DRUG DEVELOPMENT PROCESS:
Drug development starts at R&D and ends at chemist. The
process time are 12-15 years and cost around 10 thousand corers. At the
starting of trial we start up with 30000 compounds and ends up with 10
compounds. On resultant compounds clinical trial begins.
PHASE-0 : The first stage of clinical trial is
Preclinical trials or phase 0 studies or animal testing (1.5-2 yrs.)-
To find out toxicity of compound. Single ascending dose and multiple ascending
doses are given to animals to know toxicity. This data is submitted to FDA to
obtain IND (Navigational New Drug).
After IND approval we are eligible test drug on human this
process will conducted in 3 phases.
PHASE-1: We will find out pharmacokinetic properties around
20-80 healthy volunteers. These studies are done to know the safety of drug.
PHASE 2: These are exploratory studies done on around
100-300 subjects. We will know the efficacy reconsidering the safety. These is
done on target study population.
PHASE 3: these are large clinical trials on populations
number in 100 to thousands of patients .these are done to show that new drug is
both safe and efficacious n target study population if these are successful we
will get NDA (new drug application) approval. This means the drug is ready for
marketing.
PHASE 4: these are post marketing trials conducted to
monitor long term safety of new drug after drug is already in market.
CLINICAL DATA MANAGEMENT:
The sponsor and investigator and statistician will prepare
the protocol or sponsor will handle the investigation to the CRO. Where CRO
appoints the investigator and statistician .the investigator conduct the study
as per protocol and collects the laboratory values of study subjects and
the statistician designs the statistical plan as per protocol. The
investigator will fill the CRF sends back filled CRF to data management team.
Mean while the DM team will design the data base and data entry will done by 2
different people .2 people will enter the same information and third person
will check the consistency of data the non CRF data like lab data will be loaded
in to data base by data base loading or data loading. After data entered in to
data base batch validation will be performed on data at regular intervals in
order to find any miss matches or errors.
After data base is completely validated we lock and freeze
the database so that we can prevent any further modification. After database is
locked and freeze biostatic team will extract the database in to sas datasets.
BIOSTASTICS :
Biostastics comprises of 2 teams one is sas programmers other
statistician . statisticians is responsible to analyze reports created by SAS
programmer and draw conclusions based on the data. Sas programmer is
responsible to create reports like TLF (Tables,Listings,Graphs/Figures) which are
created from derived datasets.
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