Clinical research provides essential medical information about the
effects of drugs in the human body. Carefully controlled clinical
trials evaluate new medicines or existing medicines used in a new
way. The results have far-reaching, significant impact on medical
treatment for people all over the world.
Hyperion Clinical Research is the first regional network for clinical
trials in West Virginia. The Charleston company is owned and operated
by Natalie Tappe and Julie Mobayed, two sisters, both nurses with
master’s degrees and clinical research experience. “This
is exciting work”, Natalie says. “We know what we do may
help our children and our grandchildren. We know we are contributing
to saving lives, now and in the future - maybe even our own.”
Their work often involves the current events of medicine, Julie says,
noting “We are running a study now of Prempro hormone replacement
therapy, and one for women with a low sex drive.” They are presently
administering 16 different clinical trials and have another 20 that
will be starting soon. The studies will last from one to five years.
Originally from Charleston, in 1997 the two were working in Virginia
in clinical research when they were invited by a local hospital to
start a centralized clinical trial center in their home state. Last
October, they formed their own company.
Natalie and Whitney Robinson, another nurse coordinator, have the
most patient contact. Natalie says one big advantage to participating
in the trial studies is the quality of medical care received. “Patients
are seen frequently, medications are provided at no charge, physician
care is provided at no charge, the patients see the same nurse each
visit. If the patient has health problems unrelated to the study,
we help with referrals and programs. Most nurses aren’t allowed
enough time to provide the kind of personal nursing attention our
patients get.
Julie is strictly operational, involved with the regulatory and negotiating
side of the business, working with the pharmaceutical and research
contract companies. “Every drug on the market had to go through
clinical trials. We have over 20 physicians who are primary investigators
and we recruit participants. Out of hundreds of applicants, sometimes
only a handful will qualify. Each study has certain inclusions and
exclusions. Most studies have 5-15 participants, but they can range
from 5-500. These same studies are being duplicated across the United
States, or even internationally.”
Both nurses are adamant about informed consent in the trials. Natalie
says “We don’t do anything until someone reads, understands
and signs their consent form. It is our most basic principle.”
Julie agrees. “They must be truly informed. We make certain
people understand what they are doing and what will be done.”
Hyperion collects the data and sends it to the pharmaceutical companies.
They do not analyze or interpret the results. Pharmaceutical companies
send them a budget and an FDA approved protocol for the test. Physicians
from the Hyperion network are contacted to be responsible for the
study. Potential study subjects are found and qualified.
Natalie says, “There are four phases of clinical testing. Phase
I is on healthy volunteers. Phase II is testing on a small population
with the pertinent condition. These tests often relate to dosages.
Phase III is testing large numbers of people for a drug’s safety
and efficacy. Phase IV happens after the drug has been approved and
additional studies are needed related to adverse affects or additional
benefits that have been found. We do Phase II, III and IV trials.”
Julie says they are currently recruiting participants for studies
on adult and pediatric asthma, and women who experienced natural menopause.
“We also have studies starting on type II diabetes, stomach
ulcers, triglyceride and cholesterol, hypertension and chronic emphysema.”
The two are particularly gratified that their work allows them to
recruit patients from West Virginia. Natalie says, “Patients
get to be extended family. We see them often, talk to them frequently
on the phone, carefully monitor their health conditions We feel good
that we are helping people receive good medical care.. Our clinical
research is bringing advanced medicine to people in our area.”
To participate in a study, contact Hyperion Clinical Research
at
866-298-2880 or 400 Court Street, Suite 310, Charleston.
Send an Email About This Article