Frequently Asked Questions
What Is a Clinical Trial?
A clinical trial, or research study, is a carefully supervised study in human volunteers to evaluate the safety and effectiveness of an investigational medication or device. The Food and Drug Administration (FDA) requires that all pharmaceutical companies test their new medications or devices before they are allowed to become available to customers. All prescription medications in use today were first proven to be safe and effective in clinical trials.
Is There Any Cost to Participate?
No. There is no cost to the patient for any study-related visits, tests, procedures, or medications. Your insurance is not billed either. In fact, no insurance is necessary.
Do I Receive Payment to Participate?
If you qualify for a trial, you will be compensated for your time and travel. These amounts vary per study. Your compensation amount will be described in the informed consent document.
Are Clinical Trials Safe?
Your safety is our highest priority. The ethical and legal codes that govern medical practice also apply to clinical trials, and most clinical research is federally regulated with built-in safeguards to protect participants.
What Are the Phases of Clinical Trials?
Clinical trials are a crucial component of the drug development process, allowing researchers to evaluate the safety and effectiveness of new medical treatments, therapies, and interventions. Clinical trials typically consist of several phases, each serving a specific purpose and providing valuable information about the investigational product. The phases of a clinical trial are as follows:u003cbru003eu003cbru003eu003cstrongu003e1. Phase 0 (Exploratory):u003c/strongu003e Also known as a u0022microdoseu0022 study, Phase 0 is a relatively new phase that involves administering a very small dose of the investigational drug to a small number of participants (usually less than 15). The goal is to gather initial data on how the drug behaves in the body and how it is metabolized.u003cbru003eu003cbru003eu003cstrongu003e2. Phase I (Safety):u003c/strongu003e This phase involves a small group of healthy volunteers or individuals with the target condition. The primary focus is on assessing the safety and tolerability of the drug, as well as determining appropriate dosages. Researchers also gather initial information on the drug’s pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted) and pharmacodynamics (how the drug affects the body).u003cbru003eu003cbru003eu003cstrongu003e3. Phase II (Efficacy and Safety):u003c/strongu003e In Phase II, a larger group of participants, typically comprising individuals with the target condition, receive the investigational drug. This phase assesses the drug’s efficacy in treating the condition while continuing to monitor its safety and side effects. Researchers may also explore different dosages and refine the dosing regimen.u003cbru003eu003cbru003eu003cstrongu003e4. Phase III (Confirmation):u003c/strongu003e Phase III trials involve an even larger group of participants and are designed to provide further evidence of the drug’s efficacy, safety, and overall benefit-risk profile. These trials are often randomized and controlled, comparing the investigational drug to either a placebo or an existing standard treatment. The results of Phase III trials are crucial for regulatory approval and determining the appropriate use of the drug in clinical practice.u003cbru003eu003cbru003eu003cstrongu003e5. Phase IV (Post-Marketing Surveillance):u003c/strongu003e Also known as post-marketing studies or surveillance trials, Phase IV occurs after the drug has been approved by regulatory agencies and is available on the market. These trials monitor the long-term safety and effectiveness of the drug in a larger and more diverse patient population. Any previously unidentified side effects or interactions may become evident during this phase.u003cbru003eu003cbru003eIt’s important to note that not all drugs or interventions progress through all of these phases, as the specific phases a product goes through depend on factors such as the nature of the treatment, the condition being treated, and the results obtained in earlier phases. Additionally, the clinical trial process involves rigorous ethical standards, informed consent from participants, and oversight from regulatory authorities to ensure the safety and well-being of participants and the validity of the research findings.u003cbru003eu003cbru003eTandem Clinical Research conducts trials for Phase I to IV studies.
What Are the Eligibility Criteria?
Inclusion and exclusion criteria are essential components of clinical trial design that help researchers identify and select the appropriate participants for a study. These criteria ensure that the study results are meaningful, accurate, and applicable to the intended population. Inclusion criteria are characteristics or conditions that participants must have in order to be eligible for the trial, while exclusion criteria are characteristics or conditions that would disqualify someone from participating.u003cbru003eu003cbru003eu003cstrongu003eInclusion Criteria:u003c/strongu003eu003cbru003eu003cbru003eInclusion criteria define the characteristics that potential participants must possess to be considered for enrollment in a clinical trial. These criteria are determined based on the research objectives and the specific population the trial aims to study. Inclusion criteria ensure that the participants are representative of the target patient population and that the results of the trial can be applied to individuals with the condition under investigation. Examples of inclusion criteria might include:u003cbru003eu003cbru003e- Age range: Specifying a certain age group relevant to the condition being studied.u003cbru003e- Gender: If the condition affects a specific gender.u003cbru003e- Disease or condition diagnosis: Ensuring that participants have the condition of interest.u003cbru003e- Disease severity: Specifying a particular level of disease severity to target a specific population.u003cbru003e- Relevant medical history: Certain past medical conditions or treatments that are relevant to the trial.u003cbru003e- Previous treatment status: Whether participants have or have not received specific prior treatments.u003cbru003e- Lab values: Requiring specific laboratory test results to confirm eligibility.u003cbru003eu003cbru003eu003cstrongu003eExclusion Criteria:u003c/strongu003eu003cbru003eu003cbru003eExclusion criteria are established to prevent the inclusion of participants who might compromise the validity of the study results or could be at risk if exposed to the experimental intervention. Exclusion criteria help ensure participant safety, maintain study integrity, and reduce confounding variables. Examples of exclusion criteria might include:u003cbru003eu003cbru003e- Certain medical conditions or comorbidities: Excluding participants with conditions that could interfere with the study outcomes or pose safety risks.u003cbru003e- Medication use: Excluding participants taking medications that might interact with the investigational treatment.u003cbru003e- Allergies: Excluding participants with known allergies to components of the investigational product.u003cbru003e- Pregnancy or breastfeeding: Excluding women who are pregnant or nursing due to potential risks to the fetus or infant.u003cbru003e- Participation in other trials: Excluding participants currently enrolled in other clinical trials.u003cbru003e- Mental health conditions: Excluding participants with certain mental health conditions that could affect their ability to comply with the study requirements.u003cbru003e- Substance abuse: Excluding individuals with substance abuse issues that might impact their ability to participate reliably.u003cbru003eu003cbru003eBoth inclusion and exclusion criteria are carefully designed to create a well-defined participant pool that enhances the study’s scientific validity, safety, and ethical considerations. They are thoroughly documented in the study protocol, ensuring transparency and consistency in participant selection across all trial sites.
Can I Stop Participating at Any Time?
Yes, participants in a clinical trial have the right to stop participating at any time, for any reason, without facing any negative consequences or penalties. This principle is known as u0022voluntary withdrawalu0022 or u0022voluntary discontinuation.u0022u003cbru003eu003cbru003eWhen individuals choose to stop participating in a clinical trial, they should communicate their decision to the study team as soon as possible. This allows the researchers to document the withdrawal and ensure that the participant’s safety is taken into consideration. It’s also helpful for the study team to understand the reasons behind the decision to withdraw, as this information can contribute to the overall understanding of the trial and its impact on participants.u003cbru003eu003cbru003eIt’s important to note that stopping participation in a clinical trial is a personal decision, and participants should never feel obligated to continue if they are uncomfortable, experiencing adverse effects, or if their circumstances change. Their health and well-being are the top priority, and their decision to withdraw will not affect the quality of care they receive in the future.
How Long Does It Take It to Participate in a Clinical Research Study?
The duration of participation in a clinical trial can vary widely depending on several factors, including the type of trial, the specific study protocol, the treatment being investigated, and the outcomes being measured. Clinical trials are typically divided into different phases, each with its own timeline. Here’s a general overview of the timeframes for each phase:u003cbru003eu003cbru003eu003cstrongu003ePhase I (Safety):u003c/strongu003e Phase I trials usually span several months. Participants may be required to stay in a research facility for short periods to closely monitor initial safety and dosage information.u003cbru003eu003cbru003eu003cstrongu003ePhase II (Efficacy and Safety):u003c/strongu003e Phase II trials typically last from several months to a couple of years. Participants are closely monitored to assess the drug’s efficacy and safety in a larger group.u003cbru003eu003cbru003eu003cstrongu003ePhase III (Confirmation):u003c/strongu003e Phase III trials are the longest and can last anywhere from one to several years. This phase involves a larger patient population and rigorous monitoring to confirm the drug’s effectiveness, safety, and side effects.u003cbru003eu003cbru003eu003cstrongu003ePhase IV (Post-Marketing Surveillance):u003c/strongu003e Participation in Phase IV trials can vary widely depending on the specific objectives. These trials monitor the long-term safety and effectiveness of the drug after it’s been approved and can last for several years.u003cbru003eu003cbru003eThe time commitment for participants also includes various factors such as screening, enrollment, treatment administration, follow-up visits, and data collection. Some trials may involve more frequent visits and assessments, while others might have fewer interactions.u003cbru003eu003cbru003eIt’s important to note that clinical trial participation is voluntary, and participants can withdraw from the trial at any time if they choose to do so. Before enrolling, participants are provided with information about the study’s expected duration, procedures, and requirements so they can make an informed decision based on their own circumstances.u003cbru003eu003cbru003eIf you’re considering participating in a clinical trial, it’s recommended to thoroughly review the study protocol, discuss any questions with the research team, and carefully consider the time commitment and potential impact on your daily life.
Are Clinical Trials Covered by Insurance?
No, insurance is required or accepted for most clinical trials. Care and medication are provided at no cost, and in fact, the patient is often compensated for time and travel.
What Should I Consider Before Agreeing to Participate?
If you’re considering participating in a clinical trial, it’s recommended to thoroughly review the study protocol, discuss any questions with the research team, and carefully consider the time commitment and potential impact on your daily life.