CAR T-cell therapy clinical trials are among the most exciting medical advances of the past decade. Since 2017, the FDA has approved 6 CAR T-cell treatments for blood cancers, including lymphomas, some forms of leukemia, and multiple myeloma.
CAR T-cell therapy offers hope for many patients who have relapsed or whose cancer hasn’t responded to standard treatments like chemotherapy, surgery, or radiation. Because of this, sponsors have raced to launch CAR T-cell trials.
More than 1,000 CAR T-cell trials are registered with the FDA, with 627 currently active, and the number of trial starts has grown 38.7% year over year.
But the majority of these trials (40.7%) are still in Phase 1–and patients whose cancer isn’t responding to treatment or who have already relapsed can’t afford delays. Technology can help speed up CAR T-cell clinical trials and make them more accessible for patients who need them.
The Potential of CAR T-Cell Therapy
CAR T-cell therapy teaches the patient’s own immune system to fight cancer. The research site collects T-cells from the patient and engineers them to produce proteins called chimeric antigen receptors (CARs).
The CAR T-cells are then put back into the patient’s body, where, if all goes well, they recognize specific antigens on cancer cells, bind to those cells, and kill them. This form of immunotherapy has proven effective for patients with relapsed or refractory (treatment-resistant) cancers like:
- B-cell acute lymphoblastic leukemia (ALL)
- B-cell non-Hodgkin lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Multiple myeloma
But while current CAR T-cell therapies have tremendous benefits for oncology patients, they also have limitations.
First, they’re expensive. Recent CAR T-cell treatments cost around $450,000, and whether patients can get coverage often depends on the insurance they have.
Second, CAR T-cell therapy clinical trials often move slowly or become stuck in early phases. 40.7% of all current CAR T-cell trials are still in Phase 1, and only 1% are in Phase 3.
Advanced, complex treatments like CAR T-cell therapy will always be somewhat expensive. And no one wants treatments to reach Phase II or III if they’re unsafe or ineffective.
But trials can also become more costly and slower for preventable reasons, like:
- Patient recruitment delays
- Limited site capacity, especially with the rapid growth of clinical trials
- Staffing shortages leading to slower monitoring visits
These areas are where technology can help.
Speeding Up Patient Recruitment for CAR T-Cell Trials
Slow recruitment is a problem for many oncology trials, not just CAR T-cell therapy studies. This is because new cancer treatments often fall into the category of precision medicine, medicine personalized for a patient based on their genetic or molecular profile.
Patient recruitment is difficult in general, with 80% of trials failing to meet their enrollment goals on time. With precision medicine, the pool of potential patients is smaller, which can make recruitment even slower.
Only 11% of Americans have discussed precision medicine treatments with their doctors. This is partly because busy primary care physicians often don’t have easy access to their patients’ genetic data or to listings of which trials their patients are eligible for. We need to make information on precision medicine trials more accessible if we want to improve patient recruitment.
Steps to Improve Patient Recruitment
Solving this problem requires a few steps:
- Patients who are willing to undergo genetic testing need access to it. 79% of patients would be willing to share their genetic information with a precision medicine database. But only 50% of patients who qualify for genetic testing because of their family history receive that testing.
- When physicians receive patients’ genetic testing results, they should be able to cross-reference those results with available clinical trials. Medical professionals need software that can quickly compare patient data from the EHR with the criteria listed in clinical trial databases. But this software is not yet widely available.
- Patients must be empowered to look for clinical trials themselves. Many precision medicine trials, including CAR T-cell trials, are listed on online databases. But those databases need to be accessible, including for patients who use screen readers or need translations.
Helping precision medicine trials recruit patients more quickly could make trials faster, less expensive, and more accessible. But it won’t solve the problem of sites being overworked.
The Capacity Gap and CAR T-Cell Therapy Trials
The number of clinical trials is growing quickly, especially the number of CAR T-cell trials. 2021 saw:
- A 14% increase in clinical trial starts over 2020
- A 19% increase in clinical trial starts over 2019
- A 38.7% increase in CAR T-cell therapy trial starts
But site capacity isn’t growing at the same rate. In fact, with staff turnover rates as high as 50%, many experienced sites can’t keep up with the trials they’ve already committed to. Clinical research staff also report high levels of burnout, and sites recount having anywhere from 30-70 studies sitting in their backlog, waiting to be activated.
Research sites want to offer potentially life-saving studies to their patients, and patients want access to cutting-edge treatments like CAR T-cell therapy. But sites need to have enough staff capacity to run trials safely.
One solution for this problem is to move trials to new, less-experienced sites or into participants’ homes using patient-facing technology. These tactics work well for routine check-ins or for trials that don’t require complex treatments. But CAR T-cell trials will always need the expertise of an academic medical center, cancer center, or highly-advanced research site.
Closing the Capacity Gap with Technology
But technology can help highly-qualified staff members spend less time on repetitive paperwork and more time on patient visits and data management. The right software can also help investigators focus on important procedures like CAR T-cell therapy instead of on tedious signatures and CVs.
For more on how technology can help close research’s capacity gap, check out:
- Too Many Trials, Too Few CRAs: Closing the Capacity Gap in Clinical Trials (blog)
- Too Many Trials, Too Few CRAs: Maximizing CRA Efficiency (webinar)
- How Frontier Sites and Hybrid Clinical Trials Can Help Research Sites
- Technology Can Help Sites and Sponsors Prepare for the Rapid Growth of Clinical Trials
Improving Document Management and eSignatures
The right technology platform can help Clinical Research Coordinators spend less time copying and scanning documents and more time on strategy, analysis, and interacting with patients.
But what does that technology platform look like? Here are a few features that can help clinical research site staff spend less time on tedious paperwork:
- Ability to share, upload, edit, and comment on documents remotely
- Tasks and placeholders with email reminders
- Up-to-date and legible electronic logs/eLogs
- Automated audit trails and version control
eSignature platforms can also save time for clinical research staff and Principal Investigators (PI). Clinical research staff won’t have to run across hospitals or campuses to find investigators for wet-ink signatures.
Instead, clinical trial coordinators can send a signature request straight to the PI’s phone or computer. The investigator can then quickly sign from their office, in between patient appointments, or while grabbing coffee.
This efficiency is only possible, however, if the eSignatures are FDA 21 CFR Part 11 and EU Annex 11-compliant. You can learn more about 21 CFR Part 11 and about Annex 11 requirements here:
Giving Sponsors Remote Site Access
- Distribute documents in bulk to sites
- Create document templates for all the sites in a study
- Build in document placeholders for sites
For maximum efficiency, sponsors can perform all these functions within the electronic Investigator Site File the site already uses. They can use that same eISF to check on documents and data, leave notes for sites, and track site progress.
With these features, sponsors can lift some of the heavy administrative burden on sites–and give sites more capacity to focus on trials with complex procedures, like CAR T-cell therapy.
Speeding Up Medical Innovation
CAR T-cell therapy could extend the lives of thousands of people with leukemia, lymphoma and multiple myeloma. CAR T-cell therapy and other immunotherapy treatments may also one day help patients with solid-tumor cancers.
But to make these medical innovations a reality, we need to ensure that overworked sites can focus on what they do best: treating patients–and not spend all of their team uploading, printing, and signing repetitive regulatory documentation. This is where technology must step in and help sites.
To learn more about how clinical trial technology can help sites overcome staffing shortages and successfully run trials, check out this webinar on closing the capacity gap in clinical research.