KELOMPOK 1

INFORMASI OBAT
Randomized Clinical Trial (RCT)
& Off Label

Risna Islamiah 12330046 Mia Khana Kallista 14330007

Dini Oktaviana 12330066 F ikriyah Dzaki 14330015
Mia Aty Dolok Rosa 14330024
Syena Azwari 12330069
Eni Kusrini 14330039
Rebbeca Theovany S 12330077 Linda Wahyuni 14330048

Dosen : Rara Merinda Puspitasari, M.Farm. Apt

Type of study Alternate name Unit of study
Observational studies
Descriptive studies
Analytical studies
Ecological Correlational Populations
Cross-sectional Prevalence Individuals
Case-Control Case-Reference Individuals
Cohort Follow-up/ Longitudinal Individuals
Experimental/ intervention Studies
Randomized Controlled Clinical Trial Patients
Studies
Field Trial Healthy person
Community Trial Community intervention Communities
studies
Eni
Risna
 CASP

Randomised controlled trial

new treatment

group 1 Outcome

inclusion/
population exclusion

group 2 Outcome

control treatment

Syena
Randomised Controlled Trials (RCTs)
 A planned intervention study in which each member of a
study population has the same chance of receiving one or
more experimental or control treatments

Mia
 Advantages
 Efficient for investigating causality because ‘cause’
precedes the ‘effect’
 Possible confounding factors balanced
 Randomisation facilitates simple statistical analysis
 Practical way to minimise several sources of bias
(notably, selection bias)

Mia
 Disadvantages
 Requires rigorous control of the allocation process
 Can be long and/or expensive
 May not be ideal for rare conditions or problems with a long
latency
 Generalisability (often screen out vulnerable groups)
 Beware the volunteer!

Linda
Dini
WHAT IS OFF-LABEL USE?
 Prescribing medication in a way that differs from
the BPOM /Marketing Authorisation (MA),
approved label.

 Can include changes in:

 Disease being treated
 Dosage
 Method of administration
 Patient demographics

Nia
Data analysis

 Comparing the data with drug brochures and books then

evaluated using a reference Ioni cross-tabulation and
frequencies SPSS

Nia
The percentage of off-label drug based
class of drugs

Riri
Analysis of off-label criteria

Riri
Rebecca