The Office of Clinical Trials serves the needs of investigators carrying out original and sponsored research. Conducting quality research with attention to detail is our commitment to physicians and sponsors. Conducting ethical research with attention to the rights and welfare of human subjects is our commitment to those who volunteer to participate.
Who Participates in a Clinical Trial
Most advances in medicine will involve a clinical trial. Clinical trials and device trials assist in establishing medication dosages, side effects or comparative effectiveness. Whether someone is a subject volunteer or a clinical investigator, those who participate in clinical trials are pioneers who are helping to shape the future of medical treatment.
An Independent Research Organization
Patients enrolled as subjects in clinical trials can present a dilemma to the clinician-investigator because serving the best interests of the patient may not always coincide with doing what is best for a protocol. This problem can be partially addressed by using independent clinical coordinators who do not participate directly in caring for patients, but can safeguard the welfare of participants as research subjects (rather than as patients) and assure the integrity of the protocol.
The Office of Clinical Trials can provide physicians and other healthcare professionals with a full range of services required to conduct clinical studies sponsored by pharmaceutical companies or funded by granting agencies. These services include:
Negotiating and monitoring contracts and budgets.
Recruiting personnel to assist in a study.
Providing the services of clinical research coordinators (registered nurses) and research pharmacists to:
Prepare Informed Consent Documents and other documents for presentation to the Institutional Review Board.
Recruit and screen potential subjects and enroll qualified subjects.
Schedule and attend all subject visits and collect and send samples for laboratory analysis.
Gather and report data.
Prepare and dispense investigational medications and maintain medication usage records.
Assist with visits from study monitors.
Additionally, the Office of Clinical Trials organizes training sessions and workshops on conducting clinical trials.
Studies are currently being conducted in the areas of: Cardiology, Hematology, Nephrology, Neurology, Pediatrics, Pulmonology, Radiology and Surgery. If you are interested in participating in a clinical or device trial, or if you have questions, please contact us by phone at 515-241-6727 or 800-843-0429, or by fax at 515-241-6045.
Links to Resources:
FDA Consumer Magazine: Inside Clinical Trials