HJAR Sep/Oct 2020

HEALTHCARE JOURNAL OF ARKANSAS I  SEP / OCT 2020 19 What are the pros and cons of Right to Try and expanded access? Patel PROS: By definition, these laws give patients access to novel treatments off study. They gain the ability to try one more option that they might otherwise have been ineligible for based on various financial or location barriers. If the patient has a good performance status of a 1 or 2, they should be able to try any and all available options, even investigational. CONS: Because expanded access and Right to Try make investigational medical products available topatients, there is always an inherent risk of adverse side effects. As the physician, I always consider the fact that I am the connecting link between the patient and the sponsor, and at the end of the day, I’m the one signing off on my patients partaking in these investigative treatments. That is why I am so grateful for our entire clinical research team for their diligence in exploring early study results, and ensuring we are enrolling our patients in studies we feel comfortable with. Additionally, their continued monitoring of patients ensures that we are watching them as they progress through the trial. CARTI has a dedicated team of nurses and study coordinators assigned to support our principal investigators in conducting a clinical trial. Each trial has a schedule of events that must be strictly followed, and all data must be reported. Institutional Review Boards (IRB) and study sponsors also monitor the site’s activities to assure patients’ safety, and the quality of the reported data. Conducting a treatment trial requires a large commitment of resources from an organization, and this limits the number of clinical trials an organization can successfully conduct. Completing the requirements of an expanded access program or Right to Try would be difficult and time consuming without a research staff familiar with the regulatory and reporting processes. There is no compensation to the site for this process, so this could be a potential roadblock for some physicians who do not have the dedicated staff. Are you seeing promising results at your facility for either Right to Try or expanded access? Patel The expanded access program (EAP) we currently have patients enrolled in deals with patients who have KRAS-mutated met- astatic colorectal cancer. The treating phy- sician completes a treatment request form and seeks approval from the sponsor. The physician checks patient eligibility for on- going clinical trials and contraindications. Once approval is given, the IRB approves the site to provide treatment, and an informed consent form is provided. The physician ex- plains the treatment to the patient or legal representative, along with expected adverse effects, and ensures that the patient under- stands the information. Once informed con- sent is signed, the treatment period begins. In this situation, the sponsor is supplying the investigational product free to the pa- tient. All other standard care is billed to the patient’s insurance. The research staff main- tains all regulatory documents and drug ac- countability. The physician also reports any adverse reactions to the sponsor and IRB. We recently enrolled our patients in the EAP, so unfortunately, it is too soon to have any results. However, the results from the early phase clinical trials are promising, and our patients are very happy to have an oppor- tunity to participate and receive the investi- gational product. Naturally, they want to ex- plore every shot available at extending their survival and improving their quality of life. It is CARTI’s mission to provide compassion-