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Journal : Indonesian Journal of Pharmacology and Therapy

Biomarkers improving decisions making in clinical trials: explanations and examples Faiha, Dhea Kirana; Lupitasari, Florentina Bety Indah; Fitria, Humairah; Salamah, Umi; Supriyati, Vidia Ajeng
Indonesian Journal of Pharmacology and Therapy Vol 5 No 3 (2024)
Publisher : Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada and Indonesian Pharmacologist Association or Ikatan Farmakologi Indonesia (IKAFARI)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/ijpther.13088

Abstract

Biomarkers are originate from physiological processes, medical imaging, tissues, or chemicals. They are potentially useful indicators for every type of disease and have important roles on drug discovery and development, disease progression tracking, prognosis, diagnosis, and therapy response. Biomarkers provide precision measurement results, lower bias result, also faster early warning signal. Therefore, they can be used as a basis for clinical decisions. Biomarkers found in tissues, blood, and other bodily fluids. Depend on their purpose of usage, biomarkers can be categorized of diagnostic, prognostic to predicts disease progression, pharmacodynamic to measures the effect of a drug on a biological system, and predictive to predicts response to a specific treatment. In clinical trials, biomarker can be used as basic of decisions making. Therefore, several steps required to incorporate biomarkers in clinical trials are determine roles and functions of biomarkers, choose specific test and laboratory according to purpose of trial, describe test and protocol, carry out and report analysis validation appropriate for trial, implement test in trial, and plan sustainability of biomarker uses in future research. Biomarker have been used as basis of decision making in clinical trials in phase I-IV to recruit participants or making a decision whether the trial will be terminated or continued. In this review, we outlined general explanations about molecular biomarkers, step of biomarkers incorporation in clinical trial, and examples of several studies using molecular biomarkers in clinical trial as basis of decision-making.
Co-Authors - Jenuri, - Abdul Bashith Abdurrahman, Annas Agus Budianto Agus Naba Aishnabila, Shinta Akhwani Akhwani, Akhwani Al Khowarizmi Alwiyah Alwiyah Andi Prastowo Andromeda Andromeda Anggraeini, Cita Anggraeni Dwi Puspita , Reny Anggraeni, Feny Dwi Apik Rusdiarna Indra Praja Aprilia K. D, Novi Ardi, Subhan Zul Arofi, Mohammad Fahmi AS, Adelia Atina, Vihi Azahra, Elsa Azkia, Soviatul Bahtiar Bahtiar Bambang Gonggo Murcitro Barchia, M Faiz Bustaman, Hendri Bustaman, Hendri Cornelia Sugijantoro, Alviana Dewi, Mellita Diah Agustina Prihastiwi Djutaharta, Triasih Dwi Ardiansyah, Nico Dwi Finna Syolendra Eka Saputra, Helfi Elen Puspitasari Endang Sumarti Ery purwanti Esti Suryani Faiha, Dhea Kirana Farizza, Rifqi Al Fatkhurozak, Fatkhurozak Fauziah, Salsa Alya Fernando, Riky Firdausiyah, Luluk Fitria, Humairah Ghozali Maski HAJRIAL ASWIDINNOOR Halimatus Sa’diyah Hanis Ratnasari Hariyadi Soetedjo Haryadi, Bagus Herlawati Herlawati Herman, Welly Heru Widiyono, Heru Hidaayah, Nur Hidayatulloh, Arif Hilmi, Isom Humang, Windra Priatna Husna, Muhimmatul I.P, Apik Rusdiarna Ilfi Nur Diana Indah, Erna Nikmatul Intan Chairun Nisa Joni Iskandar, Joni Juliadi, Ertawan Kasuwi Saiban Khasanah, Muthi’atul Khasbulloh, M. Wahab Khodijah Khodijah KHOIRUL ANAM Kusuma, Damar Yoga Kusumo, Djati Wulan Lioni Anka Monalisa, Lioni Anka Lismaiyar Lula Nadia Lupitasari, Florentina Bety Indah M Choirul Muzaini M. Luthfi Oktarianto M. Yamin Jinca Mahir, Imran Makhrus, Ali Mardhotillah, Rachma Rizqina Marwanto Marwanto, Marwanto Mas’udah, Laili Maulana Fatih Falahuddin Mayadiana Suwarma, Dina Merakati Handajaningsih Misbahul Munir Moestin, Moestin Mohamad Yusak Anshori Mufidah, Yasmin Muhammad Nasir Muhammad Taufiq Muharjono, Muharjono Muliyono, Nurwakhid Mulyana, Desi Nurlaela Muryani, Susi Nadatien , Ima Nadhif, Moh. Nafi’ah, Nafi’ah Naysilla, Nawang Nindita, Anggi Noviyanti, Rinda - Novyriana, Ekka Nugraha, Nursila Dwi Nur Hayati Nur Khasanah Nurhidayati, Titin Nurlaily, Diana Oktira Roka Aji Panggabean, Donwill Permatasari, Eka Diana Persada, Yuris Indria Pradityo Utomo Pratama, Fadil Priatna, Agnes Hilmi Purwanto, Bulan Putri, Della K. Putri, Masmoni Ade Qonitatul Hidayah Qonitatul Hidayah Qusaeri, Muammar Afif Al Rahmat Rahmat Rahmatan Idul Rahmawan, Rizki Dwi Rahmayani Rahmayani Ratnasari, Khurin'in Raudhatun Nuzul ZA, Raudhatun Razak, Faisal Rizki, Aji Nur Rofiatul Hosna Rofiq, M. Nafiur Rokhyanto Rokhyanto, Rokhyanto Rossa Puteri Baharie, Sri Sa'dun Akbar Said, Achmad Said, Akhmad Salsabila, Alfiyyah Samosir, Omas B. Sayama Malabar Setyawan Purnomo Sakti Sihwi, Sari W. Singgih Purnomo Siti Helmyati Siti Mutholingah Sopar Sri Handayaningsih Sri Rosita Sumardi . Sunarti, Zeni Supanjani, Supanjani Supanjani, Supanjani Supriyati, Vidia Ajeng Susanto Susanto Triyo Supriyatno Ubaidillah, Ibnu Ulfa, Mariya W Udi, Siti Muslima Wahyu Adhi Saputro Wahyuni Ganefianti, Dwi Widhiastuti, Ratna Widodo, Yessy Pramita Wiharto Wiharto Wiharto Wiliyanto, Wiliyanto Willy Bayuardi Suwarno Wisnu Widiarto Yenny Sariasih Yudha, Ery Permana Yudi Ari Adi, Yudi Ari Yulia Fitri Yuni Astuti Yuniasari, Fenni Yuniawatika Zaenal Abidin Zaenu Zuhdi Zaki, Amin Zul Ardi, Subhan