Are Clinical Trials Safe?

Sorry it's been over a week since my last blog....had some health issues that kept me out of the office some last week.  All better now :)

I talk to a lot of people that are considering participating or having a loved-one participate in a clinical trial.  Everyone's personal situation is different and you have to make the right decision for YOU! 

Most clinical research is federally regulated with built in safeguards to protect the participants.  We only participate in sponsored research studies at our facility, which means we contract with the pharmaceutical companies developing an investigational medication or device.  We are usually one of many sites participating in either a national or even international study.  The FDA regulates the protocol of the study and the IRB also oversees the trial for the safety of the patients.

There are always benefits/risks that you need to consider before participating:
Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research.

Risks

There are risks to clinical trials.

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

As I have mentioned before, our site specializes in Neurological diseases such as Epilepsy, Alzheimer's, Parkinson's, MS and Diabetic Neuropathy.  Knowing that there is no current cure for these diseases and having a loved one suffer from Alzheimer's, I would personally put a family member into a clinical trial for these type of progressive diseases.  Same thing with Cancer or any other disease in which a clinical trial might be your best HOPE. 

Of course, there is no guarantee that a clinical trial will make you better, but at the very least you are helping with future research and understanding of these diseases so that we might one day find a cure.  So in a way, you are helping others!

As a site our first priority is our patients safety, and it should be that way at every clinical research facility.  Be sure to ask questions and stay informed - that is your right as a clinical trial participant. 

Are there possible side effects?  Of Course!!!  Are there possible side effects to that medication you are currently taking?  Of Course!!!  There are always risks/side effects to any medication, but do the benefits out-weight the risks?

I don't know if this was helpful or not, so please ask me any questions you might have.  Until next week...