Can managed care organizations partner with manufacturers for comparative effectiveness research?
OBJECTIVE
To describe 2 published pragmatic or practical clinical trials (PCTs) as case studies illustrating successful partnerships between managed care organizations (MCOs) and pharmaceutical manufacturers.


METHODS
In today's environment, there is increasing concern about the comparative effectiveness of medical interventions. Various opinion leaders and stakeholders lament the dearth of such evidence and are calling for the public and private sectors to invest up to billions of dollars to create better comparative evidence.


METHODS
We selected 2 PCTs conducted at different points in the drug life cycle to highlight strengths, limitations, and policy implications. The phase IV study compared fluoxetine hydrochloride vs 2 generic tricyclic antidepressants in selected primary care clinics of a health maintenance organization from 1992 through 1994. The phase IIIb study compared daily budesonide via dry powder inhaler vs triamcinolone acetonide metered-dose inhaler in adult patients with persistent asthma in 25 MCOs from 1995 through 1998.


RESULTS
Both PCTs were successfully sponsored and funded by pharmaceutical manufacturers in collaboration with MCOs and provided potentially useful evidence of real-world effectiveness and evidence of value to healthcare decision makers.


CONCLUSIONS
Industry-sponsored PCTs in managed care are feasible when manufacturer and MCO incentives align and can provide real-world evidence of comparative effectiveness and value for money. These trials can be conducted successfully in the phase IIIb and phase IV environments.
Luce
Bryan R
BR
United BioSource Corporation, 7101 Wisconsin Ave, Ste 600, Bethesda, MD 20814, USA. bryan.luce@unitedbiosource.com
Paramore
L Clark
LC
Parasuraman
Bhash
B
Liljas
Bengt
B
de Lissovoy
Gregory
G
D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D019819:Budesonide / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004345:Drug Industry; D005473:Fluoxetine / Q000627:therapeutic use*; D006291:Health Policy / Q000639:trends; D006801:Humans; D007373:Interinstitutional Relations; D008329:Managed Care Programs
D018687:Antidepressive Agents, Second-Generation; D001993:Bronchodilator Agents; D005473:Fluoxetine; D019819:Budesonide