Providence Health Partners — Center for Clinical Research

A clinical trial is a research study conducted with volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

All clinical trials have guidelines about who can participate. Some research studies seek participants with illnesses or conditions to be studied in a clinical trial, while others need healthy participants. Criteria for acceptance into a trial are not used to reject people personally—the criteria are only used to identify appropriate participants and keep them safe.

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. An informed consent document details the study’s purpose, duration, required procedures, risks and potential benefits, and key contact. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study.

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having a health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

In holding the senior medical administrative position of Medical Director at Providence Medical Group, Dr. Paul Opsahl helps oversee all activities related to the delivery of medical care, clinical services, quality assurance and regulatory compliance.

Dr. Opsahl is a Board Certified family practice physician, and continues to serve his patients at Waynesville Health Care in Waynesville, Ohio. He has been a member physician with Providence Medical Group since its founding, and serves with distinction on its Board of Directors.

Sharing the post of Medical Director with Dr. Paul Opsahl, Dr. Joni Koren serves a vital role in assuring that Providence patients always receive the high standard of care promised by the group’s standing as a recognized Patient-Centered Medical Home.

A past president of Providence Medical Group, Dr. Koren continues to serve on the company’s Board of Directors, and is a past chair of the group’s Clinical Committee. A board certified physician for over 32 years, Dr. Koren recently retired from private practice.