7 posts · 1,196 views
A review of issues in clinical trials
Paul Ivsin
7 posts
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- May 15, 2013
- 10:48 PM
- 38 views
Placebos: Banned in Helsinki?
by Paul Ivsin in Placebo Control
One of the unintended consequences of my (admittedly, somewhat impulsive) decision to name this blog is that I get a fair bit of traffic from Google: people searching for placebo-related information.
Some recent searches have been about the proposed new revisions to the Declaration of Helsinki, and how the new draft version will prohibit or restrict the use of placebo controls in clinical trials. This was a bit puzzling, given that the publicly-released draft revisions [PDF] didn't app........ Read more »
Emanuel, E. (2013) Reconsidering the Declaration of Helsinki. The Lancet, 381(9877), 1532-1533. DOI: 10.1016/S0140-6736(13)60970-8
- November 16, 2012
- 02:53 PM
- 165 views
The Accuracy of Patient Reported Diagnoses
by Paul Ivsin in Placebo Control
Novelist Phillip Roth recently got embroiled in a small spat with the editors of Wikipedia regarding the background inspiration for one of his books. After a colleague attempted to correct the entry for The Human Stain on Roth's behalf, he received the following reply from a Wikipedia editor:
I understand your point that the author is the greatest authority on their own work, but we require secondary sources.
Report: 0% of decapitees could accurately recall their diagnosis
The editor'........ Read more »
Cascade, E., Marr, P., Winslow, M., Burgess, A., & Nixon, M. (2012) Conducting Research on the Internet: Medical Record Data Integration with Patient-Reported Outcomes. Journal of Medical Internet Research, 14(5). DOI: 10.2196/jmir.2202
- September 18, 2012
- 12:52 PM
- 232 views
Delivering the Placebic Payload
by Paul Ivsin in Placebo Control
Two recent articles on placebo effects caught my attention. Although they come to the topic from very different angles, they both bear on the psychological mechanisms by which the placebo effect delivers its therapeutic payload, so it seems worthwhile to look at them together.
Placebo delivery: there's got to be a better way!
The first item is a write up of 2 small studies, Nonconscious activation of placebo and nocebo pain responses. (The article is behind a paywall at PNAS: if you can’t........ Read more »
Karin B. Jensen, Ted J. Kaptchuk, Irving Kirsch, Jacqueline Raicek, Kara M. Lindstrom, Chantal Berna, Randy L. Gollub, Martin Ingvar, & Jian Kong. (2012) Nonconscious activation of placebo and nocebo pain responses. PNAS. DOI: 10.1073/pnas.1202056109
- August 16, 2012
- 03:09 PM
- 165 views
Clinical Trial Alerts: Nuisance or Annoyance?
by Paul Ivsin in Placebo Control
Will physicians change their answers when tired of alerts?
I am an enormous fan of electronic health records (EMRs). Or rather, more precisely, I am an enormous fan of what EMRs will someday become – current versions tend to leave a lot to be desired. Reaction to these systems among physicians I’ve spoken with has generally ranged from "annoying" to "*$%#^ annoying", and my experience does not seem to be at all unique.
The (eventual) promise of EMRs in identifying eligible clinical ........ Read more »
Embi PJ, & Leonard AC. (2012) Evaluating alert fatigue over time to EHR-based clinical trial alerts: findings from a randomized controlled study. Journal of the American Medical Informatics Association : JAMIA, 19(e1). PMID: 22534081
- August 13, 2012
- 05:58 PM
- 195 views
Most* Clinical Trials Are Too** Small
by Paul Ivsin in Placebo Control
* for some value of "most"** for some value of "too"
[Note: this is a companion to a previous post, Clouding the Debate on Clinical Trials: Pediatric Edition.]
Are many current clinical trials underpowered? That is, will they not enroll enough patients to adequately answer the research question they were designed to answer? Are we wasting time and money – and even worse, the time and effort of researchers and patient-volunteers – by conducting research that is essentially doomed to produce........ Read more »
Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, & Tasneem A. (2012) Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA : the journal of the American Medical Association, 307(17), 1838-47. PMID: 22550198
- July 31, 2012
- 01:58 PM
- 220 views
Clouding the Debate on Clinical Trials: Pediatric Edition
by Paul Ivsin in Placebo Control
I would like to propose a rule for clinical trial benchmarks. This rule may appear so blindingly obvious that I run the risk of seeming simple-minded and naïve for even bringing it up.
The rule is this: if you’re going to introduce a benchmark for clinical trial design or conduct, explain its value.
Are we not putting enough resources into pediatric research, or have we over-incentivized risky experimentation on a vulnerable population? This is a critically important question in desperate ........ Read more »
Bourgeois FT, Murthy S, Pinto C, Olson KL, Ioannidis JP, & Mandl KD. (2012) Pediatric Versus Adult Drug Trials for Conditions With High Pediatric Disease Burden. Pediatrics. PMID: 22826574
- July 5, 2012
- 01:03 PM
- 181 views
The Placebo Effect (No Placebo Necessary)
by Paul Ivsin in Placebo Control
4 out of 5 non-doctors recommend starting with "regular strength", and titrating up from there... (Photo from inventedbyamother.com)
The modern clinical trial’s Informed Consent Form (ICF) is a daunting document. It is packed with a mind-numbing litany of procedures, potential risks, possible adverse events, and substantial additional information – in general, if someone, somewhere, might find a fact relevant, then it gets into the form. A run-of-the-mill ICF in a phase 2 or ........ Read more »
Bishop FL, Adams AEM, Kaptchuk TJ, Lewith GT. (2012) Informed Consent and Placebo Effects: A Content Analysis of Information Leaflets to Identify What Clinical Trial Participants Are Told about Placebos. . PLoS ONE. DOI: 10.1371/journal.pone.0039661
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