About Clinical Trials
What is a clinical trial? >
Clinical trials are studies conducted to test the safety and effectiveness of drugs and medical devices before they obtain market approval by regulatory agencies such as the Food and Drug Administration (FDA). DCR and HCP Clinical Research conduct these studies with participants at our early research clinics in Denver and Minneapolis and at physicians’ offices and dialysis centers nationwide.
Are clinical trials safe? >
There are several checks in place that are designed to monitor the safety of clinical trial participants.
Drugs – Pre-Clinical Testing
Before investigational drugs are ever tested in humans, they must first undergo hundreds of tests in the laboratory.
Regulatory Approval Prior to Testing in Humans
The FDA will review the data from those tests before they give the okay for a drug to be tested in humans. Much like drugs, medical device trials must also receive regulatory approval prior to being tested in humans.
Institutional Review Board (IRB) Approval
The study sponsor, typically a pharmaceutical or biotech company, will create a study design that is reviewed by the FDA. In addition, an institutional review board (IRB), an independent review board that regularly reviews clinical trials, will review the study in order to try to ensure the benefit to the subject outweighs the risk. The IRB will then reject or approve the study. If the IRB approves, our research team will then work with the sponsor to administer the study.
Prior to enrolling participants in a study, the study staff obtains informed consent from each study participant. To do this, the study staff provides an informed consent document to each participant, which includes details about the study including its purpose, duration, required procedures, and potential benefits and risks, if any, of participation.
During the Study
During the study, our trained medical professionals are available 24/7 to help protect the health and safety of study participants. In addition, throughout the clinical trial, the study sponsor will monitor all of the data collected during the study for potential safety concerns.
Are there risks to participating? >
Although efforts are made to control the risks to study participants, some risks may be unavoidable because of the uncertainty inherent in medical research activities involving new medical treatments. The details of the risks and benefits of participation are outlined in the informed consent.
What are the responsibilities of a clinical study participant? >
Participants must follow the instructions they are given. For example, you may be asked to refrain from caffeine or alcohol prior to or during office visits for the study. Most studies require you to provide blood or urine samples at intervals during your participation. Study medication is provided to the participant with clear instructions for use. You’ll be required to attend all study appointments and to keep in contact with the study physician or coordinator if you have any changes in your health.
Am I paid for my time? >
You may be compensated for time and travel as described in the informed consent document.
Will my information be kept confidential? >
Your privacy will be respected by our staff. Your information will not be provided to any third parties except as authorized by you, or required by law. For example, the study sponsor and its representatives, applicable regulatory agencies such as the US Food and Drug Administration, and the authorized independent review board may inspect your clinical research study medical records. The results of the clinical research study may be presented at meetings or in publications. However, you will not be personally identified in any data, presentations, or publications.
Do I need permission from my primary care physician to participate? >
A referral from your primary care physician is not required to participate. However, many of our study participants are recommended to us by other physicians. As with any medical treatments, it is important to keep your primary care physician informed of all changes in your health and medications. We will notify your primary care physician of your participation upon your request.
Will it cost something? Does insurance cover it? >
Study related procedures are provided at no cost to the participant and are not billed to your insurance.
Will my doctor be notified of my results? >
Study participants may choose to have their participation and information shared with their physician.
Will I still receive treatment as a participant? >
Some participants in a clinical trial may be randomized into a placebo or control treatment group. The odds of being randomized into the placebo or control group will be explained during the informed consent process. You should continue all other treatments and medications you receive outside of the study unless they are specifically excluded by the trial protocol.
What happens if I get sicker? What happens if my condition worsens? >
As with any medical treatment there is no guarantee that treatments will have the expected outcome for everyone. The health and safety of participants are paramount, so if the investigator, study sponsor, or regulatory bodies conclude the participant’s health and safety are at risk they will remove the participant immediately and, if needed, begin alternative treatments.
Can I drop out? >
Yes. All participation in clinical trials is completely voluntary. You may be asked to participate in an end of trial visit or follow-up visits, but you may drop out at any time.
What is in it for me? >
There are many benefits to participating in a clinical trial.
- You will be playing an active role in your own healthcare
- You will contribute to medical knowledge overall
- You will have access to knowledgeable staff and receive medical care at a healthcare facility
About In-patient Studies
Can I have visitors? >
It depends on the study. To ensure accurate results of the study and to ensure confidentiality for our study participants, we restrict visitors to certain days and times. Your recruiter will be able to tell you if you’ll be able to have visitors if you decide to participate in a study for which you are eligible.
Is there a workout room? Can I exercise during my inpatient stays? >
Our in-patient research clinics do not have workout facilities. The natural effects of exercise in the human body can invalidate the data collected during the study. For this reason, exercise is not allowed during in-patient stays.
Is there a laundry room? >
You should bring enough clean clothes sufficient for the period you will be required to stay at the clinic. Laundry service will only be provided for specific studies which you will be made aware of during your screening process.
Is food provided? What will I eat? >
All meals at our in-patient clinics are provided at no cost to the volunteers. All menus are created based on the requirements of each particular study, so the food items served will vary from study to study. Some studies have very specific menus and may require that volunteers consume the entire portion of food items served. Please discuss any personal dietary concerns with your recruiter; your recruiter will let you know if any upcoming studies can accommodate your special dietary needs.
Are mobile phones and laptop computers allowed? >
Yes. You’re more than welcome to bring your own and use them during your free time. You may have to leave your phone or computer in your room during study procedures.
Can I leave the unit? >
Unless you’ve been told you can go home as part of your study, we ask you to stay in the unit. If there is something important you need, a staff member will be happy to assist you.