Académique Documents
Professionnel Documents
Culture Documents
RESEARCH DESIGN
OBSERVATIONAL EXPERIMENTAL
Descriptive
Exposures & outcomes are measured at the same time
Analytic
Outcome Cause
RCT
Exposure Disease
Quasi experimental
Crosssectional
Cohort Study
We typically have a particular cause in mind, and want to know if it has an effect on an outcome, and if so, to what degree.
Definitions
Independent Variables (IVs)
What is being manipulated or changed by the researcher, e.g., hypertension, hyperlipidemia, smoking, life style
Definitions
All variables other than the IVs that may have caused the DVs that the researcher didnt take into consideration in the design E.g.: age, income, geographic location, competitors actions, weather conditions, world events, time of day, consumers mood, etc.
Extraneous Variables
Terminology: Experiment
An investigation in which
Experimental Study
Definitions
Experimental group (EG) Control group (CG)
A group not exposed to changes or manipulations that serves as a baseline comparison to the experimental group
Definitions
Internal validity Extent to which change in the DV is due to manipulation or changes made in IVs and not extraneous variables External validity
Extent to which results of the experiment are generalizable to the real world
The cause must precede the effect The cause must be related to the effect We can find no other plausible alternative explanation for the effect other than the cause
RCT
Investigator
Participants
Clinical Manoeuvre
RCT
Quantitative
Comparative
Control Experiment
Objectives of RCT
RCT
Drug patient population
Efficacy
Safety
Kategori Evidence
Ia Ib IIA IIb
evidence dari meta analisis pada RCT evidence dari minimal 1 RCT evidence dgn kelompok kontrol, tanpa randomisasi evidence dari suatu quasi experimental evidence dari nonexperimental/descriptive study evidence dari laporan Expert Committee/pendapat ahli
III IV
Explanatory Trial
inclusion criteria sangat ketat highly homogeneous study groups Mis. Hanya pasien usia 40 50 tahun, tanpa penyakit penyerta
Pragmatic Trials
Memasukkan subyek dengan karakteristik yang heterogen Sesuai dengan pasien yang ditemui di ruang praktek Menggunakan kontrol aktif (mis antihypertensive vs. b-blocker), flexible regimens
Efficacy trials
Effectiveness trials
Ideal setting
Semua variabel yang berpengaruh thd outcome dikendalikan e.g. Keparahan penyakit Ketaatan minum obat, Setelah/sebelum makan
Real setting
Fase I
sukarelawan sehat efek samping & toleransi hubungan dosis-efek farmakokinetika uncontrolled subyek terbatas kemungkinan efek tx controlled trial efek terapi definitif pms efek samping yg jarang
DESIGN
(RCT-parallel design)
RCT-parallel design
Random
Treatment B
eligible
Treatment A Random
Treatment B
O U T C O M E
Treatment B
Treatment A
O U T C O M E
RCT-factorial design
Patient
tx A
eligible Random Tx B
tx A + tx B
O U T C O M E
RCTs according to whether the investigators and participants know which intervention is being assessed
Non-random selections
Non-random assignments
PRECLINICAL TRIALS :
Experimental research
In vivo & in vitro research Utilize animal models
Consist of :
Pharmacodynamic studies Toxicological studies
Potency Very high High Intermediate Less toxic Nearly toxic Relative nontoxic
LD50 value (Pure compound) < 1 mg / kg. BW 1-50 mg / kg. BW 50-500 mg / kg. BW 500-5000 mg/ kg. BW 5-15 g/ kg. BW > 15 g/ kg. BW
The most common measure of acute toxicity is the LD50 LD50 and/or ED50 value, depends on the route of administration
In vivo
Whole animals
In vitro
Isolated organs and tissues Blood and its components Cell culture, etc.
Methods
-In vivo
Advantages
-Biochemical and physiolo gical function are normal -May predict effect in human -Least expensive -Mechanistic effects -Molecular level
Disadvantages
-May not provide mechanistic effects -May not provide metabolic activati on ( e.g. prodrug)
-In vitro
ANIMALS :
Rodent or nonrodent (may depend on desired effect) Healthy or diseasedanimal model Sex : male and/or female Number : adequate for statistical analysis
Route of administration :
Per Oral- similar to human use
Dose :
Based on Dose-Response Relationship One or more doses that provide a desired effect Dose conversion from human to animal Calculation of ED50
Control group :