2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC8
Submitter : Ms. Tracy Blumenfeld Date & Time: 03/25/2005 05:03:46
Organization : RapidTrials
Category : Drug Industry
Issue Areas/Comments
I am writing with regards to precautions we can take to protect the study volunteers who allow all of us to benefit.

Last year 100's Americans who participated in clinical trials died as a result of a drug related serious adverse event (SAE). Part of the problem is that when a study volunteer suffers a medical crisis while participating in a clinical trial, and is rushed to an emergency room, the Emergency Room (ER) staff has no way of knowing that the patient is enrolled in a clinical trial or what test drug the patient is taking. In the absence of this information, the ER staff will treat the patient according to usual and customary procedures, thus putting the patient in jeopardy, which can lead to unnecessary deaths or injuries.

While industry and regulatory bodies and IRBs are focused on capturing Serious Adverse Events occurrences through tracking and reporting systems, I am not aware of any programs that are commonly adopted that protect study volunteers 'proactively' other than informing subjects of the risk of participation through the informed consent process. Consequently, this raises the question whether clinical trial subjects are getting the highest levels of care available to them from sponsor companies?

For over two years, my Company, RapidTrials, in partnership with the MedicAlert(r) Foundation has been offering pharmaceutical and medical device companies the opportunity to better protect the safety of clinical trial volunteers. Our program utilizes low cost proven solutions to ensure study volunteers are protected in a medical crisis. By adapting the MedicAlert(r) 24-Hour Emergency Response Service, we are able to provide `Subject Safety and Identification Service? to the clinical research process thereby ensuring instantaneous communication of clinical trial test drug or medical devise information to emergency responders and mitigate potential loss of life or injury to a clinical trial participant. As a result, this program can help save study subject lives. While the response by Medical Safety Experts at Pharmaceutical Companies to this concept has been overwhelmingly positive, and, in fact, some have thought this program should be the Standard of Care, program participation is virtually non existent due to expense and simply because there are no laws or mechanisms to encourage them to act more proactively. The cost of the MedicAlert program is insignificant as a percentage of the cost spent of clinical trials.
With the recent drug withdrawals from market due to safety risks, it may be time to expand clinical research subject safety beyond just the informed consent process, by providing study volunteers with a service that actually can save their lives?

I am hopeful that government, industry and healthcare providers will adopt more proactive measures to provide clinical trial volunteers the greatest degree of safety available.

I would be happy to provide you with additional information on the MedicAlert program. Or visit the link on our website http://rapidtrials.com/ss_med_rapid.jsp

Thank you.

Best Regards,

Tracy Harmon Blumenfeld
President and CEO
1008 Upper Gulph Rd
Wayne, PA 19087
P: 610-989-0660
F: 610-989-0599