Is the clinical trials field doing enough to centre the needs and concerns of patients in research? That was the question posed by Keya Watkins, Senior Vice President at Catalyst Clinical Research at a recent discussion at the 15th Annual Clinical Trial in Oncology West Coast (CTO) conference, which took place 14–15 May in Burlingame, California.
Experts gathered at the oncology-focused conference discussed the different ways in which stakeholders are approaching patient centricity. While outlining best practices, Steve Warner, Senior Vice President and Head of Translational Research & Medicine and Oncology at Sumitomo Pharma America, mentioned that one of the most effective ways to engage clinical sites and patients in trials is to only advance therapeutic agents that demonstrate compelling and meaningful signals during development. Sites and patients want to be engaged with truly transformative trials and agents whereas site and patient engagement become issues when the potential for benefit become ambiguous, he added. Sponsors can more proactively prioritise the advancement of agents that demonstrate strong early clinical signals, while also making the often difficult decision to halt or deprioritise those lacking clear potential, he said. According to Warner, advancing agents into Phase II or III studies without compelling activity in early development (such as Phase I or IIa trials) can strain limited site and patient engagement capacity, resources that could be more effectively allocated to more promising candidates.
Abhijit Ramachandran, Director of Clinical Development Operations of Oncology at Menlo Park, California-based Corcept Therapeutics, agreed that it comes down to the drugs’ activity, and also noted that it is about “making life easy for the sites”. Ramachandran discussed the burden on sites due to multiple systems and the need for a single sign-on platform including e-learning systems to streamline site operations. He said sponsors can use innovative engagement strategies to identify eligible patients for enrollment, train sites, and ensure reimbursement for patients by using methods like prepaid cards.
Edward Owen, Therapeutic Area Director of Oncology and Early Clinical Development at Genentech, a part of Roche, stressed the importance of site involvement in technology development. He gave one instance where a digital consent platform was developed for a trial, but the sites did not want to use it. Owen urged sponsors to receive feedback from the sites on what they need before applying any future innovation. He also highlighted that the potential of using artificial intelligence (AI) for patient screening and protocol inquiries is significant.
In regards to the patient experience, Warner discussed that with all the current technological advancements to connect with sites in automated and digital ways, the field has been reminded that personal and in-person contact with sites is irreplaceable. He added that in-person contact needs to be incorporated to augment any technologically advanced way to engage with sites. Ramachandran mentioned the impact of decentralisation and patient-centric approaches for enhancing the patient experience. He underlined that any innovative solutions “that we do offer are more difficult to implement for large oncology trials, while for smaller studies it might be easier”.
Pragmatic approaches in the setting of oncology clinical trials
There’s no clear answer when it comes to applying pragmatic approaches in oncology trials. While certain procedures like chemotherapy must be done in clinical settings, some aspects, such as patient check-ins, can be done remotely to increase comfort and flexibility, said Ramachandran. The panelists noted that it is not about the sponsor dictating what is best, but about creating adaptable options for the patients.
Owen agreed that involving patient advocacy groups to ensure patient voices are considered is crucial. Offering flexibility in protocols, such as an option to choose between remote or in-person visits, respects patient preferences, which can vary, he added. While new technologies are often tested in early phase trials due to lower risk, their benefits may be more significant in later phases, he emphasised. Owen noted that the use of remote monitoring with devices might not even be feasible in early-phase trials.
Lastly, Ramachandran highlighted the importance of reassuring trial sites that sponsors are present and supportive and can go beyond just offering technology solutions. Warner added that a “white glove” approach, offering hands-on support and being highly responsive, has been effective. Support staff and nurses play a crucial role in enhancing the patient and site experience and thus exchanging information with them in-person at oncology conferences is very valuable, especially in group settings, such as “investigator meetings”, he said.
