PMLS Virtual Series 2021 – Clinical Trials in Precision Medicine

11:25-11:30am EST

11:30-12:15pm EST

12:20-1:15pm  EST

Clinical Trials Post COVID19; Decentralized Trials, Just-In-Time, Use of AI and Digital Solutions

Moderator: Arturo Loaiza-Bonilla, MD, MSEd, FACP, Vice Chair, Department of Medical Oncology, CTCA, Chief Medical Advisor & Co-Founder, Massive Bio

Panelists: Sundarkia Hill, MS, Director, Precision Enrollment Network, IQVIA;Selin Kurnaz, PhD, Chief Executive Officer & Co-Founder, Massive Bio 

It has been widely recognized that COVID19 has led to “democratization” of clinical trial conduct with increase incorporation of telemedicine and virtual visits, allowance of local and less frequent testing including imaging, lower administrative burden, allowing drugs to be self-administered by patients and less stringent follow-up restrictions. This may lead to a technological revolution in the conduct of clinical trials with an emphasis on patient preference and safety while preserving scientific integrity. The audience will be able to learn further about novel technologies around decentralized clinical trials, ‘Just-In-Time (JIT) activation, a NASA-style Clinical Trial Mission Control Center, as will have the opportunity to learn how different stakeholders are adapting to recent FDA policies and regulations for their R&D post COVID19.

1:20-1:55pm  EST 

Challenges in Executing Precision Oncology Trials During the Pandemic 

Kamal S. Saini, MD, Executive Medical Director, Oncology, Covance Clinical Development Services

The COVID-19 pandemic has exposed several weaknesses in the traditional cancer trial paradigm, including challenges in startup, recruitment, logistics, medical monitoring, patient journey, and regulatory aspects. In this talk, Dr Saini will highlight some of these challenges, and discuss ways to re-imagine how cancer trials should be planned and executed during global emergencies such as pandemics, with a special focus on precision oncology studies.

2:00-2:45pm  EST 

Keynote – A  Regulatory Perspective of Decentralized Clinical Trials in the Era of Precision Medicine

Isaac R. Rodriguez-Chavez, PhD, MHS, MS, Senior Vice President, Scientific and Clinical Affairs, Global Center of Excellence for Decentralized Clinical Trials, PRA Health Sciences 

In this historical transition time in clinical research and in the era of precision medicine in which many traditional trial approaches are being progressively replaced by novel decentralized clinical trials (DCT) enabled by digital health technologies (DHTs), Dr. Rodriguez-Chavez will discuss the multiple elements that have influenced this irreversible transformation and how a regulatory roadmap is being created globally. Special emphasis will be made on how regulations are: (1) guiding the development of inter-operable and multi-functional technologies customized for fit-for-purpose to enhance DCT-related activities; (2) increasing the convenience of participants; and (3) setting up expectations for the inclusion of diverse populations in multiple DCT therapeutic areas. The clinical research as a care option for participants, also known as PRA’s CRAACO principle will be discussed and its interception with regulations, technologies and digital health.

2:50-3:15pm  EST

The Evolving Landscape of Oncology Clinical Trials: Clinician Perspectives on Drivers and Barriers to Pharmaceutical Innovation

Colin Enderlein, MS, Senior Associate, DeciBio Consulting

Despite numerous innovations intended to enhance the reach of clinical trials and identify eligible participants, overall participation in oncology clinical research remains incredibly low. Beyond identifying and enrolling patients, there are numerous other factors that can lead to trial delays or outright failures, leading to costly setbacks and delayed drug launches. It is a common belief that the growing menu of ‘precision medicine’ tools serves to expand trial access and ultimate success, however, repeated accounts from clinical stakeholders indicate that without careful implementation, some clinical settings risk being left behind or experiencing new barriers to participating in trials.

DeciBio Consulting surveyed numerous clinical stakeholders (i.e. oncologists, pathologists, lab directors, trial site coordinators) involved in oncology trials with the aim of identifying exactly where in trials the greatest bottlenecks occur in terms of setbacks or failures, and subsequently what solutions are emerging that may be capable of improving trial access and success.

3:20pm  EST

Closing Remarks