Post-Trial Access
At argenx, we believe participation in a clinical trial within a controlled setting is the most appropriate way to access investigational products.
In our clinical trials, the information shared with participants and health care professionals clearly states the length of the study and how long participants will be treated with the investigational product.
However, argenx recognizes that during a clinical trial, some participants may feel they have benefited from the investigational product, yet they do not have access to the product after their participation in the trial has ended because it is not yet approved or commercially available in their country. Under specific circumstances, if an individual request is received from a clinical trial investigator, argenx may provide access to the investigational product post-trial but before it is approved or commercially available.
argenx will evaluate each request on a case-by-case basis, weighing all of the following criteria:
- Participant has serious or immediately life-threatening condition, has no other suitable treatment option available and does not qualify for another ongoing clinical trial
- Investigational product not yet approved/authorized for the indication or not available by other means in the country where the trial was conducted
- Request for post-trial access made by the clinical trial investigator
- Participant was part of a clinical trial in which the investigational product was administered
- Risks and benefits of using investigational product in the disease or condition of interest is generally well characterized, and the benefits the participant received from administration of the product clearly outweighed any potential risks based on the investigator’s assessment of the participant’s response to the intervention, in consultation with argenx
- Adequate supply of investigational product to provide to the participant requesting access and, if applicable, to support on-going clinical trials that are critical to getting the new treatment approved and thereby reach the broadest possible patient population
- Providing Post-trial access to an investigational product must be in compliance with all applicable national and local laws and regulations
Post-trial responsibilities are shared among all stakeholders: sponsor, investigator, health care provider, health care system and the participant. If continuing medical care and/or infrastructure are necessary for the appropriate provision of the investigational product post-trial, all stakeholders must work together to ensure their provision.
argenx reserves the right to provide access either through a larger program or on an individual patient basis in countries where argenx intends to seek regulatory approval; otherwise, the preferred approach will be named (or individual) patient programs.
argenx will periodically re-evaluate its post-trial access responsibilities during the course of the participant’s post-trial access. If new information becomes known about the investigational product, the ongoing health of the individual and/or market availability of the product or alternative therapies, post-trial access may be terminated with clear communication to investigator and patient of rationale.