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.
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
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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