Policy for Access to Investigational Agents
We are committed to helping patients who have not had success with existing, available therapies and may benefit from our investigational therapies currently in development. Context Therapeutics' Policy for Access to Investigational Agents describes the principles and procedures that the company will follow when considering a request. Please see below for further details.
I. Context Therapeutics Policy for Evaluating Access to Investigational Agents Outside of Context Therapeutics Clinical Trials
Cancer is a life-threatening illness that is often poorly treated by available therapies. Context Therapeutic was founded to address this unmet medical need. Our product pipeline consists of investigational therapies for cancer that are currently being tested in clinical trials and have not yet been approved by the US Food and Drug Administration (FDA) or other regulatory bodies for commercial sale. We have conducted and are conducting research on our investigational product pipeline so that we can better understand how these investigational therapies work, which cancers in humans are most likely to benefit from these investigational therapies, and how to understand fully the safety and efficacy of the investigational therapies.
Patients with cancer often exhaust standard treatment options and seek out investigational therapies being tested in clinical trials. People who take part in clinical trials help society by contributing to medical research, the development of new therapies, and the advancement of patient care. Other times, patients may not be able to participate in a clinical trial. When patients are not able to participate in a clinical trial, their physicians may request that a drug company like Context Therapeutics makes its investigational therapy available outside of a clinical trial.
Context Therapeutic is committed to helping patients who have failed available therapies and may benefit from treatment access to the investigational therapies that we are developing in a manner that is both scientifically and ethically responsible. This Context Therapeutic Policy for Access to Investigational Agents describes the principles, criteria and government regulations that we will follow when considering a request for access to an investigational agent outside of a clinical trial.
1. The investigational therapy must be in active clinical development. Context Therapeutic must be actively studying the investigational therapy in human subjects. In this way, Context Therapeutic is able to comply with local regulations regarding manufacturing, preclinical safety and reporting obligations. Restricting access to investigational therapies with active clinical programs also ensures that there are Context Therapeutic personnel who are trained and responsible for the safe release of the investigational therapy. A possible exception to this criterion could exist in a case where an investigational therapy is in the later stages of preclinical testing, on its way to clinical testing, though an acute medical need requires earlier access. In such a case, Context Therapeutic, at its sole discretion, could explore the safety and feasibility of providing access, so long as relevant regulatory authorities are in agreement.
2. Patients must be first considered for ongoing clinical trials of the investigational therapy. Treating physicians interested in treating their patient with Context Therapeutics investigational therapies in active clinical development must first try to enroll their patients in a clinical trial studying the investigational therapy. Clinical trials incorporate regular safety monitoring, and create a venue for investigator training on the potential risks of the investigational therapy. In addition, Context Therapeutics has a scientific and ethical obligation to complete clinical trials that could support health authority approval of the medicine. Clinical trials have the ability to establish clinical benefit for the investigational therapy, and thus transform an investigational therapy into an approved drug capable of offering benefit to a wider population.
3. The patient must have a serious disease or condition.
4. There must be a positive benefit-risk ratio for the patient. The potential benefits to the patient seeking access to the investigational therapy must always outweigh the collective potential risks to the patient of offering the investigational therapy. In establishing the benefit-risk ratio, Context Therapeutics will consider the outcome of the disease itself.
5. The physician who requests access must be:
Qualified, agree to directly supervise treatment, be willing to obtain relevant health authority approval/clearance, otherwise comply with relevant local and/or country regulations, and agree to follow Context Therapeutics' policies applicable to expanded use in general and any conditions or restrictions set by Context Therapeutics for the particular drug and patient.
The physician may be asked to comply with special monitoring procedures and to provide ongoing clinical information, as requested by Context Therapeutics. Such requests would be made in the interest of patient safety and ensuring that a positive benefit-risk ratio persists for the patient.
6. The physician requesting access must provide:
A scientifically justified rationale for the theoretical benefit that the investigational therapy could provide
A statement that approved therapies typically used to treat the disease have been exhausted and the patient is no longer responsive to, or able to tolerate, these therapies
A statement that there are no other viable therapy options, including participation in ongoing relevant clinical trials
7. There must be sufficient clinical data to identify an appropriate dose (amount and frequency of the investigational therapy given) and appropriate formulation.
8. After meeting the needs of clinical trials and other existing patients on therapy, Context Therapeutics must have a sufficient supply of the investigational therapy to reasonably accommodate the likely duration of treatment.
II. Procedure for Requesting Expanded Access and Response Times
1. Treating physicians interested in treating a patient with a Context Therapeutics investigational drug that is in active clinical development must submit the Context Therapeutics Expanded Access Program request form to email@example.com. Treating physicians should take care not to include identifying personal health information (PHI).
2. Context Therapeutics will acknowledge a satisfactorily completed and submitted request via email within 5 business days.
3. Making a request does not guarantee the granting of access to an investigational drug. Context Therapeutics will review the request in the context of its Policy for Evaluating Access to Investigational Agents Outside of Context Therapeutics Clinical Trials. Context Therapeutics will attempt to make a decision to grant or deny the request, or ask for more information, within 10 business days.
III. Contact for Further Information
Questions about Context Therapeutics' policy and procedures for expanded access, or about expanded access to Context Therapeutics investigational drugs, should be sent by email to: firstname.lastname@example.org.