Under the direction of Dr. Amarnath Kathresal, Durham Nephrology Associates, P.A. partners with Frenova Renal Research to conduct clinical trials. Frenova Renal Research, a Fresenius Medical Care North America company, is the only Phase I-IV drug and device clinical development services provider dedicated exclusively to renal research. Frenova provides access to the largest renal research site network
in the world.
What is a Clinical Trial?
A clinical trial is a study that involves human subjects who volunteer to participate in researching the answer for a specific health question. During a clinical trial, participants may receive an investigational drug, device or method of treatment. All drugs, devices or methods of treatment have not been approved by the Food & Drug Administration (FDA.) During the course of a clinical trial, participant progress is monitored carefully by a clinical team consisting of Clinical Research Coordinators, Nurses, Advanced Practitioners (such as Physician Assistants and Nurse Practitioners) and the Primary Investigator, who is a Medical Doctor.
All clinical trials follow a carefully constructed plan to study the effects on the participant of the drug, device or treatment method. This plan is called a protocol. The protocol provides specific information for what type of patient the study is researching and the schedule of medication doses and treatments during the study.
To protect patient’s rights and welfare, there are at least two federal agencies that oversee clinical trials in the United States. The agencies are the Food and Drug Administration and the National Institutes of Health (NIH.) Both agencies review the work of individuals and facilities conducting research. In addition, there is oversight for centers where clinical trials take place. This oversight is conducted by Institutional Review Boards (IRB) to make sure that the protocol is reviewed and approved and that all trials are ethical and protect volunteer rights. IRBs are also inspected by the FDA and NIH.
Before a patient participates in a study, they are given information about what they can expect with their treatment including benefits, risks and the possibility that they may be given a placebo-a harmless pill, medicine or procedure that is used as a control (has no effect) in testing. It is important that patients understand all of the information in the protocol and agree to participate in writing. This is called informed consent. Participation is always voluntary. Patients may choose at any time to stop participating for any reason.
Why would I want to participate in a clinical trial?
Patients choose to participate for a variety of reasons. Clinical trials study potential new drugs or improved treatment options. Patients may be able to compare a new drug versus their existing drugs during the clinical trial and determine if the new drug is more effective in managing their symptoms, is easier to use or have less side effects.
Possible benefits to participation include:
- Having access to new research
- Receiving expert care for your condition from your doctor, who is a specialist in the disease/treatment being studied
- Receiving help with an ongoing medical issue through use of a previously unavailable drug, device or treatment
- Helping other patients by contributing your experience to advance medicine
- You may receive compensation for your participation in the study
Possible risks to participation include:
- All information about the drug, device or treatment may not be available because it has not been used previously
- Treatment may not be effective or may cause side effects that may be mild to severe in nature
- Participation involves utilization of your time as a participant