 |
 Research
is essential if we are going to improve the healthcare
of people today and generations to come. Our healthcare team
is working on cures, treatments to stop threatening illnesses, and
ways to prevent diseases.
Clinical research is an important part of our hospital operations
and brings superior patient care. Our
patients have an opportunity to access the newest approaches to medicine.
This is what distinguishes us from other community hospitals.
 There
are strict scientific and ethical principles used in clinical trials.
Researchers must follow the study’s protocol, which is the plan
for conducting the trial. The Institutional Review Board (IRB) at
St. Francis Medical Center must approve the protocol before the study
can start. The board, which includes clergy, consumers and health
professionals, ensures that the study will be conducted fairly and
that the participants will not likely be harmed. The IRB also conducts
ongoing review of the study. The chair of the IRB at St. Francis Medical
Center is Dr. J. Michael Smith.
The study is thoroughly explained to potential patients through the
Informed consent process. During this process, the researchers discuss
the study’s purpose, tests, possible risks and benefits and
other procedures and answer any questions that the patient’s
may have. Participation in clinical trials is completely voluntary,
and the patients always remain anonymous. The informed consent process
continues throughout the study. Any new information that arises on
benefits, risks, or side effects is given to the participants immediately.
Participants are able to withdraw from the study at any time.
Phases of Clinical Trials
Clinical trials are conducted in four phases:
- Phase I studies test a new drug or treatment for the first time
in people (20-80) to evaluate its safety, to determine a safe dosage
range, and to identify side effects.
- Phase II studies focus on learning whether the new treatment can
effect on the disease that the study drug is intended for. These
studies involve 100-300 people.
- Phase III studies compare the results of people taking the new
treatment with results of people taking the standard treatment.
Participants are assigned by chance (randomized)
into separate groups that compare the different treatments. Neither
researchers nor participants can choose which groups they will
be placed in. Using chance to assign people to groups means that
the groups will be similar and that the treatments they receive
can be compared objectively. At the time of the trial, no one knows
which treatment will be best. Phase III studies include 1000-3000
people.
- Phase IV studies collect more information on a drug or treatment
after the FDA approves it, including the best way to use it and
its risks and benefits.
Breast
S0221 A Phase III trial of continuous schedule
AC + G vs every 2 week schedule AC, followed by paclitaxel given
either every 2 weeks or weekly for 12weeks as post-operative adjuvant
therapy in node + or high risk node negative breast cancer.
Principal
Investigator: Dr. E. Rosvold
NSABP B-39 A Phase III Study of conventional whole
breast irradiation (WBI)
versus partial breast irradiation (PBI) for women with stage 0,1,
or II
breast cancer.
Principal Investigator: Dr. Jo Ann Chalal
CALGB 40302 Endocrine Therapy with or without inhibition
of EGF and
HER2 growth factor receptors: A randomized double blind placebo
controlled Phase III trial of fulvestrant with or without lapatinib
for
postmenopausal women with hormone receptor positive advanced breast
cancer.
Principal Investigator: Dr. E. Rosvold
ACOSOG Z1031A A randomized phase III trial comparing
16 to 18 weeks
of neoadjuvant exemestane, letrozole or anastrozole in postmenopausal
women with clinical stage II and III ER + breast cancer.
Principal Investigator: Dr. E. Rosvold
NSABP-B-42 Clinical trial to determine the efficacy
of 5 years of Letrozole
compared to placebo in patients completing five years of hormonal
therapy
consisting of an armatase inhibitor (AI) or Tamoxifen followed by
an AI
in prolonging disease-free survival in postmenopausal women with
hormone
receptor positive breast cancer.
Principle Investigator: Dr. E. Rosvold
Gastro-Intestinal
E 5202 A Randomized Phase III Study comparing 5FU,
Leucovorin andoxaliplatin vs 5FU, Leucovorin, oxaliplatin and bevacizumab
in patients
with stage II colon cancer at high risk for recurrence to determine
prospectively the prognostic value of molecular markers.
Principal Investigator: Dr. E. Rosvold
N0147 A Randomized Phase III Trial of Oxaliplatin,
plus 5FU/Leucovorin
with or without Cetuximab after curative resection for patients with
stage
III colon cancer.
Principal Investigator: Dr. E. Rosvold
S0600 A Phase III Trial of Irinotecan based chemotherapy
plus cetuximab
with or without bevacizumab as second-line therapy for patients
with metastatic colorectal cancer who have progressed on bevacizumab
with either
folfox,optimox or xelox.
Principal Investigator: Dr. E. Rosvold
Genitourinary
S0421 SF07-36: A phase III study of Docetaxel and Atrasentan
VS Docetaxel and placebo for patients with advanced hormone refractory
prostate cancer.
Principal Investigator: Dr. E. Rosvold
Lung
E1505 A Phase III Study Randomized Trial of adjuvant
chemotherapy
with or without bevacizumab for completely resected stage IB-IIIA
NSCLC.
Principal Investigator: Dr. E. Rosvold
Prostate Cancer
S0421 Phase III study of Docetaxel and Atrasentan versus Docetaxel
placebo for patients with advanced hormone refractory prostate cancer.
Principle Investigator: Dr. E. Rosvold
The
purpose of this study is to compare differences in knowledge of
medications
prior to and after nurse intervention. Procedure: Information
about
the knowledge of prescribed medications will be assessed at
three
clinic visits. If patients cannot identify the purpose of the prescribed
medications,
nurses will provide the education.
Lauren
Valyo, RN, C Principle Investigator
Co-Investigators: Kathleen
Messineo, BSN, RN, CCRN, Margaret Nucero
MS,
FNP, BC, Colleen Rudnick, RN, Barbara Simonds, MSN, RN, CNS,CNAA,
Yvonne
Hill, MHS, Tish Pitcherello, RPSGT, Mary Kolaski and Susan Moran.
~
The purpose of this
study is to determine differences in time that oral nutrition is
introduced to patients with acute ischemic
stroke prior to and after
the introduction of a dysphagia screening form.
Kathleen M. Messineo, BSN, RN, CCRN, Principle Investigator,
Co-Investigators: Marilyn Greenberg, MA, CCC-SLP, Margaret Nucero,
MS, FNP, BC, Rebecca Raymond, RN, Colleen Rudnick, RN, Barbara M. Simonds, MSN,
RN, CAN, Priscilla O’Connor, PhD, APRN, BC, Consultant.
~
The purpose of this study is to compare the number of
injuries
prior and after the use of equipment and an educational
program.
Investigators:Dale Festa, RN, Margaret Nucero,
MSN, CRNP, BC,
Priscilla O’Connor, PhD, APRN, BC
Nursing Research Day
June 23, 2009
11:00am - 3:00pm
SFMC Cafeteria
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