Clinical Trials

Clinical trials are a type of research involving a group of volunteers that studies new tests and treatments (e.g. vaccines, drugs, dietary supplements, medical devices, medical procedures and behavioral intervention) to evaluate their safety and effects on human health outcomes. When proved to be effective and safe, these treatments may become tomorrow’s standard of care.

Clinical trials are part of a long, meticulous process, which may take many years. Research scientists may study a new treatment in a lab, in animals and also in people. This is done in three to four steps, or what is known as phases of clinical trials. Your doctor may offer you a clinical trial as a treatment option.

Clinical trials are carefully designed, reviewed, and need to be approved by the Ethics Committee (e.g. Medical Research and Ethics Committee/ PHKL Research and Ethics Committee) and Regulatory Authorities (e.g. National Pharmaceutical Regulatory Agency/ FDA) before they can start.

• Types of Clinical Trials

  These are the most common kinds of clinical trials.

  1. Treatment trials test new therapeutic drugs or new combinations of existing drugs. They also test new approaches to surgery or radiation therapy.
  2. Prevention trials test new ways to prevent cancer in people who have never had it, or to stop it from coming back in people who have. These approaches may include medicines, vaccines, vitamins, or lifestyle changes.
  3. Diagnostic trials are conducted to find better tests or procedures to diagnose a particular disease or condition.
  4. Screening trials evaluate the best way to detect cancer.
  5. Quality-of-life trials (also called supportive care trials) explore ways to improve comfort for people who are living with illnesses.
• Clinical Trials Phases
  

  Clinical trials used in drug development are described by phase. These phases are defined by the Food and Drug Administration (FDA). A clinical trial involves four different phases.

  Phase I

  Phase I studies usually test new drugs for the first time in a small group of people (20 to 80 volunteers). This phase determines a safe dosage range and identifies any adverse effects (possibility of side effects, etc) to ensure the safety aspects and enhance the deliverables of the treatment.

  Phase II

  Treatments which is found to be safe in Phase I trial will continue to Phase II. In Phase II trials, the new treatments are given to a larger group of people (100-300). Phase II trials involves additional testing of the safety of the new treatments and begin to test the effectiveness. Only 30% of the Phase II trials will move into Phase III.

  Phase III

  During this phase, the new treatment will be given to a larger group of people (300 to 3000) to confirm the effectiveness of the new treatment that was observed during the Phase II trial. In this phase, the new treatments will be often compared to an existing treatment or to a “dummy” drug, placebo to assess the treatment’s true effectiveness.

  Phase IV

  This is the final phase after a treatment is approved by the regulators (e.g. U.S Food and Drug Administration, National Pharmaceutical Regulatory Agency, etc.). Investigators use this phase to gather more information about the treatment’s long-term effectiveness, side effects and other benefits.

• Clinical Research Centre @ Pantai Hospital Kuala Lumpur

  Pantai Hospital Kuala Lumpur stands strong in our mission to improve patients’ health outcomes through ethical and quality clinical research. We conduct various clinical trials in our own hospital setting to test new treatment modalities for both common and rare diseases. If you would like to know more about our clinical trials or would like to volunteer, look through our database to see if you are eligible to participate.

• Frequently Asked Questions

  1. What are the potential benefits of participating in a clinical trial?

  • You may gain access to new drugs and other treatments, often before they are widely available to other patients.
  • You will be mentioned closely for any side effects.
  • You will have the chance to take an active rule in your own health.
  • You will be making a valuable contribution to cancer research.

  2. What are the possible risks of participating in a clinical trial?

  • Participating in a clinical trial can sometimes require more time and medical attention than the standard one. This may include more frequent visits to see your doctor, phone calls, more treatments, hospital admission, or a more complicated treatment regimen. (It is always best to ask your doctor for detailed information about the trial you are considering.)
  • The treatment might not work.
  • The treatment might cause serious side effects.
  • Even if a new approach helps some patients, it might not help you.

  3. What are the chances I will get a placebo?

  • A placebo is a pill or other substance that is designed to have no therapeutic value. If a placebo is part of the trial you’re considering, you will be fully informed of that fact ahead of time. You would only be considered for such a trial when it’s safe and medically appropriate.
  • A placebo in cancer treatment is most commonly used when a standard treatment is available to patients and we want to compare that standard treatment to a new treatment.

  4. Do I have to pay to participate in a clinical trial?

  • Patients generally do not have to pay extra costs for treatments studied as part of a trial. Most clinical trials have sponsors and they usually pay for all research related costs and any special testing.

  5. How do I know if I’m eligible to join a clinical trial?

  • All clinical trials have guidelines, or what is known as eligibility criteria, spelling out who can and who cannot participate. The factors that may affect your eligibility to participate in a clinical trial inclde age, gender, the type and stage of your disease, previous treatment history, and other medical conditions. Following eligibility criteria help us keep you safe and ensures that our researchers learn the information they need.

  6. At what point during my treatment can I join a clinical trial?

  • You can look for clinical trials at any time during your care, from first diagnosis onward. At Pantai Hospital Kuala Lumpur, your consultant will identify the most appropriate time to begin the clinical trial and advise you further. Find out how to join clinical trial.

  7. Can I quit a clinical trial?

  • Yes. You can always leave a clinical trial at any time and for any reason.

  8. Can children participate in clinical trials?

  • Clinical trials in children are very important to find out whether at treatment is safe, and well tolerated by children. It’s important that you and your child understand the potential risks and benefits before enrolling your child into the clinical trials. As the legally authorized represeentative for your child, you would be required to provide informed consent allowing them to join the clnical trials. In addition, the research team will explain the trial to your child in language they can understand and assent from your child would be obtained to ensure they understand the basic facts in taking part in a clinical trail.

  9. Do I have to pay to participate in a clinical trial?

  • Every clinical trials is approved and monitored by Pantai Hospital Kuala Lumpur’s Research and Ethics Commiteed (REC) to make sure the risks are as low as possible and are worth any potential benefits.
  • Pantai Hospital Kuala Lumpur’s REC includes consultants, research scientists, communicty advocates, and others who make sure that each clinical trials is ethical and that your safety is utmost priority.
  • Once the trial is approved by the REC, the organizers of the study will follow a drawn-out plan, called a protocol, that describes exactly what will happen during the study. Your doctor will explain the full details of the protocol prior to joining any clinical trial.

  10. What is informed consent?

  • Informed consent is the process of learning about the clinical trial before you decide to take part in it. The research team running the trial will explain the trial’s purpose, how long it will take, what will happen, all potential risks and benefits, and information on the privacy of your medical records.
  • If you wish to participate, you will be read and will be required to sign a consent form that details all of the information that has been discussed with the research team. You will be able to take that form home and refer to it at any time. Even though you have signed the consent form, you still have the right to leave the study at any time and for any reason.

  11. Why should I join a clinical trial at Pantai Hospital Kuala Lumpur?

  • Pantai Hospital Kuala Lumpur’s team runs many clinical trials with proven success. Patients who choose to participate in one of our clinical trials benefit from our number of options, the close collaboration between our doctors and reaserch scientists, and our experienced staff who focus on our patient safety and care

  12. Who can I contact if I would like to know more about clinical trials in Pantai Hospital Kuala Lumpur?

  • You may contact Pantai Hospital Kuala Lumpur’s research team to know more.