It's time for a "digital therapeutic" in Cancer Care!
There has been an enormous amount of news coverage over the last few years discussing the benefits, challenges, and costs of the new cell therapy cancer treatments called CAR-T (chimeric antigen receptor – T). Without going in-depth about the medical science and various approaches, the idea is to genetically modify T-cells outside of the body through various methodologies, then reintroduce the modified T-Cells to fight specific complex cancers. The CAR-T approach has shown promising results for cancer patients who have not responded to more traditional therapies but there are also significant short and long term side effects and the FDA does not have enough patient data to determine the true human costs of these new therapies. Yet, there has been very little effort to create a real time data collection mechanism as part of the clinical trial process despite the enormous benefit to both the evaluation process and the patients' quality of life during the therapy trials.
The goal of any new therapy trial is to evaluate the direct benefit of these new approaches at treating the targeted illness, but this must be measured against the quality of life for the patient once the treatment has been adopted, and long after the treatment course is complete. With one form of the new CAR-T therapies called allogeneic, an effort to reduce medical variables related to side effects and cost, the patients natural T-Cells must be eliminated to allow the modified T-Cell to operate uninhibited. This approach effectively eliminates the patient’s immune system to save the patient. The suppression of the patient’s immune system can drastically impact the patient’s quality of life and life span. Effectively, the patient may be trading one lethal disease for another illness just as dangerous but unnamed. The patient may require a new set of expensive and potentially painful treatments for the balance of their life but once the cancer is cured the drug companies have no vested interest in the patients ongoing quality of life. There should be advocacy for the patients quality of life, impacted by the trial therapy, to require those benefiting from administration of the therapy to monitor and support that life after the initial trial is over.
Additionally, the National Institute of Health has deep expertise in the trial process but collecting safety data on this new therapy category or any new therapy is difficult to collect because the drug owners have little incentive to link adverse effects and lethal outcomes directly to the new therapies. This is where a patient driven mobile solution would directly benefit both the drug companies that are heavily invested in the drugs financial success and the FDA and oncologists who are most concerned with safety and health. Only the patient is directly invested in providing the most honest and immediate data on the state of the patient. Research has also shown that cancer survivors have a vested personal interest in providing support to new cancer patients about all aspects of their treatment options. This connection would create a rich repository of data about the patient’s state of health both during and long after the initial trial is over.
The potential benefits of the new CAR-T class of therapies cannot be denied but without a long term solution for directly engaging the patient in their own care and quality of life this benefit cannot be fully realized. A solution of this type also provides a way to mine and disseminate the real time data that only the patient can generate giving all participants a transparent process with the highest level of safety regardless of initial interests.