Have you ever wondered, “how does a clinical trial work?”
A clinical trial is a scientific experiment to test new medicines or treatments for people who have certain health conditions. In a trial, scientists carefully study how well a new treatment works and if it’s safe for people to use.
If you decide to join a clinical trial, you might be trying a new medicine, treatment method, diagnostic tool or other therapy. Scientists will closely watch how you’re doing and collect information to understand if the new approach is better than what’s already available. It’s a way to help find better methods to treat illnesses and improve healthcare for everyone.
Before you join, you’ll get a lot of information about the trial, and you can ask questions to make sure you understand everything. It’s a choice, and you can decide if you want to be a part of it. The goal is to advance science and find better treatments, therapies, and medical devices.
Different Types of Clinical Trials:
Clinical trials come in different study designs. Some are observational studies, where researchers observe participants without intervening or assigning treatments. Others are randomized controlled trials (RCTs), where participants are randomly assigned to different treatment groups.
Randomized clinical trials often have “active treatment” and “placebo control” groups. Being in an active treatment group means that you will receive the medication that is being studied. Being in a placebo control group means that you will receive no “active” medication. A placebo is an inactive substance or treatment that looks like a real medical intervention but doesn’t have any therapeutic effect. It is often used in clinical trials, as a control to compare the effects of a real treatment with the effects of something that has no active ingredients. Understanding these differences is essential.
While most clinical trials conducted at Butchertown Clinical Trials test medicines, some clinical trials aim to test new medical devices. The length of time a participant is involved in a clinical trial varies depending on the design of the study.
Participating in a clinical trial:
1. Research and Information Gathering:
– Before participating in a clinical trial it is important to perform your own research. Look for clinical trials relevant to your medical condition or area of interest. There are many public resources available that advertise and promote various clinical trials. In addition to online databases, you can consult with your healthcare provider, and explore trial listings on official websites such as ClinicalTrials.gov or ButchertownClinicalTrials.com.
2. Initial Contact:
– When you have found a clinical trial that interests you the first step is to reach out to the trial coordinator or research team associated with the selected trial. This initial interaction aims to provide you with basic information, answer preliminary questions, and determine your potential eligibility based on initial criteria.
3. Pre-Screening:
– In order to determine if you may be a good fit for a clinical trial you may be asked to undergo a pre-screening process via phone call. The research team will assess your eligibility through inquiries about your medical history, current health status, and details about medications you may be taking. The purpose of pre-screening is to help the research team match patients with a clinical trial that best suits their health condition and/ or scheduling needs.
4. Screening Visit:
– After passing the initial pre-screening and being matched with a clinical trial that best suits you our site staff will work with you to schedule your screening visit. During a screening visit a more in-depth evaluation is conducted after you have signed the informed consent form. This visit may involve comprehensive physical examinations, laboratory tests, imaging studies, eye exams and questionnaires to ensure alignment with all necessary criteria. A comprehensive medical and medication history will be recorded at this visit. We highly recommend bringing a list of your medications that includes the dates you started taking each medication as this information must be recorded during your visit. Having a list of your medications and diagnoses will help your visit go by faster and make recalling your history easier for you!
5. Inclusion and Exclusion Criteria:
– Clinical trials have specific inclusion and exclusion criteria. Inclusion criteria define the characteristics required for participation, while exclusion criteria identify factors that may disqualify individuals from taking part. Key Inclusion and Exclusion criteria will be evaluated at your screening visit and potentially at your second visit. You must pass this portion of the visit in order to be considered for enrollment in the trial. Some assessments cannot be evaluated via pre-screening phone which is why the on site screening visit is essential prior to determining if you qualify.
6. Enrollment:
– Upon meeting all criteria and being deemed eligible, you may officially enroll in the clinical trial. After enrolling in the clinical trial the clinical research coordinator will work with you to schedule your office visits and provide you with all of the materials necessary for your participation. Some clinical trials ask that participants record entries in a daily diary to document symptoms and doses. If applicable the research coordinator will go over specific instructions and provide you with all the tools you need to succeed.
7. Participation:
– Actively engage in the trial by adhering to the study protocol. This may include attending regular visits to the study site, following the trial protocol, taking study medication, undergoing specific interventions outlined in the protocol, and providing regular updates on your health status. It is important to follow instructions to the best of your ability. Your compliance with study instructions is important to the overall success of a trial. If at any time you have questions, concerns or curiosities do not hesitate to reach out to your assigned coordinator. We are here to help you and want to guide you through a successful study experience.
8. Monitoring and Follow-up:
Throughout the entirety of your participation (Screening up until Study Exit) you will be closely monitored by the research team throughout the trial. Regular follow-up visits will be scheduled to assess your health and collect necessary data. Open communication about any changes in your health or concerns is crucial during this period. If at any time during your study participation, you experience a change in medical history or medication you must disclose that information to the study team. If at any time you are hospitalized or experience any injury whether or not it is related to your study participation the study team must be notified.
9. Conclusion and Results:
– Once the trial concludes, you will not be informed of the results. However, some public information is available on the study sponsor’s website. If at any time you would like to find out this information your study coordinator can assist you with finding their webpage. Depending on what phase the study is in, your results may or may not be submitted to the FDA as evidence for the effectiveness of a treatment or device after your participation concludes. Some participants may continue to receive follow-up care even after the trial concludes on an as-needed basis. It’s essential to remain engaged and informed about the outcomes of the trial.
Remember, participation is entirely voluntary, and you retain the right to withdraw at any point. Understanding the distinctions between observational studies and randomized controlled trials is crucial, as each design serves different purposes in advancing medical knowledge and treatment options. Informed consent ensures transparency in these diverse study approaches. We look forward to advancing healthcare with you!
