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Patient Guide

A. What is a clinical trial and why is it conducted?

Clinical trials are health or medical related research conducted in humans, which are conducted to find out the risks and how well a particular experimental treatment, drug, procedure of medical device it may or may not work. Researchers usually come up with the idea for a clinical trial.

Long Before Humans….
A drug or treatment goes through stringent pre-clinical and laboratory research and findings from both these stages need to be approved before any human studies are conducted.

B. How is a clinical trial conducted?

  1. A pharmaceutical, biotechnology or medical devices company, any other medical research organization or the government (through its National Institutes of Health – NIH) identifies and approaches physicians to be involved as investigators in a particular trial. Other healthcare professionals may also be involved. The companies or organizations (sponsoring party) provide the treatment and pays for all trial expenses
  2. The investigators and the sponsoring party then prepare the study protocol (study plan) and other relevant documents for submission to an Institutional Review Board (IRB) for approval. ALL CLINICAL TRIALS IN MALAYSIA MUST BE APPROVED AND MONITORED BY THE IRB. Some countries such as the US, UK and Malaysia have designated centres to handle matters related to clinical research.

The IRB’s motto – Patient Safety first

  • The primary goal of the committee is to ensure that the rights, safety and wellbeing of people recruited in the trial is protected
  • The board must ensure that the risks are minimal and there is potential benefit to the patients
  • This independent committee is made up of healthcare personnel’s and other professionals. At least one member is from a non-scientific field
  • This committee carefully goes through every aspect of a trial and discusses whether the procedures of a trial comply with the strict rules that are set before a clinical trial is conducted. The members then collectively decide whether to approve, ask for amendments or reject the trial
  • The committee will regularly check the progress of the trial, so a person participating in a trial can be assured of the safety of the research they are involved in.

3. Once the trial is approved, volunteers, who could be either healthy people or patients, are recruited according to the criteria set in the protocol.

4. Before a participant is selected into a trial, details such as study design, treatment risk, if any, and potential benefits are thoroughly explained and all participants’ enquiries are adequately addressed.

5. Participant signs a consent form.

6. Trial is conducted according to the set schedule. Progress of participants is assessed closely and evaluated at regular intervals. Participants are kept informed throughout the study. The medical stakeholders, which may be the research team, sponsoring company or even the IRB, may choose to terminate the entire trial or remove only certain patients at anytime during the trial, depending on the safety and efficacy of the treatment. Participants may also opt to stop at anytime.

Picking Perfect Participants
Malaysia is the ideal place to conduct clinical trials as it is a multi-ethnic population and this diverse culture provides clinicians a bigger scope in recruiting patients

C. Who conducts a clinical trial?
A pharmaceutical, biotechnology or medical devices company, any other medical research organization or the NIH appoints physicians to conduct these trials. These physicians are known as investigators, and each trial may have a principal investigator who acts as the leader. The investigators can be attached to either public or private institutions and these institutions can be hospitals or universities with access to patients. Most physicians are specialists, and these trials often involve doctors from various specialties. In addition to doctors, others may be involved in the research team and these include nurses, social workers, laboratory assistants and other healthcare professionals.

D. Who pays for a clinical trial?
The party that pays for the clinical trial is called a sponsor. A sponsor can be any organization, medical institution, foundation, pharmaceutical, biotechnology or medical device company, federal agency or even individuals.

E. Where is a clinical trial conducted?
Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

Strong and Stable Support

The Clinical Research Centre (CRC), which has been operational since 2002, functions as the clinical research arm of the Ministry of Health, Malaysia. CRC acts as a one-stop centre and offers a comprehensive range of services to support clinical trials in Malaysia and the South East Asia region.

F. What are participant’s rights, roles and responsibilities?
Before agreeing, participants should ask as much questions as possible, so that they are clear on the trial procedure, their role, as well as their rights as participants. One Patient’s Story  The Malaysian Medical Association (MMA) in its patient charter stated the following conditions for protecting clinical trial participant:

  • a participant is informed of the study objectives, design and results
  • a participant has access to his or her medical records and the findings within are explained
  • a participant is aware of any alternative procedure or treatment that is available for the particular disease or therapeutic area
  • a participant is informed of the risks, side-effects, after-effects, problem associated with recuperation, success rate of the treatment, and whether students will be present during the procedure
  • a participant has the right to know the credentials of the health professional involved in his or her care
  • a participant is informed of every aspect of the treatment, drug or procedure
  • a participant has the choice to withdraw his or her participation prior to or during the trial.

When agreeing to participate in a trial, a participant is expected to adhere to the procedures as explained by the physician and provide accurate and honest report on his or her progress.

Protecting Participants with Clear-cut Rules
More information on a patient’s right is available at http://www.mma.org.my/Resources/Charters/Patientscharter/tabid/81/Default.aspx
http://www.cc.nih.gov/participate/patientinfo/legal/bill_of_rights.shtml

G. What happens if the participant is a minor? Are there any special considerations?
Due to different childhood development, clinical research in minors (those below the age of 18 years) is much more difficult and restricted than in adults. One or both parents will act as legal representative for the minor and make decisions on the child’s behalf. However, a child of school-going age or adolescents may be able to understand certain aspects of the trial and the doctor is obligated to explain to them the procedures.

Clinical Trials in Children

One example of an initiative to improve the development of safe and effective medicines for children is the UK’s National Institute for Health Research Medicines for Children Research Network

H. Are there any risks involved?
As clinical trials involve experimental treatment, participants may experience adverse reactions or side effects. These events can be minor, serious or life-threatening. Adverse reaction or side effects include headache, nausea, hair loss, skin irritation, rash or other physical problems. In addition, the treatment may not confer any beneficial, significant or otherwise, for the participant. Your doctor may stop treatment, if any of these risks apply, as a doctor is responsible for carefully evaluating both short-term and long term effects as well as the effectiveness of the treatment for an individual participant.

Strict Safety Supervision
Medical research such as clinical trials is governed by ethical and legal codes and regulated by the federal government to ensure safe and proper drug testing in humans

I. How does a clinical trial benefit the participant?

  • The participant has early access to cutting-edge treatment or drug, which most of the time, is even before the therapy is available in the market
  • The participant receives good medical attention and care, which most of the time is free.
  • The participant is more involved in his or her own healthcare and gains valuable medical information.

J. Does the participant have the choice to leave a clinical trial after it has begun?

Yes but the participant should inform the research team before withdrawing from the trial.

Participants’ Preference – AT ANY TIME
A participant has a say on whether to participate or not to participate to stay in or drop out

K. How does a clinical trial benefit the society in general?
Investigators and key decision makers can gain a considerable amount of information on the disease process and the effect of a particular treatment or procedure by observing clinical parameters in people involved in a clinical trial. Without the participation of these volunteers, you and I would not have access to the treatments, medications and procedures we use today. Ultimately, participants of a clinical trial will significantly contribute to medical research and the advancement of healthcare technology.

Clinical Unity to Achieve Medical Excellence
Malaysia offers a large pool of experienced, qualified and English literate clinical investigators as well as established clinical research centres to ensure high quality and reliable research.

L. More Information on Clinical Trials….

Different types of clinical trials

1. Treatment trials
Tests experimental treatments, drugs, surgery technique or radiation therapy

2. Prevention trials
Tests for better ways to prevent a disease

3. Diagnostic trials
To find better tests to identify a disease

4. Screening trials
To find better ways to detect a disease or health condition

5.Quality of Life trials
To find better ways to improve the quality of life of patients with chronic diseases

Clinical trials are conducted in phases:

1.Phase I trials

  • The experimental drug/treatment is tested for the first time in humans.
  • Involves a small number of people
  • To test the safety of the drug/treatment, to establish the dosage range and to reveal any side effects

2. Phase II trials

  • The experimental drug/treatment is tested in a larger group of people
  • To test for the effectiveness and safety of the drug/treatment

3. Phase III trials

  • The experimental drug/treatment is tested in large groups of people
  • To confirm the effectiveness of the drug/treatment and to test for side effects, to compare to other treatments and to collect any other information

4. Phase IV trials

  • Also known as post marketing studies
  • To collect more information on the drug/treatment’s risks, benefits and optimal use

What is a

  • control: To compare the effectiveness and the safety of a new drug/treatment, most clinical trials will have two groups of participants. One group is given the experimental drug and the other which is known as the control group will be given either a standard treatment for the particular disease of health condition or a placebo
  • placebo: To determine the effectiveness and the safety of a new drug/treatment, most clinical trials will compare it to a placebo, which is an inactive pill, liquid or powder (depending on the form of the experimental drug) and has no treatment value
  • protocol: A carefully designed study plan that explains in detail all aspects of a clinical trial. A protocol has information on the types of participants that are right for the trial, the study design, medications, dosages and tests that are to be performed. A clinical trial strictly follows its protocol
Checklist of enquiries for your doctor or research coordinator
Plan ahead the questions you want to ask
Bring a friend or relative for support
Duration of trial;

  • How long will the trial last?
  • How often are the treatment /follow-up visits?
Location of trial;

  • Where will it be conducted?
  • Who are the investigators involved and what are their credentials?
Type of treatment;

  • What kind of therapy or drug is used?
  • What are the dosage and prescription details?
Purpose of trial;

  • What do the investigators aim to achieve with this study?
  • How are patients chosen?
Safety monitoring and risks;

  • Are there any risks involved?
  • How do the investigators monitor for side effects and other safety issues?
Benefits;

  • How do I benefit from this trial?
  • Has this treatment been used in patients before, if yes what was the results?
  • What other treatments are used/available for this disease/therapeutic area?
Trial sponsor and expenses;

  • Who is paying for this research?
  • Is participation in this trial for free?
  • Are there any costs involved?
  • Will I be compensated for any expenses I incur during this trial?
Trial procedure;

  • What are my roles and responsibilities as a participant?
  • Are there any specific requirements (e.g. fasting, special diet, change in daily routine) prior to treatment /follow-up visits?
During the trial;

  • Can I discuss the trial with others?
  • Can I recommend others to be involved?
  • Can I stop at anytime, even if the trial is ongoing?
After the trial;

  • Can I still continue with the treatment, after the trial has ended?’

Please contact us is you have any enquiries on clinical trials
contact@crc.gov.my

Clinical Trial Compensation Guideline – A simple and expeditious procedure in relation to the provision of compensation for injury caused by participation in Clinical trial (by Association of the British Pharmaceutical Industry ) – Click for details

Additional resources

The Malaysia Medical Association is responsible for maintaining the professional standards of medical ethics, and this include patients’ rights and responsibilities, which are outlined in the MMA website. A patient has the right to be provided with sufficient information on all aspects of medical treatment which would include information on the health provider’s credentials, the prescribed medications or treatment and any associated safety concerns

http://www.mma.org.my/Resources/Charters/Patientscharter/tabid/81/Default.aspx

Center Watch is a US-based Clinical trial listing service. One section of the website is dedicated to educating parents on matters relating to clinical trials. Information volunteering for a clinical trial and the informed consent process is explained in an easy and understandable formathttp://www.centerwatch.com/patient/index.html

The US Food and Drugs Administration has designated a section of its website for a comprehensive compilation of various clinical trial related topics in a simple, Q&A format. Additional resources are also provided. http://www.fda.gov/oashi/clinicaltrials/default.htm

Although the American Cancer Society discusses cancer-focused clinical trials, the topics included still addresses all aspects of general clinical research and the information can be applied for clinical trials for any disease. http://www.cancer.org/docroot/ETO/ETO_6.asp

The National Institutes of Health discusses clinical research in detail for the public to understand. There is also a patient handbook that covers all the matters associated with being involved in a trial in the NIH Clinical Centre.as well as a list of links for additional information. The NIH also has numerous resources for clinical trials involving children. http://clinicalcenter.nih.gov/participate.shtml

The Emergency Care Research Institute (ECRI) website has a section for patients where they can get information on clinical trials on serious of life-threatening illnesses. In this section, there is also a technical report which reviews published papers on the topic of patient’s participation in clinical trials http://www.ecri.org/Patients/References/Pages/Clinical_Trials_Patient_Reference_Guide.aspx

This is a website by the US National Institutes of Health and it provides basic information about clinical trials as well as advanced resources from sources like the FDA and the NIH http://clinicaltrials.gov/ct2/info/resources

This is a clinical trial patient worksheet from the American Cancer Society. It outlines clinical trial-related questions for the doctor. It also has explains the process when agreeing to participate in a trial as well as the staff involved in the research http://www.cancer.org/downloads/ETO/Clinical_Trial_Patient_Worksheet.pdf

This website from the US National Library of Medicine and the National Institutes of Health has interactive slides and video for viewers and it is a simple but fun way of understanding the complexities of clinical trials http://www.nlm.nih.gov/medlineplus/tutorials/cancerclinicaltri als/htm/index.htm

This document from the European Commission has detailed information on ethical considerations for clinical trials involving children. Cleck here…