√ 7 Tahapan UJI KLINIS OBAT

Tahapan uji klinis obat – pentingnya uji klinis obat harus diterapkan di semua industri farmasi yang memproduksi obat-obatan sebelum diedarkan di pasaran. Tahapan uji klinis obat ada beberapa tahapan yang harus dilalui satu persatu oleh semua produsen pabrik farmasi sebelum obat dipasarkan. Masing-masing tahapan uji klinis obat memiliki tugas fungsi masing-masing sesuai dengan prosedur tentang standar uji klinik obat di pabrik tersebut. Maka dari itu dapat dipastikan jika ada obat di pasaran yang memiliki mutu jelek dan tidak berkhasiat maka standar uji klinik obat di pabriktersebut belum memenuhi standar parameter uji klinik obat yang ditetapkan oleh pemerintah. 
Dalam dunia medis masa kini, setiap macam obat hanya boleh diproduksi, diedarkan dan digunakan terhadap pasien setelah diuji dan dibuktikan khasiatnya serta dilakukan uji toksisitas obat untuk menentukan racun melalui uji klinik yang memenuhi prinsip-prinsip ilmiah. Prosedur uji klinik obat harus memperhatikan persyaratan kepraktisan dan mampu-laksana, secara berlanjut mengalami perkembangan dan penyempurnaan dari masa ke masa. Penguasaan prinsip – prinsip dasar uji klinik demikian dibutuhkan untuk dapat melaksanakan pengujian obat-obat baru yang jumlahnya berkembang dengan pesat.
Pengertian Uji Klinis Obat                    
Uji klinis adalah seperangkat prosedur dalam penelitian farmakologi klinis untuk menilai atau menguji suatu zat berkhasiat pada manusia, guna menentukan pengobatan yang paling tepat untuk penyakit tertentu dan untuk memungkinkan diperolehnya informasi tentang reaksi obat yang merugikan dan efek samping, serta kemanjuran data yang akan dikumpulkan untuk intervensi kesehatan (misalnya : obat-obatan, diagnostik, perangkat, dan terapi protokol). Tujuan uji klinis adalah untuk menguji efektifitas suatu obat/pengobatan pada sekelompok manusia sehat/ penderita dalam jumlah terbatas supaya hasilnya dapat diterapkan pada penderita lain di kemudian hari secara rutin.
Dalam percobaan pra klinik belum menggunakan subyek manusia. Pengaruh-pengaruh suatu obat baru diselidiki pada hewan percobaan. Setiap obat yang ditemukan melalui eksperimen in vitro atau hewan coba tidak terjamin bahwa khasiatnya benar-benar akan terlihat pada penderita. Pengujian pada manusia sendirilah yang dapat menjamin apakah hasil in vitro atau hewan sama dengan manusia.
Penelitian dan pengembangan obat obat baru diawali dari penemuan zat yang memiliki efek farmakologis, sampai dapat digunakan secara klinis, dan biasanya melalui beberapa tahapan uji berikut ini, antara lain :
1. Drug Screening, atau penapisan obat, yaitu pencarian dan penemuan obat baru yang berkhasiat farmakologis.
2. Preclinical Testing, yaitu pengujian pada binatang percobaan, bertujuan untuk menguji keamanan pemakaian obat tersebut, seperti uji toksik, efek farmakodinamika, efek farmakokinetika, dan pengaruh obat terhadap organ tubuh serta dosis yang efektif dan aman bagi manusia.
3. Clinical Trial, yaitu uji klinis.
Secara garis besar ada 4 tahapan uji klinik obat, yaitu :
Farmakologi dan Toksikologi, untuk menentukan batas keamanan dan efektivitas obat dan dilakukan terhadap hewan, biasanya mencit, tikus, dan kera. Pada hewan, dalam penelitian pra klinik, telah diteliti sifat-sifat farmakologik suatu obat baru.
4. Fase 1 , fase ini merupakan pengujian suatu obat baru untuk pertama kalinya pada manusia. Yang diteliti ialah keamanan obat, bukan efektivitasnya, maka biasanya dilakukan pada 20 – 50 sukarelawan sehat. Tujuan penelitian fase ini ialah meneliti sifat-sifat farmakologik obat tersebut sehingga tercapai efek terapeutik maksimum.
5. Fase 2, untuk menentukan dosis terapi obat. Pada fase ini obat dicobakan untuk pertama kalinya pada sekelompok kecil penderita yang kelak akan diobati dengan calon obat. Untuk membuktikan bahwa suatu obat berkhasiat, perlu dilakukan uji klinik komparatif untuk membandingkannya dengan plasebo, atau bila plasebo tidak memenuhi syarat etik, obat dibandingkan dengan obat standar yang telah dikenal. Ini  dilakukan pada akhir fase 2 atau awal fase 3. Jumlah subyek yang mendapat obat baru pada fase ini antara 100 – 200 penderita.
6. Fase 3, untuk memastikan bahwa suatu obat baru benar-benar berkhasiat (sama dengan penelitian pada fase 2) dan untuk mengetahui kedudukannya dibandingkan dengan obat standar. Keputusan untuk memasuki fase 3 diambil bila para peneliti yakin bahwa rasio manfaat dibanding resiko obat itu dapat diterima. Pasien yang dilibatkan paling sedikit 500 orang.
7. Fase 4, uji klinik setelah obat dipasarkan, jika diminta oleh badan yang berwenang. Fase ini sering disebut Post Marketing Drug Surveillance karena merupakan pengamatan terhadap obat yang telah dipasarkan. Dapat dikatakan fase 4 mencakup semua penelitian yang telah dilakukan setelah obat baru mendapat ijin untuk pemasarannya. Oleh sebab itu penelitian fase 4 harus didesain untuk mengungkapkan :
a. Efek samping akibat penggunaan
b. Manfaat obat dalam penggunaan jangka panjang
c. Data – data komparatif lainnya dalam penggunaan jangka panjang
d. Pengunaan – penggunaan baru dan indikasi baru
e. Penilaian kemungkinan penyalahgunaan obat
f. Penilaian kemungkinan penggunaan obat secara berlebihan
g. Interaksi obat dengan obat lainnya.
Waktu yang diperlukan untuk pengembangan suatu obat baru, mulai dari sintesis bahan kimianya sampai dipasarkan, mencapai waktu 10 tahun atau lebih. Setelah obat dipasarkan dan digunakan secara luas, dapat ditemukan kemungkinan manfaat lain yang mulanya muncul sebagai efek samping. Obat demikian kemudian diteliti lagi di klinik untuk indikasi yang lain, tanpa melalui uji fase 1. Hal seperti ini terjadi pada golongan salisilat yang semula ditemukan sebagai antireumatik dan antiipiretik. Efek urikosurik dan anti plateletnya ditemukan belakangan.
Demikian sedikit ulasan mengenai beberapa tahapan uji yang dilakukan pada obat sebelum dipasarkan. Semoga ulasan tentang tahapan uji klinis obat ini dapat bermanfaat dan menambah wawasan anda

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