The disruption of the COVID-19 pandemic has shown just how resilient the clinical research industry can be, with sites and sponsors having to choose between adopting new technologies and practices and hitting the pause button on their important work. During Oracle Health Sciences Connect, a two-day online event on April 20 and 21, experts from various corners of the field will gather to share tools and tips that will enable clinical research professionals to stay on top of innovations, now and in the future; presenters represent organizations like the Moffit Cancer Center, Takeda, Decentralized Trials and Research Alliance, .and the White House.
To learn more about the event, Outsourcing-Pharma connected with Henry McNamara, senior vice president and general manager of Oracle Health Sciences.
OSP: Please tell us the reasons why Oracle is presenting this particular event and the reasons behind this agenda of forward-looking topics.
HM: The pandemic has forever changed the way clinical research is conducted. The industry is not going back to “the old way,” of conducting clinical trials, so sponsors and CROs need to set themselves up to operate successfully in this new model. Fortunately, the technology and software to support these changes exist today and are designed to carry the industry into the future of clinical trials.
At Oracle Health Sciences Connect we will present an agenda that highlights these technologies and approaches and how they are reshaping approaches to clinical trials. Today, there is an increasing focus on all constituents’ experiences and the need to meet multiple user needs. We want to ensure that as approaches to clinical trials continue to evolve, study teams, site staff, and patients can best take advantage of the technological solutions available.
OSP: Could you talk about the title of the keynote, “Embrace the future: innovation at the speed of science”? How does that title relate to the pharmaceutical industry’s reputation for being relatively slow to embrace change? Could you share a few reasons why embracing change more readily could benefit the field?
HM: The ongoing pandemic has forced the life sciences industry to pivot and adopt alternative approaches to clinical trials faster than anyone thought possible. The digital transformation roadmap for how clinical trials are planned and conducted was compressed and accelerated. Many methods that have been available for years but not widely used were suddenly adopted at scale in clinical trials during the pandemic.
The challenges caused by the pandemic presented an opportunity to reimagine and reinvigorate studies with new drug development models and processes, including machine learning, decentralized trials, and direct-to-patient services. The keynote session will discuss how companies can embrace innovation and accelerate their digital transformation roadmaps with a “patient-centric” objective.
We’ll also discuss why the companies who take this approach will bring diversity to our clinical research, efficiency to our methods, and ultimately, bring new therapies to market faster. They will be the true leaders in the industry in the years to come.
OSP: Could you tell us a little bit about the sensor integration panel—what do you expect the participants to bring to the table, and what might attendees come away knowing that they didn’t before?
HM: While newly adopted methods of data collection, like sensors, were able to keep clinical trials operational during the early days of the pandemic, the industry still needed to have confidence that the data generated by these new sources were relevant and trustworthy to make informed decisions about medical care. The answer has been an overwhelming “yes.”
In a study we conducted in the fall of 2021 entitled Clinical Trial Management in a Post-Pandemic World, 92% of respondents who implemented new clinical trial methods during the pandemic are equally or more confident in the data collected from these methods, compared to data collected via pre-pandemic methods.
Moving forward, the collection of, and confidence, in reliable data to make better and faster decisions across drug development and care delivery will require an understanding of all stakeholder needs and the implementation of best practices to ensure that these needs are met. In this session, the Digital Medicine Society (DiMe) will discuss how they launched a new multistakeholder Sensor Data Integration Tour of Duty to address these challenges and provide a clear direction on how sensor data can fulfill its potential to enhance patient lives.
OSP: Relating to the patient-centric/site-centric session: could you talk a bit about how the two complement each other, and how they might be at odds?
HM: Clinical trials must be designed with the patient as the focus. Our research found that many respondents (61%) believe allowing patients’ choice will have a positive impact on clinical research and over half (58%) said that their organizations plan to give patients the option to choose how they participate in clinical trials moving forward. As a result, it’s important to have a streamlined, transparent, and efficient process between site and sponsor to create a higher-quality experience for both the patient and the site staff.
For example, it’s critical for pharmaceutical companies to make it easier for patients to incorporate trials visits into their routine. To this end, communal sites such as US retailers like CVS and Walgreens are becoming popular as trial hosts. Selecting these locations - that offer patients convenience and familiarity - can boost recruitment. The site team operations are evolving and with processes engaging partners and enhanced by technology.
OSP: What might attendees expect from the next DCT frontier session? Also, could you talk about the transition from the previous frontier to the next—what is different between these two stages?
HM: Prior to the pandemic the industry was in the early stages of the transition to decentralized trials. Now we are in the process of determining how to harness the data we have gathered from newly adopted sources and which of those sources will remain in regular use. But one thing is clear, many of the newly adopted methods will remain – 97% of respondents to our survey indicated their organization will continue using at least one method of monitoring they adopted over the last two years, such as video visits, EHR, and phone visits being the approaches most likely to continue.
So, what does this mean for the future of clinical trials? In this session, we will bring the world’s leading DCT proponents together to share their insights on the future of decentralized research and the barriers we will need to overcome to truly unlock the potential and value of direct-to-and-from patient participation in clinical studies.
We’ll also explore the shifts in clinical trial models that are expected moving forward. For example, our survey found that respondents expect their organizations to increase their use of hybrid (44%) and fit-for-purpose models (42%).
OSP: Do you have anything to add?
HM: The last two years have presented unprecedented challenges for the life sciences industry, but we have also seen unprecedented advancements. We are looking forward to coming together at Oracle Health Sciences Connect to discuss these advancements, opportunities, and challenges that lie ahead for the industry. And, this year, for the first time, we are excited to extend an invitation to the entire life sciences industry.
The event will be an opportunity for industry leaders and peers to discuss how they are using technology to innovate at the speed of science to meet the demands of today’s clinical research and drug safety market and to prepare for the trials of tomorrow and the challenges of post-market surveillance. We are really excited about this year’s event and what we will learn through our impressive line-up of guest speakers.