Who regulates clinical trials?
Clinical trials are monitored by several bodies to ensure that the trials are done safely and with the patient’s best interest in mind. Overall, trials are monitored by the FDA to ensure that the treatments being investigated are beneficial to the participants. At a more local level, the COMIRB is responsible for overseeing the regulation of clinical trials. They are “an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Colorado Denver and its affiliates.” At a level above the COMIRB is the WIRB, an organization with identical governing oversight but at a larger level. A link to these websites may be found below in the related links section.
Who sponsors clinical trials?
Clinical trials are sponsored by pharmaceutical companies, government agencies, health care institutions, physicians, and any other companies that develop medical equipment, devices, or medications.
Who can participate in clinical trials?
Anyone can participate in clinical trials so long as they meet the requirements to join the study in question. These requirements are called the inclusion/exclusion criteria. These vary by study, and can call for patients of a specific age, race, medical background, etc. The inclusion/exclusion criteria are important for identifying potential patients as well as protecting the health of these participants. If you are considering participating in a clinical trial, it is important that you answer the inclusion/exclusion criteria truthfully and to the best of your knowledge to provide the most accurate data and ensure your health and safety during the trial.
What will happen if I decide to join a clinical trial?
Great! You have decided to participate in a clinical trial. Now what? The first step is coming for a screening appointment. At this visit, you will first read an informed consent, a document that explains the study in detail and acknowledgement of your rights as a patient. This is required to participate in any research study, and is a perfect time to ask the research staff any questions you may have. After this, the research staff will again review inclusion/exclusion criteria to make sure you are an eligible candidate, and they will then proceed with a health checkup. This often consists of blood pressure, height, weight, and a brief physical exam by a licensed care provider on the research team. After this is completed, the clinical research coordinator and provider will monitor you as you continue throughout the study, and will be there for you for all follow-up appointments, telephone calls, and questions you may have until the study is completed.
What is a placebo and why is it used?
A placebo is an inactive treatment that looks identical to the active treatment being investigated in the study. They are commonly referred to as sugar pills. By inactive, this means they do not have any active ingredients to elicit a response from your body. Placebos are used in research trials to ensure that the data being collected by the researcher is accurate and not confounded by any variables. Furthermore, it lets researchers know if a participant is improving because of the medication or because the patient believes they should be improving. Placebos are not issued if a patient has a life threatening condition and there exists an effective treatment, as this would be considered withholding treatment.
What does it mean when a study is Single-Blinded or Double-Blinded?
These terms refer to who in the study knows whether the medication administered is placebo or active medication. A single-blind study is one in which the participant does not know whether the medication is active or placebo, but the research staff do know which medication the subject is receiving. A double-blind study is one in which neither the participant nor the study staff knows whether the medication is active or placebo. Double-blind studies are more common, and they are structured this way to ensure that the study staff cannot influence the results of the study based on their expectations or personal desires. In an emergency situations, it is possible for the study staff to “break the blind” to see which medication the participant was receiving.
What are the common side effects experienced during clinical research trials? Am I safe?
The answer is yes: you are safe. All participants of research studies are under the direct care of a research team, including the clinical research coordinators and healthcare providers. Additionally, there is a phone number listed on your copy of the informed consent that will connect you directly to a member of the research team in the event that you are feeling funny, ill, or experience an unfavorable reaction to the medication. If necessary, the provider can stop the study if this type of negative reaction occurs. Currently, we do not have any Phase 1 studies, meaning that the medications being investigated here have been tested in many people and have been determined safe before reaching this stage. The common side effects vary from study to study, so be sure to ask your research team this question if you want to know.
What questions should I ask if I am uncertain about joining a clinical trial?
There are many questions to ask if you are trying to make a decision, but here are a few to aid in your choice:
What do I need to do for my first appointment?
We encourage patients to try and arrive early to ensure timely completion of the screening appointment. Sometimes, first visits require you to be fasting, but not all have this requirement. We also encourage participants to bring their medications or a list of medications with them to ensure the research staff knows all other medications and conditions present during the study. If you have any questions, send us an email or give us a call!
Will I be paid to participate in clinical trials?
Generally, most studies do pay a stipend to cover the cost of time and transportation to and from the University of Colorado Anschutz Medical Campus. The amount of compensation received does vary between studies, however, and sometimes not all visits are covered.
What if I decide I no longer wish to participate in a clinical trial?
That is ok! There can be any number of reasons why participants would no longer wish to participate in a research study once they’ve started, including a bad reaction to the medication, or not experiencing any benefit from the medication. If you decide you no longer wish to participate, that is your right. Just inform the research team that you wish to withdraw, and let us know why. Sometimes the study requires performing a final safety visit before completely exiting the study.