Category Archives: Genetic Medicine

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A new survey of 500+ clinical research site professionals outlines the  impact of complex, clinical trials in clinical trial sites. The survey focused on 3-year trial trends and found key challenges in subject recruitment/retention and tracking and reporting data. Increased complexity also impacted trial financials– especially negotiating contracts and managing profitability.

The December, 2010 survey was conducted among investigators, study coordinators and other clinical site professionals from large organizations, such as Mayo Clinic and Johns Hopkins, hospitals like Rush Presbyterian and the Hospital for Sick Children, as well as multi-specialty and private practices. Clinical Research Site Training (CRST), conducted the survey.

Analysis of the survey findings shows that

• 66% of large organizations report an increase in trials conducted
• 60% of trial sites report increasing difficulty in managing trial profitability
• 40% report increasing difficulty in recruiting and retaining subjects
• Training remains a major issue, even though over 50% report an increase in training
• 80%+ of nurses want more QA training
• 60%+ of all respondents want more FDA Audits training

The survey also explored sites’ Web use for work information. In spite of increased specialized Web content about the clinical research site “world”, awareness and usage were both relatively low.

• Google (or other search sites) was the primary information tool
• Only the NIH and Clinical Trial Network sites have over 50% awareness among all site professionals
• Usage of major specialized sites averaged less than 40% for nurses and less than 20% for doctors

CRST suggest that clinical research sites should:

• Increase training on financial management, site QA, subject recruitment/retention and FDA inspections;
• Manage the convergence of increased and more complex trials by improving both new staff recruitment and experienced staff retention;
• Reach out on the Web for new/improved ways of working from both formal information sites and clinical research site communities.”

Full results of the survey are available on the CRST website http://www.crstnet.com

Contacts

CRST
Lester Levine, 484-798-7503
President
Fax: 215-477-2522
lester.levine@crstnet.com

Dr. Pauline Chen in the NY Times reports that “When Patients Share Their Stories, Health May Improve”. HC Catalyst uses the same methodology to increase patient adherence to prescription medicines.

hcCatalyst Adherence Driver uses patients to motivate other patients to stay adherent. And, we do this without remunerating, scripting or training. It’s genuine and without the liability issues associated with paid or trained spokespersons.

Details on http://www.hccatalyst.com/solutions.html

AstraZeneca Pharmaceuticals LP (NYSE: AZN) and HealthCore, Inc., the health outcomes research subsidiary of WellPoint, Inc. (NYSE: WLP), announced a collaborative agreement to conduct real-world studies designed to determine how to most effectively and economically treat disease

Unlike controlled clinical trials, real-world evidence studies use observational data such as electronic medical records, claims information and patient surveys. By examining data associated with the delivery of care, real-world analyses can assess treatment impact on hospital length of stay, readmissions, overall health status, cost of care and other key evidence-based outcomes.

A leader in health outcomes research, HealthCore maintains the largest data environment in the nation. HealthCore’s near real-time, fully-integrated data environment combines medical, pharmacy, laboratory results and other information drawn from 36 million enrollees in local Blue Cross and/or Blue Shield plans with concentrated populations in 16 states.