Posts Tagged Clinical Trials

News flash! Doctors aren’t all compliant pharma drones!

There’s an oft-quoted saying that’s become a bit of a cliché among skeptics that goes something like this: There are two kinds of medicine: medicine that’s been proven scientifically to work, and medicine that hasn’t. This is then often followed up with a rhetorical question and its answer: What do call “alternative medicine” that’s been proven to work? Medicine. Of course, being the kind of guy that I am, I have to make it a bit more complicated than that while driving home in essence the same message. In my hands, the way this argument goes is that the whole concept of “alternative” medicine is a false dichotomy. There is no such thing. In reality, there are three kinds of medicine: Medicine that has been shown to efficacious and safe (i.e., shown to work); medicine that has not yet been shown to work (i.e., that is unproven); and medicine that has been shown not to work (i.e., that is disproven). So-called “complementary and alternative medicine” (CAM or, its newer, shinier name, “integrative medicine”) consists almost completely of the latter two categories.

Part of the reason why this saying and its variants have become so commonplace among those of us who support science-based medicine is that they strike at a common truth about medicine, both science-based and “alternative.” That common truth is what we here at SBM have been arguing since the very inception of this blog, namely that there must be one science-based standard of evidence for all treatments, be they “alternative” or the latest creation of big pharma. That point informs everything I write here and everything my blogging parters in crime write about too. What that means is a single, clear set of standards for evaluating medical evidence, in which clinical evidence is coupled to basic science and scientific plausibility. Indeed, one of our main complaints against CAM and its supporters has been how they invoke a double standard, in which they expect their therapies to be accepted as “working” on the basis of a much lower standard of evidence. Indeed, when they see high quality clinical trials demonstrating that, for example, acupuncture doesn’t work, they will frequently advocate the use of “pragmatic” trials, lower quality trials of “real world effectiveness” that do not adequately control for placebo effects. It’s putting the cart before the horse.

Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Related by coincidence only? University and medical journal press releases versus journal articles

There are certain topics in Science-Based Medicine (or, in this case, considering the difference between SBM and quackery) that keep recurring over and over. One of these, which is of particular interest to me because I am a cancer surgeon specializing in breast cancer, is the issue of alternative medicine use for cancer therapy. Yesterday, I posted a link to an interview that I did for Uprising Radio that aired on KPFK 90.7 Los Angeles. My original intent was to do a followup post about how that interview came about and to discuss the Gerson therapy, a particularly pernicious and persistent form of quackery. However, it occurred to me as I began to write the article that it would be better to wait a week. The reason is that part of how this interview came about involved three movies, one of which I’ve seen and reviewed before, two of which I have not. In other words, there appears to be a concerted effort to promote the Gerson therapy more than ever before, and it seems to be bearing fruit. In order to give you, our readers, the best discussion possible, I felt it was essential to watch the other two movies. So discussion of the Gerson protocol will have to wait a week or two.

In the meantime, there’s something else that’s been eating me. Whether it’s confirmation bias or something else, whenever something’s been bugging me it’s usually not long before I find a paper or online source to discuss it. In this case, it’s the issue of why scientific studies are reported so badly in the press. It’s a common theme, one that’s popped upon SBM time and time again. Why are medical and scientific studies reported so badly in the lay press? Some would argue that it has something to do with the decline of old-fashioned dead tree media. With content all moving online and newspapers, magazines, and other media are struggling to find a way to provide content (which Internet users have come to expect to be free online) and still make a profit. The result has been the decline of specialized journalists, such as science and medical writers. That’s too easy of an answer, though. As is usually the case, things are a bit more complicated. More importantly, we in academia need to take our share of the blame. A few months ago, Lisa Schwartz and colleagues (the same Lisa Schwartz who with Steven Woloshin at Dartmouth University co-authored an editorial criticizing the Susan G. Komen Foundation for having used an inappropriate measure in one of its ads) actually attempted to look at how much we as an academic community might be responsible for bad reporting of new scientific findings by examining the relationship between the quality of press releases issued by medical journals to describe research findings by their physicians and scientists and the subsequent media reports of those very same findings. The CliffsNotes version of their findings is that we have a problem in academia, and our hands are not entirely clean of the taint of misleading and exaggerated reporting. The version as reported by Schwartz et al in their article published in BMJ entitled Influence of medical journal press releases on the quality of associated newspaper coverage: retrospective cohort study. It’s an article I can’t believe I missed when it came out earlier this year.

Posted in: Clinical Trials, Medical Academia, Science and the Media

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Meet the new drugs, same as the old drugs?

“Targeted therapy.” It’s the holy grail of cancer research these days. If you listen to its most vocal proponents, it’s the path towards “personalized medicine” that improves survival with much lower toxicity. With the advent of the revolution in genomics that has transformed cancer research over the last decade, including the petabytes of sequence and gene expression data that pour out of universities and research institutes, the promise of one day being able to a patient’s tumor, determining the specific derangements in genome and gene expression that drive its uncontrolled proliferation, and finding drugs to target these abnormalities seems more tantalizingly close than ever. Indeed, it seems so close that even dubious practitioners, such as Stanislaw Burzynski, have jumped on the bandwagon, co-opting the terms used by real oncologists and real cancer researchers to sell “personalized gene-targeted cancer therapy,” which in their hands are really no more than a parody of efforts to synthesize the enormous quantity of genomic data each patient’s tumor possesses and figure out how best to take advantage of it, a “personalized genomic therapy for dummies,” if you will.

That’s not to say that there aren’t roadblocks to realizing this vision. The problems to be overcome are substantial, and I’ve discussed them multiple times before. For example, just a couple of weeks ago I discussed an example of just what it takes to apply these new genomic techniques to an individual patient. The resources required are staggering, and, more problematic, there often aren’t any single “magic bullet” molecular pathways identified that can be targeted with existing drugs. The case I discussed was a fortunate man indeed in that such a pathway was identified, but most tumors are driven by many derangements in growth control, metabolism, migration, and the other hallmarks of malignancy described by Robert Weinberg. Worse, in many cases we don’t even have drugs that can attack many of the abnormalities that drive cancer progression. Then there’s the issue of tumor heterogeneity, which comes about because cancer is as good example of a disease as I can think of in which evolution due to natural selection results in incredible differences in the cancer cells in one part of the tumor compared to other parts of the tumor or in the tumor metastases. A “targeted” therapy that targets the genetic abnormalities in one part of the cancer might well fail to target the genetic abnormalities driving another part of the tumor.

These, and many other reasons, are why we haven’t “cured cancer” yet.

Posted in: Cancer, Clinical Trials

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The problem with preclinical research? Or: A former pharma exec discovers the nature of science

If there’s one thing about quacks, it’s that they are profoundly hostile to science. Actually, they have a seriously mixed up view of science in that they hate it because it doesn’t support what they believe. Yet at the same time they very much crave the imprimatur that science provides. When science tells them they are wrong, they therefore often try to attack the scientific method itself or claim that they are the true scientists. We see this behavior not just in quackery but any time scientific findings collide with entrenched belief systems, for example, medicine, evolution, anthropogenic global warming, and many others. So it was not surprising that a rant I saw a few weeks ago by a well-known supporter of pseudoscience who blogs under the pseudonym of Vox Day caught my interest. Basically, he saw a news report about an article in Nature condemning the quality of current preclinical research. From it, he draws exactly the wrong conclusions about what this article means for medical science:

Fascinating. That’s an 88.6 percent unreliability rate for landmark, gold-standard science. Imagine how bad it is in the stuff that is only peer-reviewed and isn’t even theoretically replicable, like evolutionary biology. Keep that figure in mind the next time some secularist is claiming that we should structure society around scientific technocracy; they are arguing for the foundation of society upon something that has a reliability rate of 11 percent.

Now, I’ve noted previously that atheists often attempt to compare ideal science with real theology and noted that in a fair comparison, ideal theology trumps ideal science. But as we gather more evidence about the true reliability of science, it is becoming increasingly obvious that real theology also trumps real science. The selling point of science is supposed to be its replicability… so what is the value of science that cannot be repeated?

No, a problem with science as it is carried out by scientists in the real world doesn’t mean that religion is true or that a crank like Vox is somehow the “real” intellectual defender of science. Later, Vox doubles down on his misunderstanding by trying to argue that the problem in this article means that science is not, in fact, “self-correcting.” This is, of course, nonsense in that the very article Vox is touting is an example of science trying to correct itself. Be that at it may, none of this is surprising, given that Vox has demonstrated considerable crank magnetism, being antivaccine, anti-evolution, an anthropogenic global warming denialist, and just in general anti-science, but he’s not alone. Quackery supporters of all stripes are jumping on the bandwagon to imply that this study somehow “proves” that the scientific basis of medicine is invalid. A writer at Mike Adams’ wretched hive of scum and quackery,, crows:

Begley says he cannot publish the names of the studies whose findings are false. But since it is now apparent that the vast majority of them are invalid, it only follows that the vast majority of modern approaches to cancer treatment are also invalid.

But does this study show this? I must admit that it was a topic of conversation at the recent AACR meeting, given that the article was published shortly before the meeting. It’s also been a topic of e-mail conversations and debates at my very own institution. But do the findings reported in this article mean that the scientific basis of cancer treatment is so off-base that quackery of the sort championed by Mike Adams is a viable alternative or that science-based medicine is irrevocably broken?

Not so fast there, pardner…

Posted in: Basic Science, Cancer, Clinical Trials

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Revisiting Daniel Moerman and “placebo effects”

About three weeks ago, ironically enough, right around the time of TAM 9, the New England Journal of Medicine (NEJM) inadvertently provided us in the form of a new study on asthma and placebo effects not only material for our discussion panel on placebo effects but material for multiple posts, including one by me, one by Kimball Atwood, and one by Peter Lipson, the latter two of whom tried to point out that the sorts of uses of these results could result in patients dying. Meanwhile, Mark Crislip, in his ever-inimitable fashion, discussed the study as well, using it to liken complementary and alternative medicine (CAM) as the “beer goggles of medicine,” a line I totally plan on stealing. The study itself, we all agreed, was actually pretty well done. What it showed is that in asthma a patient’s subjective assessment of how well he’s doing is a poor guide to how well his lungs are actually doing from an objective, functional standpoint. For the most part, the authors came to this conclusion as well, although their hedging and hawing over their results made almost palpable their disappointment that their chosen placebos utterly failed to produce anything resembling an objective response improving lung function as measured by changes (or lack thereof) in FEV1.

In actuality, where most of our criticism landed, and landed hard—deservedly, in my opinion—was on the accompanying editorial, written by Dr. Daniel Moerman, an emeritus professor of anthropology at the University of Michigan-Dearborn. There was a time when I thought that anthropologists might have a lot to tell us about how we practice medicine, and maybe they actually do. Unfortunately, my opinion in this matter has been considerably soured by much of what I’ve read when anthropologists try to dabble in medicine. Recently, I became aware that Moerman appeared on the Clinical Conversations podcast around the time his editorial was published, and, even though the podcast is less than 18 minutes long, Moerman’s appearance in the podcast provides a rich vein of material to mine regarding what, exactly, placebo effects are or are not, not to mention evidence that Dr. Moerman appears to like to make like Humpty-Dumpty in this passage:

Posted in: Acupuncture, Basic Science, Clinical Trials, Neuroscience/Mental Health, Science and the Media

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Lies, damned lies, and…science-based medicine?

I realize that in the question-and-answer session after my talk at the Lorne Trottier Public Science Symposium a week ago I suggested in response to a man named Leon Maliniak, who monopolized the first part of what was already a too-brief Q&A session by expounding on the supposed genius of Royal Rife, that I would be doing a post about the Rife Machine soon. And so I probably will; such a post is long overdue at this blog, and I’m surprised that no one’s done one after nearly three years. However, as I arrived back home in the Detroit area Tuesday evening, I was greeted by an article that, I believe, requires a timely response. (No, it wasn’t this article, although responding to it might be amusing even though it’s a rant against me based on a post that is two and a half years old.) Rather, this time around, the article is in the most recent issue of The Atlantic and on the surface appears to be yet another indictment of science-based medicine, this time in the form of a hagiography of Greek researcher John Ioannidis. The article, trumpeted by Tara Parker-Pope, comes under the heading of “Brave Thinkers” and is entitled Lies, Damned Lies, and Medical Science. It is being promoted in news stories like this, where the story is spun as indicating that medical science is so flawed that even the cell-phone cancer data can’t be trusted:

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Let me mention two things before I delve into the meat of the article. First, these days I’m not nearly as enamored of The Atlantic as I used to be. I was a long-time subscriber (at least 20 years) until last fall, when The Atlantic published an article so egregiously bad on the H1N1 vaccine that our very own Mark Crislip decided to annotate it in his own inimitable fashion. That article was so awful that I decided not to renew my subscription; it is to my shame that I didn’t find the time to write a letter to The Atlantic explaining why. Fortunately, this article isn’t as bad (it’s a mixed bag, actually, making some good points and then undermining some of them by overreaching), although it does lay on the praise for Ioannidis and the attacks on SBM a bit thick. Be that as it may, clearly The Atlantic has developed a penchant for “brave maverick doctors” and using them to cast doubt on science-based medicine. Second, I actually happen to love John Ioannidis’ work, so much so that I’ve written about it at least twice over the last three years, including The life cycle of translational research and Does popularity lead to unreliability in scientific research?, where I introduced the topic using Ioannidis’ work. Indeed, I find nothing at all threatening to me as an advocate of science-based medicine in Ioannidis’ two most famous papers, Contradicted and Initially Stronger Effects in Highly Cited Clinical Research and Why Most Published Research Findings Are False. The conclusions of these papers to me are akin to concluding that water is wet and everybody dies. It is, however, quite good that Ioannidis is there to spell out these difficulties with SBM, because he tries to keep us honest.

Posted in: Clinical Trials, Science and Medicine

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The continuum of surgical research in science-based medicine

Editor’s note: Three members of the SBM blogging crew had a…very interesting meeting on Friday, one none of us expected, the details of which will be reported later this week–meaning you’d better keep reading this week if you want to find out. (Hint, hint.) However, what that means is that I was away Thursday and Friday; between the trip and the various family gatherings I didn’t have time for one of my usual 4,000 word screeds of fresh material. However, there is something I’ve been meaning to discuss on SBM, and it’s perfect for SBM. Fortunately, I did write something about it elsewhere three years ago. This seems like the perfect time to spiff it up, update it, and republish it. In doing so, I found myself writing far more than I had expected, making it a lot more different from the old post than I had expected, but I guess that’s just me.

In the meantime, the hunt for new bloggers goes on, with some promising results. If we haven’t gotten back to you yet (namely most of you), please be patient. This meeting and the holiday–not to mention my real life job–have interfered with that, too.

The continuum of surgical research in science-based medicine

One of the things about science-based medicine that makes it so fascinating is that it encompasses such a wide variety of modalities that it takes a similarly wide variety of science and scientific techniques to investigate various diseases. Some medical disciplines consist of mainly of problems that are relatively straightforward to study. Don’t get me wrong, though. By “straightforward,” I don’t mean that they’re easy, simply that the experimental design of a clinical trial to test a treatment is fairly easily encompassed by the paradigm of randomized clinical trials. Medical oncology is just one example, where new drugs can be tested in randomized, double-blinded trials against or in addition to the standard of care without having to account for many difficulties that arise from difficulties blinding. We’ve discussed such difficulties before, for instance, in the context of constructing adequate placebos for acupuncture trials. Indeed, this topic is critical to the application of science-based medicine to various “complementary and alternative medicine” modalities, which do not as easily lend themselves to randomized double-blind placebo-controlled trials, although I would hasten to point out that, just because it can be very difficult to do such trials is not an excuse for not doing them. The development of various “sham acupuncture” controls, one of which consisted even of just twirling a toothpick gently poked onto the skin, shows that.

One area of medicine where it is difficult to construct randomized controlled trials is surgery. The reasons are multiple. For one thing, it’s virtually impossible to blind the person doing the surgery to what he or she is doing. One way around that would be to have the surgeons who do the operations not be involved with the postoperative care of the patients at all, while the postoperative team doesn’t know which operation the patient actually got. However, most surgeons would consider this not only undesirable, but downright unethical. At least, I would. Another problem comes when the surgeries are sufficiently different that it is impossible to hide from the patient which operation he got. Moreover, surgery itself has a powerful placebo effect, as has been shown time and time again. Even so, surgical trials are very important and produce important results. For instance, I wrote about two trials for vertebral kyphoplasty for ostoporotic fractures, both of which produced negative results showing kyphoplasty to be no better than placebo. Some surgical trials have been critical to defining a science-based approach to how we treat patients, such as trials showing that survival rates are the same in breast cancer treated with lumpectomy and radiation therapy as they are when the treatment is mastectomy. Still, surgery is a set of disciplines where applying science-based medicine is arguably not as straightforward as it is in many specialties. At times, applying science-based medicine to it can be nearly as difficult as it is to do for various CAM modalities, mainly because of the difficulties in blinding. That’s why I’m always fascinated by strategies by which we as surgeons try to make our discipline more science-based.

Posted in: Clinical Trials, Science and Medicine, Surgical Procedures

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Tom Harkin, NCCAM, health care reform, and a cancer treatment that is worse than useless


It was a bad week for science-based medicine. It was a good week (sort of) for science-based medcine.

First the bad.

There has been a development that anyone who supports science in medicine and opposes quackery will likely find disturbing. Do you remember Senator Tom Harkin (D-IA)? We’ve written about him extensively over the last several months on this blog. First of all, he is the man most responsible for the creation of that government-sanctioned, government-funded bastion of pseudoscience, the National Center for Complementary and Alternative Medicine. He’s also one of the men most responsible for the Dietary Supplement Health and Education Act (DSHEA) of 1994, which has done more to protect the supplement industry from making dubious health claims than any other piece of federal legislation. More recently, Harkin has made a name for himself in the health care reform debate currently ongoing by inviting advocates of “integrative” medicine (IM), which in essence integrates quackery and the pseudoscientific with scientific medicine, to Capitol Hill as a means of trying to persuade his fellow legislators to include a CAM/IM version of “wellness” care as part of any bill that might pass this fall. In essence, he is trying to hijack any health care reform bill to include government sanction of unscientific medicine. Meanwhile, he has been chastising NCCAM because it hasn’t “validated” enough “alternative medicine” for his taste. (Actually, it’s validated none, because virtually none of it is likely to be valid.)

This is the man who, according to reports, will almost certainly be taking over the chair of the Senate Committee on Health, Education, Labor, and Pensions (HELP) after the death of its former chair, Senator Edward Kennedy. This committee is among the most important for government health policy and will be in the thick of the final negotiations and battles over any health care reform that may arise from Congress this fall.

The existence of powerful supporters of pseudoscience in the highest eschelons of government has real consequences. As I’ve described before, NCCAM, being based entirely on studying highly–even ridiculously implausible–notions about disease and how to treat it, has resulted in the infiltration of quackery into academia, where ideas once rightly dismissed as quackery are respectfully given deference and studied as though they were anything other than Tooth Fairy science, a process that Dr. R. W. Donnell has amusingly termed “quackademic medicine.” One result was the expenditure of $30 million on an unethical, poorly designed, and corrupt trial of chelation therapy for cardiovascular disease. Another result was an even more unethical trial of an even more scientifically implausible remedy for a deadly cancer. Although the fact that the trial was even done is a horror, at least last week we finally found out the results, which had been suppressed for nearly four years, namely that this protocol is not just useless, but worse than useless. It’s a Pyrrhic victory for science-based medicine and cold comfort to patients with pancreatic cancer who may have continued to use this protocol during those four years, but at least we finally know.

Let’s take a look at the study. But first, a little background.

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Fun with homeopaths and meta-analyses of homeopathy trials

ResearchBlogging.orgHomeopathy amuses me.

Well, actually it both amuses me and appalls me. The amusement comes from just how utterly ridiculous the concepts behind homeopathy are. Think about it. It is nothing but pure magical thinking. Indeed, at the very core of homeopathy is a concept that can only be considered to be magic. In homeopathy, the main principles are that “like heals like” and that dilution increases potency. Thus, in homeopathy, to cure an illness, you pick something that causes symptoms similar to those of that illness and then dilute it from 20C to 30C, where each “C” represents a 1:100 dilution. Given that such levels of dilution exceed Avagaddro’s number by many orders of magnitude, even if any sort of active medicine was used, there is no active ingredient left after a series of homeopathic dilutions. Indeed, this was known as far back as the mid-1800’s. Of course, this doesn’t stop homeopaths, who argue that water somehow retains the “essence” of whatever homeopathic remedy it has been in contact with, and that’s how homeopathy “works.” Add to that the mystical need to “succuss” (vigorously shake) the homeopathic remedy at each dilution (I’ve been told by homeopaths, with all seriousness, that if each dilution isn’t properly succussed then the homeopathic remedy will not attain its potency), and it’s magic all the way down, just as creationism has been described as “turtles all the way down.” Even more amusing are the contortions of science and logic that are used by otherwise intelligent people to make arguments for homeopathy. For example, just read some of Lionel Milgrom‘s inappropriate invocations of quantum theory at the macroscopic level for some of the most amazing woo you’ve ever seen, or Rustum Roy‘s claims for the “memory of water.” Indeed, if you want to find out just how scientifically bankrupt everything about homepathy is, my co-blogger Dr. Kimball Atwood started his tenure on Science-Based Medicine with a five part series on homeopathy.

At the same time, homeopathy appalls me. There are many reasons for this, not the least of which is how anyone claiming to have a rational or scientific viewpoint can fall so far as to twist science brutally to justify magic. Worse, homepaths and physicians sucked into belief into the sorcery that his homeopathy are driven by their belief to carry out unethical clinical trials in Third World countries, even on children. Meanwhile, time, resources, and precious cash are wasted chasing after pixie dust by our own government through the National Center for Complementary and Alternative Medicine (NCCAM). So while I laugh at the antics of homeopaths going on and on about the “memory of water” or quantum gyroscopic models” in order to justify homeopathy as anything more than an elaborate placebo, I’m crying a little inside as I watch.

The Lancet, meta-analysis, and homeopathy

If there’s one thing that homepaths hate–I mean really, really, really hate–it’s a meta-analysis of high quality homeopathy trials published by Professor Matthias Egger in the Department of Social and Preventative Medicine at the University of Berne in Switzerland, entitled Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.

Posted in: Clinical Trials, Homeopathy

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FDA approval of drugs and transparency in clinical trial results

ResearchBlogging.orgNote: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so.

One thing that science relies on almost absolutely is transparency. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist’s results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it.

Arguably nowhere is this transparency quite as critical as in the world of clinical trials. The reason is that medications are approved on the basis of these trials; physicians choose treatments; and different medications become accepted as the standard of care. Physicians rely on these trials, as do regulatory bodies. Moreover, there is also the issue of publication bias. It is known that “positive” trials, trials in which the study medication or treatment is found to be either efficacious compared to a placebo or more efficacious than the older drug or treatment it is to replace, are more likely to be published. That is why, more and more, steps are being taken to assure that all clinical trial results are made publicly available. For example, federal law requires that all federally-funded clinical trials be registered at at their inception, and peer-reviewed journals will not publish the results of a clinical trial if it hasn’t been registered there. Also, beginning September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank,” described thusly. Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial’s registration, generally within a year of the trial’s completion, whether or not these results have been published. Although there are some practical issues over this law, for example determining how much information can be disseminated this way without constituting prior publication, which is normally a reason to disqualify a manuscript from publication.

Posted in: Clinical Trials, Medical devices, Politics and Regulation, Science and Medicine

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