Overview
A clinical trial is a research study that explores if an investigational treatment – such as a drug, medical device, procedure, or lifestyle change – can improve health. Clinical trials are necessary in the drug development process to learn whether a new treatment is safe and effective. In general, new medications are tested in a progressive series of clinical trials, classified by phase depending on the nature of the study, to ensure the benefit-risk profile of the treatment is well understood before it is approved and available to large populations of patients.
Clinical studies occur in clinics and hospitals around the world and rely on the participation of volunteers who not only potentially gain early access to treatments that may provide relief for their diseases but also contribute to the advancement of research that may benefit others in the future. All clinical trials, regardless of phase, geographical location, or clinical setting, are required to follow strict regulations set by authorities to ensure proper conduct and the safety of participants. For example, all clinical trials conducted in the United States must conform to rules set by the U.S. Food and Drug Administration (FDA) which help protect the rights and safety of those who volunteer to take part in clinical studies.
Joining a study is completely voluntary, and participants may leave at any time. At Autobahn, your health and comfort matter most. We are here to support you every step of the way during your clinical trial experience.
Clinical Trial Transparency
At Autobahn, we are dedicated to transparency in our clinical research efforts. We believe that openly sharing information with patients, healthcare professionals, and the broader scientific community is essential to advancing science and raising awareness.
We uphold the practice of registering all of our clinical studies in publicly accessible trial registries, such as www.clinicaltrials.gov, in accordance with regulations set by the U.S. FDA and other regulatory authorities.
Autobahn’s goal is to advance research to help patients. As such, we commit to sharing clinical trial results on our studies in compliance with applicable regulatory disclosure requirements and timelines. We aim to help the scientific and patient communities in our mission to provide hope for people suffering from CNS disorders. Results from our studies may be available, for example, on websites such as www.clinicaltrials.gov, published in peer-reviewed journals, or presented at medical conferences.
Steps to Join
a Clinical Trial
1) Identify and Evaluate: Talk to your doctor to see if a clinical trial is right for you. Use trusted sites like www.clinicaltrials.gov to find studies and check if you meet the eligibility criteria (age, diagnosis, medications).
2) Informed Consent and Screen: If you qualify, you will be asked to review the study details (purpose, risks, benefits) with the clinical site’s staff, who will assist in conducting the activities on behalf of the sponsor. Consider the benefits, like access to new treatments, and the risks, such as side effects. Discuss these with your healthcare provider to make the best choice for you.
3) Study Treatment Period and Follow-up: If you decide to participate, you’ll sign the Informed Consent Form and be assigned a study treatment. In cases where there is the possibility of either receiving the investigational medication or placebo (i.e., randomized, placebo-controlled studies), participants and the clinical study staff will be “blinded”, meaning that neither will know whether the participant received the study medication or placebo. Studies typically include regular visits, laboratory tests, and other assessments to evaluate the safety and efficacy of an investigational treatment. Clinical studies are run for a specified duration of time where participants receive a study treatment (the treatment period) and often require a follow-up check-in. In some cases, participants may be offered the opportunity to enter a post-study clinical trial (Open Label Extension) where participants will be given the opportunity to receive the investigational medicine for a prolonged period of time. The study staff at your site will continually monitor your health and ensure your safety is the highest priority throughout your time in a clinical trial.