When can I participate in an expanded access program (compassionate use)?

An expanded access program is carried out at discretion of physicians for patients with an unmet medical need. It usually has broader inclusion criteria. The eligibility criteria of expanded access programs usually allow for a broader group of patients. This means that a patient who is not eligible for a clinical trial might be able to access an investigational drug via an expanded access program. 

Some patients who are not eligible to participate in a clinical trial may be able to access investigational drugs outside of a clinical trial through an expanded access program. 

In general, patients should meet the following criteria for an expanded access program: 

• Have a serious and life-threatening condition 
• Are not eligible for any current clinical trial of the drug 
• Have no other comparable treatment options 
• Are likely to have benefits that outweigh the risks involved

In addition, each expanded access program will have its own specific criteria for patients. For most patients, the only way to access investigational therapies is to participate in a clinical trial. For a patient to enter an expanded access program, the pharmaceutical company must be willing to provide the drug through an expanded access program. myTomorrows can help with requesting this from the pharmaceutical company.

Their treating physician should discuss this with their patient and decide whether requesting the investigational drug is in their patient’s best interest. Physicians then prescribe the drug and oversee their treatment.