Latest / Cardio Pod: Heart of the Matter / Are we making progress with the recruitment of women in heart failure trials?

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Are we making progress with the recruitment of women in heart failure trials? · Cardio Pod: Heart of the Matter

0:00
Good afternoon. I'm Chris O'Connor, principal investigator of the Heart Failure Collaboratory.
0:08
And we're here today with our Heart of the Matter podcast and a very important and special
0:14
topic today that we're going to discuss with our distinguished panel. And I'll introduce
0:19
them shortly. But are we doing enough to improve the recruitment of women in heart failure
0:26
clinical trials? This has been a concern for the three decades that I've been involved
0:31
in clinical trial conduct. I think progress has been slow. There's many good ideas and
0:38
important initiatives. I think that we have to use this forum, the Collaboratory, the
0:44
podcast to increase awareness and to really try to accelerate some of these excellent
0:49
initiatives that are out there. And so before we get started, I'd like to introduce our
0:55
distinguished panel, Dr. Mariel Jessup, who's the chief science and medical officer from
1:01
the American Heart Association. Mariel, welcome. Would you like to say a word or two about
1:06
yourself?
1:07
Well, thank you. It's great to be with this very distinguished panel and with you, Chris.
1:12
Let's see, what can I say? I was watching a marching band this weekend and it brought
1:18
to mind that I used to spend several summers when I was in middle school marching in fireman's
1:25
parades and I was a clarinetist. And the reason that I thought about it was if you saw the
1:32
coronation, there was a band that was on horseback and I thought, oh my gosh, it was hard enough
1:39
to walk and play the clarinet. I can't imagine riding on a horse and trying to play the clarinet.
1:45
Oh my gosh.
1:46
I know. It was, I just don't know how it didn't, you know, the reed didn't go up into the roof
1:52
of your mouth.
1:53
Well, I think the R value of musical talent and heart filler specialists, and we'll ask
2:00
Wayne Batchelor if he is a musical specialist because it's very high in this group. And
2:05
we've been thinking about starting through the collaboratory, the S3 Gallup band. And
2:11
Mariel, we're going to invite you to be in that band as our clarinetist. Dr. Wayne Batchelor,
2:16
who's associate director of the Inova Heart and Vastor Institute and director of interventional
2:21
cardiology. Wayne, welcome. Give us a little word about yourself.
2:25
Well, thanks, Chris. I'm really pleased to be amongst this illustrious panel. Maybe a
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couple of things you may not know about me is I grew up north of the border in Canada
2:36
obsessed with hockey. I was convinced I was going to go to the NHL until I realized it
2:41
was much easier to get into medical school than make that leap went in a different direction.
2:46
But I'm convinced I'm the best left winger at the Inova Heart and Vastor Institute. I'm
2:50
convinced of that to this day.
2:53
That's terrific. And go Carolina, by the way, they got some headwinds against some teams.
3:01
Dr. Joanne, go ahead, Wayne.
3:03
It bothers me immensely to see a Florida team beat up my maple leaves. I'm just going to
3:08
leave it at that.
3:09
Dr. Joanne Lindenfeld, who's professor of medicine and distinguished professor at Vanderbilt
3:13
University in heart failure.
3:16
Like Marielle, I played the saxophone in the marching band, but I really wanted to play
3:19
the French horn but cannot carry a tune to save my life. So I had to give up for that.
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It's a pleasure to be here today.
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I tell you, we've got the team. Dr. Constanzo, Maria Rosa, welcome.
3:32
Thank you for having me. My most important news is that I sold my first photograph from
3:41
an exhibit. And so I'm very excited about photography. Unfortunately, or fortunately,
3:52
the buyer was an attorney, but it was a view of the Andes in Colombia just before sunrise.
4:03
So I think I tried to determine why I like photography so much. And I think I discovered
4:12
the reason. And that is that I'm always thinking about what I need to do next. What do I need
4:21
to finish next? What is coming next? And photography is the only activity where when I'm taking
4:30
a photograph, I am truly in the present and I don't think about anything else.
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That's really well said. And those of you who have seen Maria Rosa's photography, it's
4:41
truly spectacular. Thank you for pursuing that passion. Dr. Bill Abraham, professor of medicine
4:48
at Ohio State University, the you, as they say. Bill, welcome again. You've been a regular
4:54
on our team here.
4:55
Hi, Chris. Well, look, I have no musical ability, so don't ask me to join the band. But like
5:01
Maria Rosa, I do share a love of photography. I'm not nearly as good at it as she is, but
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little known fact. As a high school student and in college, working my way through college,
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I served as an apprentice to a professional photographer, shooting weddings and parties
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and other events and made a little bit of money that helped offset tuition back in the
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day.
5:26
That's awesome. And thank you, Bill. And Dr. Fuzat, who works as an advisor to the FDA
5:34
on faculty at Duke University and a leader in the Hartz-Filler Collaboratory, welcome.
5:40
Thank you, Mona Fuzat. Great to be with this group. I previously disclosed that I played
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the drums as well as the piano, so I can be in the band. Great to be here again.
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Makes the S3 Gallup team here. Well, let's jump into the heart of the matter here. And
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let me just give you a couple statistics that we've been struggling with as a community.
6:04
Obviously, the Collaboratory is a multi-stakeholder team that is trying to optimize clinical trial
6:12
conduct, therapeutic conduct in the United States and the world through improvement in
6:20
the quality, value, efficiency of the process. And one of the important areas of our focus
6:29
has been how do we get better representation in heart failure clinical trials. We've discussed
6:36
previously in one of our podcasts underrepresented minorities, and today we're discussing the
6:41
recruitment of women in heart failure trials. And let me just give you some facts. In 2001,
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I was part of the leadership team. Milton Packer was the principal investigator of the
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Copernicus trial. You can already hear two males involved in that trial. Recruitment
6:57
of women in that trial was 20% in an advanced HEFREF trial. Paradigm HF, 2014, Dr. Scott
7:08
and John McMurray, part of that leadership team. Recruitment in that heart failure reduced
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ejection fraction clinical trial, 21%. And then Galactic HF, just recently published
7:22
well over a year ago now, New England Journal, 2021, 21% recruitment of women. And yet we
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know that women represent about 35 to 40% of patients with heart failure and reduced
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ejection fraction. And so I'm going to open it up by asking Dr. Jessup, what is the deal
7:44
here? Why are we not making any progress?
7:48
I think like any really troublesome problem, it's multifactorial. One thing that keeps
7:55
coming out over and over again is that when women are leading the clinical trial investigator
8:04
team or part of the clinical trial investigator team, there's more women recruited into the
8:10
study. And the unfortunate fact in heart failure trials, not to mention most other cardiovascular
8:20
trials, is that a handful of trials have been led by women. We had two of the PIs of this
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handful, Dr. Lyndon Telden, Dr. Costanza, but not only have there not been leaders of
8:36
the clinical trial, there haven't even been women on the steering committee over and over
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and over again. So that's the first problem.
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The second problem is that women have different motivations for coming into clinical trials
8:53
and need to hear the answers to what they're seeking for motivations. And I don't think
9:01
that that's really been well studied and has not been therefore published. And I certainly
9:10
think that women in general are underrepresented throughout all cardiology, including heart
9:16
failure. Not only is the number of 20% reminiscent of how many women come into HFREF trials,
9:24
that's actually reminiscent of the number of women in cardiology. And that hasn't changed
9:29
for 30 years either, which is astonishing to me since right now, 50% of women are in
9:37
medical school classes. That's just my opening remarks of the couple of the issues around
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this thorny problem.
9:46
Well, those are terrific. And obviously, you have been advocating appropriately the number
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one killer of women in the world, the United States, is cardiovascular disease. So this
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is particularly an important challenge from the whole ecosystem that you just nicely described.
10:06
Joanne, compliment Mariel's comments.
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I would emphasize what Mariel already said, but I think it as so often happens, there's
10:13
some deeper issues that reflect society. And I think one of the reasons we started being
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interested in this way back when, when we did the only beta blocker trial that failed
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in HFREF, which was Bucyndallol. But we were not recruiting enough women. It was a partially
10:26
NIH sponsored trial. So we looked into the reasons. And we were able by the end to recruit
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33% from the non-VA site. So we did pretty well by providing extra monies for women.
10:36
And the reasons for that is that women tend to be older. They are much more often likely
10:41
to be without a partner when they have HFREF. They're economically disadvantaged. And they
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drive, they have fewer, less often have driver's licenses. All those things are true. So getting
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back and forth to extra appointments is more expensive and more difficult for women. And
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I think until we address that, we will miss quite a few in these trials.
11:01
Excellent points. And really nice how you said with the best trial, 33%. And that was,
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I think before the NIH moved forward with their act, really a strong stick to say, listen,
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there should be recruitment targets and goals in clinical trials. And I think it's been
11:21
effective. Maria Rosa?
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Let me just interject though. You just said it hasn't changed. I would argue that that
11:28
NIH stick has been ineffective and is not backed up by any sort of teeth, so to speak.
11:37
Yeah. Well, let's push back on that a little bit. So the investigators who run these trials
11:43
are very nervous about funding and the funding can be pulled. Now, whether it has been pulled,
11:50
probably not to the extent that we based on that. But I do think the data is there and
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we'll have to look at this. But I think the data says in the NIH conducted HFREF trials,
12:01
that prevalence of women recruited is higher than in the private trials in contrast. That
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doesn't mean we're doing great. I mean, I don't think 28 to 33% is the right number,
12:13
but I think it is better than the 20% we're seeing in the non-NIH trials. Maria Rosa?
12:20
Well, I think that what I'm seeing, not only in HFREF trials, so what I want to say really
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is that I think the Heart Failure Collaboratory has a great opportunity to try to change things.
12:40
The reason is that, as you said, we have multiple stakeholders, and this includes not only the
12:49
NIH, but also industry. What I'm finding out is that a lot of people from industry actually
12:58
join in our discussions, and they come to me and ask me questions about our discussions.
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And I think that non-NIH bodies like industry, they are a major offender in this particular
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area. Because what they do is that no matter what study they have, they go back to the
13:29
same people to lead the trials. They never inquire about the interests of other people.
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I know it's a different area, but even worse is the area of pulmonary hypertension. I looked
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at all the trials done in the last 20 years, and not only there are few women that are
13:55
leaders, but the principal investigator and the steering committee are the same people
14:03
for 20 years. And I think they need to expand their horizons. Just today, I had a conversation
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with a medical liaison from Novo Nordisk, who is now entering the cardiovascular space,
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and they're doing a trial with an anti-inflammatory agent in FPATH. And this lady, another woman,
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interestingly, she was extremely surprised that I knew so much about heart failure. I
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said, well, I've been in this area for a few years, and so I've been following these trials,
14:51
and she was totally, she did not know not only about me, but other women that could
14:59
lead clinical trials because they keep going back to the same group of people.
15:06
That's a great observation. That pulmonary hypertension is a great observation. But Dr.
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Batcher has actually studied this when it comes to how to select sites and enhance recruitment
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of Black patients in clinical trials. Wayne, maybe you could talk about that, and are there
15:28
lessons learned from your research?
15:31
Yeah, thanks, Chris. There are some lessons learned, and there are some similarities, but
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there are also some differences in terms of methods that you can undertake to improve
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enrollment of women versus other underrepresented groups, such as minorities in clinical trials.
15:47
If you look at the entire trial ecosystem, there have been some comments made in terms
15:51
of representation of women on leadership committees. That's crucial. It's been shown for every
15:57
single additional woman on a research leadership role. There's about an 8% increase in proportion
16:04
of women enrolled in those trials. Interestingly, that also improves diversity across other
16:12
definitions, including minority enrollment. Women tend to do a better job somehow enrolling
16:18
minorities in clinical trials. Now, we've got to do a better job of understanding predictors
16:24
of female enrollment beyond that. There are some interesting observations for the mix
16:30
between outside United States sites versus inside United States sites. US sites actually
16:36
enroll more women. It's been shown time and time again in trials and more minorities,
16:43
whereas OUS, I'm not sure why exactly, but there's actually a little bit lower proportion
16:48
of women enrolled. So there are a lot of different, as Mariel mentioned, this is a multifaceted
16:54
problem, but our lack of ability to address it not only impacts female enrollment, I think
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it actually has an impact on diverse enrollment in general. So if I had $100 to put into this,
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I'd really look at the leadership thing first. And then as Maria Rosa mentioned, also look
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at industry studies, because the NIH actually has shown a little bit better traction in
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this regard, and a little bit more effectiveness for enrolling women than industry sponsored
17:25
studies. Industry sponsored trials have actually not moved the needle at all. We got a lot
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of work to do.
17:31
Terrific, Wayne. And I'm going to ask Bill Abraham to comment about the VICE trials specifically
17:37
in women. And then I'm going to ask Dr. Fusat to comment on what we've heard about the carrot
17:43
versus the stick policy of enhancing recruitment in special populations. Bill, talk about the
17:50
VICE trials. There's challenges, but there's also, I know in the Momentum III LVAD trial,
17:56
19% enrollment, but I also know that you've been involved with a lot of VICE sponsors
18:01
that have made great progress.
18:02
I think we are making progress. First, I'll say this is a particular challenge for VICE
18:08
trials. I think for reasons already stated by others, in particular by Joanne, sometimes
18:15
VICE trials involve different sorts of and perhaps more intense follow-up schedules.
18:22
They involve procedures and sometimes device implantation and return to study visits for
18:28
following and monitoring all of that. So issues around transportation, childcare, being away
18:34
from the home, et cetera, et cetera, become even more magnified, I think, in the setting
18:39
of VICE trials.
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But I think, on the other hand, because the VICE trials tend to be smaller than drug trials,
18:46
there often is more focus and a more concerted effort to try to recruit women and underrepresented
18:53
minority candidates in these trials. And we've seen in some studies like CHAMPION, for example,
18:58
and others, a better than proportionate representation of some underrepresented minority groups in
19:05
those studies as well. And I think it really takes getting all of our stakeholders to buy
19:12
into this.
19:13
As I think I'll allow here, Chris, perhaps one thing the collaborator could do here is
19:18
to just come up with some best practices for industry in particular. In BEST, you may recall
19:26
that there was offered to sites a differential payment, a little bit more, for recruiting
19:33
a woman compared to a man, because it was appreciated that it took more time and effort
19:39
on the part of the research site to recruit women because of all of these barriers that
19:44
we've already been talking about.
19:46
And, you know, we ought to be fully covering patients' expenses for participating in clinical
19:52
trials. If they have to get daycare, if they need transportation, the mileage and parking,
19:58
whatever it may be, we've got to lower any of the barriers that affect our trials participants
20:04
or potential trials participants in general, and certainly those barriers that affect the
20:10
inclusion of women and underrepresented minorities, I think disproportionately or in particular.
20:17
And then maybe, and I'm really interested to hear what Mona has to say, maybe it's time
20:21
for a bit more of a stick here as well. And I want to hear Mona's views on this, but perhaps
20:26
we can come back to that, because I think it's time that study sponsors, whether they
20:30
be NIH or industry, need to be a bit more firm in their assistance, in insistence that
20:38
we enroll these populations proportionate to their representation in the disease.
20:44
That's terrific. And when we say industry, I want to make it clear, there's an ecosystem
20:49
in the industry trials. There's principal investigators, there's, and the influence
20:54
of the steering committee and the executive committee plays a role. So we can't just say
21:01
that, well, it's industry's fault. It's the leadership that plays a big role in who gets
21:09
on those committees, who gets in that leadership position. So that's really important too.
21:14
Mona, what are your thoughts on the carrot versus the stick? This is something we've
21:18
been tossing around in the collaboratory now for a year, and there's been some good progress.
21:23
There were. There are different ways to look at this, and certainly the FDA can play a
21:29
role. And to make it clear, the FDA's initiatives are set forth by Congress. So it literally
21:38
takes an act of Congress to change these things. But we've been working in the collaboratory
21:43
to perhaps approach this through more of a carrot approach so that it is a little more
21:50
favorable to incentivize people to do it rather than just putting up another barrier, let's
21:57
say from the FDA, which is a little bit counterintuitive to what we're trying to do in the collaboratory,
22:04
which is make things a little more accessible to patients. And so our general concept here
22:12
is what has been done in the pediatric space, which has set a brilliant example. Historically,
22:21
drugs and devices were not studied in the pediatric population, and it was left to everyone
22:26
to figure it out. And since they've had these policies in place of a six-month patent extension,
22:33
expedited review, just that six-month patent extension alone can drive so much industry
22:40
to do this, to do the right thing. And although, of course, it's driven by capitalism, and
22:46
some people may feel that we shouldn't continue to line the pockets of industry more, nonetheless,
22:53
it's been effective. And we do live in a capitalist society here in America, and so we know it
22:59
works. And so we have tried to get some support to take that approach, which is just a six-month
23:07
patent extension, perhaps a little more resources to promote both women and underrepresented
23:15
minorities in doing the right thing, rather than just telling people they need to do the
23:21
right thing or believing that they'll do it because it's the right thing to do. And there's
23:26
examples, I think several of you were probably involved in the Platinum Diversity Trial,
23:31
for example, which actually finished ahead of schedule and had a great enrollment rate.
23:37
So it was a great concept to prove that how enrolling women and minorities does not slow
23:44
down the enrollment process. But different people feel differently, and some may feel
23:50
that the stick approach is more of the appropriate approach. In my view, putting up more barriers
23:59
to drug approvals or device approvals is perhaps not the way to go because it does ultimately
24:06
hurt patients.
24:07
Well, let's go around the room, and I think, Bill, you may have stimulated this, talking
24:13
about best practices. Let's say if there was one initiative that the collaboratory should
24:19
focus on this year going forward, what should it be to improve recruitment of women in heart
24:26
failure clinical trials?
24:27
Bill?
24:29
Number one, saying it is our goal. This is our number one goal, and we're going to try
24:35
and do everything we can to tackle this issue. And I think we should do a compilation of
24:44
best practices. You may know that the AHA has funded a strategically focused research
24:51
network about diversity in clinical trial enrollment, and one of their charges is we
24:57
want to see a playbook at the end. We call those journal publications, but I call it
25:03
a playbook about how to do this, reproduce scientifically validated within the context
25:09
of this science network. And so I think we can start that process within the collaboratory.
25:18
And I know that there are a lot of people that feel very strongly that they know how
25:22
to do this. Let's find out why they think that, what's the evidence, and collect that
25:29
and we can publish it.
25:31
Great suggestion. Joanne? On mute.
25:35
I agree with Mariel. As we've said, we should really try to have more women as investigators
25:41
and on committees to help with this, because that will help. That's been shown many times.
25:45
But I think also, as Mariel said, I think we really have to focus on trying a strategy.
25:49
For example, if women are less able to get, do we pay more for travel? And let's try that
25:55
and see if that helps. And just put that into a study for a period of time and then say,
26:00
okay, if this works, this doesn't work. I think just one other thing about, again, I
26:04
point out, women are far more often to be single when they come for these, so they don't
26:09
have someone to discuss as much. And perhaps creating a group that they can discuss things
26:15
with to just go over with about what are the positives and the negatives of participating
26:20
or support group there would be helpful. But I think we just need to say, these are the
26:24
number of things we can do. Let's try them. Let's implement them in different studies
26:28
and see if they're helpful.
26:30
Really great, great comments. Maria Rosa?
26:33
I think we need to shake up the laziness of all sponsors. And when they are thinking about
26:42
a trial, they really need to do their work and their research, find out who published
26:50
in that area and who may have expertise in that area and go beyond the usual group of
26:59
people that they return to over and over again. Because there are people out there that may
27:07
have expertise beyond the usual group of people.
27:13
And also, I would like to bring something up following what Joanne said. I think as
27:20
women, what I see when I try to recruit women in clinical trials is really a double whammy.
27:29
Because the women that don't have a partner have the challenges that Joanne alluded to.
27:37
But I see probably a similar challenge in women that do have a partner, because nine
27:47
out of 10 times, they are the caretaker of that partner. And I hear over and over again,
27:55
I would like to participate, but I have to take care of my husband. I have to prepare
28:01
his medications. I have to make sure he doesn't fall. Whether you are single or have a partner,
28:10
there are different challenges that prevent women from participating. Anything, not just
28:17
transportation, but anything that can help women free themselves up to participating
28:25
in the trials.
28:26
We call that, I have to ask my son who lives in California syndrome. So men would never
28:32
want to say, I have to ask somebody. I have to ask my wife if I can do it. But women always
28:38
say, well, I have to ask my husband who's not here, or I have to ask my son who lives
28:41
in California, which is usually three time zones away from where we are.
28:46
And so being a no, which is another barrier. Wayne?
28:51
These are great points already made. Just to emphasize, strategy and tactics stem from
28:57
leadership, which also sets the stage for culture of an ecosystem and culture of a group
29:02
of individuals working together. So the women leadership positions is crucial, both at the
29:08
executive and steering committee level and also as the PI level. And we should have a
29:12
better way of selecting and finding those individuals and really put our money where
29:16
our mouth is.
29:17
Another thing that I'd love to hear more about is I'd love to do an exit interview on the
29:22
women and minorities who say no to clinical trials. All these surveys are just general
29:27
surveys. We never actually ask anything about the folks who say no. I'd love to do a study
29:32
looking at those individuals and rank order all these different impediments that we're
29:37
talking about. So we have some contemporary real data on why people say no today. Is it
29:44
money? Is it risk aversion? Is it lack of insight or understanding? Whatever it is,
29:51
that's probably the missing link that perhaps we could fill a gap for in the future with
29:56
our surveys and other studies.
29:58
Wayne, there is another huge missing link that I face every single day, and that is
30:07
the primary care physicians. I cannot tell you how many times I have a patient that is
30:14
seriously thinking about participating in the trial, and they want to have the approval
30:22
of their primary care physician. And the primary care physician, most of the time, says, well,
30:31
that's too experimental, say no. And so at the next visit, the patient comes back and
30:38
says, my physician said that it's too experimental and I should stay away. So we have a lot of
30:46
work to do with the people that the patients rely on to help them make decisions.
30:52
Chris, I can't believe we've gotten this far into the conversation, and artificial intelligence
30:57
hasn't been mentioned. So I'm going to put it out there. It seems to be the topic of
31:01
almost all conversations these days. The last thing is whether or not we can identify patients
31:06
who are appropriate for clinical trials, women in particular, who fulfill the inclusion and
31:11
exclusion criteria better with cardiac intelligence software or other software. I don't know.
31:16
That remains to be seen. It's a pipe dream somewhat, but there is potential for that.
31:20
So we might be able to target our efforts a little bit more strategically in terms of
31:24
the resources that we have to identify potential clinical trial participants with AI. There's
31:29
a potential for it.
31:31
I think you're exactly right. We're not using our EHR in a way to benefit women to be aware
31:38
of the trials that we're doing.
31:42
We need to educate the primary physicians to what a clinical trial is and that in a
31:52
clinical trial, we go to very lengthy measures to ensure the patient's safety. And because
32:01
the patient is in a clinical trial, it doesn't mean that we are experimenting on the patient
32:07
without regard for safety. And I don't think these primary care physicians really realize
32:16
this.
32:17
Well, that's a bigger issue than what we're talking today, but it is one of the charges
32:21
of the laboratory, less than 1% of patients with heart failure enrolled in clinical trials.
32:26
And the whole ecosystem needs help. But Bill, give us a charge on this topic for next year.
32:35
So look, I'm going to try to address the question you asked, which I think was pick one thing.
32:41
I think I would start with improving the involvement of women both as site investigators and in
32:48
the leadership of clinical trials. And I think in particular as an action item, if we could
32:53
get our industry members of the collaboratory to include this, for example, in their site
33:00
interactions and site qualification visits, let's add a question to the site qualification
33:06
visit.
33:07
Do you have a woman working in this subspecialty who could serve as a sub investigator or principal
33:12
investigator for this trial? Just something as simple as that. And we may be able to identify
33:18
more women that way also to include on steering committees and executive committees, publication
33:23
committees and so on and so forth.
33:25
But if we could ask that question with every site that's being considered and preferentially
33:31
select those who check the box, yes, we might make some progress here. Because I think by
33:37
having women at sites and on these leadership committees advocating all the other great
33:44
ideas that have come up here, we could maybe really make some progress.
33:48
I couldn't agree more. And Mona, in your comments, you might also mention about the data safety
33:54
monitoring board training program that we're doing and the initial success of identifying
34:00
young women to be part of that program.
34:03
Do you refer to me?
34:04
Absolutely.
34:05
Yes, as a young woman.
34:08
Well, it'll be great to have you there as an example of success, Maria Rosa. But yeah,
34:15
I think everything everyone said being intentional about this, we've been working on it through
34:19
the collaboratory. There has been some legislation, which is a start that the FDA is also working
34:27
through. There's a diversity committee now at the FDA working on some of these issues
34:32
already. But to the extent that, you know, legislators are hearing about it as something
34:38
that really needs to be done, I think giving the FDA authority to do those things is another
34:44
area that we didn't really discuss, but I think would make a huge difference.
34:48
And then to your point, what the collaboratory is doing, we've involved many young women
34:53
in our efforts, our projects, the DSMB training that's coming up, we identified the majority
35:00
of the trainees as women so that they will be considered on committees going forward.
35:06
And I think really what you've all said is we've got to improve the culture. I think
35:11
Wayne said this nicely, we've got to enhance the culture and we've got to catch up. There's
35:16
been a years of gap of inattention to this issue. And therefore, the number of people
35:25
that we can get into these leadership positions is really a subset of what it should be. And
35:32
I've made a thousand mistakes in clinical trial conduct. And I've supervised more neutral
35:39
and negative trials than any heart failure clinical trialist. But one thing I feel good
35:44
about is that we asked Dr. Ileana Pina in 2000 when we were running the HF Action to
35:52
be chair of the Heart Failure Action Executive Committee. And our recruitment, as Joanne
35:59
said, in the non-VA sites overall was 28 percent. At that time, 20 percent was normal, over
36:04
30 percent in the non-VA sites. And frankly, the results, there was enough statistical
36:10
power, most people don't know that, that the benefits of exercise were actually statistically
36:15
significant and greater in women. And that's why we have to have this type of recruitment
36:20
and efforts going forward. I want to take this opportunity to really thank this panel
36:25
for an outstanding discussion. Like we often do with Heart of the Matter, we raise a lot
36:30
of issues. We answer a few. But I think we're prodding and pushing to go forward. And I
36:37
like what Mariel and Joanne said. Let's get our best practices, best experiences, and
36:43
create a playbook that we can work with now and articulate what we need to do going forward.