Clinical Trial FAQ
Clinical Trial FAQ
Clinical trials are run by a qualified team of research-focused and clinical staff including:
Principal Investigator (PI)– ahealth care professional responsible for all aspects of the study.
Sub-Investigator (Sub-I) – a health care professional that assists the PI with patient care on a research study.
Research Coordinator–the individual(s) who facilitate all aspects of the study andstrive to create a positive research experience.
Research Pharmacist –the pharmacist or pharmacy staff responsible forstudymedications.
Trial Sponsor –the organization initiating and often funding the research and reviewingdatawith patient information removed after the study begins.
Institutional Review Board (IRB) – a board of health care professionals that review studies to ensure they are following ethical and safetystandards.
Anyone could be eligible to participate. Each clinical trial is different from one another and focus on varioushealth conditions and patient populations. Some trials are designed for pediatric patients, others for adults, andboth might includeotherwise healthy participants as a comparison. Each trial has eligibility criteria that a patient must meet to be considered for the study.
People who join research studies are commonly referred to as“Research Participants” or “Research Subjects.” This is done out of respect for your privacy when researchers are speaking with one another and to protect your confidentiality as a participant.
Yes! Some studies will ask for participants without disease known as “Healthy Controls” to enroll to a trial to compare health outcomes.
Only you can decide if participating in a clinical trial is right for you.
- To access treatments
- To access boarder team
- To access boarder team
- Benefit other patients
People who are interested in participating in a clinical trial should speak to their primary care provider to discuss the benefits and drawbacks for their specific health needs. You can contact our research office to discuss any questions or concerns you may have about participating in a research trial at any time.
Clinical research is designed to find safe and effective ways to treat patients now and in the future. Trials have several safeguards in place to ensure safety for participants, including several reviews by the FDA (when applicable), IRB, study sponsor, and clinicians to ensure it is right for Renown Health and our patients. Additionally, clinical staff are trained on each trial and must follow the approved study procedures. Patients are monitored routinely at each study visit.
Observational Studies: An observational study is a type of research where researchers watch what happens to people without changing anything. They simply observe and collect information about how people behave or what happens to them naturally. This helps researchers find patterns and learn more about different health conditions. These studies can include specimen collection studies, where samples like blood or urine are collected, or data registries, where information about people's health is recorded.
Interventional Studies: Interventional trials are a type of clinical study where researchers actively introduce changes or interventions to study participants to evaluate the effects of these interventions on health outcomes. These trials are designed to test the safety and effectiveness of treatments and processes aimed at treating diseases.
More information can be found: Link back to Types of research in our community page
There are four stages of clinical research to ensure safety, each trying to address a simple question:
Clinical trials occur in phases to ensure safety and efficacy for use in humans. These occur like in phases one through 4, for detailed information on each phase of the trial please visit our understanding clinical research page and then have it linked to that section.
Here are some questions to ask your doctor or research staff to help you decide if you want to take part in a clinical trial:
- What is the trial trying to find out?
- What kinds of test and exams will I have to take while I’m on the study? How much time do these take? What is involved in each test?
- How often does the study require me to go to the doctor or clinic?
- Will my health insurance pay for it? What are the costs to me?
- What follow-up and communications can I expect?
- What will happen at the end of the study?
- What are my other treatment choices? How do they compare with the treatment being studied?
- What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment?
- How long will the study last? How long will I need to be followed for the trial?
- What is required of me if I agree to participate?
- Do I have to make any lifestyle changes to participate?
- Does the study pay for travel costs, childcare, or a caregiver to assist me?
- Do both parents need to consent for my child to participate in a research study?
You do not need a referral from your care provider. You may find it valuable to speak to your primary care provider about your healthcare options when considering a clinical trial.
Pediatric clinical trials have several safeguards in place to ensure the child participating is protected, including what is call “Age of Assent.” While the age itself varies study-to-study, the age of assent describes the age at which a child has enough awareness to decide whether to participate for themselves. The parent can consent for a child to receive treatment, but the child must assent, as well. Both must be obtained before any research can begin.
Another safeguard put in place for pediatric studies is “Age of Majority.” This is when a minor turns 18 and can decide whether to continue treatment or not.
Clinical procedures vary based on thecondition being treated and trial design. A clinical trial involves many of the same procedures you would expect during standard treatment. In the case of an observational study, this could look like an additional questionnaire or an extra sample collection during your regular visits. In an interventional trial, this may mean additional scans or procedures to monitoryour health condition. Participating in the clinical trial also gives you access to a broader clinical team to support you during your healthcare journey.
Yes. Enrolling in a clinical trial gives you access to a broader health care team and does not take away from your current team. Your PCP will continue to be apart of your care team and available during the duration of the Trial.
Any procedures, medical equipment or medications related to the research study and that are not typically included in the care plan for someone with your conditionwill be provided at no cost. Your insurance is responsible for anything that would be considered standard treatment for your illness and can vary depending on your health condition.
No. All identifying information is removed from any study documentation being sent to an external party.
Research staff will work with you to schedule all patient visits and find times that would best for you and your family.
In Research, this is called “Withdrawing Consent.”Participants who wish to withdraw can from part or all the research study at any point in their treatment plan. Withdrawing from research does not impact your health care or relationship with your healthcare providers.
This depends on the results of the study. For promising treatments, study sponsors will create an extension trial that provides the medication to patients who participatedon the original study.Oncethe medication is approved for everyone, you can work with your care providerto explore continued use.
It can vary by study. While many clinical trials inform participants of the results, it depends on the trial's policies and regulations. In the U.S., some trials must post results on ClinicalTrials.gov, but this doesn't guarantee direct communication to all participants. Always check with your research team for specific details. Once the study is completed and the data has been analyzed, a summary of the results may be made available to all participants in a clear and understandable format.
Supporting a family member on a clinical trial can look different person to person, but some easy ways to get involved include:
- Respecting their decision to participate in a trial
- Ask if and how you can support them
- Offer to drive them to and from clinical visits.
- Offer to attend clinical visits and asking the research team questions to get a full understanding of the research being conducted.
- Making note of any symptoms you notice during the duration of the trial, especially new ones.
- Doing personal research on their condition.
- Offer to be an advocate for them when they need one.
- Get to know their research team.
- Offer to bring comfort items during clinical visits or procedures.
- For interventional drug trials, keep a detailed log of when and how the medication is taken.
Support from family members and loved ones can make the process of receiving treatment for health concerns less daunting. With the help of family members, patients can have a sense of safety in an unfamiliar environment.
A list of our current clinical trial catalog can be found: https://www.renown.org/clinical-trials/clinical-trial-directory
Additional general contact information:
General Research: 775-982-3646
Oncology Research: 775-982-5050
Renown-CRD@renown.org