Issue:May 2019

EXECUTIVE INTERVIEW - PAREXEL: Advancing Patient-Centric Drug Development to Improve Clinical Trial Success

A recent report from The Economist Intelligence Unit (EIU) commissioned by PAREXEL found that drugs developed across the industry using patient-centric trial designs had faster study enrollment times and were 19% more likely to be launched. However, only 5.2% of Phase II and III trials utilized patient-centric designs. For this reason, PAREXEL announced the creation of its Patient Innovation Center this past September to help sponsors improve the drug development process and optimize patient involvement and engagement. Drug Development & Delivery recently spoke with Sy Pretorius, MD, Senior Vice President, Medical & Scientific Services at PAREXEL, about the new Patient Innovation Center and how it is helping to improve the patient experience, enhance study recruitment and retention, reduce costs, and deliver better data.

Q: Tell us more about how you define patient-centricity and why it’s so important in clinical trials.

A: Patient-centricity keeps patients at the center of what we do, incorporating their input into all aspects of clinical development to enhance patient satisfaction and simplify the journey to new treatments. PAREXEL has been practicing a patient-centric approach for years and recently introduced our Patient Innovation Center, which takes patient-centricity and being patient-centric to the next level. One of our main goals is to empower patients to become active participants in the study planning process, using their feedback and ultimately simplifying the patient journey to enhance their experience, satisfaction, and increase compliance with study requirements. Without patients, we are unable to advance the development of new therapies. To this end, as an industry, we need patients to be interested in clinical trials and to participate in clinical trials. The reality is that less than 0.002% of the global population participates in clinical trials. To increase awareness and participation them, we need to partner with patients, their families, and caregivers in ways that align what we need to accomplish as an industry with their needs. We need to address the barriers to participation in clinical studies. It starts when and where patients hear about a study – how do we make it as easy as possible for them to obtain and understand information related to clinical trials. Constantly thinking about creative ways to reduce the burden of participation, while maximizing the benefits associated with participation.

Q: Can you elaborate on what motivated the launch of the Patient Innovation Center (PIC) and what your goals are for the PIC?

A: While the evidence is clear that patient-centric approaches can improve the drug development process, many sponsors face challenges when attempting to apply these strategies. Knowing how critical patient engagement and retention are to successful clinical development, PAREXEL launched the PIC to help sponsors implement patient-first strategies and decrease barriers to implementation. PAREXEL is also looking forward to seeing how the PIC can foster innovation in patient-centric approaches, such as virtual (or at-home) trials and direct-with-patient studies. Even more, PAREXEL’s goal is to uncover practical challenges within trial design that can be addressed proactively to achieve the right balance between scientific rigor and feasibility for patients. Further on is an example of what a patient-centric trial might look like as part of PAREXEL’s PIC.

Before the study begins, PAREXEL uses its innovative patient-centric protocol optimization approach to identify and address practical challenges to patient participation. PAREXEL helps design a protocol through a combination of web listening and, patient, caregiver, and site staff input to optimize the clinical study experience for participants, leading to more engaged patients, lower drop-out rates, and greater compliance with study requirements. Simultaneously, PAREXEL also proactively seeks opportunities to address the needs of commercial stakeholders and build a better value story. The company’s regulatory experts incorporate guidance to address agency requirements from a patient-centric perspective.

During the study, PAREXEL leverages feedback from patients to select the tools and services necessary to enhance the patient experience and reduce the practical, financial, and geographic barriers to participation. This may include enhancing the informed consent process to implementing a virtual study solution that incorporates elements such as at-home nurse visits, telehealth visits to reduce the number of trips to the trial site, direct-to-patient drug shipments, and PAREXEL’s Patient Sensor Solution that utilizes wearables to remotely capture, transmit, and store data in a secure platform powered by the Perceptive Cloud.

As a patient’s involvement in the study concludes, PAREXEL deploys a closure plan to help patients feel valued and understand the next steps. This includes trial summaries with clear terminology patients can understand, and a thank you card to show appreciation for their efforts. In addition, PAREXEL considers ways to transition them to a post-study treatment plan. In some cases, PAREXEL’s managed access program can help patients obtain access to treatments based on compassionate use.

Q: How is recruitment and retention affected by a patient-centric strategy?

A: Studies show that only about a third of clinical trial sites meet their accrual enrollment targets, and 50% are forced to extend their enrollment periods beyond their original projections. There are various factors contributing to patient recruitment failure, including overly optimistic projections, restrictive inclusion/exclusion criteria, intensive protocol leading to high patient burden, and a focus on outcomes that are not important to patients. However, according to PAREXEL’s recent research with the EIU, patient-centric trials took just half the time to recruit participants.

Patient-centric strategies can help recruitment and retention by reducing the practical, financial, and geographical barriers patients and caregivers often face, and optimizing patient involvement and engagement. For example, these trials may offer options for patients to stay at home during trials and continue treatment with familiar caregivers, instead of traveling to the trial site. These types of accommodations can make trials more manageable for patients and reduce drop-out rates.

Q: How does PAREXEL recommend companies implement a patient-centric strategy?

A: To set up a patient-centric trial for success, you must incorporate the patient perspective into the design. PAREXEL’s recommendations include, but are not limited to:

Create a Patient Profile: Having a detailed profile of a trial’s patient population and understanding who they are as people can lead to the creation of a more specific protocol that makes the difference between the success and failure of a trial. In addition to demographics of the target patient population, companies should consider such real-world elements as the type of treatment being tested, payment, and disease impact. For example, companies should consider such questions about their population as: “Are they elderly and may have difficulty leaving home?” “Are they young adults who can travel easily?” “Are they small children who must be supervised by parents?” “Is the treatment curative or palliative?” “What is life like with this disease?” “Are there routine hospitalizations?”

Crowdsource Patients & Caregivers: Survey patients, caregivers, and nurses/physicians to understand how a study may be received. These parties have a practical view on the impact of the study design as well as the participant’s ability to join and remain in a trial. Eliciting this feedback can result in great value.

Scan the Web to “Hear” the Patient Voice: There has been an explosion of open online forums, tweets, blogs, and other social media where patients share stories about their disease and treatment options. “Listening” to the web through key search terms, and dipping into online chatter can give companies an unfiltered insight into what it’s like to live with a disease in nonmedical terms — and what matters to patients.

Consult With Experts to Mitigate Study Burdens: Patients know a lot about living with their disease, but they are inexperienced in planning clinical research logistics. It is the organizers’ job to probe further into what exactly participation in your trial would mean for the participant. Nurse specialists with experience at high-performing investigative sites, for example, are a good resource in judging the burdens a clinical trial can impose on patients. Their analysis of the potential benefits and challenges should be taken into account when sponsors are evaluating the patient journey.

Simplify & Standardize Informed Consent: A typical informed consent form is notoriously long and can include a lot of terminology that patients are unfamiliar with. Make the core document easier for patients and caregivers to understand, for example, by breaking the elements of a study into short video modules.

Q: Despite the advantages of a patient-centric trial, why do you believe patient-centric strategies are so rarely implemented?

A: PAREXEL’s recent research with the EIU found that between 2012 and 2017, only about 5% of Phase II and Phase III trials included patient-centric themes, which is surprisingly low given all the attention that this topic is getting throughout the industry. Many are hesitant to take that leap because of the resources required upfront, although these costs could save time and money in the end. This approach also requires improved communication between all stakeholders and additional training to those onsite, both of which can be difficult to coordinate, especially among legacy processes. Even if companies want to implement patient-centric strategies, most often they do not know where to start.

This is where PAREXEL hopes the PIC will make a meaningful impact. Our dedicated team is passionate about understanding patient needs and reducing patient burden, making the clinical trial journey more streamlined for all involved. To accompany this effort, PAREXEL is investing heavily in innovative technology, including at-home monitoring with wearable devices, which make it easier for patients to participate in trials they otherwise would not have been able to geographically access.