
information out so in the rural evidence space the HIPAA privacy role is how we operate for
|
|
|
|
25:36.780 --> 25:42.780
|
|
helping protect that information and the understanding that not everything in the research space is
|
|
|
|
25:42.780 --> 25:49.100
|
|
covered under under HIPAA that the access and use for the common role helps provide a little
|
|
|
|
25:49.100 --> 25:57.020
|
|
additional context there but that being said information in the rural setting has been used
|
|
|
|
25:57.020 --> 26:03.420
|
|
in many different spaces there for indication expansion for new indications for condition of
|
|
|
|
26:03.420 --> 26:07.900
|
|
approval in both a pre-market and post-market setting and all these slides will be available
|
|
|
|
26:08.300 --> 26:14.620
|
|
online if you want to do a deep dive but there has certainly been information collected from
|
|
|
|
26:14.620 --> 26:19.820
|
|
multiple different venues and the point is please be creative and don't limit yourself
|
|
|
|
26:19.820 --> 26:24.140
|
|
to that information. The perfect example which I think may have a degree of applicability
|
|
|
|
26:24.700 --> 26:33.180
|
|
in this setting in particular is the note of an ability to actually utilize a publicly maintained
|
|
|
|
26:33.180 --> 26:38.620
|
|
database when we actually partner together what was able to happen here in the next
|
|
|
|
26:38.620 --> 26:42.780
|
|
chance sequencey space and I think that something that could be replicated in an EUA space next
|
|
|
|
26:42.780 --> 26:50.620
|
|
gen sequencing appropriately set up is in lieu of full traditional studies what we're able to use
|
|
|
|
26:51.260 --> 27:00.700
|
|
is information directly harvested from a publicly retained a publicly maintained database because
|
|
|
|
27:00.780 --> 27:09.020
|
|
there was collaboration that happened up front between the sponsors between the database folders
|
|
|
|
27:09.660 --> 27:15.180
|
|
and between FDA and when we actually partner together to get interoperability for that data
|
|
|
|
27:15.740 --> 27:20.860
|
|
and establish appropriate quality checks which are achievable it was achievable in this case
|
|
|
|
27:20.860 --> 27:25.740
|
|
and it'll be achievable in the future we can actually work together if you have questions
|
|
|
|
27:25.740 --> 27:31.100
|
|
about real-world evidence there is actually an email address if you don't want to contact
|
|
|
|
27:31.100 --> 27:36.700
|
|
the divisions directly you can you can email c3h clinical evidence at fda.h just.gov and if you
|
|
|
|
27:36.700 --> 27:40.860
|
|
want to learn more about some of the public private partnerships you can contact c3h clinical
|
|
|
|
27:40.860 --> 27:47.580
|
|
evidence at fda.h just.gov or if you want to learn more about shield in the diagnostic space you can
|
|
|
|
27:47.660 --> 28:01.820
|
|
contact me thank you so thank you to all of the fda colleagues for sharing the fda perspective
|
|
|
|
28:01.820 --> 28:07.820
|
|
today I think it sets a wonderful foundation for our discussions today and I look forward to
|
|
|
|
28:07.820 --> 28:12.780
|
|
your engagement throughout the day as well we're going to take a break now and I'm going to make
|
|
|
|
28:12.780 --> 28:19.020
|
|
a deal with you you guys silence your phones I'm hearing some phones and I promise we'll work
|
|
|
|
28:19.020 --> 28:24.380
|
|
on getting those technology smoothing up here how's that for a deal wow so they're done that
|
|
|
|
28:24.380 --> 28:30.780
|
|
was the end of that one and that's fine I knew it was not the much left because I didn't want to
|
|
|
|
28:30.780 --> 28:37.740
|
|
leave it till after practice and then have to do that so we are still here ladies and gentlemen
|
|
|
|
28:37.740 --> 28:40.860
|
|
at the same place where we have been for a very long time
|
|
|
|
28:43.340 --> 28:45.660
|
|
oh I didn't mean to do that I apologize
|
|
|
|
28:48.460 --> 28:52.380
|
|
you like that thing though I don't think it's that bad it actually looks pretty good that's also
|
|
|
|
28:52.380 --> 28:58.220
|
|
render forest you know render forest is kind of fun so that was the last part of the market seminar
|
|
|
|
28:58.220 --> 29:03.660
|
|
we won't do that one anymore I've taken my notes I've got my stuff I've got a lot more work to do
|
|
|
|
29:03.660 --> 29:09.500
|
|
on Uve Sheriffs patents and some of the country companies that he worked for and we're going to
|
|
|
|
29:09.500 --> 29:14.700
|
|
look at I'm going to look at some of his publications and try to decide if it's possible that maybe he
|
|
|
|
29:14.700 --> 29:22.140
|
|
was doing more than just giving out EUAs maybe he was involved in the Human Genome Project or
|
|
|
|
29:22.140 --> 29:26.860
|
|
in collaboration with companies that were involved in the Human Genome Project and
|
|
|
|
29:26.860 --> 29:31.420
|
|
that might give us a clue to why he was in charge of giving away diagnostic EUAs
|
|
|
|
29:32.060 --> 29:37.820
|
|
and and why it would be that EUAs would be given away by single people or by some weird
|
|
|
|
29:40.540 --> 29:47.020
|
|
division called microbiome microbiological devices which is a very bizarre thing
|
|
|
|
29:47.900 --> 29:52.940
|
|
so thanks for coming back for the last half hour if you missed it live thanks for coming back and
|
|
|
|
29:52.940 --> 29:58.220
|
|
checking it out I will try to be on later this evening and later this evening I've got at least
|
|
|
|
29:58.940 --> 30:06.380
|
|
a list of 20 or so things that I could cover and so we'll just see which of these pending
|
|
|
|
30:07.020 --> 30:11.740
|
|
sort of study halls that is necessary to do that I'll do at eight o'clock and I'll see you then
|
|
|
|
30:11.740 --> 30:19.980
|
|
thanks very much for coming and we'll be back soon
|
|
|
|
|