By Ed Miseta, Chief Editor, Clinical Leader
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Rafael Pharmaceuticals is a late stage clinical focused on cancer metabolism-therapeutics in oncology. With the COVID-19 pandemic hitting countries around the world, many sponsor companies and sites are scrambling to protect their patients while not disrupting the data collection process. One solution is patients staying at home and making use of remote visits or remote monitoring. Unfortunately, for some patients that is not an option.
“This is a difficult time for cancer patients and companies conducting oncology trials,” says Sanjeev Luther, president and CEO of Rafael. “The FDA has issued guidance advising sponsor companies to protect the health of patients during this pandemic. Some of the patients are immunocompromised because the backbone of oncology treatments is chemotherapy. Protecting those patients will be a challenge for pharma companies. But patient safety is number one for Rafael,” said Luther.
Oncology Patients Are At Risk
With the COVID-19 pandemic, immunocompromised patients, such as those being treated with chemotherapy, are considered to be high-risk. Rafael Pharmaceuticals is also treating patients with pancreatic cancer, and that presents an additional challenge: many of those patients are elderly.
“If your patients are immunocompromised and are older individuals, that presents a problem,” says Luther. “Our company has formed a COVID-19 task force that is monitoring this pandemic very closely. Like other companies, we are less focused on recruiting new patients and are more concerned with making sure we can treat those patients who are already participating in a trial. Our Phase 3 trial for patients with metastatic pancreatic cancer currently has 400 patients enrolled.”
If that situation was not difficult enough, Luther throws in one additional concern. Pancreatic cancer is very aggressive and fast moving. With other types of cancer that develop more slowly, you have time to find and treat your patients. Unfortunately, many pancreatic cancer patients do not have long to live.
Infusion is the main challenge facing cancer researchers. Even in countries where remote monitoring technologies are making their way into studies, combining two drugs and infusing them in patients is something that must be performed in a clinic or hospital.
That puts researchers in a tough position. If patients cannot be treated in their homes, do you bring these older, immunocompromised patients into the clinic, or do you risk not administering their treatments?
Some changes have been made to keep patients safe. For example, Rafael’s protocol has patients coming in on day seven for a blood draw, a requirement of the FDA for pharmacokinetic (PK) analysis. That requirement was discussed with the agency, which decided it would no longer be mandatory. These deviations will be coded in the paperwork as exceptions due to COVID-19. Currently, the only required visits are for infusions.
Virtual Approaches Not An Option
The COVID-19 pandemic suddenly has sponsor companies and sites scrambling for virtual technology solutions that will keep patients engaged in trials but safe at home. New technology solutions have slowly been making their way into clinical trials, and the adoption rate has suddenly been fast-tracked due to COVID-19. Virtual trials, ePRO, remote monitoring, remote visits, and telemedicine technologies are easing the trial burden on patients and cutting down on visits to clinics. Unfortunately, for cancer patients, Luther states virtual approaches are simply not an option.
“In a trial like ours, there are two drugs being used in combination, modified FOLFIRINOX (mFFX) and our lead clinical compound CPI-613 (devimistat),” he says. “This infusion cannot be performed in a patient’s home. A second roadblock is hospitals outside the U.S. not having electronic systems that provide access to their EMRs. Even in the U.S., many sites have been reluctant to provide that access.”
Although infusions must be performed in a hospital or clinic, some technologies are helping oncology patients reduce the number of required visits. ePro is one of them. Rafael Pharmaceuticals is using that technology in both of its Phase 3 trials. Patients using an iPad can note how they are feeling from the comfort of their homes. Luther notes this approach is not 100 percent accurate, since the assessments may not be performed as mandated. “For example, a patient may wait three or four days before completing the questionnaire,” notes Luther. “Despite the limitations, it is a good solution for reducing patient visits.”
An Uncertain Future
Looking towards the future, Luther does not see technology evolving to the point where virtual trials will be possible in the oncology space. Rafael’s treatment and all chemotherapies are administered in a hospital under a hood. One day it may become easier to access hospital EMRs, but infusions will still be an issue. Luther has some optimism that advancements in treatments could make virtual trials a possibility. That would require oncology treatments to evolve from an infusion to an oral dosage form.
Cancer researchers are certainly in uncharted territory. Luther believes a shortage of site staff is one of the biggest challenges. Staff members are busy taking care of sicker patients, many of whom are infected with COVID-19. Some staff are sick themselves while others are not coming in to work due to fears for their health and the safety of their families. Luther even tried reaching out to CROs to see if their employees could assist site staff but was told hospitals would not allow it. Many clinics are now refusing to perform any monitoring for at least three to five weeks, or until the influx of COVID-19 patients slows.
Countries were simply unprepared for this pandemic, and Luther believes the best thing we can do right now is delay the start of new trials and put a hold on trial recruitment, when necessary. He notes it is easy to perhaps halt a diabetes trial. You can also put potentially a cardiovascular trial on hold if that is necessary to protect the health of patients. But patients in a pancreatic trial cannot be put on hold. The disease is so aggressive that any hold will put their lives in jeopardy.
“Oncology trials must move forward,” he says. “How can you halt them? For patients who have a very aggressive cancer, how can you tell them their treatment is being put on hold? It’s not fair to tell them they can’t receive their life-saving infusion because of COVID-19. If we delay a trial for three months, they may not be alive when it commences. These trials must go on.”