January 4, 2024 | Last year was full of growing pains for clinical research as decentralized trial models continued to mature, AI took a more aggressive role in study planning and execution, and the player landscape continued to shake out. Here are the top stories from Clinical Research News as well as thought leaders in the industry. –The Editors

As CVS Slowly Exits Clinical Trial Business, Walgreens Continues Ramp-Up

Deborah Borfitz speaks with both Jill Pellegrino, vice president of recruitment and real-world evidence at CVS Health Clinical Trial Services and Walgreens Chief Clinical Trials Officer Ramita Tandon to explore the market drivers that caused one major player to exit clinical trials while another pushes ahead.

Ardy Arianpour on Seqster’s Mission, Growth, and Pharma Tipping Point

When Seqster was first founded in 2016, co-founder Ardy Arianpour had a lot of experience in next-gen sequencing and a vision for how consumers could control their health information. Now, Arianpour flags Seqster’s 2020 agreement with Takeda Pharmaceuticals as a tipping point. He speaks with Deborah Borfitz on the Scope of Things podcast about a future powered by the Seqster Operating System.

CROs Leading The Way In Modern-Day Clinical Data Management

Contract research organizations (CROs) increasingly find themselves on the leading edge of changes afoot in clinical data management, making it less about the policing of information and more about extracting meaningful insights from it. Several CROs talk about the risk an opportunities they face.

Multi-Purpose Cancer Drug Could Extend Life Of Terminally Ill Cancer Patients

Jens-Peter Marschner, M.D., chief medical officer of APIM Therapeutics, takes on the global challenge of cancer treatment, notably including solid tumors and hematological malignancies, via a promising, highly specific drug, known as ATX-101, whose molecular target orchestrates many different processes in the cells.

Novo Nordisk Home-Grows Group To Digitalize Early Clinical Research

Novo Nordisk launched a digital science and innovation group early in 2022 with the intention of digitalizing clinical research activities, mirroring the way the commercial side of the house has been operating for years. Novo Nordisk embedded the group within the research organization, and the group serves the entire portfolio of research and early development projects, including the diabetes, obesity, cardiovascular, kidney, and sickle cell disease areas.

Dealing With Data Biases and Overwhelm in Clinical Research

Allison Proffitt reports from the ViVE event in Nashville, Tenn., on a discussion about unbiased data in health care featuring Ramita Tandon, Chief Clinical Trials Officer at Walgreens; Alisahah Jackson,​President Lloyd H. Dean Institute for Humankindness & Health Justice, CommonSpirit Health; John Kraus, Executive Vice President, Chief Medical Officer, Otsuka America Pharmaceuticals; and Shannon West, Chief Product Officer, Datavant; moderated by Kulleni Gebreyes of Deloitte.

Predictive Analytics Giving The Lowdown on Clinical Trial Performance

Lokavant’s data-agnostic integration platform for optimizing trial planning and conduct hit the streets three years ago, bringing near-real-time insights about every participant, site, country, region, and study to companies struggling to reduce the cost and speed the pace of clinical research. Rohit Nambisan, CEO and cofounder, reports on their progress.

Time Is Now To Take A Hard Look At Decentralized Trials

Many assumptions have been made about how decentralized clinical trials (DCTs) could help with clinical trial diversity although little “rigorous evidence” exists regarding actual effects on study enrollment. That will require randomized controlled trials to compare DCTs head-to-head with traditional, in-person trials.

AI Bringing Major Change To The Way Studies Get Conducted

Clinical research stakeholders, most especially study sponsors, are now firmly onboard with the idea of using artificial intelligence (AI) to improve the conduct of clinical trials. The U.S. Food and Drug Administration (FDA) expects increasing use of different AI approaches, including natural language processing (NLP), and is actively inviting different use cases around it. ConcertAI talks about what this will look like in practice.

Success in Simplicity: Complex Clinical Trials and the eCOA Systems That Support Them

Comment: Suvoda’s Jill V. Platko knows that clinical trials are becoming more complex. Advancements in technology are enabling sponsors, clinicians, and trial teams to gather more information than ever before. However, she says, the latest “bells and whistles” can add complexity to trials and distract trial teams from their main focus: collecting data to advance therapies for very ill patients who need them most. 

Rescuing a Study in Jeopardy with Comprehensive Clinical Adjudication

Comment: Sponsors of global clinical trials are wisely seeking out independent adjudication of clinical events, or endpoints, that occur over the course of the trial to ensure patient safety and the efficacy of drugs and devices, says Judy Narisi of Clario. While endpoint adjudication is not required by regulatory bodies, it can deliver valuable insights during a trial and lend strong, unbiased support for approvals down the road. 

Data Matters: Creating the Perfect Health Research Cohort

Comment: An important foundation of research is cohort creation; many critical decisions are made based on how the cohort is built and designed. Better cohort creation can lead to more accurate findings and better care outcomes. But how do you build a better cohort? It all starts with the research question and the data at hand says Gai Elhanan, Center for Genomic Medicine, Desert Research Institute.

Three Ways AI Can Accelerate Innovations in Clinical Research

Comment: Jayme Strauss, Viz.ai, outlines how artificial intelligence (AI) enabled technologies are showing potential to increase efficiencies by improving both site and patient recruitment in clinical trials: improving diversity, the accuracy of screening, and bridging gaps between trial research and clinical care.

Realizing The Benefits Of Bringing The Trial To The Patient

Comment: Ashmee Bharadia, Accellacare In Home Services, part of ICON, explores how in-home services are being baked into trial protocols not out of dire necessity, but rather out of an appreciation for their value in supporting patient-centric trials with decentralized components.