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Jun. 24, 2020

TOPIC: Featured News, Patients & Members

FDA Oncology Center of Excellence Listening Session with NORD: A Patient Perspective

Posted by Valaree DonFrancesco

A Note from NORD: 

In May, NORD was approached by the Oncology Center of Excellence (OCE) at the US Food and Drug Administration (FDA) to collaborate on a new initiative to help enhance communication revolving around the conduct of clinical trials for rare cancer drug development during the COVID-19 pandemic.  

Earlier this month, NORD, NORD’s Rare Cancer Coalition, and the FDA OCE hosted an hour-long listening session to exchange information regarding how COVID-19 has impacted rare cancer drug development, and ways in which FDA and the entire stakeholder community are working to address the challenges that are emerging, particularly with respect to the conduct of clinical trials in rare oncology.   

NORD’s Rare Cancer Coalition identified rare cancer patients and caregivers to share their experiences with the FDA around participating in clinical trials during the pandemic. NORD also shared the results of its COVID-19 Community Survey with the FDA during this meeting. The Rare Cancer Coalition, patients, caregivers and NORD had the opportunity to submit questions in advance, including what every rare cancer patient should know about clinical trials during the pandemic, and how the FDA has responded to help rare cancer research continue considering the circumstances. 

While participation was limited during the live session, it was recorded so that others may hear directly from the FDA OCE about their response to important questions around rare cancer clinical trials and drug development during the pandemic. Following are the reflections of a patient who participated, along with a link to the recording. 


A Patient’s Perspective: Ned’s Experience at the FDA OCE Listening Session, June 2020


I am 77 years-old and was diagnosed with primary myelofibrosis in November of 2018. I was honored and excited to be asked by NORD to participate in the June 2020 FDA Oncology Center of Excellence Listening Session to share my experience with a clinical trial during the COVID-19 pandemic. 

I was pleased with the organization of the video conference and the very large number of FDA representatives who participated. The presentations were very clear and informative. I especially liked to see the FDA Guidance on Conduct of Clinical Trials of Medical Products for those conducting and participating in clinical trials during the pandemic. I was relieved to see that some of the requirements could be loosened due to difficulties in patients to attend appointments in person. This is particularly relevant in my situation, as I live 800 miles from my trial clinic and, due to various co-morbidities, I have not wanted to fly to the clinic. I have been able to arrange for testing locally with a follow-up phone interview with my research team at UCLA. My trial is planned for two years and I have about nine months more to go. I am hoping that the pandemic relents either due to a vaccine, a drug or people being more careful in how they conduct their lives so that I can continue my therapy in this trial. I did drive to UCLA once so far in mid-May, but it involved a 4-day trip. With flexibility at UCLA and the company sponsor, I do not have to go again until mid-August. Since the study drug is an oral therapy, I can be sent further supplies at home. However, at certain times it is required that I have an MRI and Bone Marrow Biopsy at UCLA. 

I found the FDA representatives very well informed and they listened with great interest and seemed to be empathetic to the needs of the patient presenters. One presenter, who was not able to participate in a clinical trial in Australia due to the current travel restrictions, was met with great concern and understanding. I was quite moved by her story and hoped the FDA would find a way to guide her through alternative methods to get the medication she needs. Expansion of Compassionate Use for patients is of the utmost importance as demonstrated by her case. 

The session was recorded and the audio can be replayed here: 


Play recording (1 hr 11 min 38 sec)