Clinical Research

Amherst Family Practice Clinical Research

Clinical Research Trials

What is it?  A variety of studies that assess the safety and efficacy of investigational drugs or treatments. The studies answer scientific questions and find new and/or improved ways to treat specific conditions.

Types of Clinical Trials:

• Treatment –  tests experimental treatments, new drug combinations, new surgery/radiation therapy.
• Prevention – find new/better ways to prevent a disease initially or from it returning, may include medications (including vitamins and minerals), vaccines, and/or lifestyle changes.
• Diagnostic – find better tests/procedures for diagnosis of a disease/condition.
• Screening – tests the best way to detect a disease/condition.
• Quality of Life – explores ways to improve comfort and quality of life for chronic Illnesses.

Phases of Clinical Trials:

• Phase I – healthy volunteers, a small group of people (20-80), tests experimental product for the first time to evaluate the safety, dose range, and side effects.
• Phase II – an experimental product is given to a larger group of people (100-300) with specific condition to determine the efficacy and further safety.
• Phase III – larger groups of people (1000-3000), to confirm effectiveness, monitor side effects, compare it to other current similar treatments and collect further information that allows experimental product to be used safely.
• Phase IV – post-marketing studies that give additional information (drug risks and benefits, optimal use).

Definitions:

• Informed Consent:  study volunteer learns the key information about a clinical trial before deciding whether or not to participate; ongoing process that gives study information to participants; both the doctor and nurse are involved in the process; an informed consent document is presented with the study details; participants voluntarily decide whether to sign the consent and participate in the study.
• Protocol:  the study plan which all studies/trials are based on; it states who can participate, schedule of visits and tests, medication, length of study; it is carefully designed to safeguard the health of participants while also answering specific research questions.
• IRB:  Institutional Review Board, a committee that approves, monitors and reviews clinical trials; the aim is to protect the rights and welfare of research participants.
• Adverse Events:  side effects, any undesired effects of experimental products; must be evaluated for immediate and long-term side effects.

Amherst Family Practice Clinical Research

Participant Rights:

• the right to privacy
• the right to informed consent
• the right that your participation is truly voluntary
• the right to have exposure to risk minimized
• the right to assume that risk exposure is balanced by societal benefits expected to result from research and importance of the knowledge that is to be gained by the study

AFP Clinical Research (General)

Amherst Family Practice has been participating in Clinical Research Trials full time since June 2009 as a RxTrials Partner Site. Studies range from acute illnesses to chronic conditions, such as upper respiratory infections, influenza, shingles, diabetes, hypertension, and a variety of vaccines.  All Amherst Family Practice providers participate in the trials. The research team is led by Principal Investigator, Dr. Patricia Houser, who has been involved in a variety of aspects of clinical research for over 20 years.

Contact Information:
Theresa Seddon, RN:  540-667-3658

Clinical Trials at AFP
Coming soon…

Links of Interest:

• www.rxtrialsinc.com
• www.clinicaltrials.gov
• www.ciscrp.org

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