As oncology clinical trials become more complex and regulators continue to implement new regulations, how is efficiency maintained and patient experience kept central?
These are some of the topics that will be explored at the upcoming Clinical trials In Oncology West Coast 2024 held on 23-24 April in Burlingame, US. Speakers from the pharmaceutical and biotech industry will come to discuss the current landscape of clinical trials for cancer therapeutics and trends. The event will be divided into two streams, one which focuses on patient experience and the other on streamlining clinical operations.
Patient centricity
One of the conference’s opening keynotes will place the spotlight on cancer patient experiences during clinical trials. The keynote, which involves Christine Von Raesfeld, founder of People of Empathy – a non-profit that aims to improve the quality of life for patients – and Bill Paseman, patient advocate of rare kidney cancer, will discuss the relationship between those living with cancer and their experiences in clinical trials. Issues such as financial burden, patient data, and how cancer affects participation will all be addressed.
Patient focus remains on the agenda later in the morning on day one as Daichii Sankyo investigates how real-world data collected from patient engagement activities could guide and shape better clinical trial outcomes.
Come the afternoon, a buzzword in clinical trial design – decentralisation – will be the focus as home oncology trials are outlined by ASC Therapeutics’ chief medical officer Oscar Segurado. The barriers, if any, to sponsors sending drugs to local pharmacies and homes will also feature.
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After a panel reviews the current relationship between patients and trial sponsors and investigates how to grow trust between the two parties in oncology trials, attention will turn to improving diversity and increasing accessibility. The US Food and Drug Administration (FDA) is currently issuing enrollment goals to increase diversity in clinical trial populations.
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By GlobalDataGlobalData analyst and chair of the event Jasminemay Barcelon highlights the importance of a holistic approach to trials, and the importance of patient advocacy groups: “[These groups] allow newly diagnosed patients to communicate with those who have undergone, about to undergo treatment or those with a genetic predisposition to cancer.
Barcelon adds that this allows patients to share their experiences in a more personalised way, providing an aspect of mental and social support.
“It gives them an avenue to gain more information and share their experiences with some clinical trials they have encountered. Utilising these groups is important to increase the visibility of drug trials.”
Trial streamlining
Set against the backdrop of a boom in cancer therapeutics such as the promising cell and gene therapy space and innovative antibody-drug conjugates other sessions will discuss trends in clinical trial activity and how FDA guidance is shaping trial design.
Haematological cancers could well come up as examples, as they are one of the main oncological success stories of cell and gene therapies.
Barcelon says: “Cell therapies will be the most impactful in haematological cancers. In addition to non-Hodgkin’s lymphoma, there’s also multiple myeloma and acute lymphocytic leukaemia – these have large eligible patient populations. CAR-Ts are expected to continue dominating the blood cancer space and this has led to a huge wave of research and development investment.”
Other modalities could be involved in discussions too. For example, the regulatory spotlight was recently on Regeneron Pharmaceuticals when its blood cancer therapy antibody odronextamab was rejected by the FDA amid concerns about the enrolment status of the ongoing confirmatory trials.
One session at the conference will discuss Project Optimus, an FDA initiative to reform the current paradigm for dose selection in oncology drug development. How Optimus will impact clinical research and alter trial design will be covered.
A panel discussion with clinical operations professionals from biopharma companies will also look into the current trends in oncology trial research and current restrictions surrounding clinical cancer trials, such as the FDA’s stance on single-arm trial designs and post-marketing requirements.
A director of clinical operations and director of site liaison from Pliant Therapeutics will discuss how site management and relationships can increase trial success.
Barcelon gives the example of ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx), approved for a type of ovarian cancer and now owned by AbbVie after a $10bn deal, as to how site efficiency streamlined the drug’s clinical journey.
“What supported the success of Elahere was that ImmunoGen created an easier environment for providers to administer this drug. This includes an approved companion diagnostic and collaborating with other specialists such as ophthalmologists, to manage known ocular toxicities.”
Day two will see delegates join roundtable discussions tackling patient diversity in trials, protocol design efficiencies and tailored cancer therapies.
