Is Experimental Treatment Right for You?

7 Facts You Need to Know About Clinical Trials

If you could choose the most cutting edge medical cure for a stroke, would you want to?

When the reality of a serious stroke hits, most stroke survivors and their loved ones want the best possible treatment available. For many, this means getting the most proven and safe intervention possible. But the definition of ‘the best’ and ‘the most up to date’ differs for different individuals.

Stroke research is moving at a fast pace. Medical scientists are discovering new ways to treat stroke that may take years to validate and to deem safe enough for the public. The process of developing a new medical treatment often requires methodical experimental trials. When an innovative therapy is ready for real live patients, volunteers are often recruited to help assess whether the treatment is safe and effective through clinical trials.

What are Clinical Trials?

Clinical trials are experiments designed to determine if a new medication or treatment is effective. The foundation of any clinical trial is the comparison between two groups of patients- usually one group who is receiving a type of intervention and another group who is receiving a different intervention or no intervention. The treatment and data are carefully monitored by a research team and then evaluated to assess the difference in outcomes between the 2 groups.

Who Oversees Clinical Trials?

Approval and oversight of clinical trials is quite stringent- requiring detailed applications and approvals at multiple levels. Researchers must be experienced and qualified in order to obtain authorization to implement clinical trials. Generally, a hospital or university or pharmaceutical manufacturer requires preliminary data on safety, sometimes obtained through animal testing, before allowing a human study.

Usually, a federal organization, such as the Federal Food and Drug Administration provides structured oversight and criteria.

Who Pays for Clinical Trials? 

Pharmaceutical companies, medical device manufacturers, government grants, foundations or non-profit charities often fund the experimental costs. Sometimes, research scientists at universities receive finding from one or more of these sources, and may work in collaboration with teams from multiple clinics.

Pros of Clinical Trials

  • Some trials provide reimbursement to patients for medical costs or even cash compensation.
  • Volunteers have the opportunity to try new therapeutic options.
  • Volunteers do not have to miss out on new treatments just because they haven't been approved 'yet.'
  • Some volunteers have no other medical option besides experimental treatment when faced with a bad prognosis.
  • Volunteers can usually end participation at any time if they do not like the intervention.
  • The experiment might require more medical visits and monitoring, and thus possibly more personal attention and better health care as a 'built in' benefit.
  • Some volunteers appreciate the opportunity to play an active role in scientific progress.

Cons of Clinical Trials

  • In some research experiments, the safety is not well established.
  • The benefits of many experimental treatments are not well established.
  • There are many unknowns.
  • Volunteers and their health care providers might not know if they are in the treatment group or the no-treatment group.
  • Volunteers may experience a placebo effect. A placebo effect occurs when someone has symptoms (they might be good or bad) because of expectations related to treatment or lack of treatment.
  • The experiment might require more medical visits and monitoring, which can be time-consuming.

How Can You Find a Clinical Trial? 

In some cases, your doctor might suggest a clinical trial for you to give you access to treatment you might not otherwise be able to get.

You can ask your doctor if there is an experimental treatment that you qualify for. You can also search the hospital website or the website of nearby universities by searching for 'clinical trials,' or 'research.'

You can look for trials through the National Institute of Health database or the National Institute of Health patient information site. The American Academy of Neurology provides information about stroke research. Non-profit organizations and disease-specific foundations may also help provide some direction when they fund clinical trials.

Deciding if Clinical Trials are Right for You

For some, the best treatment means the safest and most proven available. For others, the best intervention means the absolute best around - anywhere- even if it hasn't been tried and true or proven to be safe.

No matter where you see yourself on the spectrum, it never hurts to learn about experimental treatment for your illness, and learning about them does not require you to sign up.

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