Sunday, September 15, 2013

BRAIN CORNER: Clinical Trials and Memory Disorders: Your Top Questions Answered

WHAT IS A CLINICAL TRIAL AND WHY IS IT CALLED A TRIAL?
“Clinical” is the word used to describe all things patient related, while “trial” is the word used when in the process of proving or trying something.  Together, a clinical trial is essentially a research study that involves human volunteers as the participants.  The volunteers try a treatment, which may include new or updated drugs, devices, procedures, or action plans.  The side effects, safety, optimal dosage, and the overall effectiveness of the treatment are determined as a result of the clinical trial.  Clinical trials are a vital component of the research process; without them, we would not have safe, regulated, and effective drugs available for disease treatment.


WHY SHOULD I PARTICIPATE?
Some participants may significantly benefit from the study. They may have see that their condition is developing at a slower pace or experience an ease of symptoms. In some cases, a cure may even be found. Some trials do not result in direct, immediate benefits, but they help researchers to continue to develop treatments.  Participants that do not receive any direct benefit should understand that their participation will further the medical community’s knowledge of the disease and hopefully, lead to a cure. 


HOW DO I DECIDE IF THIS IS RIGHT FOR ME OR MY FAMILY MEMBER?
When deciding whether or not a clinical trial is right for you, it is important to be both an informed and savvy participant.  There are many places where you can find information about your condition as well as current trials. Organizations like the NIH and Drexel Medicine are great places to find  up to date information about diseases and current initiatives (specific links included at the end of the post). Also do not be afraid to express your concerns and hesitations to the research study team. Keep in mind the following questions: What options do I currently have for treatment?  Am I comfortable with the conditions of the trial?  Are both my caregiver and I willing to fully commit to this process attending scheduled appointments, following directions, and adhering to all procedures?  What are the risks associated with this study?  Are the risks worth the potential reward?  Does my doctor and family support and encourage my participation in this trial?

WON'T I JUST BE PART OF AN EXPERIMENT? 

A common myth is that clinical trials are “science experiments” and the participants are “guinea pigs”.  An informed participant will tell you, this is not the case.  Volunteers are respected individuals and valued within the scientific community; often regarded as heroic. A new drug is not just created on a whim and immediately given to a volunteer; the new drug must first go through a number of carefully carried out tests. The Drug Development Plan is strictly regulated by the Food and Drug Administration. Click here for a deeper explanation of the drug development process and how the drug gets from the lab to the person.

HOW SAFE IS CLINICAL RESEARCH?
Researchers take a number of steps to make clinical trials as safe as possible, both medically and ethically.  Trials are well regulated to make sure potential side effects are not missed. Throughout the trial, all volunteers report any adverse events.  This includes both minor issues, such as a headache or dizziness, or serious problems, including hospitalizations and death.  If patterns of serious problems arise, the clinical trial may be stopped to prevent any further medical issues.  Clinical trials are also ethically sound, as they must first be reviewed by an Institutional Review Board (IRB). The IRBs’ mission is to protect the safety and welfare of the volunteers.  The IRB oversees the study procedures, ensures all staff have been properly trained, and ensures responsible conduct of the study.  Click here to learn more about Drexel’s IRB and patient protection.

WHO WILL I BE WORKING WITH?
Clinical trials include a team of people with important, individual roles.  The “Principal Investigator”, or PI, is the doctor who supervises the trial at a certain location.  The PI is responsible for all aspects of the research.  The “Study Coordinator” is your main point of contact.  The coordinator works directly with the PI and schedules appointments, draws blood for labs, takes vital signs, administers drugs, and collects and reports data.  The “Sponsor” is the company that develops the specific drug.  Typically, a pharmaceutical company develops a drug and picks different sites to carry out the study.  As a volunteer you will have limited to no contact with the sponsor.  The “Participants” are the patients that volunteer to be in the study.  The participants are a key aspect to the clinical trials team.  All members of the clinical trials team work together to reach the ultimate goal of a productive and worthwhile clinical trial experience.



SOUNDS GOOD...HOW CAN I GET INVOLVED?
The Memory Disorders Program at Drexel University College of Medicine, directed by Carol Lippa, MD( https://www.drexelmedicine.org/find-a-doctor/l/carol-lippa-f/), hosts a variety of clinical trials.  The trials explore different interventions for memory disorders including mild memory loss, Alzheimer’s disease, frontotemporal dementia, and the common symptoms associated with memory loss (agitation, aggression, emotional changes).  Examples of previous trials include vaccines, immunotherapies, vitamins, nutritional supplements, genetic screens, and technology research.  The clinical trials team members have extensive experience managing trials and they encourage patients and their caregivers to participate. Visit the following link to see what Memory Disorder Trials are underway at Drexel:  http://www.drexelmedicine.org/patient-services/neurology/clinical-studies/memory-disorder-studies/.  If interested in learning more about the clinical trials in the Memory Disorders Program, contact Carolyn Edwards at 215-762-7783 or cedwards@DrexelMed.edu


Resources for conditions mentioned in this blog post:

Alzheimer's Disease : http://www.nia.nih.gov/alzheimers 


Frontotemporal Dementia (Pick Disease): http://drexel.adam.com/content.aspx?productId=117&pid=1&gid=000744 



2 comments:

  1. Millions of people worldwide are experiencing memory loss for family members who are suffering from this disease it has been nice to read this article.It's helps on how to prevent this disease.

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