Dr. Aung Soe @ Aung Kyaw Moe, Retired State Medical Superintendent
Researchs all over the world are conducted by qualified people who have experience in clinical trials and the skills needed for any new procedure being investigated Same is in Myanmar.
The perceived benefits of the new treatment should outweigh the possible risks or side effects. All medicines have side-effects. They usually become obvious in very early studies in animals and human volunteers. Comparisons with drugs of similar chemical structure already in use also give clues to undesirable reactions.
In the simplest form of a clinical trial, one group of patients (called the treated group) receives the drug. A second control group receives the current standard drug for the particular disease. In some trials, a third control group will receive a placebo-an inactive substance.
Placebo controls may replace the second group. Patients do not know if they are taking a placebo or medicine.
Patients are allocated to a test or control group randomly. The whole trial is now called a randomised controlled trial.
Better organised trials are “blinded” __ neither the doctor nor the patient knows which group the patient belongs to. This prevents any bias in the way the patient and investigator respond to the treatment.
When it reviews a protocol, the IRB first has to study various issues in the interests of patient safety and well-being.
It is up to investigators to see if adverse reactions could cause physical or mental distress, and to make sure a patient is not given a treatment known to be inferior to established therapies.
Safety is paramount. The IRB examines the available information on the properties and history of use of the new drug. This includes whether it has been tested vigorously in the laboratory and, where appropriate, in cell cultures, animals as well as preliminary studies in people.
Another consideration is the recruitment of subjects. How do the doctor and his team plan to recruit patients? Who actually recruits, and where will recruitment take place? What are the criteria for deciding who takes part in the trial?
Researchers must adopt rules at the outset of a study on when to stop when certain agreed outcomes are reached. Commercially initiated trials often employ data and safety monitoring boards to oversee the way a trial progresses.
This may lead to a trial being stopped because patients in one group are doing far worse than others.
Finally, there should be a patient information sheet that fully and objectively explains all relevant aspects of the trial in such a way that if the patient consents to participate, that consent is given freely.
Enrolling a person as a research subject is justified only if that person, or someone authourised to act on his behalf, understands the process and consents in writing.
It is important to realise that obtaining consent is a continuous process rather than a single event that ends with the signing of a form. If conditions affecting the trial change for instance, because of fresh evidence of the medicine’s efficacy the patient must be informed. Depending on the nature of the new findings, authorisation by the patient to continue in the trial may have to be renewed.
Special attention is paid to obtaining informed consent from vulnerable patients who may lack the ability to make informed choices, such as children and the mentrally handicapped.
Patients must be told the facts in simple, non-technical language. These generally include the purpose of the research and the procedures involved, including the randomisation process.
The possible benefits to the patient and to medical science must be explained, together with the foreseeable risks, discomforts and inconveniences.
Should blood, urine and tissue samples be taken, they must be told how frequently, as well as what happens to these samples, how they will be stored and for how long.
“The patient must also be informed that he is free to say no, or withdraw from the study at any time without penalty.
He must be assured that all data will be kept confidential, unless required by law to be disclosed. ”
Patient Information Sheets will also contain information on payment to compensate for travel, meals and inconvenience. The IRB ensures that financial inducement does not distort the judgment of the patient as to his participation.
Clinical research is essentially a communal venture, as members of our society are being asked to assist in research.
Researchers must regard those who register for the trials as partners. In this way they can work together with respect and candour to achieve their goals.
Research papers presented at the Myanmar Health Research Congress held annually could be considered as impact indicators of Research Capacity Strengthening (RCS) actions by Ministry of Health and sports. Opportunities prevail to exchange innovative ideas and experiences, new knowledge and technologies as regards priority research needs of the country. Knowledge gaps are filled considering ethical principles: informed consent, privacy and confidentiality. Stringent ethical review, peer review and technical review procedures are essential leading towards quality research proposals. Inter-sectorial coordination and wider stakeholder involvement let evidence-based research findings more convenient to utilize in improvement of policies and programmes.
It is very encouraging to note that a variety papers are to be presented and posters are to be displayed at 46th Myanmar Health Research Congress 2018. There is a wide range of good quality research works portraying the different disciplines of medical science as well as the various aspects of national health problems. We should congratulate to all the professionals for their energetic efforts in preparing the research papers and posters, to the national as well as the international professionals who made presentations at this scientific symposia. I sincerely hope that all these research findings are applicable to improvement of health status and further setting of new research agenda in line with national health priorities.
“It is very encouraging to note that a variety papers are to be presented and posters are to be displayed at 46th Myanmar Health Research Congress 2018. There is a wide range of good quality research works portraying the different disciplines of medical science as well as the various aspects of national health problems. We should congratulate to all the professionals for their energetic efforts in preparing the research papers and posters. ”
Ref – Health-update,
Ahmedabad, India 2016
– Straits Times 2-1-16