A double-blind clinical trial is starting for the first time in Bangladesh to approve the use of a conventional drug to reduce the risk of cancer in women suffering from molar pregnancy.
Molar pregnancy – an uncommon type of pregnancy loss where an egg is fertilised but a baby does not develop – is one of the causes of morbidity and mortality in pregnant women. 7.3 women per thousand suffer from this complication, which increases the risk of cancer during pregnancy.
The Bangladesh Gynecological Cancer Clinical Trial Group (BGCTG) of Gynecological Oncology Society of Bangladesh (GOSB) is going to complete the clinical trial. Beacon Pharmaceuticals Ltd will provide 500 vials of Injection Methotrexate (50mg) and Placebo each for the trial.
Beacon Pharmaceuticals Ltd handed over the injection and Placebo to the authorities in an event at Dhaka Club On Wednesday.
Professor Sayed Akram Hussain, coordinator of the Cancer Centre at Square Hospitals Limited and one of the principal investigators of the trial, said initially, this trial will be started on 500 patients of Dhaka Medical College Hospital, Bangabandhu Sheikh Mujib Medical University Hospital, and Shaheed Suhrawardy Medical College and Hospital.
They also have a plan to conduct this trial on 2,000 patients by expanding it to eight hospitals in the country later, he added.
This is going to be a preventive study, he said, adding that it will start with a very low-cost drug.
He expressed hope that they would be able to start the trial work soon, which will be completed in two years.
At the event, noted gynaecologist Prof Dr TA Chowdhury said according to the rules of double-blind research, no doctor or patient can know who is given medicine and who is given a placebo.
"Both the doctor and the patient will be blind to this. Those who accommodate the research paper will know what the ultimate result will be."
This is the highest standard of research, which has been done in very few institutes here, he said, adding, "We do not have the manpower and support required for this kind of research. Such research is going to be done by our own people which is a matter of pride for us. It will be an example for the country if done properly. Much will depend on the sincerity of those who will collect the data. The patients should be properly monitored."
Beacon Pharma Executive Vice President SM Mahmudul Haque Pallab who handed over the injections and placebo vials to the researchers on the occasion said they have provided the inputs so that the trial can be conducted in the best possible manner.
He also expressed hope that through this the risk of cancer and death of pregnant mothers will be reduced.