‘’Patient is doing us a favour by enrolling in a trial’’

Dr V K Chopra

The drug: India is the diabetes capital of the world and the search is always on to find newer methods of treatment. Majority of deaths in diabetic patients occur because of heart diseases. A new set of injectable medicines not only control blood sugar but also reduce the incidence of heart disease in patients. An inbuilt safety mechanism ensures that although blood sugar comes down to normal, it does not cause hypoglycemia, including other complications of present day medicines including loss of consciousness, sweating etc. Approved for use in Europe, it is still under consideration in the US.

The trial: Called the ELIXA trial, the aim is to validate reduction in cardiovascular events in diabetics, who have had a recent acute coronary syndrome Extending over a period of 3.5 years, the multinational trial is being conducted in 35 centres in India. Long-term trials such as this one, give meaningful results, they are harder to do, but the information is much more useful.

Selection of patients: Out of the hundreds of patients that we see over the course of 10-11 months, we have been able to recruit 17 patients for the study. This is itself indicative of the transparency of the process. We have several patients undergoing angioplasty or those admitted with a heart disease. Ideally we take the permission of the physician under whom they are undergoing treatment to enroll them for the study. Usually patients who live nearby are preferred since they need to make frequent visits to the hospital. Our selection criteria are strict. We explain the study details to the patient, address their queries and apprehensions and if they are willing, give them an informed consent form in the language they understand. We need to judge whether the person is likely to continue during the course of the trial, or might drop out midway. More people dropping out takes away from the value of the trial.

Transparency is important: If you keep the process very transparent, only a small number agree, but that is how to do things. Out of 50 people, four or five may agree. Adverse publicity has instilled fear in people and that has to change. The blame also lies on us, because there are people who have done things they should not have done. It has to be an ethical transparent process. Above all, we need to remember that the patient is doing us a favour by enrolling in a trial.

Caring for the patient: Trust works both ways, When a patient trusts you, you also feel more responsible. Also such patients would follow instructions much more carefully. We meet them personally on every visit. They are given a diary to keep track and blood sugar checked on a daily basis, which is stored in the glucometer. This data is logged in once the patient visits us, more frequent intially and less later as we adjust the dose. At the end of the study, we’ll call them after a month to see that there are no long-term adverse events.

Safety is paramount: The patient may either be on placebo or may be taking the drug. It is an end point driven study, blind data is analysed at the end of the study. Only the Data Safety Monitoring Agency has access to unblinded data. If they find that in one arm there are more adverse events, they can stop the study, or if they see the drug getting more benefits than the placebo, they can stop the trial and say that it is unethical to withhold the trial. This board meets once in three months and will have acces to all 700 sites. They are responsible for ensuring the safety of the patients.

[email protected]