While cancer treatment has advanced far beyond chemotherapy, the unmet needs of oncology patients remain huge, particularly in rare cancers, which account for roughly a quarter of all diagnoses.

In 2024, approximately one in every four clinical trials initiated worldwide was focused on oncology. New cancer trials have increased 92% between 2010 and 2024 according to GlobalData’s Clinical Trials database. Oncology has been the largest therapy area for many years, and continues to grow as cancer’s burden on global healthcare systems rises. For example, the International Agency for Research on Cancer predicts a 77% increase in new cases between 2022 and 2050.

As of August 2025, there were over 5,700 oncology drugs in clinical development or with an IND/CTA filed. The pipeline is vast and varied, with an increasing focus on targeted modalities such as antibody-drug conjugates and monoclonal antibodies. From checkpoint inhibitors targeting proteins like PD-1 to emerging classes of cell therapies and preventative and therapeutic cancer vaccines based on nucleic acids, there is an increasing focus on immunotherapy approaches that harness or manipulate the immune system. As part of this, researchers are also exploring combinations of traditional chemotherapy agents with newer immunotherapy ones – an approach which has already seen success in the metastatic non-small cell lung cancer space, where the combination of chemotherapy with PD-L1 inhibitors has increased response rates and overall survival rates significantly.

Research is expanding rapidly in oncology, but the paradigm under which clinical trials are delivered has seen little advancement over the decades, with trials traditionally and still typically centered around leading cancer research hospitals. This model limits participation and means that hundreds of sponsors are often vying for the same geographically concentrated pools of participants, creating competition that will only increase as research expands.

While sponsors in other therapeutic areas have begun exploring the potential for community settings and home environments to improve the reach of their trials, the adoption of decentralized elements in oncology has been much slower, with 6% of new trials using decentralized elements in 2024 compared to 13% in metabolic diseases, for example.

The data shows growth, nevertheless. The proportion of new cancer trials using one or more elements of decentralization has doubled from 2015 to 2024. In 2024, the most common type of decentralization was mobile healthcare, which includes telemedicine (the most frequently used element), followed by remote monitoring and mobile visits.  

Enrollment challenges plague oncology trials

Oncology studies are often characterized by complex and intricate protocols, with frequent visits and safety assessments, blood draws, and other invasive procedures such as biopsies and magnetic resonance imaging (MRI) scans. Of the 5,700-plus drugs in development, more than two-thirds are administered via injection, and 67% of these are intravenous infusions. Meanwhile, oral dosage forms accounted for 30% of the pipeline therapies.

Long follow-up periods are also common, since endpoints for pivotal trials typically include progression-free survival and overall survival. Since most patients are located considerable distances from the research center, the back-and-forth of appointments can become taxing and may act as a deterrent or reason to withdraw, especially for a terminally ill patient whose wish is to be at home with family. Enrollment and retention of trial participants has become one of the more challenging aspects of oncology studies, and the impact of these issues on the quality and efficiency of clinical studies present in the numbers.

According to GlobalData’s Clinical Trials database, oncology studies from Phase I to III have been more likely to under-enroll over the past decade. At the same time, they have taken significantly longer to complete enrollment than average. These effects are particularly significant in Phase I, where enrollment efficiency is 77% for oncology (vs the 91% average) and enrollment timelines are more than double the average. Phase I drugs are associated with uncertain therapeutic effects and safety profiles. This can act as an additional barrier to enrollment for patients and the physicians referring them for clinical trials, with many concerned that the burden of participating in an early-phase study could outweigh the benefits.

The data highlights a serious problem, since sufficient and diverse enrollment in Phase I cancer trials is critical for determining appropriate doses. Moreover, with the FDA’s Oncology Center of Excellence pushing for more comprehensive dose optimization studies under Project Optimus, these early trials are set to become more intricate, requiring a larger and more diverse sample size to enable the assessment of multiple doses across biologically diverse populations[i]. Put simply, more participants will be critical for future Phase I oncology studies, but how will the industry find them under the current model?

What about representation?

Patients from certain backgrounds may be less likely to enroll and remain in a demanding protocol from start to finish, with socioeconomics playing a huge part in determining who has the time, money, and support to participate. The realities of this are stark in recent oncology trial participation figures provided by GlobalData, which show that since 2020, 4.8% of participants in US-based oncology trials were Black/African American, while less than 1% were Native American. Many trials did not release racial data and could not be included in the analysis.  

Diverse representation is critical across clinical research but often goes a step further in oncology, where the burden of disease is sometimes significantly higher among the racial and ethnic groups that are underrepresented in clinical trials. One example of this mismatch can be seen in multiple myeloma (MM), where Black Americans account for approximately 22% of yearly cases yet represent a median enrollment percentage of 4.5% across MM trials.

Race and ethnicity can also impact efficacy and toxicity outcomes, underscoring the importance of diverse enrollment. For example, analysis has shown Hispanic patients to be more likely to experience severe cytokine release syndrome after receiving CAR-T cell therapy for B-cell acute lymphoblastic leukemia.

Bringing oncology research into homes and communities

Considering the challenges faced by both participants and researchers in this area, there is a pressing need to make trials easier on patients – a compassionate move that could ultimately lead to better reach and results for sponsors. Decentralization is not a new concept but is one that is yet to be adopted at scale in oncology, likely due to concerns over complex treatment protocols that require in-person monitoring and sizeable, specialized equipment. However, as the industry advances and specialist service providers with a focus on community-based care emerge and strengthen, it is now possible to decentralize many components of an oncology trial in a hybrid model.

EmVenio Clinical Research is championing this approach by bringing research activities into participants’ homes and communities, offering comprehensive, high-quality research services with a focus on flexibility, convenience, and compliance. One option the company provides is community research sites – mobile units which are embedded in local neighborhoods to rapidly expand a trial’s geographic reach. Another is mobile visits, where clinicians implement protocols and assessments directly in patients’ homes.

A broad range of research activities can safely and effectively be conducted in the home or a community-based research site. As one example, remote intravenous infusions can provide a more convenient and comfortable option to patients. Infusions can last anywhere from 30 minutes to half a day in cancer protocols, followed by a few hours for PK/PD sampling. These lengthy procedures make home-based or localized care the preferred option for patients who don’t live near traditional research centers.

Many oncology trials will require some activities, such as MRI scans, to be conducted in a more traditional hospital setting. Through a unique partnership with Prime Healthcare, EmVenio is building a network of community research centers within the Prime Healthcare hospital system. These centers are purpose-built spaces designed to enhance the flexibility of EmVenio’s offering, with on-site, community, and fully mobile services supporting enhanced optionality for patients when combined within a single trial. So far, EmVenio has opened four hospital-embedded research centers in the southwest, with plans to expand the network across further research-naïve pockets of the US.

As the oncology community continues to recognize the power of community research to address longstanding challenges in patient enrollment and diversity, EmVenio Clinical Research is poised to expand its support for oncology sponsors looking to bring innovation, access, and patient-centric care to the fore of modern cancer research.

“Clinical trials in oncology are an important therapeutic option for patients,” says Dr. Mark McKenzie, M.D, Chief Medical Officer at EmVenio Research. “Many communities across this country and others do not have access to active clinical trials. Our solutions of community sites, mobile clinician home visits, and patient navigator help to bridge the gap by expanding reach and continued participation. Establishing a clinical research site in areas that lack or have less access provides benefits to those communities and medical science.”

[i] https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus