
Spring 2005
Clinical trials offer more treatment options,
new insights into disease
Research is critical in the development of new and better medicines,
medical devices and surgical procedures.
Through St. John’s Medical
Research and Cancer Research for the Ozarks (a joint venture between St.
John’s and CoxHealth), St. John’s physicians conduct clinical trials in a
variety of specialties, including allergy and asthma, cancer, cardiology,
endocrinology, neurology, ophthalmology, orthopedic surgery and urology.
Ophthalmologist
Shachar Tauber, M.D., and his colleagues are currently
conducting seven clinical trials in their office at St. John’s Surgery
Center.
“We’ve reached a level in medicine, particularly at St. John’s, where
we’re beyond just treating disease,” Tauber says. “We must understand the
process of disease. Patients who are willing to participate in clinical
trials provide a wonderful opportunity for us to learn from them. St.
John’s high rate of patient satisfaction gives us the luxury of asking our
patients to participate in trials. Fortunately, many of them are willing
to help us.”
Tauber’s current trials include a study to evaluate the effectiveness of a
rapid screening test for conjunctivitis (pink eye.)
“The rapid screening test’s purpose is to indicate if the patient has
viral conjunctivitis. Most pink-eye patients are treated with antibiotic
eye drops. If their pink eye is caused by a virus, the antibiotic wouldn’t
cure them. If this test is successful in the trial, we could one day start
treating viral pink-eye patients with comfort measures – ‘chicken soup’ –
such as lubricating eye drops and cold compresses, instead of prescribing
them unnecessary antibiotics,” Tauber says.
Benefits of Participating In Clinical Trials
• Free clinic visits and medication
• Frequent contact with medical personnel
• Potential to help others
• Education
•Modest reimbursement
Some patients participate in medical trials because of the broader
treatment options studies offer.
“Medical trials are often conducted to determine if a drug that is
FDA-approved to treat one condition could also be used to treat another
condition effectively,” says Pete Miles, director of St. John’s Medical
Research. “People who participate in medical trials receive very good
care. They also receive medication and/or treatment that may not otherwise
be available to them.”
Safeguards
By federal law, researchers must take several steps to make clinical
trials as safe as possible.
These include:
• A written examination about the content of clinical research and ethical
responsibilities of researchers;
• preclinical studies that show that a new treatment is safe and effective
in laboratory and animal tests;
• use of a strict protocol, which is an outline prepared before the
beginning of a study that describes exactly what will take place during
the trial;
• a written description of all the information that you will need to make
an informed decision about joining a clinical trial. The process of giving
you this information is called informed consent;
• approval of the trial by an Institutional Review Board (IRB) – a
volunteer group of doctors, health care experts and selected non-medical
community members that approves all clinical trials. An IRB evaluates the
merits of a trial and ensures that the clinical trial poses no unnecessary
or inappropriate risks.
“St. John’s is very fortunate to have a great IRB. Their dedication and
responsiveness is what allows us to do the research that we do,” Miles
says. Trials conducted by Cancer Research of the Ozarks must be approved
by both St. John’s and CoxHealth’s IRBs.
St. John’s Institutional Review Board Members
• Debra M. Barnhart, MPH, director, St. John’s Medical Management Services
• Marilyn S. Bauer, MEd, MHA, St. John’s Cancer Center Oncology Program
coordinator, IRB Chairman
• Charles Beasley, Ph.D., St. John’s diagnostic medical health physicist
• Roger Boss, MA, chaplain, St. John’s
• Sam Brown, Ph.D., SMSU faculty member
• Michael Buono, AIA, director, Hammons School of Architecture, Drury
University
• Carolyn Combs, BS director, St. John’s Hospital Inpatient Therapy
• Russ Conroy, MBA, program director, St. John’s Complementary Health
Services
• Anna Beth Crabtree, MLS, MS, director, St. John’s Medical Libraries
• Sharon Davis, BSN, director, St. John’s Breast Center
• Daniel Dwyer, Ph.D. director, St. John’s Ethics Program
• Tregg Geren, BSN, nursing director, St. John’s Hospital Inpatient Neuro
• Patrick L. Gomez, M.D., oncologist, St. John’s Clinic – Cancer &
Hematology
• Kenneth Herfkens, M.D., retired internist and cardiologist
• Shirlee C. Hicks, R.N., ME.d., retired nurse
• Pat Higham, BSN, retired nurse
• Rick Higham, BS, retired GE management
• Fred R. Maxwell, Ph.D., SMSU psychology department chairman
• Michael Merrigan, J.D., St. John’s vice president and general counsel
(non-voting)
• James O’Brien, Ph.D.
• Mike L. Peters, BA, St. John’s vice president (non-voting)
• Drew Rogers, M.D., retired radiation oncologist, IRB Medical Director
• Arnie Shreffler, BS, RT, director of outpatient oncology services
• Allan Weston, M.D., gastroenterologist, St. John’s Clinic –
Gastroenterology
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