About Us

The Northern Indiana Cancer Research Consortium (NICRC) is a group of six hospital systems including physicians, research nurses and supporting staff which has come together to support clinical research in cancer prevention, control and treatment.  The NICRC is a member of a Community Clinical Oncology Program (CCOP).  A CCOP is a group of community hospitals that team up with cooperative groups and cancer centers to offer cancer clinical trials to their patients.  CCOP was established by the National Cancer Institute in 1983 and its main purpose was to assure that cancer patients have access to cutting edge clinical trials and quality medical care.  The following community hospitals make up the NICRC and form Indiana’s first CCOP.

·       Elkhart General Hospital, Elkhart, Indiana ( www.egh.org )

·       Howard Regional Health System, Kokomo, Indiana ( www.howardcommunity.org )

·       LaPorte Regional Health System, LaPorte, Indiana  ( www.laportehealth.org ) 

·       Memorial Hospital & Health System, South Bend, Indiana  ( www.memorialsb.org )

·       St. Joseph Regional Health System, South Bend, Mishawaka, & Plymouth, Indiana  ( www.sjrmc.org )

·       Lakeland Regional Health Systems, St. Joseph and Niles, Michigan  ( www.lakelandhealth.org )

The following affiliations exist with the NICRC, providing some of the funding along with a federal grant from the National cancer Institute (NCI), plus it creates avenues or opportunities for patients to pursue clinical trials and these include:

·       Cancer & Leukemia Group B (CALGB)

·       Eastern Cooperative Group (ECOG)

·       Hoosier Oncology Group (HOG)

·       Gynecology Oncology Group (GOG)

·       National Surgical adjuvant Breast & Bowel Project (NSABP)

·       North Central Cancer Tumor Group (NCCTG)

·       Phase II Consortium, University of Chicago

·       Radiation Therapy Oncology Group

·       Pharmaceutical Studies

·       University of Michigan CCOP Research Base

·       Michigan State University

·       University of Notre Dame Transgene Program

Most of the above mentioned hospital systems came together in 2000 and became part of a Community Clinical Oncology Program (CCOP), sharing and collaborating research information on a scale as never before seen in cancer research.  The NICRC became the first CCOP in Indiana, which provides our patients the opportunity to participate in different prevention, control and treatment cancer research trials within our own hospital communities.  These trials are the same trials as those offered at the Mayo Clinic, MD Anderson, University of Chicago and other major cancer research centers, which are instrumental in accruing patients quicker, getting quicker results and thus continually improving the standard of care for many of the cancers we are facing today.

Patients choose to take part in clinical trials for many reasons, including the obvious, the hope that the treatment will benefit them personally, that a cure will be found, or that the treatment will prolong their life.  They also hope that the treatment will make them feel better or that their contribution in a study will benefit others.

What is a Clinical Trial?

Clinical trials are research studies which are looking to answer important questions about medical care.  If you choose to participate, you and the study team will work to see if a new method of cancer treatment, diagnosis, or prevention is effective.  Researchers don’t know if a new method is better than the standard of care for patients who are being treated now, but asking the questions will the treatments or interventions in the clinical trials result in better treatments for patients in the future.  However, without participation in clinical trials, little change would occur in the way we treat cancer patients, leaving little hope for the future.  Clinical trials often compare the current practice of care to a new treatment that will, hopefully, be superior or at least offer another alternative.  Cancer patients participating in clinical research trials are given an opportunity to receive a new or emerging therapy in addition to standard therapy.  Prevention trials are available for high risk populations.

There are four phases of clinical trials and they include:

Phase I: How much of a new treatment can be given with reasonable safety?  The goal is to find out three things:

·       how much of a new drug can be given safely

·       how often the drug needs to be given

·       what are the side effects of  the new drug

If you are one of the first patients to take part in a Phase I study, you will receive a small amount of the drug, based on animal testing or the safe dose of a similar medication given to other people.  If there are no serious side effects, people who participate in a later study will receive more of the drug, until the study team learns the maximum amount that can be given safely. These studies are generally carried out at academic medical centers or large hospitals. Generally, only 20 to 30 people are involved in phase I studies.

Phase II: Does the new treatment work on a specific type of cancer?  The goals of Phase II studies are to find out the following:

·       Continue to monitor information about the safety of the drug

·       See if the drug works against a specific type of cancer

Patients in Phase II studies with a specific type of cancer are given the highest dose of the new drug that’s thought to be safe, based on Phase I results.  Typically, no more than 100 people are enrolled in Phase II studies.  Researchers do not know if the new drug will be effective against a specific cancer when the phase II trials are conducted.

Phase III: Compares the new treatment against the standard treatment for a specific type of cancer:

·       Patients are assigned randomly to a group that receives either the standard treatment or to a group that receives the new treatment.

·       Patient is assigned to a group by chance. The patient has an equal chance of being assigned to any one of the groups.

·       In Phase III studies, the treatment is given to hundreds or thousands of people.  The same studies are carried out at many treatment centers nationwide.

Phase IV: Post marketing studies outline in detail additional information including:

.       The drug's risks, benefits and optimal use.  

Patient Safety: There are three ways to keep patients as safe as possible while participating in a study: protocol review, eligibility and monitoring.

1.      Protocol review is done by a group of people called the Institutional Review Board (IRB).  They are responsible for reviewing the protocol, which is a detailed plan of the study, prepared by the researcher who wants to perform the clinical trial.  The trial cannot begin until the IRB is satisfied. The IRB is made up of physicians, nurses, scientists, etc., who may work at the facility offering the trial and at least one person who is not connected with the health care facility.  The Food & Drug Administration (FDA) or the National Cancer Institute (NCI) may also review the study. Finally, during the course of the study, the IRB gets regular updates to assure safety issues are being addressed in a timely manner and the study is being conducted according to the protocol.

2.      Patients must meet certain eligibility requirements before taking part in a clinical trial. If a patients risk is greater than any benefit received, a patient may not be able to take part in the study. Also, people in the study must be similar to one another in areas like age, disease type, or a persons ability to carry out the normal activities of daily living so that the study team can learn whether the new treatment works the same as or better than the standard treatment.

3.      Safety to the patient is vital, so monitoring of the patient is critical.  During a study, the team will always try to identify safety issues like side effects to the study treatment as quickly as possible.  Many more tests and physical exams are performed on patients participating in clinical trials than for someone receiving the standard of care.

Informed Consent:  The Informed Consent is a mandatory requirement of the Clinical Trial process.  This process includes communicating to the patient information about the clinical trial including any major safety issues which might occur during the course of the study.  If interested in a Clinical Trial, a member of the research team will discuss the trial in detail with the patient, including the purpose of the study, procedures required, duration, benefits and potential risks.  After this meeting, the patient will be given written information regarding the trial, so as to formulate any questions the patient may have.  Sharing this information with his or her physician, family and friends plus taking the time to think over the decision.  It’s always a good idea for the patient to prepare a list of questions such as: What is the purpose of the study?  What are the risks involved during the study? What is difference in the care a patient receives through the NICRC compared to the more traditional treatment plant?  How long will the trial last? Or how will I know if the treatment is working? If the patient decides to join the trial, he or she will be asked to sign the informed consent document, which says that the patient understands and agrees to the conditions of the trial.  Once enrolled in the study, the patient will receive frequent evaluations about how the treatment is affecting them.  The patient is encouraged to ask questions and the study team will provide honest and complete answers.  If a patient decides at any time throughout the study that he or she wants to withdraw, for any reason, they are free to do so.  Likewise, if a patient’s evaluation shows that his or her condition has progressed since being on a study, they will be removed from the study.  The entire Informed Consent process is about open & honest communication to assure safe & ethical research standards are being adhered to. Joining a clinical trial is a commitment from both the research staff and the patient. A patient’s commitment involves both time & energy to receive the treatment and follow up visits to monitor their progress.  Therefore careful consideration should be given before joining the study. 

What about Clinical Trial Costs?

Generally, both the study originator and the patient are responsible for clinical trial costs.  The patient may be required to pick up routine costs, like hospital fees, doctor visits and tests.  However, some of these costs may be covered by a patient’s health insurance.  It’s always a good idea to ask your doctor, nurse or other health care provider about these costs before joining a study.

Where do I go or who should I contact if I want to find out more about clinical trials?

If you have additional questions about the NICRC and cancer research, you can inquire to your doctor about the NICRC, contact one of the member hospital sites listed above, call 1-800-284-7370, or visit our web site www.nicrc.org.  By participating in a clinical trial, patients will be exposed to cutting edge research, get treatment within their own communities and allows the patient to have a sense of control in determining their treatment and outcomes, not to mention the possibility of improving treatments for future patients.