1. Am I eligible for clinical trials for my condition at HCG?
This depends on the disease stage and your overall health status. Each study has specific eligibility criteria based on clinical examination, lab tests, radiology, previous treatments received etc., following which a patient is selected for that particular study. This is to ensure that it is safe for you. It is a good idea to be informed about ongoing studies for your specific cancer early on. You can find this information on our HCG website or discuss it with your oncologist even during your first visit.
2. What if my condition worsens during the clinical trial?
Once you are enrolled in a clinical trial, you will be closely monitored with regular physical examination, blood tests, radiological examination and so on to look for any side effects from the treatment and for response/progression of your disease. If you develop side effects, it will be managed on an outpatient or inpatient basis as appropriate and the study team will decide if there is a need to modify the dose. If we see that you continue to have intolerable side effects or if the disease progresses while in the study, we will consider withdrawing you from the study.
Alternately, you have the right to withdraw from the study at any time even after enrollment.
3. What are the risks involved in clinical trials?
Almost every treatment entails some level of risk. The degree of risk depends on the kind of treatment administered and the overall condition of the patient. All possible risks of a particular study drug will be explained by the study team prior to your enrollment into the study. You will be enrolled in the study only if the team feels that the benefit outweighs the risk.
4. What should I do when my doctor asks me to register for a cancer clinical trial?
If a doctor is suggesting the possibility of your participation in a clinical trial, it means that he/she sees that a particular study drug may be of benefit to you. You can request more information regarding the study and discuss the details with the study team.
5. To what extent will the research team bear my treatment expenses?
The research sponsor may bear your treatment expenses at variable degrees. It largely depends on the type of clinical study, and the phase that you are enrolled in.
For patients participating in phase 1, phase 2 and phase 3 trials, the research sponsor bears the expenses of drugs, tests and scans and hospitalization, if any.
During the fourth phase, drugs are given free of cost. The required tests and hospitalization expenses will also be borne by the sponsor during the specified duration of the study. Following completion of the study, the company will provide the drug free of cost to the patients that were part of the study; however, the investigation expenses (lab tests, radiology etc.) would not be paid.
6. What are some of the common questions that I should ask the clinical research team?
Following are some of the common questions that you should ask your clinical research team before participating in a clinical trial:
- What is the purpose of the study?
- How long is the study going to last?
- Does it involve frequent travelling to the hospital?
- Where will I have to go for my tests and treatments?
- How will the research team ensure my safety?
- What happens if I start experiencing side effects?
- Should I be paying any money to the clinical research team?
7. What are the measures taken by HCG to ensure the safety of patients during the clinical trial?
Our doctors at HCG ensure that you are enrolled in a clinical trial only if they feel that you might benefit from being in the study. Once you are enrolled in a clinical trial, you will be closely monitored with regular physical examination, blood tests, radiological examination and so on to look for any side effects from the treatment and for response/progression of your disease.
If you develop side effects, they will be managed on an outpatient or inpatient basis as appropriate. If we see that you continue to have intolerable side effects or if the disease progresses while in the study, we will consider withdrawing you from the study. Alternately, you have the right to withdraw from the study at any time even after enrollment.
8. Where do clinical trials usually take place? Should I be admitted anywhere?
Clinical trials are conducted in a clinic or a hospital setting where there are facilities to closely monitor and manage the patient appropriately in the event of any adverse effects.
9. What if I want to quit participating in the middle of a trial?
Yes – that is possible. Our clinical research team is bound to respect your decision. You can withdraw from participating in a clinical trial at any point in time.
However, it is good for you to let the research team understand the reason for your decision. If your decision is based on practical or social reasons, the team can look into the best ways to help you out.
10. Will there be any compensation given for participating in a clinical trial?
This depends on the type of study that you would be participating in. If you are participating in an interventional study, wherein a new drug or treatment is administered to you, your treatment expenses and travel expenses will be borne by the research sponsor. However, this does not apply to observational studies.
In the case of loss of earnings caused due to extended hospital stay or other adversities, the ethics committee will discuss with the research sponsor and provide appropriate compensation on an individual basis.
For more information on the compensation given during clinical trials, please get in touch with the clinical research team.