Posts Tagged ‘clinical trials’
New Book on Health Informatics Released
February 2, 2012
The book overall includes a broad variety of chapters reflecting the maturity of health informatics from bioinformatics to clinical informatics. Written as a textbook, it will no doubt serve the growing needs of health informatics programs popping up in every state.
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Presentation on Meaningful Use and EMR in Research
January 25, 2012
Last week I was invited to present to a medical school class on bioinformatics. My topic included EMR data standards, meaningful use and the use of EMR data in research. The session was very interactive and not totally captured in the slides. The challenge was presenting to medical students who are used to group activities, case studies and a research-based curriculum.
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Social Media in Clinical Trials
October 28, 2011
Today I presented on a panel at Case Medical School on clinical trial recruitment. My notes and references are contained in these slides.
This is a topic that needs more discussion in the online community:
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Curing Cancer Clinical Trials
June 17, 2010
The Institute of Medicine has issued another groundbreaking report, this time on cancer clinical trials. An editorial about the report in the New England Journal of Medicine titled, Cancer Clinical Trials — A Chronic but Curable Crisis, makes some bold statements, such as, “the program is bloated, cumbersome, inefficient.” Slow approval processes with multiple layers and poor recruitment levels are symptomatic.
Recommended changes include improving:
- the speed and efficiency of the design,
- launch, and conduct of trials;
- innovation in science and trial design;
- trial prioritization,selection, support, and completion; and
- incentives for patient and physician participation
The full IOM report lays out participation of key stakeholders, particularly patients and physicians. The emphasis on patient participation is strong and reminiscent of the e-Patient White Paper. While the concept of the Lethal Lag Time is not directly mentioned, the overtones can be heard. I recommend this report as key to the future of the conduct of clinical trials including innovative approaches.
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Time to Revamp Clinical Trials
April 25, 2010
In an editorial today in the New York Times, the editors call for major changes in how cancer clinical trials should be run. Just two facts are enough to document the problem:
- The average time between developing the concept for a study and getting it started is about 2.5 years.
- about 40 percent of all advanced clinical trials sponsored by the Cancer Institute are never completed
One of the recommendations is to reduce the number of cooperative groups and the levels of approval required.
In a related post on The Medical Quack, there is discussion of the clinical trial experience for the patient with an excellent video below.
In both cases what I hope we all come to realize soon is the lethal lag time – a articulate by e-patient White Paper – these long lead time for studies can prove lethal for those waiting for new treatments.
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Review of Chasing Medical Miracles
February 21, 2010
The subtitle of this 2009 book by Alex O’Meara is “The Promise and Perils of Clinical Trials.” O’Meara combines this personal experience of a clinical trial using stem cells for Type I Diabetes. He reviews the risky world of clinical trials beginning with large for-profit research centers who recruit healthy volunteers and stories of the volunteers who participate for a living or to supplement their income. Some questionable situations are noted including the recruitment of low income and alcoholic men in Indianapolis and elsewhere. He details some famous cases of unethical trials which landed in the courts including those involving genetics and conflicts of interest. Fortunately, some of these potential abuses are more carefully scrutinized. He spends two chapters on international clinical trials which have shifted much of the work to developing countries with a real focus on the issues in Uganda as case study. The fact that drug companies provide medical care in addition to clinical trials creates a dilemma for developing countries with small healthcare budgets.
One outstanding story related to a patient’s right to their own data is from a Hepatitis C trial in which the subjects were not allowed to receive information on their viral load during the study as a way of discouraging drop outs. However, this in itself seems unethical in that the patient would not know whether the treatment was effective or ineffective and whether their disease was progressing. I hope that Institutional Review Boards would not approve such a procedure for trials involving serious illness. Much of the book looks at the issues with placebo controlled studies and blinding – it raises many questions which are yet to be resolved by medical scientist and bioethicists.
I would recommend this book for anyone involved in clinical research, whether in Pharma, medicine or as a patient.
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Medpedia adds Clinical Trials
February 3, 2010
Medpedia continues to add vetted health information. In addition to health topics in a Wikipedia style, they had added news and RSS feed from blogs (including this one). Now they have developed integration with ClinicalTrials.gov. The unique approach they are promoting is linking from articles to related clinical trials. I tried this for myself and was able to find that it worked particularly well for some terms like “diabetes.” Also, the search function has good features and the advanced search, called “Clinical” includes Study Type (Interventional,
Medpedia, despite its growth, has some gaps. For instance, if you look for articles by the alpha index, like leukemia, you find none, but do a search and dozens of very specific articles appear (hairy cell leukemia). Overall the number of articles, organization and layout of Medpedia continues to improve. Try out the Clinical Trials search for yourself and see what you think.
