How to ensure successful cancer clinical trial enrolment
Cara Yap , 25 February 2021
The field of cancer research is growing at an unprecedented rate globally, with myriad opportunities to reshape the industry and improve patient outcomes. According to business consulting firm Grand View Research, the global oncology clinical trial market size was valued at 10.8 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 5.4 per cent from 2020 to 2027. This upswing is propelled by increasing cancer prevalence, the need for personalised medicines and growing innovation in the field of oncology.
Amid a burgeoning biomedical sciences sector, the Asia Pacific (APAC) has emerged as the most prominent region for conducting clinical trials. According to data analytics and consulting company GlobalData, APAC accounted for over 40 per cent of the annual share of globally conducted clinical trials in 2019, with oncology charting the highest proliferation of trials started in 2019.
Why are enrolment rates for oncology trials so low?
Despite the immense potential to catalyse ground-breaking cancer research and advance medical science, cancer clinical trial enrolment rates have remained low. According to a 2019 study led by researchers from the Fred Hutchinson Cancer Research Center in Seattle that was published in Journal of the National Cancer Institute, only about eight per cent of cancer patients in the US participated in clinical trials.
Surprisingly, the study suggested that patient choice is not as responsible for low trial enrolment rate as previously thought. Among the almost 9,000 cancer patients across 13 studies, more than half were not given the option of a trial at their institution. The findings emphasise the pressing need to address structural and clinical barriers to trial participation, which stymie trial participation - among other factors:
Poor site assessment Today, trial sponsors are hindered by the inability to conduct accurate feasibility studies, which are crucial in choosing appropriate trial sites that have their targeted patient populations. Historically, site selection is typically decided based on site and investigator reputation. This may work to some extent for trials with simple or broad eligibility requirements. However, in the space of increasing complexity of cancer trials where precise patient populations are required, even large and reputable sites face challenges in identifying appropriate patients.
A disconnect in the cancer clinical trial ecosystem stands out as a key factor impeding successful feasibility assessment. Trial sites typically assume the role of the passive participant unable to translate key patient data into cogent insights, while sponsors conduct their feasibility studies with the help of data partners that lack quality population insights required to offer accurate oversight of a trial site’s true capabilities.
Lack of patient awareness A known barrier to cancer clinical trial enrolment, the lack of patient awareness often means patients harbour misconceptions (ie. That they will be treated as mere test subjects) and hence an aversion towards clinical trials. Typically, a patient’s willingness to participate in a clinical trial hinges upon his/her physician’s recommendation. The latter is often limited by a dearth of up-to-date information on available cancer clinical trials. Accustomed to searching for such trials through manual and inefficient processes, busy oncologists typically do not have time to proactively explore and discuss clinical trial options with their patients.
Structural issues According to a 2019 study led by the Fred Hutchinson Cancer Research Center, published in the Journal of the National Cancer Institute (JNCI), structural and clinical factors are the main reasons why cancer patients don’t participate in trials. The study found that when patients are offered the opportunity to participate in a trial, they do so about half the time. However, 56 percent of patients didn't have a trial available to them at their institution and nearly 22 percent were deemed ineligible for an available trial.
Increasingly complex cancer treatment - A 2019 study led by researchers in UT Southwestern's new Department of Population and Data Sciences, published in the Journal of Clinical Oncology found that emerging therapies and the changing landscape of oncology have introduced complexity in cancer trial enrolment.
Specifically, it is now more challenging for trial sites to identify eligible patients for trials, due to emerging discoveries in the realm of precision oncology. This seeks to determine the best treatment based on patient genetic, environmental, or lifestyle factors. For example, while trials in the past would enrol all patients with stage 2 breast cancer, current trials often are designed to enrol only patients with certain biomarkers.
Oncoshot offers a suite of solutions, built around its AI-powered patient-to-trial matching tool, to help both trial sites and sponsors create a more efficient and successful cancer trial enrolment process. Click here to find out more.
How to improve cancer clinical trial enrolment
Removing barriers to successful cancer clinical trial enrolment involves multiple stakeholders, from patients to oncologists, trial sites and sponsors:
Use technology to identify eligible patients. This begins at the institutional level, where physicians can be provided with resources to efficiently and effectively match their patients to the relevant trials, thus improving chances of successful trial enrolment. According to findings from a 2010 study published in the Journal of the American Medical Informatics Association, Eligibility Screening using machine-learning techniques led to a 450 per cent increase in trial screening efficiency.
Oncoshot’s AI-powered patient-to-trial matching tool is designed to help time-strapped oncologists pre-screen patients for cancer trials in real time, by filling a simple questionnaire. Healthcare partners can sign up here to start using the tool for free, and receive automatic email notifications of the latest cancer clinical trials.
Choose the right feasibility products. These are designed to give trial sponsors focused insights on patient populations - the crux of any accurate feasibility assessment. Historical data on trial sites tends to be outdated and does not fully reflect their true capabilities. Oncoshot’s feasibility assessment platform - built around our patient-to-trial matching tool - offers population insights parsed from anonymised patient profiles that are regularly shared and updated by trial sites. This allows trial sponsors to swiftly answer their most pressing question before dedicating significant resources to trial initiation: are there enough patients eligible for enrolment in my clinical trial in Trial site X?
Reimburse trial sites equitably. Healthcare systems are often hampered by insufficient resources, manpower and capacity required to host more innovative trials and boost their cachet as leaders in cancer research. While trial sponsors typically offer funding to participate in clinical trials, sites often lack a viable system for collating patient data and translating it into meaningful population insights. Oncoshot’s feasibility solution is framed around an incentivised model whereby trial sites are remunerated to share anonymised patient profiles, which our platform then parses into high-quality population insights. This gives trial sites more resources for potentially hiring dual-role clinical staff who can provide patient care while fulflilling research roles.
Digital transformation is key to enabling trial sites to manage their roster of multiple clinical studies efficiently, through work flow systems that can integrate their Electronic Medical Records (EMR). Oncoshot’s feasibility assessment platform helps speed up the trial enrolment process by giving trial sites an overview of their ongoing studies, prospective studies proposed by sponsors and forecasts for ongoing and upcoming studies. The platform also facilitates swift communication between trial sites and sponsors, with the latter using it to send detailed feasibility questionnaires to selected sites, as well as requests for additional information.
Collaborate with patient support groups. It is often challenging for patients to access information about clinical trials, with restrictions on publicising them imposed in several countries, including Singapore. A good way to spread awareness of your ongoing clinical trials is by reaching out to various patient support groups. These usually have access to the specific cancer patient populations and hold a deep understanding of their needs. Working with such groups can help ensure that your information reaches the right audience, in a manner they can easily grasp. Beyond that, it can also help you design your study protocols in a more patient-friendly manner.
Oncoshot harnesses anonymised patient data to derive high-quality population insights that can help trial sponsors assess trial site suitability. Have a question about how our platform works? Find out more here.