Claudia Berrón- Senior Vice President, Clinical Services, Avantor; Mac Winslow- Senior Director, Global Customer Development, Clinical Services, Avantor
An estimated 50% of clinical trials will be hybrid or fully virtual decentralized by 2024.1 This leaves the pharmaceutical industry faced with unique supply chain challenges in meeting patient expectations. One of those challenges comes from a shifting patient preference for a more consumer-like clinical trial experience.
For drug developers, decentralized clinical trials (DCTs), whether hybrid or virtual, improve savings, quality and speed. A recent study from the Tufts Center for the Study of Drug Development found using a DCT model in phase II and phase III trials increases a drug’s ROI up to sevenfold.2
Even more pressing than the financial benefit is the need for the patients to benefit from these life-changing therapies. With so much at stake, it is essential that CROs, pharmaceutical and biotechnology organizations provide an experience that aligns with patient expectations in a way that encourages participation and drives recruitment and retention, as well as compliance with the trial’s needs.
Patients’ desire to feel a seamless, more consumer-like experience impacts every stage of the clinical trial workflow, starting with recruitment. For example, one way to reduce patients’ burden is to make the signup process as simple as possible. Likewise, using tools like social media can help shorten recruitment times, allowing the active phases of the trial to begin more quickly and reduce patients’ wait time for participation.
Enabling — and empowering — patients to continue their participation in a way that is not overly challenging is the key to a clinical trial’s progression. For example: As consumers, when we buy an item online, we expect a certain level of information. When will my package ship? If it is not at my home yet, where is it now? When will it arrive? Was the package delivered to my mailbox or my door? Even chatbots can provide basic guidance for common consumer questions on a given e-commerce website. Those same qualities that create positive engagement for online shoppers do the same for clinical trial patients.
A patient enrolled in a DCT that uses a Direct to Patient model may receive equipment at their home and then need to ship samples back to the clinical trial lab. In some cases, they may get visits from home healthcare professionals. Patients want to know what is coming, who is coming, when they will arrive, and where they are in the process.
While the DCT ecosystem includes many important factors, such as home healthcare professionals, the digital tools and technologies that enable this are crucial. Web-based technology is another important piece of the DCT technology puzzle. From eDiary and eConsent to eCOA and electronic data collection, the technology ecosystem can create a more seamless experience for the patient, from fully automating data collection to eliminating or reducing clinical visits.
For example, DCT methodologies and technology provide patients with reminders of what steps they need to take to ensure they complete relevant activities, such as obtaining readings, taking the investigational product or noting patient-reported outcomes via ePRO. They also allow clinical trial activities to become more accessible for patients. In a traditional trial model, patients must visit a clinical site, which requires them to have the time to make the visit as well as access to transportation, which can become onerous and a barrier to participation.
When some trial activities are shifted to patients’ homes, recruitment can increase by at least 60% and retention can be maintained at over 90%.3 Digital technology, like wearable devices, can help patients move activities previously done at clinical trial sites to their homes, where they can easily collect and submit data with minimal disruption to their daily lives.
In a hybrid DCT, which blends face-to-face interaction with technology that communicates with study participants and collects data, these tools can also enhance home healthcare professionals’ ability to easily manage patients and facilitate relationships between the patient and trial providers. Home healthcare visits create a more personal experience for patients, especially if the same healthcare professional visits the patient consistently. This personal connection has the potential to create an association with the research while providing a comfort factor to the patient, both of which drive patient retention. The patient can also ask questions about the process and their role in it, helping them feel more informed about their participation.
How Can DCT Partners Evolve to Meet this Expectation?
Even as our industry continues to learn more about incorporating a business-to-consumer (B2C) mindset to the very clinical world of drug development, this moves toward giving patients the B2C experience they increasingly expect and helps get these treatments to market faster.
Transparency: A key component of creating a more consumer-like experience, transparency is a way to get patients information that helps them better understand their clinical trial experience. For example, a clinical trial patient typically answers dozens of questions during the trial, an experience that can make them feel like they are trapped in an endless bureaucracy of “checking boxes.”
Giving patients the opportunity to easily ask questions and get information can help them understand each step in the process has a purpose and helps develop the therapy further. This level of transparency can also help support patient retention; a critical consideration given about 80% of clinical trials are delayed by at least one month due to patient drop-out. Such delays can cost anything between approximately $600,000 and $8 million per day in lost revenue.4 Trials can be set back by months or even years, depending on the extent of the issues faced and how long it takes to get back on track.
Meet patients where they are: Building a B2C experience also includes an understanding that not everyone is in the same place in their digital journey. Patient-facing technology is only as powerful as its usability to patients. While one patient may be completely comfortable using a wearable medical device, another may find the technology intimidating. These factors can impact every step of the clinical trial, from patient enrollment to data integrity.
Ideally, patient-facing clinical trial technology will be as intuitive and easy to use as possible. Still, consider technology guidance that aligns with patients’ varying comfort levels. A tech-savvy patient might engage more with a pop-up reminder on their smartphone. Another patient in the same trial might engage better with a postcard reminder in the mail.
Likewise, the patient’s location should be considered. For example, a wearable device that transmits real-time data might be hindered if the patient lives in an area with connectivity issues. Regional preferences may be a challenge as well. If the clinical trial requires a wearable band device brand with which consumers in that region are unfamiliar, they may be less likely to engage than if given a more familiar device.
Factors like patient skill sets and behavioral preferences can even impact what type of DCT would be most effective: hybrid or fully virtual. Patients may not be able to conduct phlebotomy on their own at home, requiring the need for home healthcare visits. Likewise, older populations may feel more comfortable and confident engaging with a home healthcare professional rather than participating on their own.
To engage each patient with a consumer-like experience, it is important to ensure patients are comfortable with all the technology tools required to use during the trial. As an industry, if we do not treat each person as an individual, that is when we stop engaging patients. The sponsors must endeavor to make each person feel like they matter and treat them based on their circumstances, with respect and without patronization.
Remember the human element: Patient centricity is at the heart of every clinical trial, whether you are evaluating a gene therapy for children with a rare autoimmune disorder or a life-enhancing treatment for people with Type 2 diabetes.
Understanding the value of the human element — and the real-life stories behind it — is essential for those of us designing and conducting clinical trials, from executives leading CROs, pharmaceutical and biotechnology organizations to teams assembling clinical trial kits. It is also an important understanding for patients.
DCT designers can consider ways to share those human stories with clinical trial participants, particularly those enrolled in a clinical trial that won’t necessarily save their own life. For example, you might convey a story that reminds the patient how their altruistic actions will help change the lives of the patients who may ultimately receive this therapy. Regular reminders that highlight the critical role that individual patient plays can help them become — and stay — engaged.
Reach the right people. Tools like social media make it easier than ever to recruit large groups of patients, especially if time is a factor. While this level of recruitment power is impressive and attractive, it is important to ensure such efforts are targeted toward the right patients, making development of the right patient profile essential. In addition, targeting efforts must consider the value of recruitment in underrepresented and diverse populations.
Do not assume building a patient-centric trial is simple: There is more to building a patient-centric trial than adding an app to a clinical trial experience. Instead, build a truly patient-focused trial that meets their consumerization expectations. Assess your strengths as well as those of your partners and suppliers, and consider how to pull those together into a seamless, one-touch experience adapted to meet your patients where they are.
An important part of this process of pulling together partners into one mission is to manage expectations for both patients and partners. For example, a timeline that is wrong or misrepresented can impact the clinical trial and create mistrust in partners as well as patients.
Engage every step of the supply chain: While organizations like CROs, pharma and biotechs are used to dealing in a heavily regulated environment, the move toward consumerization requires those regulations, including data protection, to move further back in the supply chain. Actively engaging with suppliers and vendors to ensure data privacy and compliance with GDPR and HIPAA for personal information, like patient names and addresses, and patient health information, is key.
Collaborate with industry partners: Interoperability is key to building patient-centric DCTs. Combining stand-alone expertise with collaborative expertise that leans on each element of the supply chain helps ensure patients receive a seamless experience. For example, the process of assembling and shipping home healthcare requires coordination among various systems and stakeholders to reach the right patients at the right time and in the right location.
The behind-the-scenes process may not be as seamless, because multiple partners will need to bring together their varying systems and processes. What is most important to the patient is that it looks and feels seamless for them. Imagine a future in which a patient uses a single app to send their data, request a kit, collect a sample, call a nurse, order drug replenishment, etc.
Find the right outsourcing partners: Building a B2C-type clinical trial experience demands a higher level of protocol management and supply chain complexity. There is no one-size-fits-all solution for DCTs, so it is important to work with outsourced partners with the expertise to offer solutions for each unique clinical trial.
For example, it may be possible to consolidate multiple service partners into one vendor able to handle multiple steps in the clinical trial process. The more touchpoints you eliminate, the more you can build the experience patients expect.
A positive patient experience is at the core of every clinical trial — and delivering a more B2C-like experience is increasingly part of that equation. By working together as an industry, we can not only better understand and meet this expectation but also ensure successful clinical trials that deliver the life-changing therapies patients need.
References
- Davies, N. “How biopharma and CROs can create value in a shift to decentralized trials.” (Online) Available at: https://www.ey.com/en_us/life-sciences/how-biopharma-and-cros-can-create-value-in-a-shift-to-decentralized-trials (Accessed 1-3-2023).
- DiMasi, J., et al. “Assessing the Financial Value of Decentralized Clinical Trials.” (Online) Available at: https://pubmed.ncbi.nlm.nih.gov/36104654/ (Accessed 12-22-2022).
- Ilancheran, M. “Decentralized Trials: Trends & Technology Propelling Home Healthcare Services.” (Online) Available at: https://www.clinicalleader.com/doc/decentralized-trials[1]trends-technology-propelling-home-healthcare-services-0001 (Accessed 12-22-2022).
- “Clinical trials and their patients: The rising costs and how to stem the loss.” (Online) Available at: https://www.pharmafile.com/news/511225/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss (Accessed 01-06-2023)
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