23.02.05 () 17:32

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[Į] DCTô븦 غ
ϸ 2022-08-16 06:00:25
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[Į] DCTô븦 غ
ϸ 2022-08-16 06:00:25
̿ ̱۷ιĸ ǥ



  ̿ ̱۷ιĸ ǥ
DCT(Decentralized Clinical Trial: л ӻ) ӻ ߽ Ǿ ִ. 6 ī DIA Global Conference DCT ȸ ټ ߴ. ǿ DCT ǥ . DCT ʿ伺̳ Ǵ ٴ (sign)̴.

DIA Global Conference CRO ڽŵ DCT ش. ȯڸ ȸ Clara Health DCT Ǵ 񽺸 ϴ ȸ зϰ  150 ȸ 췮 DCT ȸ ǥߴ. Clara Health ǥ Ʈ Ե ʾ ټ ȸ鵵 DCT Ʈ ϰ ִ. Ǯ DCT ô밡 ̴.

DCT ڷγ19 ۵Ǹ鼭 Ͽ. ׷ DCT 40 ־ ߰ ̵ DCT ӻ ־. 츮 𸣰 ־ ̴.

˷ DCT PHS (Physicians' Health Study: ǻǰ). PHS1 PHS2 ִµ PHS1 1981⿡ Ͽ 1989 1996⿡ ǥ ӻ̴. PHS1 ƽǸ(aspirin) ɱٰ ȿ Ÿīƾ(beta-carotene) ȿ ϱ Ը ӻ̴. ̱ǻȸ (American Medical Association) 40~84 ǻ 26 , 22,071 ġ ܰ(run-in period) ļ 4 Ǿ ߸Ͱ Ǿ.

4 ƽǸ Ÿīƾ 뱺 ƽǸ Ÿīƾ 뱺 ƽǸ Ÿīƾ 뱺 ƽǸ Ÿīƾ 뱺, δ 2x2 (factorial design)̶ Ҹ. ׻ õ Ǿ ڰ ´. ڵ ǻ̱ ڽ ׻ ٹϴ äϿ ־ ̴. ׸ ̽, 6, 1, Ŀ ų 2 з ϵ Ͽ.

ǻ̱ ڽ ǰ ¸ ־. PHS ÿ ̸ϵ ͳݵ ô뿴 Ƴα׹ ߴ. PHS1 ƽǸ ɱٰ ̴ ȿ ְ Ÿīƾ ǰ ƹ ȿ ٴ ̾. ӻ ݵ 뷮 ƽǸ ȯ ȯڿ óϰ ִ.

PHS Ƴα ε ߿ ӻ ϴٴ ־ ̷ ӻ ֱ DCT ϰ ̴. DCT ƴϴ. ̹ 1981 Ǵ Ͽ. DCT ü ôϴ 츮 Ƿ谡 ̻ ̴.

IT 40Ⱓ νð ϸ鼭 DCT Ƴα׿ · ȭϿ. DCT Ǿٰ ؼ ӻ Ģ ޶ ƴϴ. ϴ ̸ϰ ͳ Ȱ ̴. Ƴα DCT DCT ߴ Ÿ ִ.

ӻ Ʈ ȸ Florence Healthcare DCT ߻ ִ 9 ߴ.

1. ӻ ڵ ؿ ǰ ְ ӻ ٸ ִ. 'Digital divide' ٴ ̴.

2. DCT ȯڰ ߽ Ǿ ӻ Ǹ鼭 ҵǰ ӻ ȯڿ ӻ 鼭 ȯ (protocol) ؼ ִ.

3. ȯ ȣ ʰ ִ.

4. ο Ʈ ؾ ϸ ׷ ڴ иġ ʴ.

5. ӻ ڵ ο ð ؾ Ѵ. Ʒõǰ ִ CRC CRA ū δ ִ.

6. ȯڵ  , Ʈ ο Ѵ. ο δ㰨 Ŭ ִ.

7. CRC Ǵ ӻǻ ų پ ¿ Ŀ ο Ͽ ߸ǰų Ȯ Է°ɼ ִ.

8. DCT 뼺 м ִ.

9. ͸ ϰ ݺ ϰ ִ.

DCT Ǵ ǰ ̿ܿ پϰ Ÿ. ȯ ټ , ؿ ǰ ̰ Ÿ ְ ̿ ǰ ̵ ִ. ̴ DCT ڴ ƴ϶ DCT ȹϸ鼭 ؾ ̴.

ֱ DCT ȭǾ ִ DTx (Digital Therapeutics) ӻ迡 εǰ ִ. ռ Ǿǰ ʿϴ.

Ǿǰ Ǿǰ(virtual drug) Ǿǰ(conventional drug) з . DTx (Virtual Reality, VR) ġḦ ϳ īװ Ǿǰ̶ θ . Ʈ ġ̴. 츮 ˰ ִ Ǿǰ Ǿǰ̶ θ.

Ǿǰ Ǿ Ǿǰ Ǿ Ǿǰ ϰ ȿ Ǿ ϸ ݵ ӻ ľ Ѵ. ӻ Ģ α ȣ (integrity) ϴ ̴. Ģ Ǿǰ Ǿǰ ο ȴ. Ǿǰ ݿ ټ ٸ Ģ ٸ .

ӻ ӻ Ģ ĸ ϴ. 1980 PHS DCT ̿ õ . ӻ Ģ ϰ װ ޾Ƶ鿩.

ǹ  Ǿǰ Ǿ ӻ Ģ Ű鼭 ӻ ǵ /ϴ ̴, ӻ ħ(guidance) ̰ ȭѴ. 'ħ' '' ϸ ȴ. ӻ å и ؾ Ѵ,

ľó '  Ǿǰ ӻ ' . ӻ Ǵ ӻ Ģ װ ICH ̵ο Ͽ Ͽ ϴ.

DCT ӻ ̴. ݱ ˰ ִ /ǻ߽ ӻ DCT ϴ ƴϴ. DCT ȯ Ǹ ߿ϰ ð ϸ鼭 ǰ ͸ ϴ ϳ ̴. ť ϸ 2013 2021 241 ׾ӻ コ Ͽ Ǿ. ̱ FDA Oncology Center of Excellence ׾ DCT غ ̴. ӻ ϴ ƴ϶ ӻ ̲ ٴ иϰ ִ ʶ ̴.

DCT ϴ  ִ 캸Ҵ. ̷ Ǯ ̸ ľó DCT ʴ .

DCT ƴϴ. ľó DCT ʴ Ͱ ؿܿ Ǵ ž ӻ DCT . ӻ ν ӵ ȭϰ ִ.

DCT 𸣸 ž ̱ ӻ迡 и ִ. CRO ̵带 ޾ư鼭 ӻ ϱ ̴. 츮󿡼 CRO 踦 ȭ ؾ Ѵ. CRO ICH ̵ο и Ǿ ִ. 谡 ƴϴ. CRO ICH ̵ . ľó å ̿ DCT ô븦 غ ؾ ̴.

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ֽż ݴ
ٺ Ϲݾ ǸŰ (2023 02)
౹ 62
ǰ ְ
ڶ(20) 6,500 5,500 1,000 5,954
ѽŻ÷(10) 3,500 2,200 1,300 2,824
޾(100) 25,000 22,000 3,000 23,323
Ʒγΰ(100) 30,000 24,000 6,000 27,294
īɾ(10g) 7,500 5,300 2,200 6,450
Ľõ򿬰(5g) 5,500 4,000 1,500 4,579
Ź(4) 5,000 3,500 1,500 4,182
λ絹÷(100) 35,000 3,000 32,000 32,310
̰źĸ(100) 35,000 30,000 5,000 32,293
(10) 5,500 4,200 1,300 4,937
Ժ(10) 4,000 3,000 1,000 3,362
ڱ׸(20) 5,000 3,500 1,500 4,260
ť(10) 3,500 2,200 1,300 2,769
Ȱť(1) 1,200 900 300 1,002
Ǯɾ(3.3ml) 27,000 23,000 4,000 25,036
޵𿬰(10g) 7,000 5,500 1,500 6,185
öŸ(34) 13,000 10,000 3,000 11,168
뽺ī(20g) 22,000 18,000 4,000 20,050
ġ(1) 1,000 900 100 1,000
ӽ÷(21) 10,000 7,500 2,500 9,170
ͺ(10) 3,000 2,500 500 2,893
ݿ(1ڽ) 3,000 2,000 1,000 2,777
׶÷糪ƮŸ(6) 8,000 6,000 2,000 7,427
߽Ÿ(120) 70,000 45,000 25,000 55,733
Źĸ(10ĸ) 3,000 2,500 500 2,920
Ÿ̾(120) 60,000 40,000 20,000 51,345
տ(60ĸ) 30,000 24,000 6,000 27,636
Ÿ̷ER(6) 3,000 2,000 1,000 2,465
ٿ(30g) 12,000 8,500 3,500 10,375
(120) 25,000 18,000 7,000 22,341
Ʒ(6) 4,000 3,000 1,000 3,292
ǽõĸ(270ĸ) 110,000 90,000 20,000 99,087
B(120) 70,000 60,000 10,000 60,588
׳(10) 3,000 2,000 1,000 2,589
6̺(10) 3,500 2,500 1,000 2,991
(60) 250,000 200,000 50,000 221,667
Ⱦ 12,000 9,000 3,000 10,873
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