Over the past 10 years, the number of oncology clinical trials has grown almost twice as fast as the number of trials for any other disease. Oncology trials are a vital source of income for research sites and sponsors and a vital source of hope for patients. But they’re also complicated.
Each phase of an oncology study lasts 14-18 months longer than each phase of an average trial. Oncology clinical trials as a whole take roughly 12 years, while non-oncology trials take just 8 years.
These delays have several causes. Many oncology clinical trials have highly specific recruitment guidelines that make it difficult to find participants. Oncology research sites also have to face uneven funding, complex protocols, and vulnerable patients who are at risk for adverse events.
Oncology clinical trials will always be complex. But with the judicious use of remote technology, an international outlook, and a focus on patient-centricity, research sites can ensure their oncology clinical trials run safely and efficiently.
Difficulty recruiting for oncology clinical trials
Many clinical trials have trouble enrolling participants, and oncology trials are no exception. Though 18 million people battle cancer each year, only 2-8% of them participate in a clinical trial. Here are a few reasons recruiting for oncology trials can be difficult.
Like many studies, oncology trials frequently take place at academic medical centers in large cities. These sites may not reach patients who live in rural areas or lower-income neighborhoods.
But smaller research sites don’t always have the resources for complex oncology trials. Many cancer studies require frequent patient visits, and the average oncology trial has 3.1 million data points per protocol, compared to 1.9 million points for non-oncology studies. Sites with limited staff and funding often can’t collect that much data.
One clinical research program manager for oncology trials spoke to Florence about the logistical challenges of working at a community hospital with limited clinical trial staff. She remembers telling the institution when she started, “If we are going to be successful, we have to open just one site. Because there is only one me, and we don’t want a failed study.”
Finding experienced staff able to handle the complex protocols and documentation of oncology trials remains a challenge for many smaller research sites.
The challenges of precision medicine
Oncology clinical trials also frequently involve precision medicine, treatment options that depend on a person’s genes. This means patients won’t be eligible for the study unless they have a specific type of tumor, a specific type of molecular profile, or both.
Because of these molecular requirements, oncology trials only enroll 14% of the patients they screen, while non-oncology trials enroll 54% of the patients they screen. These trials need an enormous pool of potential participants to have a chance of meeting their recruitment goals.
Improving recruitment in oncology clinical trials
Cancer networks, like the NCI Community Oncology Research Program, allow smaller sites to affiliate with larger cancer institutions. Some multicenter studies even use a single, centralized Institutional Review Board (IRB). This helps small sites contribute to recruitment for oncology trials.
In addition to forming networks, oncology research sites can use patient recruitment technology to find eligible patients. If patients willingly submit their health information to the software’s database, that software can compare their genetic data with existing clinical trials to find the trials they’re eligible for.
Sharing expertise across sites and sponsors
Research sites and sponsors can also expand their pool of trial participants by holding trials in larger regions and even across multiple countries. This strategy works especially well for trials that have strict genetic requirements.
But to expand to multiple countries, oncology clinical trials need to find multiple investigators capable of safely running the study. Physicians at smaller research sites often don’t have the training or opportunities to get involved in research. Technology can help with this problem.
Clinical trial software lets sponsors or academic medical centers share their research expertise with smaller sites. Experienced clinical research staff can use tech like video calls, CTMS programs, and eRegulatory platforms to quickly share trial documents, protocols, and guidance with local clinics and physicians.
With this support, smaller trial sites have the resources to get involved in oncology trials. They can then offer trials to patients who have never had access to them before.
Uneven funding across global oncology trials
Cancer research sites in high-income countries often receive funding from the government and charitable organizations as well as sponsors. This gives them the freedom to conduct grant-funded, investigator-initiated, or sponsor-backed oncology clinical trials.
Low- or middle-income nations don’t have as many options for funding. In fact, oncologists from those countries describe lack of funding as the number-one barrier to cancer clinical trials. This is why high-income countries have more than 100 times the number of clinical trials per capita as low-income countries.
Though sponsors may run trials in lower-income countries, they first need to make sure they can safely monitor those international sites. Some research sites in lower-income countries also hope to receive government or nonprofit funding in addition to sponsor funding. But that funding can be tricky to find.
Solutions for funding difficulties
During the COVID-19 crisis, we saw how remote monitoring allowed clinical trials to continue even when research staff were off-site and monitors weren’t allowed to travel. Our Mid-Year 2021 Survey revealed that 81% of sites either have or plan to use eRegulatory software that enables remote monitoring.
If sponsors embrace remote monitoring, they can run clinical trials in underserved countries, increasing the amount of funding available there. Technology can also help research sites raise awareness of the work they’re doing in the hope of obtaining government or nonprofit funding, though there are no guarantees that funding will be available.
Of course, underfunded sites won’t be able to pay for technology on their own. That’s why it’s essential that sponsors either pay for the technology and give it to underserved sites or let the sites pick out technology that their sponsors will reimburse them for.
With this tech, sponsors can engage in remote monitoring, collect large amounts of international data, and work with patients from all over the world. Hopefully, remote monitoring technology will eventually lead to a mix of sponsors and nonprofits running trials and making treatments available to patients everywhere.
Complex protocols for oncology clinical trials
Oncology clinical trials often have complex protocols, due to their advanced precision medicine treatments. This can cause difficulties for many clinical research sites. Phase 2 oncology studies averaged 121.8 protocol deviations between 2014 and 2019, compared to an average of 75.8 deviations for other studies.
These protocols can become even more difficult to follow when multiple international sites are involved. Countries can vary greatly in their drug supply and distribution chains as well as their ability to deliver biopsy and blood samples, images, and scans from one location to another.
Managing regulatory approval for oncology trials
Because so many oncology clinical trials take place internationally, sites and sponsors have to manage multiple regulatory agencies and review boards.
This means that study start-up times can vary greatly. One phase 3 breast cancer trial protocol received approval from review boards in just 26 days in North America but didn’t receive approval for 236 days in South America.
It’s important to make sure that every oncology research site can successfully set up their study with all of the protocols, documents, and data they need to receive regulatory approval. But how can sponsors help with that process when regulatory requirements vary so much?
Technology solutions for managing protocols and regulatory approval
In the long term, the oncology clinical trial industry needs to embrace harmonization. This has already begun to happen, with international research organizations collaborating to define cancer stages, toxicity, and endpoints across oncology clinical trials.
In the future, international research groups could come together to standardize regulations around privacy, records retention, and biospecimen ownership as well. This wouldn’t make oncology trial protocols less complex, but it would make it easier for protocols to receive regulatory approval.
But until standardized regulatory guidelines become the norm, sponsors, CROs, and large academic medical centers can help smaller research sites meet the protocol and regulatory burdens of oncology trials through document and data sharing technology. Sponsors and CROs can instantly share protocols and documents with multiple sites through bulk distribution features.
Research sites can then manage documents and data within their own private eISF and share relevant information with their sponsors instantly. Both sites and sponsors can leave comments for one another and access audit trails to see when a document has been edited and by who, making it easier to remain compliant with regulatory standards.
Illness and risk of adverse events
Adverse events can happen during any clinical trial, but they’re especially likely to occur during oncology clinical trials. Participants are already ill, often immunosuppressed, and regularly visiting doctors’ offices and hospitals where they could be exposed to other infections. All of these factors increase the risk of a serious adverse event (SAE).
Living with cancer can also make travel requirements and frequent in-person appointments feel like more of a burden than they might be otherwise. Eligible patients are often exhausted from other cancer treatments, like chemotherapy and radiotherapy, and aren’t eager to add another treatment to their schedules.
One oncology clinical trials manager shared how “even a 20- or 30-mile drive” could prove difficult for her patients who are balancing work, family obligations, and other appointments. These drives can be especially challenging for lower-income patients, patients who are disabled, or patients who rely on public transportation.
Solutions for accommodating high-risk patients
Oncology clinical trials might always have a higher risk of adverse events because the patients involved are seriously ill. But clinical trials can still employ strategies to make trials easier for high-risk patients.
Cancer research sites will need to do some clinical trial procedures in person, like tumor imaging or chemotherapy infusions. But it may be possible to do other parts of the trial remotely.
For example, many patients could fill out informed consent documents at home using an eConsent platform. eConsent forms have high completion and low error rates for oncology trials in particular.
Participants can also complete follow-up surveys and patient diaries online instead of traveling to the site. Some trials have even begun to use technology like ePRO software and wearable devices to let participants report their data directly from home or work. This can make it easier for the elderly, patients with disabilities, and patients whose illness is progressing rapidly to participate in trials.
Not all patients have WiFi or devices at home, so research sites may need to provide in-person options as well as digital ones. But letting patients choose when to come to the site (where possible) can make them more likely to engage in oncology clinical trials.
Overcoming the challenges of oncology clinical trials
Oncology clinical trials might always require specific patient populations and complex protocols. But technology can help sponsors and sites find eligible patients around the world, even in countries where research is less common and underfunded. Remote tech also helps smaller sites manage complex oncology clinical trial protocols and provide better care to patients battling cancer.
If you’d like to learn more about how remote technology can help research sites participate in trials, check out our complete guide to eISFs and remote site access.
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