Table Summarizing Neuro Clinical Trials

This forum made possible through the generous support of SDN members, donors, and sponsors. Thank you.

Soparklion

Full Member
15+ Year Member
Joined
Dec 27, 2006
Messages
58
Reaction score
8
I'm attempting to assemble a table summarizing all of the clinical trials relevant to neurology (SAMMPRIS, ISAT, ACCORD, etc.) that the Attendings and fellows quote on rounds each day... there are way too many cutesy names out there... Does anyone know where I can find a table of them already put together? It has to exist already :xf:

Thank You in advance!

SPL

Members don't see this ad.
 
how common is it for a neurologist to have the majority of their practice doing clinical trials?
 
Members don't see this ad :)
You can spend the majority of your academic time executing trials (site-PI), as there are lots out there, many pharmaceutically-sponsored these days. One can debate whether or not that is wise from a career development standpoint or not, as you are essentially an on-site deputy making sure the protocol is followed at your institution. That is distinct from your clinical time taking care of patients, although you certainly can be on service and executing trials at the same time. Depending on whether or not trials are NIH-supported, you can add some salary support from these efforts, although the NIH tends to reimburse sites meagerly, once you've paid for your screening coordinators, research nurses, etc.

On the flip side, you can have a very strong academic career as a clinical trialist who designs, gets support for, and administrates multi-center trial efforts. Some of the more famous stroke neurologists out there are well-known because of their trial work.
 
You can spend the majority of your academic time executing trials (site-PI), as there are lots out there, many pharmaceutically-sponsored these days. One can debate whether or not that is wise from a career development standpoint or not, as you are essentially an on-site deputy making sure the protocol is followed at your institution. That is distinct from your clinical time taking care of patients, although you certainly can be on service and executing trials at the same time. Depending on whether or not trials are NIH-supported, you can add some salary support from these efforts, although the NIH tends to reimburse sites meagerly, once you've paid for your screening coordinators, research nurses, etc.

On the flip side, you can have a very strong academic career as a clinical trialist who designs, gets support for, and administrates multi-center trial efforts. Some of the more famous stroke neurologists out there are well-known because of their trial work.

Taking a disparaging tone for clinical trial work is not helpful. There is some basic science which is great, but much of it is nonsense: not reproducible or not worth even trying to reproduce, clinically irrelevant, so narrow as to be of no interest, or treading of well walked grounds. This academic attitude that a clinical trial doctor is "just" a deputy prevents academic sites from truly leading clinical medicine into new advances, new therapies, new areas. Even if true, so what, is being a deputy somehow a dishonorable job? Is being a small part of a large advance, like a DMT in ALS or AD, somehow less worthy of being a big part of something tiny (a new gene association, an unregulated pathway in ____, ____ cell response to ___, 98% of all fMRI studies, the list goes on)?

Especially because even these tiny advances are less probable that most every grant that promises nothing new, no innovation, little true risk, and relies on name/institution/connections mentions bench to bedside - then forgets about the bedside as soon as the money comes in, then focuses on slicing the data into a thin paper. I have no problem if academic places want to lose their positions as leaders, retreat from the needs of society, and focus on their tiny domains, only a sense of sadness. I do object to the abuses as the old hoard their grant money at the expense of young, risk taking investigators who could make a real difference.

The fact is that a trial doctor is on the leading edge of medicine. And the people who design trials mostly work for pharm companies and their jobs are kinda boring. It takes a unique skill set, good training, and an entrepreneurial spirit to conduct clinical research: know the medicine and the models, interface with a study team, the sponsor, CROs, getting and keeping the proper subjects in a trial while keeping others out. These trials have led to real differences in care. Oncology is the best model, where trials are essentially part of the treatment plans, and never disparaged by the ivory tower. Instead, it is seems to be an ethos in the field: your fellowship entails clinical trials. Neurology has successes, DMTs in MS mostly, but has eased the suffering of millions with symptomatic medications, and we will have more. Let's all try to be part of the solutions. Seeking individual glory won't fly once all the low hanging fruit has been picked.

On a personal note, I was once being a bit churlish about a stroke study's budget, and one of your "more famous stroke neurologists out there" gently reminded me that this is a team approach, requiring sacrifice. We're a site, I guess you'd say I'm just a deputy, but I consider myself a sheriff and I'm proud of my role.

Finally, consider that your mom, friend, sibling will have early AD in 10 years. What brings you more optimism, that trials are being done or that someone is finding out, once again, that amyloid is bad for rat brains?
 
  • Like
Reactions: 1 user
Dude, I am a site PI. Get off your high horse. No one is arguing the benefit of trials. Read my message again -- I was specifically referring to the relative merits of being a site-PI alone in an academic career progression. You can't tell me there isn't a difference between Joe Broderick and a site-PI for the NINDS trial. One gets hugely famous, the other gets to sleep well at night. Both are important for the execution of the research.

And you should also probably realize that by disparaging translational research, you're just as bad as "haters" you're imagining against trials. Your AD example is laughable given that we wouldn't have highly active anti-amyloid mAbs without all that "hoarding of grant money" and "relying on name/institution", etc in your diatribe. Anti-VLA4 Abs didn't fall out of a tree either, for your MS example.

Sorry that you feel that the actual design of clinical trials is "kinda boring" because that is actually what takes the most time and effort for the trialists you so vehemently support. I fully agree that implementing a protocol at a specific site takes care and skill, but to flippantly disparage the actual act of protocol design is curious to me -- that's what actually determines whether the trial answers the question it seeks to. You know, not all trials come from industry, and those protocols need to get approved and funded by the NIH, which requires the same funding fun and games you seem to think is purely the territory of the scurrilous bench researcher.

Take your "famous stroke neurologist's" advice and realize that it is in fact a team approach, only the team is much larger than your magnanimous team of academic trialists who are singlehandedly taking on the world and asking nothing for their sacrifice. You need to stop creating these enemy narratives -- translational scientists aren't out for "personal glory" any more than the administrative PI at the top of the last trial protocol you implemented.

Cheers, mate. We're actually on the same side.
 
Dude, I am a site PI. Get off your high horse. No one is arguing the benefit of trials. Read my message again
One can debate whether or not that is wise from a career development standpoint or not, as you are essentially an on-site deputy making sure the protocol is followed at your institution.
The benefit of trials is huge, but the attitude that you can't be an academic by conducting them is a bias within academic medicine that I - rightly - called out. This academic snobbery is preventing academics from actually leading their fields. It makes them into tall and deep silos with nothing to offer the rest of us, and in the end nothing to even offer patients. And, no surprise, industry is turning away from them.
-- I was specifically referring to the relative merits of being a site-PI alone in an academic career progression. You can't tell me there isn't a difference between Joe Broderick and a site-PI for the NINDS trial. One gets hugely famous, the other gets to sleep well at night. Both are important for the execution of the research.
Please. Funny that we're talking about Broderick, who was just a humble PI on the NINDS tPA trial, just a deputy (who's team enrolled and got the job done), and I bet he spent plenty of nights awake enrolling and randomizing those midnight acute strokes as a site PI. In fact, it should be one of his proudest career accomplishments. Imagine a guy way outside the Ivy Towers (I could not find Cincinnati on a map) who's killing it, who gets the more patients than any other site!
And you should also probably realize that by disparaging translational research, you're just as bad as "haters" you're imagining against trials. Your AD example is laughable given that we wouldn't have highly active anti-amyloid mAbs without all that "hoarding of grant money" and "relying on name/institution", etc in your diatribe. Anti-VLA4 Abs didn't fall out of a tree either, for your MS example.
Neglect said:
There is some basic science which is great.
Nothing you said makes me revise my position. Some basic science is great, it has the potential to either lead to new therapies or not, but at least it is taking a chance. Some is not great, questionable, redundant, trivial, and I think it is OK to question the merits. Pretty much anyone who's ever spent more than a week in a high level academic place knows this; what I'm saying is not at all controversial. Instead, I think I'm brushing up against your biases, which are shared by so many in academics, that getting your Nature paper per year will make you an associate professor and someday you'll be 65 and have 300 papers - and not a single patient helped. And I'm sorry, but that's very much how I see some of this game. But let me hasten to say, before you get all upset, that some basic science is actually great.
 
Decent points. I would say that the translational research cycle is longer than most of our careers, so those "ivory tower" discoveries that "don't help patients" is shortsighted. This is the same perspective that frustrates me at study section -- no one wants to fund anything that doesn't have nearly immediate bedside implications and in reality most ideas aren't yet ready for bedside application. This actually stifles innovation, because people have to tailor their research to ideals that are often impractical. Bench to bedside takes far longer than people like to think, even in an ideal case.

A good example that I like to quote is the B-cell. In the 1970s the B-cells were considered nude, with no surface antigens or anything really interesting about them. They did what the T-cells told them, and if you were a "forward thinking" immunologist you worried about the T-cells because that was going to be the hot area. Lee Nadler didn't listen to them, and found CD-20 on B-cells at the end of the 1970s, early 1980s. He was a post-doc then. Everyone thought he was nuts, and was literally laughed at during scientific meetings because everyone thought he was wrong, and who cares anyway because they're just B-cells. Rituxan was approved in 2006. In retrospect it's easy to see that what he was doing was crucially important, and he was an ivory tower investigator at Columbia, Dana-Farber, and Harvard Medical School. He's a full professor with > 300 publications. You'd probably paint him as one of the "bad guys" if he were doing his early career work today.

One needs to be careful about whether we really know what science is helpful to patients and what science is masturbatory. You can question merits all you want, but you aren't carrying a crystal ball any more than anyone else. The healthiest way to promote scientific advancement in neuroscience is to balance basic, translational, epidemiologic, and interventional strategies. Thinking that all neuroscientific research needs to be geared towards immediate patient care is like saying that astronomers should quit looking at the stars because we need to have everybody focused on landing on Mars in 2020. We don't even understand the pathobiology of most of the diseases we are treating.

And look up what clinical trials NINDS is sponsoring right now. Many are guilty of the same minimal-risk, questionable-benefit issues as the crummy basic science studies you feel are so prevalent in academic medicine. In fact, the same study sections review many of these proposals. It's not like they score innovation and significance differently for an observational vs. interventional study. Walter Koroshetz is worried that NINDS is funding too little basic science, and he's the guy that designed StrokeNET.

Look, I agree that there are scientists out there who seem far more interested in maneuvering resources than actually advancing the field, but talk to the people studying toll-like receptors and I think they will give you a lot of reasons why their work is important. I don't think you should be the one to tell them they're wrong.

Good conversation.
 
Decent points. I would say that the translational research cycle is longer than most of our careers, so those "ivory tower" discoveries that "don't help patients" is shortsighted. This is the same perspective that frustrates me at study section -- no one wants to fund anything that doesn't have nearly immediate bedside implications and in reality most ideas aren't yet ready for bedside application. This actually stifles innovation, because people have to tailor their research to ideals that are often impractical. Bench to bedside takes far longer than people like to think, even in an ideal case.

A good example that I like to quote is the B-cell. In the 1970s the B-cells were considered nude, with no surface antigens or anything really interesting about them. They did what the T-cells told them, and if you were a "forward thinking" immunologist you worried about the T-cells because that was going to be the hot area. Lee Nadler didn't listen to them, and found CD-20 on B-cells at the end of the 1970s, early 1980s. He was a post-doc then. Everyone thought he was nuts, and was literally laughed at during scientific meetings because everyone thought he was wrong, and who cares anyway because they're just B-cells. Rituxan was approved in 2006. In retrospect it's easy to see that what he was doing was crucially important, and he was an ivory tower investigator at Columbia, Dana-Farber, and Harvard Medical School. He's a full professor with > 300 publications. You'd probably paint him as one of the "bad guys" if he were doing his early career work today.

Going in a direction that no-one else is going in is exactly the type of science that should be encouraged and rewarded, but isn't. (Second time I linked to this article.) I would think Nadler was, and still is, very much one of the good guys. Ditto Prusiner, who was seemingly way out there in the wilderness. My problem is with 300 publications that pretty much all agree with the status quo, that don't really advance anything or change thinking. These channels behave ____ under ____ conditions is a good example of the sort of research that is dubious, but things that are risky enter new ground and are not. I think of the early troubles to go from what was known from the 70s, Bcr-Abl protein is abnl in CML to get proto-Gleevac investigated, Drucker was on his own, suffered failures in getting grant money, and had to leave to go to Oregon.

I also very much get that the path is twisted and slow and uncertain. Someone working on Ebola three weeks ago was in the basement, but now their work takes on a new importance. And I get the fact that you have to fund multiple streams in hopes that one will find a way. So why reward some people I know, who are just doing the same work again and again, and really is purely masturbatory.

Here's an example of what I find disturbing. I walked into a lecture hall at the national meeting and all these guys were looking at imaging studies and correlating the behavioral subtypes of FTD's with their proteinopathies. There is not a way to make that relevant to FTD patients. Especially because many of the pathology studies have already been done, so this is a matter of which networks are implicated at point X of the disease. No matter what they find - that this tauopathy affects the lateral frontal lobes in case 1, but rostral in case 2 - will make FTD patients better. Nor will further research in this matter. We need meds that are anti-tau and we need to verify the tauopathies and do the trials. But to hear the people in that room, the arrogance and self congratulation and the pomposity of the questions and answer sections, you'd be forgiven for thinking FTD was a trivial disease and only of interest for classification purposes. I was horrified and literally nauseous. FTD is killing brains and stripping the human of every dignity, and these people are (mentally) jerking each other off to brain porn and mesial temporal connections.

But this is the way of the current academia. They all get their nature papers. But I wish I did have the guts to stand up there and demand them to consider the fact that I don't find their work important and I don't think it should be funded unless it is tethered to a therapeutic trial.

And look up what clinical trials NINDS is sponsoring right now. Many are guilty of the same minimal-risk, questionable-benefit issues as the crummy basic science studies you feel are so prevalent in academic medicine. In fact, the same study sections review many of these proposals. It's not like they score innovation and significance differently for an observational vs. interventional study. Walter Koroshetz is worried that NINDS is funding too little basic science, and he's the guy that designed StrokeNET.

Oh, I totally agree with this. There's just not enough forward thinking or risk or innovation to go around. And of course, every big center has to be a study hub, so that dilutes things further. Not to name names, but tpa in the too good to treat? This is a personal thing, but brain edema? I don't get it. And again, this is personal, should my brain ever contain so many dead neurons that their swelling threatens the remainder, please put the rest out of their misery with a generous morphine drip. And if I have a decent shot at rankin 2, pop the top. But I happen to know that when the NIH gets a grant that's outside the box, that is a risk - and risks might not pay off, they don't rank it. So onward to combat the dread stroke edema!
 
  • Like
Reactions: 1 user
Top