What is a Clinical Trial?

A clinical trial is a people-based medical research study. Clinical trials play a critical role in the development of safe and effective treatments, drugs, and procedures for diseases such as cancer. These studies are conducted using a controlled and structured process in order to answer specific questions relating to new medical treatments and procedures, as well as new drugs.
Why are Clinical Trials Important?

Clinical trials offer additional options to patients fighting disease and illness. Patients who participate in a clinical trial, while there is no guarantee, may in fact be helped by the treatment or medications they receive during the trial, which would not be possible otherwise.

Through the research conducted during clinical trials, new drug treatments and medical procedures are tested to identify the best results for patients. These results also contribute to the knowledge of doctors and physicians in order to provide more effective care to patients.
 Types of Clinical Trials
Treatment trials are tests for new drug combinations, experimental medical treatments, and/or options in surgery or radiation therapy.
Prevention trials are tests used to explore new preventative measures for people who have never had the disease or to prevent the return of the disease. These may include medication, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic trials help to find more conclusive diagnosing tests and procedures for a particular disease or condition.
Screening trials are conducted to determine the best detection methods for certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials) identify ways to improve the quality of life and comfort for those living with chronic illness.
 How are participants protected?
During a clinical trial, the rights and safety of its patients are held as a top priority. In most cases, the clinical research is regulated on a federal level with safeguards protecting trial participants. The same ethical and legal codes governing medical practices also govern clinical trials. Each trial follows a controlled protocol detailing what researchers will accomplish through the study. Researchers of the clinical trials are required to report results to medical journals, to various government agencies, and at scientific meetings.  Personal information on the patient remains confidential on all reporting.
 What are eligibility criteria?
In order for a clinical trial to be successful in producing answers to the questions it was designed to study, participation criteria must be established and followed. The criteria allow researchers to identify appropriate participants and keep them safe during the program. Such criteria may include age, gender, the type of disease, the stage of disease, prior treatment history, medications taken, activity level, and also other medical conditions.
 How are clinical trials conducted?
Clinical trials are conducted in phases. The purpose of each phase of a trial is to answer specific questions around a new drug or treatment.
Phase I trials are the earliest tests of a new drug or treatment. They are conducted on a very small group of patients. Scientist study how much of a drug can be given safely, the side effects of the drug, the best way to give the treatment, how the body reacts to the drug, and if the treatment actually treats the disease.
Phase II trials are conducted after a new treatment is determined to be safe.  They are conducted on a larger group of patients. This phase allows scientists to find out how and if a treatment is effective. It tests in more detail which types of disease it is effective against, the side effects and how to control them, and what the most effective dose to use will be.
Phase III trials compare the safety and effectiveness of a new treatment to the best current treatments. They are conducted on a very large group of patients and are typically randomized.   The protocol for a phase III trial is more detailed and may compare a completely new treatment with the standard treatment, different ways of administering a current treatment or different doses, or a new radiotherapy schedule with a standard one.
Phase IV trials are completed after FDA approval. This stage is not crucial to FDA approval, but seeks to answer additional questions that may have come up during the first three phases. They may also use this trial to determine additional information including risks, benefits, optimal use, and if the treatment can be used in other stages of a disease.
Links to facilities conducting clinical trials:
Oklahoma University Cancer Institute - Oklahoma City
Kena Williams     405-271-8727
Michael A. Gold, MD     Principal Investigator
Robert Mannel, MD     405-271-8787
Medical Oncology
Oklahoma University Cancer Institute - Oklahoma City
Jeanene Parker     405-271-7867
Daniel Culkin, MD, FACS     405-271-6900
Rene McNall-Knapp     405-271-5311
Howard Ozer, MD, PhD     405-271-4022
Natalie Warren Bryant Cancer Center, Saint Francis Hospital - Tulsa
David Barnes, MD, FACS     918-494-2273
Robert Swanson, MD     918-494-1585
Mark Olsen, MD, PhD     918-494-2000
Cancer Care Associates-Mercy Campus - Oklahoma City
Mohamed Kanaa, MD     405-752-0871
Howard Ozer, MD, PhD     405-271-4022
LaFortune Cancer Center, Saint John's Medical Center - Tulsa
Clinical Trials Office     918-744-2685
Oklahoma University Cancer Institute - Oklahoma City
Rene McNall-Knapp     405-271-5311
Natalie Warren Bryant Cancer Center, Saint Francis Hospital - Tulsa
Gregory Kirkpatrick     918-292-2525
David Barnes, MD, FACS     918-494-2273
Pediatric Oncology
Oklahoma University Cancer Institute - Oklahoma City
Rene McNallKnapp     405-271-5311 

” These links are being provided as a public service and are in no way considered as solicitation efforts by any Cherokee Nation entity”.

Comprehensive Cancer Control Plan

The Cherokee Nation Comprehensive Cancer Control (CNCCC) Project assists in the development of networks and collaboration that produce an infrastructure for a comprehensive approach to cancer within the Cherokee Nation. Since 2003, coalition members and partners have come together to discuss the burden of cancer in Cherokee Nation. Coalition members and partners include local, regional, state and national representatives committed to identifying areas of cancer concern, planning interventions, prioritizing greatest areas of identified need, and then implementing identified strategies and/or providing needed resources. This is the second edition of the Cherokee Nation Comprehensive Cancer Control Plan and will serve, like the first, as an information resource for health care professionals and community members, as well as a tool for the Cherokee Nation Comprehensive Cancer Control Coalition and its respective entities. The coalition is committed to the process of enhancing infrastructure for comprehensive cancer control in the Cherokee Nation with the ultimate goal of reducing morbidity and mortality among the Cherokee community.