When a person faces a serious spinal cord injury, it is natural for them to look for a “magic cure”. They just want to get better, and may be willing to do this by any means possible. In some cases, this can be dangerous. However, there are clinical studies and clinical trials that might be safe and helpful for your loved one to participate in. You can learn more about appropriate and inappropriate clinical studies here.
What are Clinical Studies and Trials?
Any new medical techniques, procedures, or treatments meant to help spinal cord injury victims need to be approved by the FDA and tested on people before they can be incorporated in mainstream treatment plans. These trials test new treatments with people to see if they assist in recovery from spinal cord injuries. Legitimate studies and trials seek to keep the patients safe while hopefully providing assistance with their injuries.
Researchers should test medications and treatments in a laboratory before proceeding to the stage of clinical trial. The FDA regulates these trials and has strict requirements for them. Trials take place in three phases.
Consulting with a Doctor
A clinical study might sound good to you or your loved one, but before they join one it is important to consider a few factors. First, you should discuss any potential clinical studies with your loved one’s doctor. They can help make sure that your family is fully informed and that the study is legitimate. A few questions that you might want to act your loved one’s medical team include:
- What trial or study options are open to my loved one?
- What will the clinical study do?
- Is this trial or study ethical?
- Has the treatment been used with people before? If so, what were the results?
- Is this procedure or treatment specifically for spinal cord injuries?
- How often will my loved one have to participate?
- How long does the study last?
- What treatments or procedures are involved?
- What happens if my loved one is harmed by the study or trial?
- Can my loved one get follow up care?
- Are there any side effects of this treatment?
- Does my loved one have to pay to be involved in this treatment?
- Will the study interfere with my loved one’s life?
- Does my loved one have to stay at a treatment facility or hospital while they participate in the trial or study?
Getting answers to these questions or other ones that your family has can help you make an informed decision about the clinical study. Your family can consider the possible benefits or drawbacks of this treatment option, along with medical professionals.
Legitimate Trials and Informed Consent
Sometimes, it can be difficult to determine a legitimate trial from something that could potentially harm your loved one. Make sure that the trial “researchers” are not asking your loved one to pay to participate – this could be part of a scam.
Researchers should provide verbal and written explanations of the trial and what will be expected of each patient. Your loved one needs the opportunity to give informed consent, and to actually give it.
If you think that your loved one has been involved in an unethical or fraudulent trial, contact my office. I can provide assistance in this situation.