Clinical Trials GPS Shares 2011 Q4 Findings; Almost 40% of Trials Aimed at Seniors, Less Than 17% Funded by The Government

Internal data shows a trend towards female participants, a surprisingly low volume of smokers, majority are willing to stay overnight, and an average age of 42. End Quote

Kansas City, MO-KS (1888PressRelease) January 25, 2012 - An analysis of the data on Clinical Trials GPS (powered by the NIH) reveals information about the 25,000+ clinical research trials being conducted in the U.S. Below is a breakdown of clinical trial data by Phase, Age Range, Type of Study, Funding Source and prospective patient trends.

CLINICAL TRIALS BY PHASE

Phase I 5,384 (22.03%)
Phase II 9,347 (38.25%)
Phase III 5,489 (22.46%)
Phase IV 4,215 (17.25%)

In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. In Phase III clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. In Phase IV clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

CLINICAL TRIALS BY AGE RANGE

Child (birth-17) 8,721 (11.64%)
Adult (18-65) 37,313 (49.81%)
Senior (66+) 28,883 (38.55%)

CLINICAL TRIALS BY FUNDING SOURCE

NIH 5,587 (13.90%)
Industry 10,827 (26.94%)
Other U.S. Federal Agency* 1,109 (2.76%)
All others (Individual, University, Organization) 22,672 (56.41%)

*Other U.S. Federal Agencies include the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Department of Veterans Affairs (VA), etc.

CLINICAL TRIALS BY STUDY TYPE
Interventional Studies 30,584 (76.76%)
Observational Studies 9,183 (23.05%)
Expanded Access Studies 75 (0.19%)

Interventional Studies are those where individuals are assigned to receive specific interventions. Participants may receive diagnostic, therapeutic or other types of interventions. Assignment of the intervention may or may not be random, and patients are tracked and biomedical or health outcomes are assessed. Observational Studies, however, are those without an intervention. Studies where biomedical and/or health outcomes are assessed in a pre-defined group of individuals. Participants may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the participants of the study. Finally, Expanded Access Studies involve records describing the procedure for obtaining an experimental drug or device for patients who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials. Expanded Access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track.

*Data provided by ClinicalTrials.gov, a service of the U.S. National Institute of Health

INTERNAL DATA

Male 39%
Female 61%
Avg Age 42
Avg Weight 179
Smokers 20%
Willing to Stay Overnight 61%

*Data provided by ClinicalTrialsGPS.com

For more Clinical Trials News, or information about participating in a clinical trial, please visit Clinical Trials GPS (http://www.clinicaltrialsgps.com) or call (877) 330-2919.

John Longan
Clinical Trials GPS
(877) 248-5589

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