The success of any clinical trial is contingent upon understanding how to implement a patient centric approach into a study design and having a partnership with an experienced CRO that has the therapeutic expertise and knowledge necessary to execute and operationalize a well-designed clinical trial. Advances in cancer research are directly dependent on effective clinical trial patient recruitment and retention. This is more attainable with a well-designed patient-centric study that reduces not only the patient burden but also the clinical site burden. 

Let's look more closely at the challenges sponsors face when trying to recruit for oncology studies and the emerging technology and resources that can help keep patients and clinical sites engaged throughout the patient journey. Lastly, how Proxima – a full-service, experienced, an oncology focused CRO- can support and help develop your strategy for oncology trials by leveraging existing industry relationships and experience to ensure your study milestones and timelines are met.

Table of Contents:

• Clinical trial patient recruitment challenges in oncology
• Why a patient-centric approach is an important critical success factor
• Emerging technology and innovative solutions for patient and site engagement
• How Proxima can help support your patient-centric focused strategy  
  

Along with their numerous approvals, regulatory requirements, depth, and longevity of clinical trials, sponsors with an oncology focus face an even greater challenge- implementing a patient-centric study for better patient recruitment. Having a patient-centric trial means designing therapies, clinical trials, and healthcare solutions around the patients in order to foster and improve better study recruitment, participation, and retention.

The patient journey should come first, and having the right clinical trial sites and an experienced CRO will shape that strategy for sponsors like you. If the patient's experience is unpleasant and burdensome, recruitment will suffer, which can also hinder trial milestones and timelines from being completed. Every client wants quick results, but what promotes efficiency and speed is creating a trial that prioritizes patient centricity while still achieving the study's objectives.

Low patient enrollment rates jeopardize more than just the performance of clinical studies; they may also impede therapy advancements and improvement opportunities. However, when done correctly, 94-96% of participants stated they would participate in clinical trials again (National Cancer Institute).

Clinical trial patient recruitment challenges in oncology

The success of your trial will be determined by the patient’s voice. Having a patient-centric trial in oncology can be challenging, it means keeping health literacy in mind, providing early communication, choosing flexible sites, having tools, resources, and services readily available, and really making all patients involved feel valued, respected, and empowered.

Being proactive and choosing the right clinical trial sites is key to addressing a big part of the patient-centric approach. Site selection can either make or break your trial due to a lack of vetting or comprehensive feasibility.  Understanding the geography or patient distribution of your targeted population, the clinical sites’ capabilities, and advancements have a direct impact on the patient's experience. Asking the right questions is an important part of the site selection and feasibility process: "Where are these patients located geographically? Does the site offer patient accommodations outside of regular business hours to reduce patient burden? Does the site have a proven track record of historical performance in clinical research?

A well-established site will have experienced, qualified, and engaged staff members, a spacious facility with all necessary equipment and capabilities for the trial, up-to-date resources and tools for patients, and a successful track record of conducting clinical research on-site with data metrics to show. One consequence of choosing the incorrect site could be patients who are misinformed or unaware of the requirements of the trial, possibly resulting in negative outcomes for both their participation and the trial. 

Early-site engagement is also important during the planning and development phase to ensure that your study can be operationalized and executed. Assessing ways to decrease the patient and site burden should also be a focus during this phase. Find out how CROs can help you with this.

The patient journey is also influenced by choosing an experienced CRO, who will assist you in determining the most suitable sites to carry out the research for you with a patient-centric approach, directly enhancing the overall clinical trial participation experience. As a biotech sponsor, it is vital that you select a CRO with the right capabilities, relationships, and connections in oncology pertinent to your unique study requirements. Proxima, for example, can help you with early site engagement with KOLs (key opinion leaders) in our oncology network. A strong CRO, such as Proxima, comes with a qualified leadership team that can leverage partnerships and helps influence the strategy, patient experience, and finalization of your oncology clinical trial.

In the United States, only about 2-8% of cancer patients take part in cancer clinical trials (National Cancer Institute). Perhaps, you're wondering why that is.  Population barriers have a significant impact on trial participation and compliance. Some examples of barriers are the expectations placed on participants, the intricacy of the trial resulting in privacy loss, limited health literacy, geographical restrictions, and more. However, as technology has helped enhance people’s lives, the patient burden has also been minimized, directly improving a patient's willingness to participate. See how you can use modern technologies to enhance your trial in more detail further down in this learning resource.

A true patient-centric trial may require a shift in focus, but a shift is necessary to have higher patient recruitment and retention rates. As clinical trial experts, CROs understand what it takes to design a clinical trial around a patient's journey, such as how to develop need-based information, how to accept and implement patient feedback, how to minimize any inconveniences with travel or cost for patients through a reimbursement system, and more. This allows you, as the sponsor, to do what you do best. 

Let's look at why having a patient-centric approach, a qualified site, and a solid CRO are necessary for an exemplary patient journey to then define the strategy for a successful oncology clinical trial.

Why a patient-centric approach is an important critical success factor

Why does your study need a patient-centric approach? It’s simple, to successfully operationalize, execute, and complete your trial.

It all may sound easy, but with the realities of the clinical research landscape, “patient dropout rates in phase 3 clinical trials can often be very substantial, sometimes more than 30%” (The Uphill Path to Successful Clinical Trials). However, longer-term success is achievable when time and dedication are put into building meaningful relationships among researchers, sites, CROs, and clinical trial participants. Having a patient-centric approach and strong recruitment also implies having adequate representation amongst demographic disparities; Many ethnic and minority groups are underrepresented during trials, resulting in healthcare inequities. Addressing these inequities and advancing cancer research by removing as many clinical trial access barriers as possible is critical for a trial's success.

Another opportunity to enhance a trial with the patient experience in mind is by reducing the number of patient visits and assessments, gathering only required data during each visit, which also makes data capture for the sites less cumbersome. Thanks to technological advancements, it is now easier than ever to develop a patient approach that is feasible, intelligible and minimizes the burden on patients to enhance recruitment and retention.

Emerging technology and innovative solutions for patient and site engagement

Innovative technologies have paved the way for evolutionary approaches to enhancing the patient journey and clinical trial recruitment challenges in oncology. Patient-centric platforms, such as smartphones or tablets, enable to provide patients simple technical information, while sensors, wearable technology such as digital trackers, social media, and other mobile apps help to reduce patient burden by better informing them.

Overall, technology has been a valuable tool for promptly enrolling and prequalifying large numbers of patients, capturing data, and providing a sense of comfort to the sites, the sponsors, oncology CROs, and most importantly the patients to collaborate and build trust. For instance, patient-recorded outcomes (PROs) can now be gathered through app-based surveys and text messages, and blockchain technology has also provided a way to improve data security so studies can receive immediate real-time data while making the patients feel empowered. Also, patients' health patterns can now be monitored and measured using a wearable activity monitor, providing a sense of control and individuality for patients by avoiding constant check-ins and questions. (American Society of Clinical Oncology).

Also, decentralized or hybrid clinical trials, which most CROs offer, have demonstrated a significant reduction in patient and site burden. Hybrid trials have been made possible by using a combination of office and home health approaches. This minimizes the patient burden for participating in a clinical trial by allowing patient assessments that would normally be done in the office to be completed from home. For example, home health nurses can now be sent to a patient's home instead of the patient needing to visit the clinic to evaluate their symptoms, draw blood, or receive medication when necessary.  

With the use of these technologies, oncology CROs can now lower costs, shorten turnaround times, and eventually increase the speed at which novel therapies reach the market. Using a variety of technology-enabled platforms helps in lowering site and patient burden, which directly correlates with an increase in patients' willingness to participate in the trial.

‍How Proxima can help support your patient-centric focused strategy  

The key to a successful oncology patient-centric trial is selecting a CRO that knows the right sites and has the right relationships for your study's patient-specific needs. As a full-service CRO, Proxima is equipped with advanced end-to-end oncology clinical trial patient-focused solutions. In addition to our services, we have extensive industry relationships and professional expertise that is necessary for a successful oncology patient recruitment experience.

We also have a strong and dependable leadership team that works with our technology and industry partners to help shape the strategy for executing your trial by helping you put your protocol into action to understand the study population, criteria, and recruitment goals, as well as guiding you through the protocol submission procedure through the various regulatory agencies.  

Are you still early on in your clinical development journey? We also offer assistance with writing your clinical trial protocol. Learn more here: Expert Tips for Writing Your Clinical Trial Protocol.

Though it has always been difficult, effective patient recruitment is critical to a clinical trial's success. Success, however, starts with creating a safe and empowering environment that centers around the patient's experience. By combining our knowledge of oncology, data administration, site partnerships, and patients’ needs, we can remove any barriers that stand in the way of a clinical trial's effective recruitment and success.