KELOMPOK 1

INFORMASI OBAT
Randomized Clinical Trial (RCT)
& Off Label
Mia Khana Kallista
14330007
Risna Islamiah 12330046 F ikriyah Dzaki
Dini Oktaviana 12330066 14330015
Mia Aty Dolok Rosa
Syena Azwari 12330069
14330024
Rebbeca Theovany S Eni Kusrini 14330039
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/ Individuals
Longitudinal
Experimental/ intervention Studies
Randomized Clinical Trial Patients
Controlled
Studies
Field Trial Healthy person
Community Trial Community intervention Communities
Eni
studies
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