How small- to mid-sized biotechs can adopt patient centricity in their oncology trials
By Lucy Clossick Thomson, Senior Director of Oncology Project Management, Icon
Clinical trials in oncology can be costly and challenging to manage. One factor that could reduce costs and reduce barriers is harnessing the patient voice in trial design to help accelerate patient enrollment. Now is the time to adopt patient-centric strategies that not only focus on patient needs, but also can maintain cost efficiency.
While the task can seem daunting for small- or medium-sized biotechs that may not have the resources, it doesn’t have to be— there are multiple opportunities for companies to integrate the patient perspective. By making two to three defined changes for each new clinical trial, investigators can reduce the risk of chasing a small pool of potential patients, reducing the study burden on the patient and increasing a patient’s consideration of a study, therefore avoiding additional costs and time to clinical trials.
Small and medium biotech companies can take those steps in a cost effective and time sensitive manner to design more patient-centric approaches in oncology clinical trials, including introducing best practices for connecting with cancer patients and using their input to reduce patient burden in oncology clinical trials.
Designing a trial to reduce burden
The first step when designing a patient-centric trial, biotechs should consider the role of patients in drug development. Engaging with patient support groups at the beginning of trial design allows sponsors to incorporate patient feedback as the protocols are being written, instead of making amendments after protocols are developed, saving time and costs. Additionally, it is critical to look at the larger patient value proposition as well as the burden. Asking patients specific questions regarding their willingness to participate can provide insights into the potential benefits and drawbacks of the protocol.
Further, sponsors should reflect on ways to reduce burden before thinking about how the treatment will affect the patient. Some companies may even consider hiring patient actors or having volunteers do a “dry” or “dummy” run of trial procedures at the site. While this may seem like a large investment in site and sponsor time, practice runs of protocols can resolve any potential issues before they occur in the current trial, and serve as a reference to prevent problems in future trials that have similar protocols.
Understanding the patient perspective
As sponsors design clinical trial protocols, they should also factor in the patient perspective on what benefit-risk tradeoffs are acceptable, which clinical outcomes are most important to patients and how to develop patient-centered endpoints. To fully grasp the patient perspective, sponsors should understand the patient’s educational, emotional, physical and financial wellbeing, in addition to travel logistics and availability of caregivers.
The patient perspective can be acquired through patient experience surveys, otherwise known as patient feasibility studies, which can capture a wider view of what patients will and won’t be able to cope with during a study. This patient feedback, married with the information already gathered from sites relating to PI interest and the perceived scientific value of the study, gives a more robust view of the overall enrolment potential.
Improving patient consent and education
A critical part of patient enrollment in cancer studies is the consent process. Here, sponsors have the opportunity to make patient education about the study more patient-centric. Developing educational materials with easy-to-understand language in informed consent — along with other resources to help patients and their families understand the study and the implications of being part of it — can increase efficiency in patient enrollment and recruitment.
After completing the standard consent paperwork, providing ongoing education is needed. Patients may need to be reminded of, or spoken with, to ensure they fully understand the schedule of events, and any apps or websites they may need to use to adhere to protocols, including appointments, tests, or whether or not they need to be in a fasted state for site visits. Therefore, sponsors should consider adopting a consent “plus” approach which would include continued patient-focused education and engagement throughout their participation.
Implementing new strategies
Small and medium biotech companies have an opportunity to change lives with a new drug or product and lead the way in changing trial design due to the lack of large pharma red tape and the desire to get it right the first time.
Biotechs contain a unique mix of scientists, industry personnel and clinical investigators who are able to combine the knowledge and skills to drive the science fast. CROs may be the first port of call for a biotech company to operationalise a study. When brought in at an early stage, CROs can combine their experience and customer solutions to prepare a tailored patient-centric strategy.