This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (237)  • Contact me when this article is cited  Related Content  • Related letters  • Similar articles in JAMA  Topic Collections  • Evidence-Based Medicine  • Statistics and Research Methods  • Health Policy  • Randomized Controlled Trial  • Alert me on articles by topic

Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy

Sean R. Tunis, MD, MSc; Daniel B. Stryer, MD; Carolyn M. Clancy, MD

JAMA. 2003;290:1624-1632.

Decision makers in health care are increasingly interested in using high-quality scientific evidence to support clinical and health policy choices; however, the quality of available scientific evidence is often found to be inadequate. Reliable evidence is essential to improve health care quality and to support efficient use of limited resources. The widespread gaps in evidence-based knowledge suggest that systematic flaws exist in the production of scientific evidence, in part because there is no consistent effort to conduct clinical trials designed to meet the needs of decision makers. Clinical trials for which the hypothesis and study design are developed specifically to answer the questions faced by decision makers are called pragmatic or practical clinical trials (PCTs). The characteristic features of PCTs are that they (1) select clinically relevant alternative interventions to compare, (2) include a diverse population of study participants, (3) recruit participants from heterogeneous practice settings, and (4) collect data on a broad range of health outcomes. The supply of PCTs is limited primarily because the major funders of clinical research, the National Institutes of Health and the medical products industry, do not focus on supporting such trials. Increasing the supply of PCTs will depend on the development of a mechanism to establish priorities for these studies, significant expansion of an infrastructure to conduct clinical research within the health care delivery system, more reliance on high-quality evidence by health care decision makers, and a substantial increase in public and private funding for these studies. For these changes to occur, clinical and health policy decision makers will need to become more involved in all aspects of clinical research, including priority setting, infrastructure development, and funding.

Author Affiliations: Centers for Medicare & Medicaid Services, Baltimore, Md (Dr Tunis); and Agency for Healthcare Research and Quality, Rockville, Md (Drs Stryer and Clancy).

RELATED LETTERS

Realizing the Benefits of Practical Clinical Trials
Joshua J. Ofman and Deborah P. Lubeck
JAMA. 2004;291(4):425-426.
EXTRACT | FULL TEXT  

Realizing the Benefits of Practical Clinical Trials—Reply
Sean R. Tunis and Daniel B. Stryer
JAMA. 2004;291(4):426.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

A Menu without Prices
Garber
ANN INTERN MED 2008;0:0000605-200806170-00223-E-223.
FULL TEXT  

Developing the evidence for evidence-based practice
Rush
CMAJ 2008;178:1313-1315.
FULL TEXT  

Comparative effectiveness of angiotensin-converting-enzyme inhibitors: Is an ACE always an ace?
Hernandez and Harrington
CMAJ 2008;178:1316-1319.
FULL TEXT  

Impact of Positron Emission Tomography/Computed Tomography and Positron Emission Tomography (PET) Alone on Expected Management of Patients With Cancer: Initial Results From the National Oncologic PET Registry
Hillner et al.
JCO 2008;26:2155-2161.
ABSTRACT | FULL TEXT  

Crossroads In Quality
O'Kane et al.
Health Aff (Millwood) 2008;27:749-758.
ABSTRACT | FULL TEXT  

Randomized Controlled Trials for Schizophrenia: Study Designs Targeted to Distinct Goals
Stroup and Geddes
Schizophr Bull 2008;34:266-274.
ABSTRACT | FULL TEXT  

CATIE and CUtLASS: can we handle the truth?
Lewis and Lieberman
Br. J. Psychiatry 2008;192:161-163.
ABSTRACT | FULL TEXT  

Surgical versus Nonsurgical Therapy for Lumbar Spinal Stenosis
Weinstein et al.
NEJM 2008;358:794-810.
ABSTRACT | FULL TEXT  

The Importance of External Validity
Steckler and McLeroy
Am. J. Public Health 2008;98:9-10.
FULL TEXT  

Regulatory and Reimbursement Challenges for Molecular Imaging
Hoffman et al.
Radiology 2007;245:645-660.
ABSTRACT | FULL TEXT  

Effects of Task-Specific Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke: Results of the STEPS Randomized Clinical Trial
Sullivan et al.
ptjournal 2007;87:1580-1602.
ABSTRACT | FULL TEXT  

The effectiveness and cost effectiveness of telephone counselling and the nicotine patch in a state tobacco quitline
Hollis et al.
Tobacco Control 2007;16:i53-i59.
ABSTRACT | FULL TEXT  

Statins for Ischemic Systolic Heart Failure
Masoudi
NEJM 2007;357:2301-2304.
FULL TEXT  

Global Health and Primary Care Research
Beasley et al.
J Am Board Fam Med 2007;20:518-526.
ABSTRACT | FULL TEXT  

Screening and brief intervention targeting risky drinkers in danish general practice A pragmatic controlled trial
Beich et al.
Alcohol Alcohol 2007;42:593-603.
ABSTRACT | FULL TEXT  

Clinical Diagnosis of Lacunar Stroke in the First 6 Hours After Symptom Onset: Analysis of Data From the Glycine Antagonist In Neuroprotection (GAIN) Americas Trial
Phillips et al.
Stroke 2007;38:2706-2711.
ABSTRACT | FULL TEXT  

Improving Patient Care by Linking Evidence-Based Medicine and Evidence-Based Management
Shortell et al.
JAMA 2007;298:673-676.
FULL TEXT  

The Decision to Conduct a Head-to-Head Comparative Trial: A Game-Theoretic Analysis
Mansley et al.
Med Decis Making 2007;27:364-379.
ABSTRACT  

Step-up combination versus switching of non-biological disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a retrospective observational study
Schoels et al.
Ann Rheum Dis 2007;66:1059-1065.
ABSTRACT | FULL TEXT  

Translation of an Efficacious Cancer-Screening Intervention to Women Enrolled in a Medicaid Managed Care Organization
Dietrich et al.
Ann Fam Med 2007;5:320-327.
ABSTRACT | FULL TEXT  

Chronic Kidney Disease and the Public Health: Gaps in Evidence From Interventional Trials
Himmelfarb
JAMA 2007;297:2630-2633.
FULL TEXT  

Potential Synergism between Hypnosis and Acupuncture--Is the Whole More Than the Sum of Its Parts?
Schiff et al.
Evid Based Complement Alternat Med 2007;4:233-240.
ABSTRACT | FULL TEXT  

Surgical versus Nonsurgical Treatment for Lumbar Degenerative Spondylolisthesis
Weinstein et al.
NEJM 2007;356:2257-2270.
ABSTRACT | FULL TEXT  

Barriers to the Appropriate Clinical Use of Medications That Improve the Cognitive Deficits of Schizophrenia
Bromley
Psychiatr. Serv. 2007;58:475-481.
ABSTRACT | FULL TEXT  

A Rapid-Learning Health System
Etheredge
Health Aff (Millwood) 2007;26:w107-w118.
ABSTRACT | FULL TEXT  

The Gap Between Evidence And Practice
Liang
Health Aff (Millwood) 2007;26:w119-w121.
ABSTRACT | FULL TEXT  

Information Technology And The Inferential Gap
Perlin and Kupersmith
Health Aff (Millwood) 2007;26:w192-w194.
ABSTRACT | FULL TEXT  

Cognitive Behavioral Therapy for Posttraumatic Stress Disorder in Women: A Randomized Controlled Trial
Schnurr et al.
JAMA 2007;297:820-830.
ABSTRACT | FULL TEXT  

Brief Intervention for Medical Inpatients with Unhealthy Alcohol Use: A Randomized, Controlled Trial
Saitz et al.
ANN INTERN MED 2007;146:167-176.
ABSTRACT | FULL TEXT  

Strategies for Academic and Clinician Engagement in Community-Participatory Partnered Research
Jones and Wells
JAMA 2007;297:407-410.
FULL TEXT  

Translational Science at the National Institute of Mental Health: Can Social Work Take Its Rightful Place?
Brekke et al.
Research on Social Work Practice 2007;17:123-133.
ABSTRACT  

Describing Primary Care Encounters: The Primary Care Network Survey and the National Ambulatory Medical Care Survey
Binns et al.
Ann Fam Med 2007;5:39-47.
ABSTRACT | FULL TEXT  

Interval versus Continuous High-Intensity Exercise in Chronic Obstructive Pulmonary Disease: A Randomized Trial
Puhan et al.
ANN INTERN MED 2006;145:816-825.
ABSTRACT | FULL TEXT  

Generalizing results of randomized trials to clinical practice: reliability and cautions
Flather et al.
Clin Trials 2006;3:508-512.
ABSTRACT  

Ten reasons to conduct a randomized study in quality improvement
Perneger
Int J Qual Health Care 2006;18:395-396.
FULL TEXT  

Challenges in the design and conduct of a randomized study of two interventions for liquid aspiration
Brandt et al.
Clin Trials 2006;3:457-468.
ABSTRACT  

Evaluating the impact of health promotion programs: using the RE-AIM framework to form summary measures for decision making involving complex issues
Glasgow et al.
Health Educ Res 2006;21:688-694.
ABSTRACT | FULL TEXT  

Comparative Effectiveness of Antipsychotic Drugs: A Commentary on Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1) and Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE).
Lieberman
Arch Gen Psychiatry 2006;63:1069-1072.
FULL TEXT  

Beyond Efficacy: The STAR{star}D Trial
Insel
Focus 2006;4:562.
FULL TEXT  

Coverage Options For Promising Technologies: Medicare's 'Coverage With Evidence Development'
Tunis and Pearson
Health Aff (Millwood) 2006;25:1218-1230.
ABSTRACT | FULL TEXT  

Medicare's requirement for research participation as a condition of coverage: is it ethical?
Pearson et al.
JAMA 2006;296:988-991.
FULL TEXT  

Ethics, Marketing, and the Medical Literature
White
Anesth. Analg. 2006;103:488-489.
FULL TEXT  

Collaborative Care for Bipolar Disorder: Part I. Intervention and Implementation in a Randomized Effectiveness Trial
Bauer et al.
Psychiatr. Serv. 2006;57:927-936.
ABSTRACT | FULL TEXT  

Depth of anaesthesia monitoring: what's available, what's validated and what's next?
Bruhn et al.
Br J Anaesth 2006;97:85-94.
ABSTRACT | FULL TEXT  

The Trial of Infant Response to Diphenhydramine: The TIRED Study--A Randomized, Controlled, Patient-Oriented Trial
Merenstein et al.
Arch Pediatr Adolesc Med 2006;160:707-712.
ABSTRACT | FULL TEXT  

Strengthening the contribution of quality improvement research to evidence based health care.
Baker
Qual Saf Health Care 2006;15:150-151.
FULL TEXT  

The midwest nursing centers consortium research network: translating research into practice.
Anderko et al.
Policy Politics Nursing Practice 2006;7:101-109.
ABSTRACT  

Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial.
Dietrich et al.
ANN INTERN MED 2006;144:563-571.
ABSTRACT | FULL TEXT  

Effects of a brief computer-assisted diabetes self-management intervention on dietary, biological and quality-of-life outcomes
Glasgow et al.
Chronic Illness 2006;2:27-38.
ABSTRACT  

Linking dementia research to policy: An example using fluorodeoxyglucose positron emission tomography for the diagnosis of Alzheimer's dementia and mild cognitive impairment
Kulasingam et al.
AM J ALZHEIMERS DIS OTHER DEMEN 2006;21:73-78.
 

Translation as a function of modality: the potential of brief interventions.
Werch et al.
Eval Health Prof 2006;29:89-125.
ABSTRACT  

Evaluating the relevance, generalization, and applicability of research: issues in external validation and translation methodology.
Green and Glasgow
Eval Health Prof 2006;29:126-153.
ABSTRACT  

Evaluating the Performance of Pay for Performance
Galvin
Med Care Res Rev 2006;63:126S-130S.
 

Beyond Efficacy: The STAR*D Trial
Insel
Am. J. Psychiatry 2006;163:5-7.
FULL TEXT  

RE-AIMing Research for Application: Ways to Improve Evidence for Family Medicine
Glasgow
J Am Board Fam Med 2006;19:11-19.
ABSTRACT | FULL TEXT  

Navigating the Terrain between Research and Practice: A Collaborative Research Network (CRN) Case Study in Diabetes Research
Handley et al.
J Am Board Fam Med 2006;19:85-92.
ABSTRACT | FULL TEXT  

Treatment of Postoperative Nausea and Vomiting with Dolasetron Versus Ondansetron: Is There a Conflict of Interest?
Roberson and Meyer
Anesth. Analg. 2005;101:1887-1888.
FULL TEXT  

Tacrolimus versus ciclosporin as primary immunosuppression for kidney transplant recipients: meta-analysis and meta-regression of randomised trial data
Webster et al.
BMJ 2005;331:810.
ABSTRACT | FULL TEXT  

Medicare and Cost-Effectiveness Analysis
Neumann et al.
NEJM 2005;353:1516-1522.
FULL TEXT  

Generalizability of Studies on Mental Health Treatment and Outcomes, 1981 to 1996
Braslow et al.
Psychiatr. Serv. 2005;56:1261-1268.
ABSTRACT | FULL TEXT  

Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia
Lieberman et al.
NEJM 2005;353:1209-1223.
ABSTRACT | FULL TEXT  

Efficacy and Safety of Second-Generation Antidepressants in the Treatment of Major Depressive Disorder
Hansen et al.
ANN INTERN MED 2005;143:415-426.
ABSTRACT | FULL TEXT  

Challenges in Systematic Reviews That Evaluate Drug Efficacy or Effectiveness
Santaguida et al.
ANN INTERN MED 2005;142:1066-1072.
ABSTRACT | FULL TEXT  

Psychopharmacology: The Need for Effectiveness Trials to Inform Evidence-Based Psychiatric Practice
Lagomasino et al.
Psychiatr. Serv. 2005;56:649-651.
FULL TEXT  

The Case for Practical Clinical Trials in Psychiatry
March et al.
Am. J. Psychiatry 2005;162:836-846.
ABSTRACT | FULL TEXT  

Individualised treatment improves depression in people with depression and diabetes
Glasgow and Price
Evid. Based Ment. Health 2005;8:40-40.
FULL TEXT  

Improving tuberculosis therapy completion after jail: translation of research to practice
White et al.
Health Educ Res 2005;20:163-174.
ABSTRACT | FULL TEXT  

Limitations of "pragmatic" trials
Ernst and Canter
Postgrad. Med. J. 2005;81:203-203.
FULL TEXT  

Simple Principles of Clinical Trials Remain Powerful
Califf
JAMA 2005;293:489-491.
FULL TEXT  

Practical and Relevant Self-Report Measures of Patient Health Behaviors for Primary Care Research
Glasgow et al.
Ann Fam Med 2005;3:73-81.
ABSTRACT | FULL TEXT  

Randomized Effectiveness Trial of a Computer-Assisted Intervention to Improve Diabetes Care
Glasgow et al.
Diabetes Care 2005;28:33-39.
ABSTRACT | FULL TEXT  

Evidence, Politics, And Technological Change
Gelijns et al.
Health Aff (Millwood) 2005;24:29-40.
ABSTRACT | FULL TEXT  

Evidence Based? Caveat Emptor!
Steinberg and Luce
Health Aff (Millwood) 2005;24:80-92.
ABSTRACT | FULL TEXT  

When Is Evidence Sufficient?
Claxton et al.
Health Aff (Millwood) 2005;24:93-101.
ABSTRACT | FULL TEXT  

Evidence-Based Practice As Mental Health Policy: Three Controversies And A Caveat
Tanenbaum
Health Aff (Millwood) 2005;24:163-173.
ABSTRACT | FULL TEXT  

A Clinical Research Strategy To Support Shared Decision Making
Tunis
Health Aff (Millwood) 2005;24:180-184.
ABSTRACT | FULL TEXT  

Medicare's National Coverage Decisions, 1999-2003: Quality Of Evidence And Review Times
Neumann et al.
Health Aff (Millwood) 2005;24:243-254.
ABSTRACT | FULL TEXT  

Lifestyle, Diabetes, and Cardiovascular Risk Factors 10 Years after Bariatric Surgery
Sjostrom et al.
NEJM 2004;351:2683-2693.
ABSTRACT | FULL TEXT  

A Multimethod Quality Improvement Intervention To Improve Preventive Cardiovascular Care: A Cluster Randomized Trial
Ornstein et al.
ANN INTERN MED 2004;141:523-532.
ABSTRACT | FULL TEXT  

Design and statistical issues in the homocysteinemia in kidney and end stage renal disease (HOST) study
Jamison et al.
Clin Trials 2004;1:451-460.
ABSTRACT  

Antidepressants, Suicide, and the FDA: A Loose Association
Finley
The Annals of Pharmacotherapy 2004;38:1739-1742.
FULL TEXT  

Clinical Trials in Late Life: New Science in Old Paradigms
Lebowitz
Gerontologist 2004;44:452-458.
ABSTRACT | FULL TEXT  

Enoxaparin vs Unfractionated Heparin in High-Risk Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Managed With an Intended Early Invasive Strategy: Primary Results of the SYNERGY Randomized Trial
SYNERGY Trial Investigators
JAMA 2004;292:45-54.
ABSTRACT | FULL TEXT  

Using Pharmacogenetics to Improve Drug Safety and Efficacy
Haga and Burke
JAMA 2004;291:2869-2871.
FULL TEXT  

Moving Diabetes Care from Science to Practice: The Evolution of the National Diabetes Prevention and Control Program
Murphy et al.
ANN INTERN MED 2004;140:978-984.
ABSTRACT | FULL TEXT  

Why Medicare Has Not Established Criteria for Coverage Decisions
Tunis
NEJM 2004;350:2196-2198.
FULL TEXT  

Feasibility of a Practical Clinical Trial for Asthma Conducted in Primary Care
Hahn and Plane
J Am Board Fam Med 2004;17:190-195.
ABSTRACT | FULL TEXT  

Outcomes-Based Drug Coverage in British Columbia
Morgan et al.
Health Aff (Millwood) 2004;23:269-276.
ABSTRACT | FULL TEXT  

Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial
Vickers et al.
BMJ 2004;328:744.
ABSTRACT | FULL TEXT  

Realizing the Benefits of Practical Clinical Trials
Ofman and Lubeck
JAMA 2004;291:425-426.
FULL TEXT