Put People First & People Get Healthy™
Clinical trials are looking for all kinds of people, but every trial is different. To learn more about whether or not you qualify for our currently enrolling studies, please contact us! Click here to contact our Clinical Research Coordinator, Maggie Rosales, or call her at 623-777-5587 (ext. 7307).
We are currently looking for qualified applicants for the following studies.
– Type 2 Diabetes
– Prior Heart Attack, Stroke, or Stents
– Uncontrolled Asthma
As a volunteer, the first step is always an Informed Consent. This fairly lengthy document informs participants of all the details and responsibilities of the trial. It also outlines any and all known or suspected side effects to the drug or device.
During the study, if any new information on the drug is discovered, the sponsor is required to notify the patient immediately. Before the patient signs the Informed Consent, he or she must voice full understanding of the trial. The participant is also given time to ask questions and take the document home for family to review if desired. After the Informed Consent Document is signed, study participation can begin.
Each trial design is different, but most start with a basic physical exam and blood draw to ensure the safety and good health of a participant. Detailed medical histories, including any current and past medications, are recorded. The patient is sometimes given a diary to record daily activities or to document taking the drug. The patient will also be asked about any changes in their medical history to ensure this is documented in their medical chart.
Clinical trials are meant to gain more information on non-approved drugs, so any changes in medical history are reported and assessed by the Principal Investigator. Every study varies in its expectations of the patient, but all studies have the option for the patient to discontinue participation at any time, for any reason. It is always strongly suggested, however, that a patient come in for a final visit to assess health and well- being before ending participation.
A Clinical Trial involves research on human subjects to evaluate the safety, efficacy, or both of a medical drug or device. Each Clinical Trial involves many different people working together to gain data and answer questions about new drugs and devices. First, there is the sponsor of the trial. This could be a drug company, a research facility, a university, a CRO (clinical research organization) or any combination of the four.
The sponsor develops a protocol– a set of very detailed instructions for the conduct of the trial. The sponsor also pays research organizations to conduct the trial under its observance. Clinical Trials can be conducted by a number of health facilities, big, small, or in between. All trials will have a Principal Investigator, usually a Medical Doctor who will oversee the conduct of the trial.
The Principal Investigator is ultimately held responsible for all of his/her staff’s actions as well as the safety of the patient. Patients, or volunteers, are subjects who agree to the terms of the clinical trial and volunteer to attend all study visits and take study medication, or use medical devices as instructed. Clinical Trials are also under the scrutiny of an IRB, or Independent Review Board. The IRB exists to protect the rights and safety of the patient, and also to serve as an Independent body in the case of misconduct.
Finally, all Clinical Trials are under the careful watch of the FDA. The FDA ultimately decides if the study device or drug is safe, and if the Clinical Trial has proven its safety and efficacy for its intended market population. See the Image above for more on the FDA approval process.
Most Clinical Trials have no direct benefit to the patient. There may be a small monetary compensation offered for your time and travel, but volunteers are primarily helping the future and development of drugs and medical devices. Volunteers in a research study receive extensive health care, usually higher than a normal standard of care. All health related assessments needed for the studies are provided free of charge. These assessments can include lab workups, ECGs, and Physical Exams.
Volunteers also receive study medication free of charge. Since the treatments being tested are not yet on the market, study volunteers gain access to new treatment options that would otherwise be unavailable to them. Study medication could be an active, non-FDA approved drug or an inactive placebo (something that looks identical to the study medication, but has no active drug in its make-up).
Most clinical trial volunteers enjoy the extra attention paid to their health while participating in a clinical trial. You should also know that without volunteers, there would be very few drugs and devices on the market today. Volunteers are essential to the success of clinical trials and are very much appreciated!
All drugs and devices carry risks, some known and some unexpected. There are also risks associated with health procedures such as blood draws. All known risks will be communicated to the patient at the time of the Informed Consent so the patient can make an educated decision regarding participation. It is also very important that the patient inform the study staff of any changes in their medical history so the staff can make sure there are no unnecessary risks or complications to the patient.
Every patient has rights when participating in a clinical trial, known as the Clinical Trial Volunteer’s Bill of Rights.
– To be told the purpose of the clinical trial
– To be told all the risks, side effects or discomforts that might be reasonably expected
– To be told of any benefits that can be reasonably expected
– To be told what will happen in the study and whether any procedures, drugs or devices are different than those that are used as standard medical treatment
– To be told about options available and how they may be better or worse than being in a clinical trial
– To be allowed to ask any questions about the trial before giving consent and at any time during the course of the study
– To be allowed ample time, without pressure, to decide whether to consent or not to consent to participate
– To refuse to participate, for any reason, before and after the trial has started
– To receive a signed and dated copy of the informed consent form
– To be told of any medical treatments available if complications occur during the trial
Source: Getz, K., & Borfitz, D. (2002). Informed Consent. Boston, MA: Thomson CenterWatch
Clinical research trials are a vital part of medical advancement. People like you are needed to participate so we can collect the data we need to further medicines and technology.
Click here to contact our Clinical Research Coordinator, Maggie Rosales, or call her at 623-777-5587 (ext. 7307).