Early Access Policy
Early Access/Compassionate Use
Decibel Therapeutics is dedicated to the treatment and prevention of hearing loss. One of our products, DB-020, is currently in clinical trials. The best way for eligible patients to have access to our investigational products is by participation in our on-going . Clinical trials are conducted to determine if the product is safe and effective for use in specific conditions or diseases. When completed, the information gained in the trial is submitted to government agencies such as the U.S. Food and Drug Administration for review. If the product meets standards for safety and effectiveness, the agencies make it available for physicians or other health care providers to potentially prescribe the product for appropriate patients. However, patients who are not part of these trials who may benefit from the product and meet certain eligibility criteria (see below) can request access to the investigational product through their physician. These situations are typically referred to as expanded access programs (EAP) or compassionate use policy.
Procedure and Eligibility Criteria
Requests for access to Decibel’s investigational products must meet the criteria listed below:
The patient has a serious or life-threatening condition
The patient does not have access to comparable or satisfactory alternative therapies
The patient does not qualify for, or have access to, any on-going Decibel clinical trials
There is substantial scientific evidence to expect that the patient may derive a clinically meaningful benefit and that the investigational product will have an acceptable safety profile in the relevant indication to support a robust risk-benefit analysis
There is substantial scientific evidence to support an appropriate dose (amount and frequency) for the investigational product
The investigational product is under active development by Decibel, and access on an early access for individual use basis will not delay, interfere with, or compromise clinical trials or the possible regulatory approval for the product
There is an adequate supply of the investigational product
The compound can be administered – and it is logistically feasible to make it available – outside of the clinical trial setting
Whether the relevant patient’s underlying medical conditions pose safety risks that have not been sufficiently studied
The request has been made by a qualified and licensed physician in the United States with expertise and facilities appropriate for the administration of the therapy, monitoring, managing and reporting side effects, as well as patient experience
Treating physicians who are interested in potential use of a Decibel product for an eligible patient should contact us at firstname.lastname@example.org. Requests are typically acknowledged within 5 business days of receiving the request.
How Requests are Evaluated
Each request for access to Decibel’s investigational products will be evaluated fairly and impartially. Decisions will be based on the criteria above. As with all investigational products, products for expanded access/compassionate use are subject to government agency and ethical committee review and approval. Patients must give informed consent and treating physicians must comply with any necessary safety monitoring and reporting requirements. Decibel cannot guarantee that the investigational product will be made available to a patient requesting access.
All decisions will be based on clinical and scientific factors that affect the benefits and risks to the individual patient.