Monday, April 6, 2009
End of an era for Pap smears?
Sunday, April 5, 2009
FDA staffers vent to President
The FDA staffers complain of a growing sense of frustration with the 'arbitrary and capricious' decision making at the upper echelons of FDA:
The latest example of wrongdoing was reported on March 23, 2009 from a Federal District Court Judge who ruled that FDA’s decision on the Plan B drug was “arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.” FDA’s top leaders at the Center for Drug Evaluation and Research (CDER) testified that they “didn’t have a choice, and . . . [weren’t] sure that [they] would be allowed to remain [in their positions if they] didn’t agree” to ignore the science and the law. To the contrary, they should be removed from their positions of authority precisely because they didn’t follow the science and the law. The judge further ruled that there was “unrebutted evidence that the FDA’s [decision] stemmed from political pressure rather than permissible health and safety concerns.” The “improper political influence” and the many “departures from its own policies” reveal that such FDA officials are incapable of ensuring integrityThey go on to report concern with the agency's culture of wrongdoing and coverup, saying 'FDA is fundamentally broken':
and science at FDA.
On January 7, 2009, FDA physicians and scientists wrote to Mr. John Podesta: “Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around. Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal. … America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re- establishing a proper and effectively functioning FDA is vital to the physical and economic health of the nation.”It's unclear from my vantage point how many of these accusations are merited. But it's certain that at least some FDA employees (names blacked out in the letter, but judging from the size of the text block, appears to be 5-10 individuals) have honest concerns about the agency's current culture and future directions. We're hopeful that the coming weeks will shed more evidence about the mistakes that have been made, and how Dr. Hamburg intends to reinvent FDA with a commitment to institutional integrity.
Radio silence explained
Yet we've been keeping busy behind the scenes, as we've sharpened our focus on grant-writing and securing stable financing for our project. Here's a recap of some of our achievements last week:
- We submitted our first grant application to Changemakers.net (an initiative of Ashokha Foundation) and have several more applications in process. In the spirit of full transparency, you can read our grant application in its entirety here.
- We welcomed Umer Raffat, M.P.H., to Clinical Trials Wiki as our new V.P. of Finance/Strategy.
- We are beginning an architectural overhaul of the site, expanding our database of publicly accessible clinical trials, and centering our content display and discussion forums around scientific publications from the clinical trial literature.
Please continue to send us your questions or feedback about our ongoing work on the site.
Monday, March 23, 2009
James Muller, M.D., joins the Board of Directors at ClinicalTrialsWiki.org
James E. Muller, M.D., was one of three American Co-founders of the International Physicians for the Prevention of Nuclear War (IPPNW) the organization awarded the 1985 Nobel Peace Prize.
Dr. Muller currently serves as CEO of InfraReDx, Inc, a company that has developed a near-infrared spectroscopy catheter for the identification of lipid-rich and presumably vulnerable coronary artery plaques.
Dr. Muller formerly served as a Professor of Medicine at the Harvard Medical School where he conducted research for over 25 years on the causes of heart attacks. In 1994, he introduced the term "vulnerable plaque" to describe those plaques likely to disrupt and cause disease onset. He co-founded InfraReDx in 1998 after a detailed search to find the optimal technology to identify lipid-rich coronary artery plaques.
Monday, March 16, 2009
Jeff Drazen, M.D., joins the Board of Directors at ClinicalTrialsWiki.org
We extend a warm welcome to Dr. Drazen as he joins our Board of Directors today. His full bio follows:
A specialist in pulmonology, Jeffrey M. Drazen, M.D., maintains an active research program. Dr. Drazen has published more than 300 articles on topics such as lung physiology and the mechanisms involved in asthma. In 1999, he delivered the Amberson Lecture, the major research address at the annual meeting of the American Thoracic Society. In 2000, he received the Chadwick Medal from the Massachusetts Thoracic Society for his contributions to the study of lung disease.
Dr. Drazen is the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School, professor of physiology at the Harvard School of Public Health, and senior physician at the Brigham and Women’s Hospital. In 2003, he was elected as a member of the Institute of Medicine. Dr. Drazen has served on numerous committees for the National Institutes of Health: the Respiratory and Applied Physiology Study Section; the Lung Biology and Pathology Study Section; the Pulmonary Disease Advisory Council; and the National Heart, Lung, and Blood Institute Advisory Council. He currently serves as the co-chair of the Institute of Medicine Drug Forum and is a member of the advisory group to the World Health Organization International Clinical Trials Registration Platform.
Dr. Drazen earned his bachelor’s degree and graduated summa cum laude from Tufts University. He received his medical degree from Harvard Medical School and completed his internship and residency at Peter Bent Brigham Hospital in Boston. Dr. Drazen received honorary degrees from the University of Ferrara, Italy, and the National and Kapodistrian University of Athens, Greece.
A native of Missouri, Dr. Drazen lives with his wife in Winchester, Massachusetts. They are the parents of two grown sons.
Wednesday, March 11, 2009
Warner Slack, M.D., joins the Board of Directors at ClinicalTrialsWiki.org
Dr. Slack brings us over 35 years of experience in health information technology. He is currently co-president of the Center for Clinical Computing and, during his medical training, helped develop one of the world's first electronic health record (EHR) systems. His full bio follows:
Dr. Slack received his bachelor's degree from Princeton University, his medical degree from Columbia University's Columbia University's College of Physicians and Surgeons, and his residency training in neurology at the University of Wisconsin. Over the past 35 years he has focused his research on the use of computers to improve communication in medicine and to empower both doctors and patients for better health care. His early work in computer-based medical interviewing at the University of Wisconsin led to the first study of patient-computer dialogue.
Over the years, he has established new computer-based approaches to the medical interview, and developed and studied programs that provide direct assistance to the patient in the management of common, important medical and psychological problems. He was an early advocate of the patient's right to participate in decisions about diagnosis and treatment.
Dr. Slack and his colleagues at the Center for Clinical Computing (CCC) and the Harvard Medical School, have developed, implemented, and studied an integrated, hospital-wide clinical computing system (the CCC system) which is used in patient care at Boston's Beth Israel Deaconess Medical Center and Brigham and Women's Hospital. Distinguishing features of the CCC system are the unparalleled intensity and extensiveness of its use by clinicians in the care of their patients and the substantial financial benefits that have been realized in conjunction with its use.
Dr. Slack is Professor of Medicine at Harvard Medical School and, with Dr. Howard L. Bleich, co-president, of the Center for Clinical Computing and co-director of the Division of Clinical Computing, Department of Medicine, Beth Israel Deaconess Medical Center.
Among his recent publications, Dr. Slack is the author of Cybermedicine: How Computing Empowers Doctors and Patients for Better Health Care (revised and updated edition, San Francisco: Jossey-Bass, 2001).
Edward Hundert, M.D., joins the Board of Directors at ClinicalTrialsWiki.org
We are delighted to welcome Dr. Edward Hundert, M.D., former President of Case Western Reserve University, to the Clinical Trials Wiki family, and as a member of our Board of Directors. His bio is below:
Dr. Hundert is an internationally known academic leader, scholar, educator, psychiatrist, and medical ethicist. Over the past 20 years, he has served as President of Case Western Reserve University, Dean of the University of Rochester School of Medicine and Dentistry, and Associate Dean for Student Affairs at Harvard Medical School. He has held professorial appointments in psychiatry, medical ethics, cognitive science, and medical humanities, and he is a leader in developing innovative institutional affiliations and curricula both in academic medical centers and across all levels of higher education.
Dr. Hundert earned his bachelor’s degree in mathematics and the history of science and medicine, summa cum laude, from Yale University, where he received Yale’s Chittenden Prize “to the graduating senior with highest standing in mathematics or the natural sciences.” He attended Oxford University as a Marshall Scholar, receiving the Batterby Prize from Hertford College for “highest first class honours in philosophy, politics and economics.” Four years later he earned the M.D. from Harvard Medical School, receiving the Sanger Prize for “excellence in psychiatric research.” He completed his psychiatric residency at McLean Hospital, a Harvard affiliate, where he served as chief resident. He has received numerous teaching, mentoring, and diversity awards, and for six consecutive years he was voted the “faculty member who did the most for the class” by Harvard Medical School graduates.
Dr. Hundert has served on many national boards, including the Association of American Universities, the American Association of Medical Colleges, and the Liaison Committee on Medical Education. He co-chaired the Institute of Medicine’s National Summit on Health Professions Education. Dr. Hundert has served as chair of the Ethics Committees of McLean Hospital and the Massachusetts Psychiatric Society, and also served as ethics column editor for the Harvard Review of Psychiatry. Dr. Hundert has written dozens of articles and chapters on a variety of topics in psychiatry, philosophy, medical ethics, and medical education, as well as two books: Philosophy, Psychiatry and Neuroscience: Three Approaches to the Mind (Oxford University Press, 1989), and Lessons from an Optical Illusion: On Nature and Nurture, Knowledge and Values (Harvard University Press, 1995).
In addition to his work in the Division of Medical Ethics, Dr. Hundert is a member of the boards of TIAA-CREF and the Rock and Roll Hall of Fame.
Two new additions to our Board of Directors
We are fortunate to count them among the Clinical Trials Wiki family.
Full bios of each new Board member will be posted shortly on this blog and our main site, ClinicalTrialsWiki.org.
Health IT: the new Apollo program?
Here's the quote (full article after the jump):
While EHR won't induce the sort of national high drama that the Apollo program did (I can see eyeballs rolling already...), Mark does have a point about the similar scale and impact of the two projects. Arguably, EHR will actually have far greater impact, through the improved patient outcomes that result from increased accessibility, consistency, and comprehensiveness of our new health records.I’m personally struck by the parallels to a historical event still vivid in my memory: Project Apollo, President Kennedy’s incredible national goal of achieving manned spaceflight to the moon.
Apollo cost $22B (in 1969 dollars, now worth five times that) and took 8 years to achieve the first moonwalk. NASA, a new government agency, spearheaded the effort, but the technology was developed by private sector contractors.
The health IT provisions of ARRA invest at least $35B to incentivize full EHR deployment, allowing 5-7 years to reach that goal – remarkably similar to Project Apollo. The Office of the National Coordinator (ONC) has been codified and funded to lead the effort, and just as in the case of Apollo, I expect much of the work will need to be accomplished by contractors in the private sector -- CCHIT included, of course, provided we quickly “grow up” to meet the enlarged responsibilities.
Yet until recently, EHR was hardly brought up in the national discourse about high-impact fixes to improve health care. James Holsinger, in all his bespectacled charm, never once mentioned the issue during his prolonged confirmation process for U.S. Surgeon General in '07.
As Mark rightly points out, the thorniest issues surround adoption of new EHR technologies -- getting a physician to give up old patterns of behavior (see NHS's initiative in England to banish white coats) may prove harder than shooting the moon.
Tuesday, March 10, 2009
Our new Facebook home
Here's how we describe ourselves on Facebook:
ClinicalTrialsWiki.org strives to be the most trusted source of clinical trials information online. You can search our database of analysis and opinion on over 65,000 clinical trials.We'd love to see you join our community!
We're structured as a 100% volunteer-run, 501(c)(3) nonprofit and, as a policy, we don't accept ads or money from the pharmaceutical and medical device industries.
That's all there is to it -- no ads, no gimmicks, and no tricks up our sleeve.
The site was developed by three friends at Harvard Medical School and M.I.T.
Sunday, March 8, 2009
Whew!
- We designed and implemented a Wikibot to automate the extraction of data from ClinicalTrials.gov
- We laid out a brand new format for our clinical trials 'data' page
- We decided on a new logo, color scheme, and website layout
- We met with friends and colleagues at HMS, the Countway medical library, and HealthMap to get feedback on our ideas and refine our thinking about the site
- We've set up meetings with NEJM and FDA to discuss possible partnership and site integration
WikiBot is Online
In the future, we're planning on creating a multi-threaded bot that will speed up the process tremendously, as well as limiting updates to new or revised content from clinicaltrials.gov. For now, we're just excited that we'll soon have more content than we'll know what to do with -- ready and waiting for your discussion and analysis!
On the aesthetics front, we're continuing to modify the layout of individual content pages to make it as easy as possible to navigate the plethora of data and find the information you're looking for. As always, we'd love your feedback and suggestions.
If you're curious, you can see the trials being added in real-time by the bot on the "New Pages" list.
Thursday, March 5, 2009
Version 2.0 is Live!
We're also putting the final touches on an automated PHP crawler bot that will keep every trial on ClinicalTrialsWiki in sync with the ClinicalTrials.gov repository, and ensure that all of the information is up-to-date.
Things are exciting around here, and I can feel the momentum building!
Wednesday, March 4, 2009
Supreme Court rules on different standards for drug and device makers
Device makers have long argued 'No': every device has risks, and the FDA-CDER premarket approval process is designed to weigh risk against benefit before permitting the introduction of a new device. The Supreme Court last year substantially agreed with this view in Reigel v Medtronic by ruling that successfully obtaining premarket approval from the FDA gives medical device makers (in this case, Medtronic, a manufacturer of ICDs) a strong defense against lawsuits filed in state courts because federal regulation "pre-empts" state law here.
Today, under presumably different logic, the court ruled in Wyeth v. Levine that drug makers can be sued in state courts, even when they have obtained FDA approval.
So why the discrepancy? The Wall Street Journal Health Blog reports on the issue today:
The 8-1 ruling in the medical device case, Riegel v. Medtronic, relied heavily on the “Medical Device Amendments” signed into law in 1976.
As the court wrote in Riegel:
The MDA provides that no State ‘may establish or continue in effect with respect to a device . . . any requirement’ relating to safety or effectiveness that is different from, or in addition to, federal requirements …
That language goes to the heart of preemption, the legal question at issue in both cases: Does federal regulation override state law? In the case of devices, the court found, MDA explicitly preempts state law.
But the MDA is all about devices, while the case decided today, Wyeth v. Levine, is all about drugs. The relevant drug law is the Food, Drug, and Cosmetic Act, enacted in 1930 and amended several times in the decades since then.
Amendments added in 1962 indicated “that a provision of state law would only be invalidated upon a ‘direct and positive conflict’ with the FDCA,” Justice Stevens wrote in his majority opinion in Wyeth v. Levine.
What’s more, Stevens added, “when Congress enacted an express pre-emption provision for medical devices in 1976″ — in the MDA — “it declined to enact such a provision for prescription drugs.”
The notion of pre-emption gets to the very heart of our national experiment with federalism, and makes for a fascinating legal discussion. But it's unfortunate for most Americans that this case hinged on the issue of pre-emption, rather than addressing the broader social ramifications of an increase in state and federal drug lawsuits in our already litigation-littered society.
Something just doesn't sit well with me about our asymmetric policy for dealing with device and drug companies (largely for historic reasons related to the recency of most device legislation, and the relative strength of industry lobbying groups). We've long been doing this to our detriment, I think, in the FDA's 510K process of rapidly approving "substantially equivalent" devices.
Medical device and pharmaceutical companies face enormous legal liability and financial risk in developing the innovative therapies that physicians and patients rely upon.
So there's a few reasons why I agree with the Court's original decision in Reigel v Medtronic:
- First, mitigating the legal liability to device companies removes downward pressure on innovation;
- Second, the tort system in our country is badly broken, with punitive damages awarded by juries in many cases exceeding the pale of reason;
- Third, I'm hoping this decision will spur legislation to give FDA broader oversight and stricter controls over device development and postmarketing surveillance.
If we're answering the question of whether the companies have been negligent, and we ask -- did their actions "cause" the damages suffered, and could a "reasonable person forsee the harm" to the patient in this case? -- then I think the answer to both questions is yes.
However, drugs and devices, by virtue of their intimate relationship with our bodies, have the potential to cause immense, sometimes irreversible, harm. We can predict, and warn about the dangers of, this harm by conducting preclinical and clinical trials.
Our regulatory process should (in the ideal world) weed out those drugs or devices whose risk/benefit profile is tipped towards risk, and protect companies and physicians who adequately educate patients about that risk prior to starting treatment. Otherwise life-saving therapies would never see the light of day for fear of a class-action lawsuit.
Tuesday, March 3, 2009
HMS featured in NYT article today
Read the full article here.
The team at ClinicalTrialsWiki.org is currently composed of fourth-year students at Harvard Medical School. We believe our site can go a long way towards promoting transparency and nonbias in medical education.
Kudos to the students who've been featured in the article for the work they are doing.
Monday, March 2, 2009
How many patients are not on a PPI these days?...should they be?
A retrospective study published in JAMA this week strongly suggests that one should be careful when prescribing PPIs upon discharge of patients hospitalized for an acute coronary syndrome (ACS). When comparing the use of a PPI in patients with ACS taking clopidrogel after discharge, Michael Ho et al. found that patients taking clopidrogel and prescribed a PPI had a higher risk of death or rehospitalization for recurrent ACS than those who were taking clopidrogel alone (Adjusted odds ratio 1.25 CI[1.11-1.41]) (1). The results of this study are supported by several translational and mechanistical studies showing that the use of PPIs reduces the antithrombotic effects of clopidrogel (2), (3).
Maybe all of us future interns should follow our pharmacology professor's suggestion to place a bottle of Omeprazol pills under each patient's pillow on the wards. That way, when asked by a tired junior resident to put Mr. Jones on a PPI, we can safely say that he's already "on" it...
(1) P. Michael Ho et al. JAMA. 2009; 301(9): 937-944
(2) Gilard M. et al. J. Thromb Haemost. 2006; 4(11): 2508-2509
(3) Gilard M et al. J Am Coll Cardiol. 2008; 51 (3): 256-260
Sunday, March 1, 2009
Redesign of main wiki page

Friday, February 27, 2009
We're live at ClinicalTrialsWiki.org!
The wiki itself is still in prototype form, but we're working quickly to populate it with objective data from each of over 65,000 federally registered trials. Here's a screenshot:

We're doing it because we're frustrated at the lack of unbiased, comprehensive sources of clinical trial information and analysis. And we're optimistic that a new service like ours could bring together students, researchers, clinicians, and industry to the common cause of improving patient outcomes.
Thursday, February 26, 2009
From call centers to... clinical trials
The study, published in Wednesday’s New England Journal of Medicine (NEJM), reports that the number of countries conducting drug testing has doubled in the past 10 years, and, in November 2007, a total of 13,521 of 24,206 investigative sites being used for studies sponsored by U.S. big pharma were international.Kevin A. Schulman, the lead author of the NEJM article and a professor of medicine at Duke, was interviewed by NYT. It is surprising just how nascent this field is:

Indeed, global outsourcing may provide ancillary benefits ("collateral rescue") to entire resource-poor communities: an executive at Millenium Pharmaceuticals recently told me that his company has invested millions of dollars directly into hospital infrastructure improvements throughout the EMEA region, simply to bring up local quality standards to meet the FDA's trial compliance guidelines.
While there's nothing inherently bad about conducting trials internationally, most criticism stems from concern that good clinical trial practices (things like informed consent, blinded controls, patient compliance and followup) are much harder to enforce abroad. It's also questionable whether data collected in one patient population (e.g., Western Saharans) can be used to justify a claim for efficacy in another (e.g., Southern Californians).
Furthermore, Phase I trials, which primarily involve healthy volunteers, will often use monetary incentives to recruit patients. The ethics of doing this in the developing world is murky at best, particularly when individual incentive structures are sharply skewed by widespread poverty, famine, or conflict. I haven't yet heard any good consensus frameworks for thinking about the ethics of risk v. benefit within the context of international trial design.
CenterWatch offers its own multi-point rebuttal of the Duke study:
- The sample size is almost half of the trials listed at the time, compared to a more comprehensive analysis of clinical trials listed in August of 2007 done by Goldman Sachs.
- The study’s analysis of the 20 largest drugmakers in the U.S. excludes more than 1,900 other companies developing drugs around the world.
- Of the 20 countries outside the U.S. doing the most trials in August of 2007 (from the Goldman study), only four—Poland (13th), Russia (17th), Brazil (19th), and the Czech Republic (20th) could be considered emerging markets.
- The percentage of clinical trials initiated overseas increased from about 13% in 1997 to about 30% in 2005. At the end of 2007, the number was just under 34%. The number of trials being conducted worldwide has gone from around 22,000 in 1997 to about 37,000 in 2007.
- While the number of clinical trials initiated overseas has increased dramatically, the study overstates the share of trials overseas by more than 20 percentage points.
Wednesday, February 25, 2009
Expansion of Clinicaltrials.gov
Feb 19, 2009 Volume 360:824-830, NEJM
http://content.nejm.org/cgi/content/full/360/8/824
Effective since September 27, 2008 section 801 of the registration and reporting requirements of the FDA amendments Act has been expanded to include the mandatory reporting of basic results of clinical trials that were ongoing on or after September 27, 2007. As Dr. Allastair Wood suggests, the expansion of the FDA amendment section 801 is an essential step forward for the public availability of clinical trial information. The author also emphasizes that this advance remains to be completed by further broadening the reporting requirements and by providing a source of clear and comprehensible review of clinical trial results.
"Ethical clinical research should contribute to generalizable knowledge and improve human health. The dedication of patients who take the risks to participate in clinical research is dishonored when their data remain secret. Section 801 of the FDA Amendments Act will greatly expand the type and amount of information available on clinical trials. The use of these data and the enhanced public access to the FDA's database on clinical trials proposed in this article will greatly improve the ability of investigators and others to assess the full set of results for a given intervention, whether FDA-approved or not, eventually leading to more accurate systematic reviews, better clinical decision making, improved patient care, and improved research efficiency and safety."
Reading this article, I thought ClinicalTrialWiki.org is emerging just in time to complement the expansion of section 801 by:
1) Providing access to clinical trial information: The "news" tab of ClinicalTrialWiki.org will provide a comprehensive source of publicly available information on ongoing and completed Clinical Trials, easily accessible to health care professionals.
2) Opening the discussion to all caregivers via the "public views" tab.
3) Providing clear and understable analysis of clinical trials: In an effort to disseminate rigorous and unbiased information to the public, a panel of experts analyzes discusses and criticizes each clinical trial in the "expert views" tab.
Tuesday, February 24, 2009
Sneak preview

I wanted to maintain a simple, clean interface while enhancing the functionality with a search bar that links directly into the wiki. Notice the fancy new "W" logo, which took all of 15 seconds to whip up on Photoshop. ;)
As always, let me know what you think.
CABG vs. stenting
Link to video after the jump.
In the international SYNTAX trial (ClinicalTrials.gov number, NCT00114972), funded by Boston Scientific (manufacturers of the TAXUS drug-eluting stent), 1800 patients with three-vessel or left main disease were randomly assigned to either revascularization with CABG or PCI involving drug-eluting stents. The paper published in NEJM (Serruys P et al. N Engl J Med 2009) shows us these dramatic Kaplan-Meir curves by treatment group:

The need for repeat revascularization was significantly lower with CABG, but the risk of stroke was significantly higher in the surgery group.
As Dr. Mohammadzadeh of CA has pointed out,
Many of the commentators have cited the difference in stroke rates in the two study groups as a justification for choosing pci over cabg. I do not see how their argument holds when there was such a vast difference between the post-procedural medical therapy that the two groups received. It seems to make good intuitive sense that if the surgical group had received as aggressive medical therapy, that not only the stroke rates may have been comparable, but the other end points such as mace would have crystallize more strikingly in favor of the surgical group. There is no question that there are patients that are better served by pci even in the setting of LM stenosis or 3-V CAD, but the bottom line should be that the patients should be given a fair and balanced explanation of their options before making a decision that is best suited for them.Exactly. The risk vs. benefit analysis has long favored CABG in three vessel or LM disease, and this study should not really change clinical practice in these circumstances. However, it is striking that CABG patients often receive subpar antiplatelet therapy on the surgical floor. Establishing clinical directives for aggressive medical therapy in CABG patients might produce a welcome drop in stroke risk and rates of repeat revascularization.
And let's not forget that, despite the heated rhetoric surrounding this trial, we're really not considering one treatment strategy versus another. PCI has a secure and well-established place in the treatment of stable angina due to CAD.
The truth about comparative effectiveness
I wasn't sure what "comparative effectiveness" actually meant, so I looked up the term at Consumer Reports:
What does it mean? Comparative effectiveness quite simply means comparing two or more treatments for a given condition. Studies may compare similar treatments, such as two drugs, or it may analyze very different approaches, such as surgery and drug therapy. Comparative effectiveness evaluations may focus only on the relative medical benefits and risks of each option, or they may also weigh both the costs and the benefits of those options. In some cases, a given treatment may prove to be more effective clinically or more cost-effective for a broad range of patients, but frequently a key issue is determining which specific types of patients would benefit most from it.Transparent, unbiased, comparative research conducted without industry support? I'm all for it, so long as Congress doesn't bypass the clinical judgment of individual physicians -- or attempt to meter out care. Reminds me a bit of the Clinton-era attempt to develop standardized clinical recommendations for wide range of conditions, from chronic back pain to diabetes.
Here's a few independent takes at the NYT health blog, THCB, and The Gray Sheet (subscription required).
Monday, February 23, 2009
Crowdsourcing
Her company is trying to leverage the collective knowledge of disease communities to discover new connections between symptom patterns and underlying diagnoses. For example, after the jump you can see a graph generated by CureTogether.com's user surveys that illustrates the most frequent co-morbidities reported with vulvodynia.
Could information like this one day be useful in clinical decision-making? Perhaps, though it would be terribly difficult to interpret. How's a doctor supposed to tease apart co-morbidities that are spuriously linked from those that represent real clues as to common etiology? Is it ethical to make clinical decisions on the basis of uncorroborated Internet surveys?
It's my hope that generic user surveys like this get tied to more robust analysis, including an attempt to tease out confounders (it sounds like CureTogether.com is trying to do this). Currently the population sizes in question are probably far too small to drive any significant outcomes analysis, but expect to see more sites like this spring up in the coming years...
The real value may be in the sense of 'working towards a cure' that it gives to patients. Here's a money passage:
Reading her comments, it strikes me that we face a similar challenge at ClinicalTrialsWiki.org in trying to develop a core community of users who are motivated to populate our site with discussion and commentary.Me: Which kinds of takes us back to your prior life in genomics and ideas about GeneTwist. Care to speculate about the actual ways that CureTogether's data and community will actually lead to cures, together?
Alexandra: Yes, the grander vision for down the road is to integrate all kinds of data - genome scans, biomarker tests, streaming data from wifi health tracking gadgets. Collaboration with the larger research community as well, integrating our data with traditional clinical trial data. We already have researchers knocking on our doors wanting to start analyzing the data.
Me: So now "all" you have to do is get more people and more data into the site. How are you going to do that?
Alexandra: That's a good question! By talking to people like you, for a start. Health and condition-specific bloggers seem happy to help spread the word. Disease foundations have also approached us, eager to help out. And media have all been coming to us so far. I just started the process of seriously getting out there in the past couple of weeks - I'm even on Twitter @accarmichael. It's still mostly a grass-roots effort though. If and when we get funding, that could change. But it's very rewarding work. At the end of the day, I know I've spent my time helping people and working to make a difference.
We're moving!
Thanks for your patience!
Welcoming a new member of the team (after the toast)

But today it's back to work, and I'd like to welcome Gaurav Singal as a new member of our team at ClinicalTrialsWiki.org. He's going to take over technology and online operations from now on. You may have noticed his name appear on the sidebar as a new contributor to this blog, and you can read his bio here.
Gaurav is a good friend of mine from medical school who brings us deep knowledge of web design and content management, in addition to having some work experience in the VC world. We're very excited to have him on board!
Sunday, February 22, 2009
New main page design
Check it out from either the '.com' or '.org' domains -- both should be live at this point! And let me know if you have any problems.
Here's what you should see:

But all that excitement can wait until Monday -- I'm taking the rest of the weekend off!
Saturday, February 21, 2009
Welcome x2
For now...looking for grant money.
Mission Statement
You can read the full text of the Mission Statement here.
A few key quotes. The first has to do with why we got this thing started in the first place:
Few sources currently exist for unbiased, data-driven analysis and commentary on the results of clinical trials; neither the pharmaceutical industry nor international regulatory bodies face the appropriate financial incentives or legal imperatives to develop a comprehensive, public source of clinical trial data and expert opinion. We intend to solve this problem by implementing a searchable wiki containing all public-domain information on clinical trials, and inviting expert thought leaders to contribute timely commentary on published trial data.And concerning our policy regarding receiving compensation from industry:
It is the policy of Clinical Trials Wiki not to receive monetary or significant non-monetary compensation from the pharmaceutical and medical device industries. This includes, but is not limited to, advertising revenue, gifts, speaking fees, and other forms of sponsorship.Finally, we came up with four principles we'd like to abide by:
We hope to make this a community-centered process, so please let us know what you think.1. Transparency: All information placed on the site will be clearly sourced and public-domain. Edits made to any section of the wiki will be cataloged so users can view the state of the wiki at any point in its recent history. A detailed budget listing each source of revenue for Clinical Trials Wiki will be posted on the blog accompanying the site, and an annual report will be made available for download each year. Biographies of each of the site's staff members, expert panelists, and Board of Advisors will be available on the blog.2. Non-bias: We believe that advertising from pharmaceutical and medical device companies undermines the mission of Clinical Trials Wiki by creating the perception of undue influence and biased reporting. Therefore it is our policy to not allow advertising from these companies on the site. We will consider limited text-based advertising from health providers (hospitals, group practices, etc.) to provide revenues necessary to sustain our operations. We also may apply for grants from charitable foundations and donations from site viewers to sustain our operations.3. Accessibility: We will attempt to make our site easy to use with a familiar wiki interface. We will attempt to be as platform-neutral as possible in delivering our web content. We will attempt to include clinical trial data from all over the world. We will not charge subscription or login fees for this service. We will not create a "premium" section of the site with enhanced content for paid subscribers.4. Comprehensiveness: Our goal is to include description, analysis, and commentary for all clinical trials whose information has ever been made public-domain.
A little about our idea...
I'm currently a fourth-year student at Harvard Medical School, and Brice is in his final year of the M.D./Ph.D. program, also at Harvard. You can read our bios on the sidebar of this blog.
A health professional can turn to www.clinicaltrials.gov for a rich database of clinical trial methodology and data, or to one of many online medical journals (e.g., NEJM, JAMA) for editorial opionion on select clinical trials. However, there's no online resource that's a "one-stop shop" for clinical trial information and analysis.
Our idea for ClinicalTrialsWiki.org is to combine a familiar wiki interface for posting information on clinical trials with a forum for discussion of the results.
We will invite users to post their original analysis and commentary and, importantly, for each trial we will convene a panel of distinguished experts (statisticians, pharmacoepidemiologists, clinicians, FDA insiders, etc.) to contribute thier own interpretations and insights.
If you have any innovative ideas, thoughtful suggestions, or staunch criticisms as we launch this collaborative project, we'd love to hear from you in the comment box below, or by email.
Welcome to our blog!
ClinicalTrialsWiki.org strives to be world's most comprehensive and unbiased source of expert opinion about clinical trials online.
As you follow our posts over the coming months, we'll describe our progress in getting the website started, and also include links to interesting editorials related to the latest clinical trial news.