Access to Clarity’s Investigational Products

Clarity is dedicated to developing next-generation radiopharmaceuticals to improve treatment outcomes of children and adults with cancer and to conduct clinical trials with the highest ethical and scientific rigour. Participation in clinical trials is a valuable opportunity for patients to access novel diagnostic and/or therapeutic agents and contribute to the understanding of these products. For patients with serious illnesses who have few options for treatment or diagnostic tests, we provide information on how they might gain early access to investigational products not yet approved by regulatory agencies.

Clinical Trials

New treatments must undergo clinical trials for safety and effectiveness assessments before they can be approved by regulatory agencies for patient use. Companies like Clarity conduct these trials, and individuals who meet specific criteria have the opportunity to support medical research that could potentially benefit not only them directly, but many other patients in the future. Results from these trials are submitted to health authorities, and they review the evidence to decide if the product can be approved and made available to a broader group of patients. For details about our current trials and potential eligibility, please speak with your doctor, check our Pipeline page or visit clinicaltrials.gov.

Expanded Access Program

For patients with severe or life-threatening conditions who cannot participate in clinical trials or have exhausted all available treatment or diagnostic test options, there may be opportunities to access investigational products outside of a clinical trial. This process, which can be referred to by various terms such as “compassionate use”, “expanded access”, “special access” or “pre-approval access”, allows for the use of investigational products under specific circumstances and must comply with local regulatory requirements. It is important that both healthcare providers and their patient carefully evaluate the potential risks and benefits when considering access to these investigational products.

Currently, Clarity does not have an expanded access program in place. This decision may change once more information on the safety and efficacy of our products become available through clinical trials. As we advance our research and gather more data, Clarity is committed to exploring ways to improve patient access to our investigational products.  

 

Effective Date: 28 Aug 2024

V1.0 – 28 Aug 2024