Clinical Research

Understanding Clinical Research Steven S. Oh, Director of Research Springfield Clinic - Department of Research

Clinical Research is…
A required step in the development of new medications and treatments to help control, improve and treat diseases

What’s in your medicine cabinet?

Clinical Research - Past
The earliest recorded clinical trial dates back to the 605-562 BC by King Nebuchadnezzar II
Bread and Water diet –vs- Meat and Wine diet
The 1 st clinical trial of a “novel therapy” was in 1537 by surgeon Ambroise Parè
Concoction of turpentine, rose oil and egg yolk prevented infections of battlefield wounds
Adapted from: Clinical Trials Centre / The History of Clinical Trials

The 1 st clinical trial using a control group was in 1747 by James Lind while at sea
Citrus fruits in the diet could prevent scurvy
50 years later, the British made lemon juice a compulsory part of the seafarer's diet.

The ethical impact of clinical trials became increasingly important in 1945
Led to strict regulation of medical experiments on human subjects
The 1 st 2 trials using properly randomized treatment and control groups were conducted in 1948 & 1950 by the Medical Research Council, UK

Clinical Research - Present
Today, because of the knowledge gained from clinical research, substantial advances have been made in the prevention, diagnosis and treatment of thousands of diseases.
Resulted in life spans that are more than 10 years longer today.

Results
Adapted from: National Vital Statistics Report, Vol. 56, No. 9, December 28, 2007

What does clinical research look for? In some clinical studies, a new drug or treatment is compared with the standard of care therapy Other studies may look to determine whether an existing drug or treatment could be used in a new way, to treat a different medical condition. Does it help other conditions? What are the side effects ? Is it effective ? Is it safe ? What is the best dosage? Does it work better than other SOC treatments? Does it improve a person’s quality of life? Does it improve a person’s health? Does it relieve symptoms? Clinical Research Investigational Product

What happens in a clinical study?
Depends on the type of study being conducted
In general…
The research team consists of physicians and their research staff (nurses, coordinators, etc)
Participants are given specific information and instructions for participating in the study
The participant and their health are monitored carefully during the clinical study
The participant is contacted after the study is completed for follow up

5 Different types of clinical research studies Clinical Research Treatment Studies Prevention Studies Diagnostic Studies Screening Studies Quality of Life Studies

5 Different types of clinical research studies
Prevention Studies
Looks for ways to reduce the risk of getting a disease
Screening Studies
Looks for ways to detect certain diseases or health conditions before the symptoms occur
Adapted from: http://clinicalresearch.nih.gov/how.html

5 Different types of clinical research studies
Diagnostic Studies
Evaluates better tests or procedures for diagnosing a particular disease or condition in its early stages
Treatment Studies
Tests new treatments, new drug combinations, or new approaches to see which is the best treatment for a disease
Quality of Life Studies
Explores and measures ways to improve the comfort and quality of life of people with a chronic illness

4 Phases of Clinical Research Phase I Phase II Phase III Phase IV

4 Phases of Clinical Research
Phase I
1 st time the investigational product / treatment is given to humans
~10-100 healthy / patient volunteers
Helps to figure out the best dosage, safety, and side effects

Phase II
~100-300 patient volunteers / study
Very strict guidelines / criteria
Tests an investigational product with a known dose and side effects
How does the body use it?
How does it help the condition / disease?

Phase III
~1000-3000 patient volunteers / study
Continued evaluations of safety and efficacy
Compared to Standard of Care treatments
Information for package insert and labeling

If the FDA approves the treatment…

Phase IV
Tracks long-term safety
More information about long term safety, side effects / risks, benefits, and optimal use
Larger groups of patient volunteers
Looks for drug interactions with other drugs, foods, and environment

Who is involved?
Physicians, pharmaceutical companies, FDA, and patient volunteers work to identify better ways for treating, preventing, diagnosing, and understanding human diseases

Pharmaceutical companies
Pharmaceutical companies around the world work to develop new treatments, medicines, and vaccines targeted at specific diseases

Physicians and research
Qualified physicians and their research teams are asked to assist in studying these investigational treatments by conducting clinical research at their clinics

Cutting Edge Research for Tomorrow’s Medicine

Springfield Clinic Department of Research
55 Physicians / Providers currently participating in Clinical Research
Chief Clinical Officer
Mary Stewart, RN, BSN
Director of Research
Steven Oh, BA
Research Business Manager
Candice Bears, BS, CCRP
Clinical Research Manager
Peg Carter, LPN, CCRP
Clinical Research Coordinators
Justin Roth, BS, CCRP
Sandi Shields, RN, OCN
Suzanne Shaffer, RN
Merri Ellen King, RN
Carlene Cowan, RN
Clinical Recruitment Coordinator
Jennifer Swan, BS
Regulatory Specialist
Marge Adams, CCRP

Why do we do it?
To provide the patients throughout the Midwest with “Cutting Edge Research for Tomorrow’s Medicine.”
Only through clinical studies can new treatments be evaluated, which may lead to treatments for life’s most deadly diseases.

Patient volunteers
Patients are given the opportunity to participate in research studies by volunteering to receive investigational treatments that may not be readily available

Why participate?
An opportunity to receive a medical research treatment that is not widely available
Access to quality medical care from doctors who specialize in the condition being studied
A chance to advance medical knowledge
The satisfaction of helping others who are suffering from a chronic, serious or life-threatening illness

Feedback from our patients
We come up here
to one place and get
everything done.
Everyone has been
so helpful through
the whole process.
Wanda, Research Patient
They just amazed me…On my first day, the Research Department was waiting for me at the front door and personally escorted me through the entire process. That’s what it’s all about – taking care of patients.
Pat, Research Patient

Where do the studies come from?
Springfield Clinic Department of Research is contacted on a weekly basis by pharmaceutical companies
The “protocol” (study cookbook) is carefully reviewed
What type of study is it?
Do we have the proper patient population?
Could our patients benefit from the study?

Where do the studies come from?
If we agree to conduct the study, we must be officially chosen to participate in the study by the pharmaceutical company
After all of the necessary reviews and approvals have been received, the study is launched and is open for patients to participate.
Research Committee
IRB

How do we get access to it?
Each clinical study has specific (inclusion / exclusion) criteria that determines whether a patient is eligible to participate in the study
Clinical Recruitment Coordinator
Springfield Clinic Department of Research
217-582-7541
x4434 (Clinical Recruitment Coordinator)
X4664 (Dept. of Research Main Number)

If I qualify for study participation…
Your written consent to participate will be obtained
You will have an assigned study coordinator who will guide you through the study
Access to the research team 24 hours / day, for any study related issues / concerns
Your progress, health, and safety will be followed by trained professional(s) throughout the study
You may decide to withdraw from the study at any time, without consequence to your medical care

How are Participants Protected?
The ethical and legal codes that govern medical practice also apply to clinical research
Clinical trials are federally regulated with built in safeguards to protect the participants
Clinical trials follow carefully controlled protocols, or study plans, which detail what researchers will do throughout the study
Individual participant names and the personal health information of the participants will be kept confidential
IRBs, Data Monitoring Committees, FDA Inspections

References
http://www.fda.gov/
http://www.ich.org/
http://centerwatch.com/
http://www.clinicaltrials.gov
http://www.springfieldclinic.com/

QUESTIONS?

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Clinical Research

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