Types of Clinical Studies

Noel J. Atienza, MD MS FCH2 SBCM

Types of Clinical Studies

Descriptive: Case Series Cross-sectional Survey Analytical: Case-Control Study Cohort Study Experimental: Clinical Trials

Case-Control Study
Subjects recruited based on disease status

Retrospective

Exposure Status

D+ D-

E+ EEE+

Case-Control Study

CLINICAL QUESTION: What happened? Rare diseases Illnesses with long latency periods Evaluation of a wide range of potential etiologic exposure

Case-Control Study :
Phenylpropanolamine and the Risk of Hemorrhagic Stroke

702 Patients with Hemorrhagic Stroke

1376 Control Patients

Intake of PPA within 30 days before Stroke Intake of PPA within 30 days before interview

Results: PPA was associated with increased risk of Hgic Stroke in women 18 49 years of age

Cohort Study
Cohort means a group of subjects followed over a period of time Main Objectives :

To

describe the incidence of certain outcomes over time (DESCRIPTIVE) To analyze associations between risk factors and those outcomes (ANALYTICAL)

Prospective Cohort Study

Recruitment of Subjects based on exposure status

Prospective

Disease Status
D+

E+ E-

DDD+

Prospective Cohort Study

CLINICAL QUESTION: What will happen? Sample of subjects without the outcome of interest Predictor variables measured Subjects followed over a period of time Most effective way to establish the temporal sequence of predictor and outcome variables

Case-Control and Prospective Cohort Studies

Manolio, T. N Engl J Med 2003;349:1587-1589

Cohort Study:
2000 Males Aged 50 to 60 years 1000 Smokers Of 10 pack-years 1000 Non-smokers
20 Years

255 Died of Lung CA

45 Died of Lung CA

Result: Smoking is a risk factor for Lung Cancer among males aged 50 to 60 years

Retrospective Cohort Study

(Historical Cohort)
Sample of subjects with the outcome of interest similar to the prospective cohort study except that baseline measurements, follow-up, and outcomes all happened in the past Only possible if there is adequate data on the risk factors and outcome

Retrospective Cohort Study

Selection of Subjects based on exposure status HIV Positive Asymptomatic Subjects

Records Review

Disease Status Blood Transfusion Drug Addiction Anal Sex

Records Review

Cross-Sectional Studies
D+ E+ DDERecruitment of a group of subjects D+ D+ E+ EEDE+

Cross-Sectional Studies

Exposure status and Disease status are measured at one point in time Useful for chronic illnesses (gradual onset, long duration) Prevalence studies Less costly than cohort studies