• Become actively involved in your healthcare.
• Learn new information about your medical condition or disease.
• Gain access to new medications or treatments and receive comprehensive expert medical care during the trial, usually at no cost to the patient.
• Receive follow-up monitoring to ensure your safety and that the new medication or treatment works as intended.
• Help others by contributing to medical and scientific knowledge that will improve medical treatment and patient care.

A clinical trial is an investigation of the effectiveness and safety of a new drug or new treatment or new medical device on a group of patients. Clinical trials are an extremely vital process in advancing medical care and treatments.

Private companies (generally pharmaceutical, medical device or biotech companies) or government agencies usually sponsor most clinical trials. In most cases they work together with public & private hospitals and universities.

An Ethics Committee (also known as an Institutional Review Board) will carefully review and approve the clinical trial before it can be implemented to ensure your rights and safety are protected and given the utmost priority. An Ethics Committee is composed of a group of scientific and non-scientific experts in various specialities and disciplines. Their role is to ensure that the clinical trial has a legitimate medical purpose, is safe for participants and will benefit the community.

Clinical trials are usually held in hospitals, universities, medical centres or doctor’s clinics. The actual implementation of the trial will be conducted by a research team that is led by a senior doctor known as the Principal Investigator. The team may also include nurses, pharmacists, dental officers, dieticians, social workers, and others, depending on the requirements of the trial.

Each clinical trial will have different requirements for participants such as age, sex, medical condition, etc. These requirements are known as the inclusion-exclusion criteria. The research team will make an evaluation based on the inclusion-exclusion criteria to decide if you are eligible to participate in the trial. The team also has to undertake an “Informed Consent” process to educate you on the potential risks-benefits of participating in the clinical trial.

Informed Consent is a process that takes place before you enroll into the trial. A qualified member of the research team will explain the purpose and objectives of the trial, the procedures involved, and the risks-benefits involved. You have the right to ask any questions you may have about the trial. You will be informed about how your personal medical history will be kept confidential and who are authorized to view it. If you decide to take part in the trial, you will be asked to sign the Informed Consent form. Please ask questions about any part of the Informed Consent form that you do not understand. Please note that even after you have signed the form, you will always have the right to change your mind and withdraw from the clinical trial at any time.

During the trial period, the research team will review your medical history, give you instructions on what to do and when-and-how to do it and monitor your health carefully. Some clinical trials may need regular tests and doctor visits. In most cases, this high standard of medical care is paid for by the trial sponsor.

Clinical trials are designed to minimize risks to their participants while maximizing the potential benefits to the community. While participants’ safety is the most important aspect in every clinical trial, there are however, some potential risks involved. These are summarized below:

• There may be unpleasant or unwanted side-effects caused by the new drug or treatment being studied.
• The new drug or treatment may not be effective.

Talk to your doctor to see if you would benefit from participating in a clinical trial. Your doctor can find out what clinical trials relevant to your medical condition that are going on or will soon be initiated by contacting Clinical Research Malaysia (CRM) or the Clinical Research Centre (CRC) Units in major public hospitals.

PRINCIPAL INVESTIGATOR OR STUDY PHYSICIAN
A medical researcher in charge of carrying out a clinical research trial.

CLINICAL RESEARCH TRIAL
A process designed to study the effects and/or safety of a new medication, treatment or medical device on a group of patients.

INFORMED CONSENT
A discussion of procedures, benefits and risks of a clinical trial between clinical investigators and persons interested in participating in the trial. The clinical investigators must reveal all relevant information pertaining to the trial. Persons who decide to volunteer for the clinical trial will have to sign an Informed Consent form to indicate they understand and accept what is expected of them and the risks-benefits associated with the clinical trial.

• Penglibatan secara aktif dalam penjagaan kesihatan anda.
• Mempelajari tentang keadaan perubatan atau penyakit anda.
• Akses kepada ubat atau rawatan baru dan menerima rawatan lengkap daripada pakar sepanjang jangkamasa kajian, biasanya tanpa sebarang kos kepada pesakit.
• Menerima pantauan susulan untuk memastikan anda dalam keadaan selamat dan ubat atau rawatan yang diberikan berfungsi dengan sepatutnya.
• Membantu mereka yang lain dengan menyumbangkan pengetahuan perubatan dan saintifik yang dapat meningkatkan rawatan perubatan dan penjagaan pesakit.

Kajian klinikal ialah penyelidikan tentang keberkesanan dan keselamatan ubat atau rawatan atau alat perubatan baru ke atas sekumpulan pesakit. Kajian klinikal merupakan proses yang amat penting untuk kemajuan penjagaan dan rawatan perubatan.

Kebanyakan kajian klinikal pada lazimnya ditaja oleh syarikat swasta (pada amnya, syarikat farmaseutikal, alat perubatan dan biotek) ataupun agensi kerajaan. Dalam kebanyakan kes, mereka berkerjasama dengan hospital dan universiti awam dan swasta.

Jawatankuasa Etika (juga dikenali sebagai Lembaga Kajian Institusi) mesti memeriksa secara teliti dan meluluskan kajian klinikal sebelum ia boleh dijalankan untuk memastikan hak dan keselamatan anda dilindungi dan diberikan keutamaan. Jawatankuasa Etika terdiri daripada sekumpulan pakar saintifik dan bukan saintifik dalam pelbagai pengkhususan dan disiplin. Mereka mesti memastikan kajian klinikal tersebut mempunyai tujuan perubatan yang sah, selamat untuk para peserta dan akan memanfaatkan masyarakat.

Kajian klinikal biasanya dijalankan di hospital, universiti, pusat perubatan atau klinik kesihatan. Pelaksanaan kajian klinikal akan dijalankan oleh sekumpulan penyelidik yang diketuai oleh doktor pakar yang digelar Penyelidik Utama. Pasukan ini mungkin termasuk para jururawat, ahli farmasi, pegawai pergigian, pakar pemakanan dan lain-lain, bergantung kepada keperluan kajian.

Setiap kajian klinikal mempunyai syarat-syarat yang berbeza untuk para peserta seperti umur, jantina, keadaan perubatan, dan lain-lain. Keperluan ini dikenali sebagai kriteria kemasukan – pengecualian.

Pasukan penyelidik akan membuat penilaian untuk memutuskan samada anda layak menyertai kajian klinikal berdasarkan kriteria kemasukan – pengecualian. Pasukan tersebut juga mesti menjalankan proses Izin Maklum untuk memaklumkan anda tentang potensi risiko-manfaat menyertai kajian klinikal tersebut.

Izin Maklum ialah proses yang dijalankan sebelum anda didaftarkan ke dalam kajian. Seorang daripada pasukan penyelidik yang layak akan menerangkan tujuan dan matlamat kajian tersebut, prosedur dan risiko-manfaat yang terlibat. Anda berhak untuk bertanya sebarang soalan berkenaan dengan kajian tersebut.

Anda akan dimaklumkan bagaimana rekod perubatan anda akan disimpan dengan rahsia dan mereka yang diberi kuasa untuk melihatnya. Jika anda mengambil keputusan untuk menyertai kajian, anda akan diminta menandatangani borang Izin Maklum. Sila tanya soalan mengenai mana-mana bahagian borang Izin Maklum yang anda tidak faham. Sila ambil perhatian bahawa walaupun anda telah menandatangani borang tersebut, anda boleh bertukar fikiran dan menarik diri daripada kajian tersebut pada bila-bila masa.

Semasa tempoh kajian, pasukan penyelidik akan mengkaji latar belakang perubatan anda, memberi arahan mengenai apa yang perlu dilakukan, bila dan bagaimana untuk melakukannya di samping memantau kesihatan anda dengan teliti. Setengah kajian klinikal mungkin melibatkan ujian dan lawatan doktor yang kerap. Bagi kebanyakan kes, rawatan perubatan bermutu tinggi tersebut akan ditanggung oleh penaja kajian.

Kajian klinikal direka dengan risiko minima kepada para sukarelawan dengan potensi membawa faedah yang besar kepada masyarakat. Walaupun dalam setiap kajian klinikal keselamatan para sukarelawan diutamakan, kemungkinan melibatkan beberapa risiko. Secara ringkasnya:

• Kemungkinan mengalami kesan sampingan kurang menyenangkan atau tidak diingini yang berpunca daripada ubat atau rawatan baru yang sedang dikaji.
• Ubat atau rawatan baru yang sedang dikaji tidak berkesan.

Bincang dengan doktor anda untuk menimbangkan samada anda akan memperolehi manfaat dari kajian klinikal. Doktor anda boleh mencari kajian klinikal yang sesuai dengan keadaan penyakit anda dengan menghubungi Clinical Research Malaysia (CRM) atau Pusat Penyelidikan Klinikal (Clinical Research Centre) di hospital-hospital utama kerajaan.