July 14, 2011 ·
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Industry Insights from Paul Meade, M. Sc, MPH
A recent article in the Wall Street Journal announced that Pfizer is conducting a clinical trial in which patients are able to use their computers and smartphones to enter information about the study, rather then spend time visiting a clinic. It was only a matter of time before clinical trials entered the social media era!
Actually, this approach makes a lot of sense, not just for the investigator, but especially for the patient. The patient is recruited over the Internet, enrolls electronically, receives laboratory tests in the mail along with test drugs, and tracks responses through an application on his or her computer or smartphone. Having participated in a clinical study before where I had to repeatedly return to the clinic, keep a paper log of reactions, bring in my responses to the study site, and answer weekly phone calls from the study nurse, I can say wholeheartedly that it was a big inconvenience. And all of that grief for the incredible reimbursement of $60!
We live in an age of instant and ubiquitous communication. I am never very far or long away from a business-related e-mail, even when I am on vacation. In fact, this instant communication has really changed the face of vacations for most people, but that is another subject ... read more »
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biopharmaceutical biotechnology clinical investigators clinical studies clinical study nurse clinical study site clinical trial computers e-visits family physicians Food and Drug Administration healthcare management healthcare system laboratory tests patient recruitment patients Pfizer pharmaceutical physicians smartphones social media Wall Street Journal
July 7, 2011 ·
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Industry Insights from Paul Meade, M. Sc, MPH
According to an article published in the Archives of Internal Medicine, Dr Joseph Ross claimed a study conducted by Parke-Davis, before it was acquired by Pfizer, using gabapentin (Neurontin), as the drug under investigation, appeared to be a “seeding” trial. And while the author states that seeding trials are not illegal, he states that they are unethical. There are really two separate issues at stake here: first, what is really an unethical trial, and second, what is really a “seeding” trial?
About 25 years ago, when a pharmaceutical company launched a new drug and wanted to get as many physicians as possible to have some experience in using this drug for appropriate patients, they would provide samples packaged in a box to resemble supplies you might receive if you were a clinical investigator. There would be cards to report on one’s experience with the new drug, such as efficacy and side effects. But these sample cards were rarely collected and reported back to the head office. The goal was really to have physicians become familiar with this new drug, and for their own information record some information. These were not formal clinical trials, not required by the regulatory authorities, and did not need the scrutiny of an Institutional Review Board. These ersatz trials became ... read more »
TAGS: academic institutions Archives of Internal Medicine clinical investigators clinical trial clinical trial data collection clinical trial design clinical trial protocol Dr Joseph Ross drug efficacy drug samples drug side effects drugs ethical review committees ethics in healthcare gabapentin healthcare hospitals institutional review board marketing trial medical ethics Neurontin Parke-Davis patients Paul Meade Pfizer pharmaceutical Phase IV clinical studies physician behaviors physicians prescribing habits of physicians sample cards seeding trial surveillance studies Thought Leader Select
