DrugWonks on Twitter

DrugWonks on Facebook

CMPI Videos


Video Montage of Third Annual Odyssey Awards Gala Featuring Governor Mitch Daniels, Montel Williams, Dr. Paul Offit and CMPI president Peter Pitts


Indiana Governor Mitch Daniels


Montel Williams, Emmy Award-Winning Talk Show Host


Paul Offit, M.D., Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, for Leadership in Transformational Medicine


CMPI president Peter J. Pitts


CMPI Web Video: "Science or Celebrity"

Social Networks



Please Follow the Drugwonks Blog on Facebook, Twitter, LinkedIn, YouTube & RSS




Add This Blog to my Technorati Favorites
Political Blogs - BlogCatalog Blog Directory

Tabloid Medicine

Please Check out the latest book by
Dr. Robert Goldberg Ph.D.
"Tabloid Medicine"

Check Out CMPI's Book

Physician Disempowerment:
A Transatlantic Malaise

Edited By: Peter J. Pitts
Download the E-Book Version
Here

CMPI Events

Donate

CMPI Reports

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP

Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum

Club For Growth
CNEhealth.org

Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare

Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst

The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
 


Without Citizen Scientists We Can't Innovation

Mon, Jan 21, 2013 | Dr. Robert Goldberg
A blog by Ed Silverman over at pharmalot  describes how the development of many medicines languish because clinical trial enrollment is non-existent:

"There is good news and bad news about enrolling patients in clincal trials. First, the good news – 89 percent of all trials meet their enrollment goals. Now, the bad news – 48 percent of the trial sites miss enrollment targets and study timelines often slip, causing extensions that are nearly double the original duration in order to meeting enrollment levels for all therapeutic areas."

Fewer patients and longer studies increases development costs without advancing science.  It's like feeding a parking meter but never leaving your car... 

But there is a solution....

FDA gives go ahead for Phase 2 trial using remote monitoring and crowd sourcing

Posted By Stephanie Baum On December 18, 2012 @ 8:02 am In Health IT,MedCity News

It looks like the U.S. Food and Drug Administration is feeling growing pressure to make clinical trial design more flexible. A newly approved Phase 2 clinical trial is the first to use both crowdsourcing and remote monitoring.  The regulator has granted New York-based biopharmaceutical startup Transparency Life Sciences [1] a greenlight to study the effectiveness of a blood pressure drug lisinopril [2] in multiple sclerosis patients, after clearing the company’s Investigational New Drug application. [3]Telemonitoring company AMC Health will work with Transparency Life Science to do remote monitoring for the trial. For the 12-month study, data will be collected from the 180 participants’ homes, using wearable monitors to collect vital signs. Secure video interaction between investigators and trial participants will facilitate communication between them.In the runup to the FDA’s clearance of the IND, Transparency Life Sciences had obtained insights from patients and and healthcare professionals to strengthen the protocol for the Phase 2 trial, such as primary and secondary endpoints, inclusion and exclusion criteria and remote monitoring strategies.

It’s a significant milestone for the FDA and for the pharmaceutical industry. The study is estimated to cost $1.5 million. Using a more traditional clinical study model, with frequent site visits, the one year study could have cost as much as $5 million, John Holland, senior vice president for research and business development for AMC Health told MedCity News in a phone interview. Another benefit is that it will reduce the geographical limitations of clinical trials.

AMC Health is also working with an unnamed pharmaceutical company in a Phase 1 study. The New York telemonitoring business has worked with pharmaceutical companies before, mostly on pilot studies evaluating the use of telemonitoring for clinical trials. It has also worked with Geisinger Center for Health Research [4] in Danville, Pennsylvania to reduce readmissions by improving post discharge patient follow up.“This will increase the quality and quantity of data, and reduce the burden on patients. Frequent data collection at home is also expected to increase patient safety, because if a side effect were to appear, researchers will know about it sooner, ” Holland said. “A lot of people are collecting electronic patient-reported outcomes so that’s not unique but I have not seen anyone else doing the biometric, medication adherence monitoring that we are doing.

”Telemonitoring is not a perfect system either. Information provided by monitors tracking vital signs can generate false alarms. Scalability is also a problem when you are looking at a clinical trial of thousands of people.

Transparency Life Sciences has been a proponent of telemonitoring
 [5] as an effective way to carry out clinical trials and ensure data is uniform. In an interview with MedCity News earlier this year, Marc Foster, Transparency’s chief operating officer said: “One of the things you see a lot these days is researcher bias, where a doctor or clinician is taking data in a clinical setting their involvement can bias the results of a clinical trial. If people are at home in their most natural setting, the ability to take their data remotely we think would be more uniform.”Industry insiders from pharmaceutical companies to health IT companies to patient advocates have been pushing for the FDA to be more innovative [6] in its approach to clinical trials. Pfizer’s attempt to use social media to carry out the tricky job of patient recruitment [7], marked a critical step in how Big Pharma view alternative approaches to clinical trial design. Pharmaceutical companies have been conducting pilot studies [8] for years to ascertain factors that could impact the accuracy of these studies. The evolution in the sophistication of devices that can monitor vital signs and transmit that data remotely without the patient keying it in makes this kind of clinical trial design more feasible. Proponents argue that they can better track participants’ health than regular site visits.