FAQs
What is a clinical study?
- Research studies that evaluate the safety and effectiveness of new medications in humans
- Before human testing, these potential treatments undergo rigorous lab animal testing to verify safety
- They are closely regulated by the US Food and Drug Administration (FDA). FDA approval is required for new treatments, ensuring they meet stringent quality and safety standards before public availability
Why should I join a clinical study?
- In-depth Healthcare Attention: Benefit from closer health monitoring and personalized care from healthcare professionals throughout the study
- Access to New Treatments: Gain early access to innovative treatments and contribute to the development of new medical therapies
- Complimentary Health Assessments: Receive free health screenings, lab tests, imaging, and exams, providing valuable insights into your health
- Contribute to Medical Advancements: Play a crucial role in advancing medical knowledge and treatments, helping to improve public health
- Safety and Volunteer Well-being: Enjoy the assurance of a safety-focused environment, with the option to withdraw at any time for your comfort
Can anyone participate in a clinical study?
- Age: There are often age minimums and maximums, depending on the study
- Health status: To be eligible for the treatment, participants must have the medical condition that the treatment intends to alleviate. There are usually criteria around the type and severity of symptoms. Certain other health conditions may also exclude someone from participating if it could impact results
- Gender: Some studies are limited to a single gender, especially early-stage studies testing drugs that interact differently with men vs. women
- Prior treatments/therapies: Another criterion often considered is whether someone has undergone previous treatments related to the condition
What are clinical study benefits and study?
- Active participation in health care
- Difficult to access and often costly treatments
- Free testing (i.e. imaging, bloodwork, exams)
- Assisting others by participating in studies for potential approval and public availability
- Side effects, both known and unknown
- Study procedures
- Treatment ineffectiveness
- Treatment is not practical for all patients
Is there any cost to me or my insurance company to participate?
Do I get compensated if I participate in a clinical study?
Studies may also offer free medical checks, laboratory tests, and study medications.
The current compensation system is not intended to incentivize taking personal risks, and any pressure to participate for payment is against ethical standards. Before enrolling in a study, the research site will disclose the compensation available for time and travel. Compensation should never be the main reason for participation; the primary goal should be helping to advance medical research.
What should I consider before enrolling in a research study?
All potential volunteers should learn as much as possible about their disease and the clinical study they are considering. Participants are encouraged to ask questions of the research staff about the study, the care they can expect while participating, and the potential risks.
The following questions may be helpful to discuss with the research team before enrolling:
- What is the purpose of the study?
- Why do the researchers believe the experimental treatment will be effective?
- Has the treatment been tested previously?
- What types of tests and experimental therapies will be used?
- How do the study’s potential risks, side effects, and benefits compare to my current treatment?
- How will my illness and the effectiveness of the treatment be tracked during the study?
- How will this study affect my daily life?
- How long will the study last?
- Who will pay for the experimental treatment and other study-related costs?
- Will I be compensated for my time, travel, or any additional expenses?
- Will I receive the study results, and if so, when?
- Who will be responsible for my healthcare during the study?
- Whom should I contact on the study team if I have questions or concerns during participation?
What happens at the first visit or screening?
Can I leave a study after I join?
Will my information be kept confidential?
Yes, your personal information is kept confidential as required by law and ethical research standards. Study records are stored securely, and only authorized members of the research team, the study sponsor, and regulatory authorities may review study records for research oversight or safety monitoring. If study results are shared, they are presented in a way that does not identify you personally.
How long do studies last and how many visits are required?
What is a placebo?
Do I need to stop my current medications to participate?
What else should I know before deciding to participate in a study?
- Before you decide to participate, it helps to understand a few important basics about how clinical studies work. Most studies begin with a first visit or screening to confirm whether the study is a good fit for you and to review the details together. The research team will explain the visit schedule, expected time commitment, and any tests or procedures involved so you know what to expect.
- Your participation is always voluntary. You can choose not to enroll, and if you do enroll, you can leave the study at any time and for any reason. That decision will not affect your regular medical care.
- Your privacy is also a priority. Personal and medical information collected during a study is kept confidential and stored securely, and only authorized research professionals, the sponsor, and regulatory agencies may review records for safety and research purposes.
- Some studies may include a placebo, which is an inactive substance that looks like the study treatment. If a placebo is part of a study, that will be clearly explained during the consent process so you can make an informed choice.
- If you have questions at any point, the research team is here to help you feel informed and supported.
If you still have questions, we are here to help. Please contact our research team at (623) 267-8314 or ClinicalResearch@TrialSphereAZ.com .
- Research studies that evaluate the safety and effectiveness of new medications in humans.
- Before human testing, these potential treatments undergo rigorous lab animal testing to verify safety.
- They are closely regulated by the US Food and Drug Administration (FDA). FDA approval is required for new treatments, ensuring they meet stringent quality and safety standards before public availability
- In-depth Healthcare Attention: Benefit from closer health monitoring and personalized care from healthcare professionals throughout the trial.
- Access to New Treatments: Gain early access to innovative treatments and contribute to the development of new medical therapies.
- Complimentary Health Assessments: Receive free health screenings, lab tests, imaging, and exams, providing valuable insights into your health.
- Contribute to Medical Advancements: Play a crucial role in advancing medical knowledge and treatments, helping to improve public health.
- Safety and Volunteer Well-being: Enjoy the assurance of a safety-focused environment, with the option to withdraw at any time for your comfort.
- Age: There are often age minimums and maximums, depending on the study.
- Health status: To be eligible for the treatment, participants must have the medical condition that the treatment intends to alleviate. There are usually criteria around the type and severity of symptoms. Certain other health conditions may also exclude someone from participating if it could impact results.
- Gender: Some trials are limited to a single gender, especially early-stage trials testing drugs that interact differently with men vs. women.
- Prior treatments/therapies: Another criterion often considered is Whether someone has undergone previous treatments related to the condition.
- Active participation in health care.
- Access to scarce and often costly treatments.
- Free testing (i.e. imaging, bloodwork, exams).
- Assisting others by participating in trials for potential approval and public availability.
- Side effects, both known and unknown.
- Study procedures.
- Treatment ineffectiveness.
- Treatment is not practical for all patients.
- In a typical clinical trial, the sponsor is responsible for covering the cost of study drugs, procedures, testing, and research appointments.
- Health insurance companies do not pay for medical costs associated with clinical trials. Some exceptions apply to problems or routine care outside the trial.
- Depending on the trial, participants may be eligible for travel reimbursement, with most reimbursement maximums set in advance. Participation in legitimate clinical studies is free. Sponsors pay the trial protocol’s medical costs to get data.
- Payment is for the time and effort outlined and specified in the study protocol. Payment amounts vary based on study length, required processes, and participant needs. The sponsor sets the amounts for these payments.
- Studies also offer free medical checks, lab tests, and medicines.
- What is the purpose of the trial?
- Why do the researchers feel the experimental treatment will be effective?
- Has it been tested previously?
- What types of tests and experimental therapies are used?
- How do the research’s potential risks, side effects, and benefits compare to my present treatment?
- How will my illness and the effectiveness of the treatment be tracked?
- How will this trial affect my daily life?
- How long will the trial be?
- Who will pay for the experimental treatment?
- Will I get compensated for additional expenses?
- Will I receive the trial results? When?
- Who will be in control of my healthcare?