Clinical Trials
Ⅰ. About Clinical Trial.
1. Definition of clinical trials
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
2.
Clinical test
Clinical trial is limited to human, therefore it is the precondition that ensuring ethicality with scientific validity of study.
Necessity of Clinical test
- Developing a new drug for Korean inherited trait
- Offering the earliest opportunity to patients
- Strengthening the capability of researchers
- Clinical trial has high added value
It is a plan th
three more patients will be treated.
Continual Reassessment Method(CRM)
All patients are
treated maximum tolerated dose.
(MTD)
The original CRM allowed for multiple dose escalations and de-escalations.
Accelerated
Titration
Design(ATD)
Standard design is used after the accelerated phase as a stopping rule.
Estimate the MTD with all toxicity data collected during the trial.
Necessity of Clinical test
- Developing a new drug for Korean inherited trait
- Offering the earliest opportunity to patients
- Strengthening the capability of researchers
- Clinical trial has high added value
It is a plan that recorded specific details
· How clinical trials should be performed
Including all aspects of the research study
· participant inclusion / exclusion
*’Nano’ means….
Nanometer: one billionth of a meter
Nano-: prefix comes from the Greek word for ‘dwarf’
Chemical, physical, and biological properties that differ from those of their larger, or bulk counterparts
Nanotechnology: The National Nanotechnology Initiative(NNI)-> the science of materials and phenomena in the range of 1 to 100nm in diameter
*Features of ‘nanoparticles
History of sulfonylurea
IPTP for typhoid fever(장티푸스) in early 1940s
Many patients died. – acute & prolonged hypoglycemia
Carbutamide
effective oral hypoglycemic
Firtst sulfonyluea hypoglycemic
WHAT IS GOUT
Gout
caused by abnormally elevated levels of uric acid in the blood (sUA *> 6.8mg/dL ) resulting in a build-up uric acid crystals throughout the body
* sUA :serum uric acid
Typical patient - young male(18–30yrs)
First, chronic pain and stiffness
in the lower part of the spine.
Associated with an inflammation of the eye, fatigue and sometimes nausea.
Tumor necrosis factor-alpha (TNF α)
& IL-1
90% of the patients express
HLA-B27 genotype
Medication- Anti-inflammatory drugs- Disease-modifying antirheumatic drug- TNF-α blocker(pr
Common Cold Flu
리노 바이러스, 코로나바이러스 등
200여종 인플루엔자 바이러스
콧물, 코 막힘, 목 아픔, 기침과 근육통
드물게 열 두통, 발열, 오한, 근육통과 같은 전신 증상이 목 통증과 기침
But most of them were unsuccessful because of their lack of efficacy a
Background
Continue to threaten global health. (Covid-19)
Older age, current smoking, or underlying clinical conditions such as cardiovascular disease, diabetes, obesity, and cancer : high risk for severe Covid-19 and associated adverse outcomes.
Twice as likely to have progression to severe Covid-19 and five times as likely to die from Covid-19 as patients without those conditions.
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