January 5, 2023 | We spoke with clinical research leaders about their expectations for the coming year. We heard predictions that digital methods and tools will become the priority as sponsors take the lead and encourage shifts toward hybrid and decentralized trials (DCTs). “With the rapid maturation of digital technologies and increasing comfort level with digital tools by patients and doctors, sponsors will adopt a digital-first mindset for every trial. Digital technologies will be considered from the start rather than force-fitting them into a trial mid-way, ensuring a more successful trial design overall,” said Joel Morse of Curavit. 

As DCTs become more prevalent, brick-and-mortar sites are expected to embrace flexibility and patient-centricity to improve retention. “The site will [place an] emphasis on the notion of heightened flexibility for the participant. We will see further adoption of innovative tools that offer options for receiving care and completing trial activity while keeping the site in control and enabling them to maintain an even increase in efficiency,” said Jim Murphy of Greenphire. 

Eric Hodgins of IQVIA predicts an uptick in in-person visits as more patients integrate into a “post-COVID” society, but not without significant adjustments to trial design. He said, “With in-person visits increasing again, we will see many trial sponsors take a more thoughtful approach to how studies are designed to drive efficiency for both sites and patients and use greater data interoperability. This will come [from] taking a ‘science up’ approach built on a foundation of standards and regulatory guidance.” 

Industry leaders anticipate that many clinical sites will be overhauled as researchers seek to reach new and diverse communities. “Nearly any trial site—including those community-based sites often closer to underserved communities—can be well-equipped to handle increasingly complex research, making them attractive alternatives. As a result, we’ll see life science organizations increasingly eschewing the same-old trial sites to bring more research into more diverse communities,” said Liz Beatty of Inato. 

In response to the threat of an economic downturn, companies will rely heavily on remote patient monitoring and wearable devices to stretch their budgets. Ed Ikeguchi of AiCure said, “Sponsors will likely streamline the tools and emphasize technology patients already own—like smartphones—to gather key data points. With many facing clinical talent shortages, services that help ease the site’s technology burden will be critical to maintaining efficiency and high-quality data capture.” Ben Casavant of Tasso emphasized the benefits of a financially lean and patient-centered approach. He said, “A more patient-centric experience will accelerate the time to market for new drugs, devices, and therapies due to the higher-quality data, better participant compliance, more accurate representation, and lower overall study costs.” 

 
Research organizations will also employ technology and real-world evidence to get products to market faster. The pandemic brought valuable lessons concerning how artificial intelligence (AI) and real-world data reduce production timelines. Mark Lambrecht of SAS asserted that to continue a real-world data-driven business trajectory, companies “will reorganize, merge, and bring together digitization experts across previously siloed departments, allowing clinical trials to run more effectively and efficiently. In addition, cell and gene therapies will become digitized and contribute to the drive for more precise personalized medicine.” 

Here are the full trends and predictions, including additional forecasts for potential mergers and acquisitions among big-name companies, software-driven approaches to structure and analyze data, automated data collection and clinical operations, and digital biomarkers to objectively capture real-world data from patient behaviors and experiences. –the Editors 

 
Miruna Sasu, President and CEO, COTA 

There will be major patient care and drug development advancements: Take DCTs, for example. At the height of the pandemic, DCTs were seen as a viable alternative to keeping the engines running on clinical trials when non-critical in-person care was paused. Unfortunately, we’ve taken our foot off the gas when it comes to new approaches to care that spiked during the pandemic, including DCTs and virtual care, which threatens to slow much-needed progress in these areas and limits our ability to respond when faced with future public health emergencies.  

 
Liz Beatty, Co-Founder and Chief Strategy Officer, Inato 

Digital health vendors and issues will cross into clinical trials for increased diversity and solutions: 2023 will represent a breakout year for clinical trial diversity because of digital health. Innovation in digital health is advancing the clinical trial industry by leaps and bounds. Digital health innovation has led to an explosion in decentralized trial adoption, enabling life sciences companies and research organizations to reach patients worldwide. Without geographical considerations, life sciences companies can execute more diverse clinical trials by remotely engaging patients in their own homes. It’s especially true for conducting trials on therapeutics for lower-acuity conditions. We’ll see digital health vendors increasingly eyeing the clinical trial market as a key area for expansion. This will be especially true as competition grows fiercer while economic and investment landscapes tighten, which could create a compounding effect that further accelerates clinical-trial diversity efforts.  

Big companies that made splashy entries into the clinical trial enablement market will struggle, but it will power a flurry of potential mergers and acquisitions (M&A): As CVS, Walmart, Walgreens, and others find their footing, competing against entrenched players while also comparing themselves against each other, we may see a flurry of M&A activity. Like we’ve seen in other parts of healthcare (e.g., home health, primary care), big tech and big retail will engage in bidding wars to acquire the companies that give them the footprint or experience to win the healthcare game of thrones. The next great healthcare arms race may occur in the clinical trial ecosystem, especially if other prominent names like Amazon deepen their clinical trial capabilities. 

 
Richard Young, Vice President of Strategy, Veeva Vault Clinical Data Management Suite 

Patient choice will push sponsors toward operational excellence: We’re entering a new era of patient choice, and it will be for data management to balance scientific endeavor with operational excellence. Patients will choose how to participate in studies from one day to the next, whether in person or through digital methods, based on their daily health status, personal preference, age, location, and condition. As a result, companies committed to patient-centric trials will reassess their technology and processes to achieve the dual objectives of advancing digital clinical trials and managing data holistically. 

Marc Gabriel, Vice President, Veeva Vault RIM Suite  

Regulatory pressure will drive innovation in data management and submissions: Increasing regulatory pressure will lead to more agile, connected data approaches that allow companies to ensure global compliance. The long-anticipated shift from document to data-based regulatory submissions will soon occur, starting with new U.S. Food and Drug Administration (FDA) and industry initiatives using data management approaches for chemistry, manufacturing, and controls submissions. This year, more companies will focus on developing the systems, infrastructure, and skill sets required to work with data-based submissions. Far from a trivial effort, it will require a whole new operating model and significant organizational change. 

 
Kyle Cunningham, Chief Product Officer, Greenphire 

Clinical trial sites will continue to digitize: While technology is designed to benefit sites, they often feel overwhelmed by the sheer number of technologies required for a given study. This year, we will see a concerted effort from sponsors, CROs, and solution providers to integrate technology platforms and workflows. For example, sites will benefit from data-driven processes, such as participant payments being automatically triggered via electronic data capture or completing participant activity within their ePRO. By integrating site platforms, we can eliminate administrative burdens, increase efficiency and empower sites to provide better care and support for their participants.” 

Ashley Leuthe, Associate Vice President of Product Management, Greenphire 

Clinical trials become even more personal: This year, it will be necessary for sponsors and CROs to establish a well-thought-out technology, data, and integration strategy that lays the foundation for a hyper-personalized patient experience. A key obstacle is that each market has varying requirements (e.g., data privacy, regulatory, data banking), expectations, and needs. Even within a particular market, patients' preferences and ways of interacting can differ. Therefore, solutions that enable better patient engagement must have a global focus, regionalized capabilities, and patient-level flexibility. 

 
Venu Mallarapu, Vice President of Global Strategy and Operations, eClinical Solutions 

Data flows will become automated and clinical trials will be held in the metaverse: This year, we will see 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. Half of the top 50 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 most will be commercial platforms. Additionally, the industry will adopt the metaverse in clinical trials within the next three years. Potential use cases include patient education for DCTs, site enablement, medical review, and real-world data collection. 

Sreekanth Gudapati, Vice President of elluminate Services, eClinical Solutions 

AI/ML will optimize end-to-end clinical workflows, and social media will be leveraged to improve outcomes: We will see multiple trends picking up steam that run the gamut—affecting several aspects of clinical trials. Firstly, I believe that the penetration of AI/ML techniques for optimizing end-to-end clinical trials will become more commonplace in tasks like protocol digitization to predictive shipment tracking. When it comes to data, I predict there will be a concerted push for real-time integration of data sources to achieve data integrity across multiple sources. Finally, I foresee that adopting social media in the space will improve success rates related to enrollment and data mining. 

 
Steve Rosenberg, CEO, uMotif 

Patients will interact more with clinical technology: Emerging technologies like artificial intelligence and machine learning can transform clinical research, but what good will they do if we don’t have good data for them to interpret? The only way to get that data is to engage patients. More companies—especially those in the eCOA/ePRO market—will try to make it easier for patients to interact with technology. Customers in pharma and biotech will recognize that quality research only happens when you stop designing studies to capture patient-reported outcomes and start building studies that begin with the patient. 

 
Dr. Angeli Möller, Vice-Chair at AAIH and Head of DIGI at Roche 

AI in patient recruitment: Patients, healthcare providers, and drug development organizations increasingly recognize the benefits of decentralized clinical trials, which allow patients to participate in a clinical study without traveling to a trial site. A 2021 Mckinsey study showed that 70% of patients in a clinical study live two or more hours travel time away from the site. AI has the opportunity to come into its own when running patient-centric, efficient decentralized trials, particularly in identifying patients who can most benefit from being part of the trial. 

Scott Uebele, Chief Operating Officer, ADVARRA 

Site centricity: In 2023, sponsors will aggressively pursue strong sponsor-site collaborations to improve process efficiencies, data sharing, and programs that offer better access to patients/participants. The pandemic taught us that managing costs is not simply cutting variable expenses, so we will see sponsors look to sites to increase their roles and responsibilities in clinical research. We predict more rigorous evaluations and oversight of site performance, inclusive of technology and transparency, ultimately impacting sponsors’ goals of accelerating new drugs/therapies to market timelines. 

Data-enabled R&D: Life science researchers are expected to manage and extract decision-making approaches from incredible volumes of data. We will see increased data sourcing and technology standardization investment to enable greater access to multi-variable datasets. For example, a clinical trial management system to an electronic medical record will set the pace for patient centricity and begin the critical framework needed to connect clinical research to real-time patient outcomes and health records. Organizations invested in technology that broadens data collection and the design and integration between sponsors and healthcare systems are well suited to ensure data-enabled clinical research is executed faster and smarter. 

Thierry Escudier, Project Manager and Theme Lead for Empowering the Patient, The Pistoia Alliance 

Social media and real-world data: 2023 will be the year pharma finally confirms the increasing role of social media in its ability to deliver real-world data and drive patient-centricity. Social media networks offer a promising opportunity to listen to patients’ voices directly, unfiltered, and in real-time. New guidance from bodies such as the FDA and the European Medicines Agency already acknowledges the power of online patient experience research. The next step will be collaborating to develop best practices and guidelines for consistent use across the biopharma industry. This will unravel the complexity of communication on these platforms and guide companies on how to employ social media as a source of real-world data and how to use this information securely.” 

 
Dr. Gen Li, Founder and President, Phesi 

The beginning of the end of the randomized controlled trial: We expect to see sponsors take a far smarter data-driven approach to studies, including the more widespread use of digital twins, to improve patient centricity, to zero the number of protocol amendments, and to remove the use of placebo arms wherever possible. A wealth of data is available today to study planners, from clinical trials to patient and regulatory records. By combining these data sets with powerful analytics, sponsors can model and predict both the outcomes of trials and the likely impacts on patients in silico. This allows investigators to move away from “gut feel,” and clinical trial design and site selection will be more bespoke and data driven. 

Mark Lambrecht, Director of EMEA & APAC Health and Life Sciences Practice, SAS 

Effective and patient-centric AI needs adoption by the scientist and clinician: Multimodal AI and multi-genomics approaches are increasingly adopted by clinical trial sponsors but only where it is embedded in clinical reality, uncovering high-potential drug leads in silico, contributing to patient insights, accelerating automation of mundane tasks, or discovery of clinical-grade digital biomarkers. First-generation high-throughput AI approaches that cannot be explained to clinicians or scientists or not relying on good quality data information spaces, have been replaced by more precise approaches due to the increasing quality of algorithms, computational clusters, and progress in explainable AI approaches. 

Anand Parikh, Co-Founder and CEO, Faeth Therapeutics 

Clinical trials will become more accessible to patients: Academic medical centers acting as gatekeepers of clinical trials will change as trial sponsors become more involved in the trial process. Delays in enrolling trials mean that sponsors are getting more involved in educating, recruiting, and even coordinating treatments for trial patients. Sponsors are learning that academic medical centers are only needed for early-phase trials with a heavy procedural burden, usually only in life-threatening conditions like oncology. As trial sponsors become more involved in the coordination of patient care, they’ll adopt trial models that minimize the role of medical centers. Virtual patient recruitment, remote trial options, and at-home clinical trials will gain more traction throughout the year.  

 
Melissa Easy, VP and General Manager of Clinical Technologies, IQVIA 

Patient centricity will improve patient retention: Personalizing the patient's experience is essential to ensuring enrollment and completion of many clinical trials. Unfortunately, many patients drop out of studies as it becomes too difficult to log in and report results, make too many appointments at a site, and use multiple reporting websites. This leaves many reluctant to participate in future research. Finding a patient-centric approach with a single online portal for patients to report their information and assist with streamlining their in-person interactions will improve this experience. This year, we will see a focus on building a more personalized experience where patients can easily interact with sponsors and sites. Similar to how retailers personalize the shopping experience with customers and interactions via texts, online sites, and more, the clinical trial industry will need to follow suit. 

 
Ed Ikeguchi, MD, CEO, AiCure 

Patient-centric approaches to improving engagement: The most meaningful innovations will help keep patients engaged with their care in a personalized way and help get to the heart of a patient’s lived experience during a clinical trial. We’ll increasingly see trials deploy AI-powered predictive analytics tools that gauge whether patients will adhere to their treatment plans. We’ll also see the advancement of more video- and audio-based digital biomarkers that objectively capture a patient’s behavior and daily experience to help inform what interventions or adjustments are needed in their treatment plan. The continued development of this technology means we can also empower more proactive, personalized care and ultimately advance precision medicine. 

Sanskriti Thakur, Chief Growth Officer, Medable    

Decentralized and hybrid clinical trials will simply become “clinical trials”: The DCT model works well. A 2022 study from the Tufts Center for the Study of Drug Development shows that DCTs can achieve net financial benefits ranging from five to 13 times more than traditional Phase II and Phase III trials, equating to roughly $10M and $39M ROI, respectively. COVID-19 made DCTs a necessity. Returns will make DCTs the de facto standard. Expect 2023 to be a pivotal year, capping a year or more of strong growth in decentralized and hybrid clinical trial deployment. The next evolution of DCTs will involve self-service tools that enable sponsors and sites to deploy and operate global studies on a common platform using standardized processes. We see evidence of this pivot from customers and partners who aim to leverage digital tools across their pipeline. Sponsors, sites, and patients expect digital tools to drive clinical trial performance, personal satisfaction, greater diversity, and better outcomes. 

 
Joel Morse, Co-Founder and CEO, Curavit 

Clinical trial sponsors will drive a new framework for DCT technology and services rather than the other way around: With nearly nine in 10 sponsors saying they will use some elements of DCT technologies, in 2023, sponsors will take the lead. Rather than technology providers dictating what their products or services can do to improve clinical research, sponsors will seek technology providers that solve their specific challenges. As they become more familiar with DCT technologies, sponsors will define what trial improvements are required, and successful technology manufacturers will pivot accordingly. 

 
Robert Groebel, VP of Global Life Sciences Strategy, Definitive Healthcare 

A wave of biopharma M&A activity: Big Pharma is flush with cash. Companies like Pfizer, Johnson & Johnson, Novartis, and others are seeing high sales and increases in revenue, thanks in part to COVID-related vaccines and treatments. With significant cash on hand, this could translate into busy deal activity going into 2023. Additionally, major product patents are about to expire, leading to a sharp decline in revenue as competition opens to generic drug makers, known as a “patent cliff.” While a wave of lower-priced generics can be great for consumers, upcoming patent expirations can seriously disrupt the operations of the largest biopharma companies. The solution to a forthcoming mass patent cliff could be acquisitions.