FAQs

Clinical trials are research studies that explore if an investigational treatment – such as a drug, medical device, procedure, or lifestyle change – can improve health. Individuals who participate in clinical trials are called “volunteers” and may also be referred to as “participants” or “subjects.”

Clinical trials progress through distinct phases, each with specific goals to ensure treatments are both safe and effective:

• Phase 1 trials examine an experimental treatment in a small group of people to assess safety, identify potential side effects, and determine appropriate dosing or delivery methods.
• Phase 2 trials expand to larger groups of participants to further evaluate safety while beginning to measure how well the treatment works for the intended condition.
• Phase 3 trials involve much larger groups of participants and compare the experimental treatment against standard treatments or placebo to confirm effectiveness, monitor side effects, and collect information for safe usage.
• Phase 4 trials occur after a treatment has received regulatory approval and entered the market, continuing to track safety, effectiveness, and optimal use in the general population.

Every clinical trial establishes specific guidelines determining who can participate, known as “eligibility criteria” or sometimes “inclusion/exclusion criteria.” These requirements are carefully designed to identify appropriate participants based on various factors including age, gender, condition severity, treatment history, and other medical conditions, and to protect the safety of participants in the trial. During screening, study staff will thoroughly evaluate whether the study is suitable for each participant while prioritizing their safety and the integrity of the research.

Participation in a clinical trial is completely voluntary, and participants maintain the right to withdraw at any point – whether before the trial begins, during the early stages, or even near completion. If a participant decides to discontinue with one of our studies, we simply ask that they notify their study staff promptly. This allows staff to provide guidance on the safe transition back to standard care and ensures participants’ wellbeing throughout the process. A research coordinator will further help address any concerns and facilitate a smooth withdrawal without compromising any participant’s future healthcare options.

Clinical trial participants receive comprehensive monitoring throughout the study period, typically with more frequent medical oversight than standard care would provide. While investigational treatments undergo extensive laboratory testing before human trials begin, there remains a possibility of experiencing side effects, as with any medical intervention. It’s important to note that clinical trials only proceed after regulatory authorities and ethics committees have reviewed and accepted the investigational treatment’s safety profile.

Before a participant joins a study, the medical professionals at their study site will thoroughly discuss potential side effects with the potential participant. These may include anticipated mild reactions that researchers are already aware of, or less common effects that emerge during the trial. Throughout a trial, the study staff maintain vigilant oversight of participants’ health status and are prepared to address any side effects promptly with appropriate medical care. This intensive monitoring is a cornerstone of the clinical trial process, designed to protect participants’ wellbeing while advancing medical knowledge.

Multiple layers of protection are in place for clinical trial participants, beginning with carefully designed research protocols and continuing through independent oversight throughout the study. Ethics review boards – comprising doctors, scientists, and patient advocates – provide critical evaluation of all research involving human participants to ensure minimal risk and maximum ethical conduct.

Key safeguards include:

• Independent Protocol Review: Before any trial begins, specialized, independent committees evaluate the study design to verify its safety and scientific merit. These committees include medical professionals, statisticians, and ethics experts who must review the protocol before recruitment can start.
• Comprehensive Informed Consent: Participation is always voluntary, and potential participants receive clear documentation explaining the trial’s purpose, procedures, duration, potential risks and benefits, and key contacts. Research staff discuss this information thoroughly, encouraging questions and allowing time for consideration. Participants can withdraw from a study at any time, even after signing the consent form.
• Ongoing Safety Monitoring: Throughout the trial, researchers continuously monitor participants’ health and promptly communicate any newly discovered risks or side effects. Regular data reviews help identify any emerging safety concerns so they can be addressed immediately.

All information pertaining to the study participants’ identity, medical history, and activity in the study will be kept confidential during and after the full course of the clinical trial. The results of the study will not identify any of the participants individually.

Please contact clinicaltrials@autobahntx.com for more information regarding participation in our trials.