How do we ensure Safety for all parties involved?
Our HIPAA and GDPR compliant research platform does not make any medical recommendations for patients. As a patient, your treatment plan, your condition, your risks, and your interest in trying new therapies are exclusively reserved for a conversation between you and your physician.
How is trial safety prioritized for patients in the U.S. and Europe?
Clinical trials are approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal when compared with potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the medical community who ensure that clinical trials are ethical and that the rights of participants are protected. You should ask your physician, or research coordinator whether the research you are considering participation in was reviewed by an IRB.
The important component of a trial is the training that research physicians, called principal investigators, receive to prioritize safety of all patients while on a trial. Many medical professional are not trained to conduct appropriate, safe, and well-organized clinical trials. Principal Investigators follow strict safety guidelines while treating patients under study. The FDA also requires informed consent which outlines the exact risks that patient could face while on a trial. It is your right as a patient to ask and seek out trials where you are comfortable with your risks and potential benefits before signing informed consent to participate.
How have Clinical Trials become safer for patients?
A trial site (healthcare system or research center) needs to ensure the following:
- There is no conflict of interest
- The risk/potential benefit is appropriate for the patient
- Informed consent truly delivers the risks, benefits, and alternatives
- The protocol is followed with precision
- Changes are made to the protocol when something occurs during the study to change the facts and these changes have a proper approval process which exists to confirm that the changes are being made only to improve the patient’s potential benefits.
- Changes are communicated between the research team and the IRB
- Change in patient condition is monitored and responded to promptly.
What are the potential benefits for patients?
In many cases patients have exhausted other treatment avenues which may be standard FDA-approved treatments. In some cases, they have seen only limited benefits or still have continued disease progression. For some of the most life-impacting diseases, clinical trials are a way for patients to have access to innovative therapies earlier before often what may be years of approval processes through traditional FDA approval channels.