Ten Years of eClinical: 10 Predictions for 2023 and Beyond
Author: eClinical SolutionsPublished: December 23, 2022 9 min read
The eClinical Anniversary Blog Series
As 2022 comes to a close, many of us take this opportunity to pause, reflect, and prepare for what’s to come. Our leadership team is anticipating how they believe the industry will evolve in 2023 (and a bit beyond), based on their experiences over the past year.
Read these 10 executives’ predictions spanning industry-wide topics from data and analytics to trial recruitment, and learn what some of our senior leaders expect for life sciences over the next few years.
1. Prediction: Adoption of more disruptive trial solutions that will require modern data infrastructure, analytics and artificial intelligence (AI)
“I predict that within the next few years, most aspects of the clinical trial value chain will be accomplished five times faster, cheaper, and better compared to how they were done in the past five years. I believe this will happen due to advancements with software-driven approaches leveraging modern data infrastructures, analytics, and artificial intelligence (AI). An example of this type of advancement is digital twins. In simulating the control group for a given patient, digital twins could enable researchers to generate statistical significance from trials that are smaller, shorter, and faster than we have ever seen. While still new technology, digital twins are a possible game-changer for clinical research — from broadening access to treatment over placebo, to revolutionizing how we conduct trials overall. But they depend on access to vast volumes of data to train machine learning (ML) models. Tapping into disruptive approaches like digital twins means we must have digital clinical pipelines capable of powering these more sophisticated AI/ML applications. We have tremendous tech tailwinds and intent; it will be up to industry to make this happen. eClinical Solutions is definitely working toward this goal.”
– Raj Indupuri, CEO and Co-Founder
2. Prediction: Addressing the talent shortage with broader tech-enabled skill development
“In 2023 and over the next few years, I expect our industry to see the continued rise in software adoption drive even more demand for data-focused talent and expertise. Life sciences companies will continue to have a critical need for data science and data analytics competencies. The demand for clinical and healthcare data fluency, knowledge and expertise will likely continue to exceed the availability of talent resources. As an industry, we already face a shortage of life sciences-specific tech talent and the industry’s rapid innovation has increased these challenges. Companies will need to be creative about bringing new people into the industry. We’ll have to be open-minded and proactive about skills development for new and existing team members and focus on building skills and process around our growing use of technology. As leaders we have a responsibility to our people to make this happen – it will develop our teams personally and professionally and at the end of the day, it will make our industry stronger.”
– Bob Arnesen, President and Co-Founder
3. Prediction: Emerging biopharma will innovate rapidly and some large pharma will struggle to keep pace
“I believe that this year, we will start to see more (and faster) innovation from some of the emerging biopharma companies — innovation that large, bureaucratic companies won’t be able to match. Smaller companies are often nimbler than their larger counterparts, allowing them to pivot and operate on the cutting edge at a faster rate and with much less friction. Smaller, nimble companies that also take risk-based approaches to innovation, processes, and adoption of new technologies will keep closing the gap while larger companies that are weighed down by processes and validations may be slower to catch up. Some of the large companies will have these realizations early enough to adjust, but some may not see it until it’s too late.”
– Sam Anwar, Chief Technology Officer
4. Predictions: Consolidation of Decentralized Clinical Trial (DCT) providers and a shift in consumer marketing for trial recruitment
“In 2023, we will see consolidation across decentralized clinical trial (DCT) providers which have been at the top of the hype cycle for several years. Existing players will combine with next generation companies, creating three major data acquisition providers that offer comprehensive platforms for data capture from participants, including both traditional electronic data capture (EDC) and DCT technologies. This will drive a greater reliance on consumer technologies that will also reduce per patient costs.
Additionally, I believe the rise of consumer marketing strategies in the space will increase the visibility of trials as a viable option. Overall demand and awareness about trials will grow as major consumer marketers are playing a larger role in the site ecosystem for chronic conditions, with giants like CVS and Walgreens entering the clinical trial space. Thus, trial enrollment will become more streamlined, and this shift will change the focus of trial operations from indications focused on broader segments of the population to be more focused on data-driven operational excellence, cycle times, and automation.”
– Sheila Rocchio, Chief Marketing Officer
5. Prediction: Dedication to change management will be required for adopting risk-informed approaches
“To succeed in our evolving, data-centric drug development world, sponsors and service providers alike will need to balance extracting maximum value from immediately available efficiency gains, but also commit to developing innovation fit for the future-state. We will likely see continued prioritization of immediate pain points (efficiency and expertise) over more strategic shifts such as risk-informed approaches and decentralization. This is where tech-enabled processes and change management must be made a priority if we want to be less reactive and more strategic in achieving longer-term gains. Sponsors and service providers must continue to access the right expertise and technologies to execute decentralized trials and dedicate time and focus to navigating the change management required for risk-informed approaches.”
– Katrina Rice, Chief Delivery Officer, Data Services
6. Prediction: The shortage of experienced data managers will intensify, driving more demand for AI/ML and tech acquisition
“The industry will continue its trajectory in having a shortage of experienced data managers that are technology-enabled and able to keep up with the complexity of increased data variety and volume. The average Phase 3 trial will have millions of data points that will further underscore the need for AI and ML solutions to generate clinical queries and identify discrepancies. AI/ML in the data review process will become the new normal, and technology acquisition will be elevated in importance as much as resource and talent acquisition in 2023.”
– Marty Roche, Chief Business Officer
7. Predictions: The industry will begin looking to the metaverse, and automated study start up
“For 2023, I predict an increase in the adoption of digital data flows across the industry that will lead to the automation of study setup in data collection and clinical operational systems, as well as content creation for submission pipelines and analytics for decision-making across the R&D value chain. In conjunction with this, I also think 50% of the top fifty life sciences companies will invest in a unified clinical data and analytics platform with capabilities that aggregate diverse data sets and provide analytics capabilities for submission and secondary use pipelines. Some of these may be custom built, while the majority of them will be commercial platforms like elluminate.
Additionally, I believe that within the next three years, the industry will start adopting the metaverse in clinical trials. As the adoption of the metaverse increases in general, I feel this will open the door for its adoption in clinical trials. Some of the potential use cases include patient education for DCTs, site enablement, medical review, and real-world data collection.”
– Venu Mallarapu, Vice President, Global Strategy and Operations
8. Prediction: Life sciences companies will ditch the status quo
“At this year’s elluminate Engage conference, many of the discussions centered around doing things differently than we have in the past. Based on the discussions and anecdotes that we heard during the conference, I firmly believe the industry-wide shift that happened in 2022 has provided us the opportunity to break away from the status quo and embrace the vision of a better tomorrow—taking risks to define and adopt more transformative solutions. In the new year, we can start on the journey to a better future by deploying achievable transformative solutions that break department boundaries and build the foundation for project team-focused solutions that deliver clinical trial results in record time. This is the year to break away from buzzwords and hype to focus on real solutions that drive true value. I expect to see more life sciences companies breaking away from traditional methods and investing in new strategies to transform their workflows. This will bring more return on investment (ROI) in cost, time, and efficiency and help ensure they’re able to keep up with the rapidly advancing industry. “
– Robert Musterer, Vice President, Product Management
9. Prediction: Real-time data integration will become more common
“I see multiple trends picking up steam in 2023, across several aspects of clinical trials. First, I believe that the penetration of AI/ML techniques will increase, and we will see AI/ML applied for optimization of clinical trials end-to-end, from protocol digitization to predictive shipment tracking. When it comes to data, I predict that we will see more demand and an even greater push for real-time data integration as companies strive to achieve data integrity across sources. Finally, I think we will see greater adoption of social media aimed at improving success rates for enrollment and data mining.”
– Sreekanth Gudapati, Vice President, elluminate Services
10. Predictions: Regulatory authorities will work together to define guidelines for DCTs; data privacy efforts will increase in the US
“Considering the growth and changes in the industry over the past few years, there will be harmonization amongst regulatory authorities, with a focus on DCTs and advancing technologies to conduct clinical trials. As companies operationalize DCTs and DCT approaches, biopharma, technology companies and sites are examining regulatory implications and looking for clarity around requirements. We will also see a continued focus on data privacy and increased emphasis on data privacy in the US, similar to what we have seen in the EU.”
– Evan Grunbaum, Vice President, Quality and Compliance
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