• Best of Show Finalists at SCOPE 2025

    Clinical Research News | The Best of Show People’s Choice Award Finalists are now announced for next week’s 2025 Summit for Clinical Ops Executives (SCOPE). With a record number of finalists, this promises to be the most competitive year yet for clinical new products.

    Jan 31, 2025

  • Proceed With Caution When Decentralizing Oncology Trials

    Clinical Research News | Patients with cancer typically have a strong emotional connection with their doctors and nurses that is an important part of their healing process. It follows that those taking an investigational therapy should be offered decentralized clinical trial (DCT) components that serve to enhance that bond rather than do away with it, according to Peter O’Neill, vice president of clinical operations at TuHURA Biosciences, Inc.

    Jan 30, 2025

  • Follow the Money: Clinical Platforms, Ophthalmology, New Trials

    Clinical Research News | New funding this month includes cash for “the anti-CRO” eClinical platform, novel obesity drugs, ophthalmology, and more.

    Jan 29, 2025

  • Community Partners Look at Trial Design, New 23andMe Research Offering, More

    Clinical Research News | A new UTHealth Houston project plans to engage community partners to improve the design of clinical trials; Advarra releases a Study Collaboration solution; 23andMe launches new clinical research product; more.

    Jan 28, 2025

  • Set For Success: Avoiding The Pitfalls Of Clinical Data Conformity In Medical Device Trials

    Clinical Research News | The Medical Devices Regulation 2017/745 and the In Vitro Diagnostic Regulation 2017/746 have greatly enhanced the requirements related to the performance, conduct, monitoring, recording and reporting of medical device clinical investigations in the European Union (EU). This tightening of clinical requirements under the EU Regulations has been cited as a key issue in the claims that medical devices are disappearing from use within the EU.

    Jan 24, 2025

  • AI-Powered Study Startup Platform Latest Addition to Pi Health Arsenal

    Clinical Research News | A spinoff of global biotech company BeiGene is looking to transform the clinical development of oncology medicines with a software platform integrating all the features study sponsors and sites need to conduct trials and communicate with each other in a compliant way.

    Jan 23, 2025

  • Digital Measures: What’s in it for Patients?

    Clinical Research News | Like two other major advancements in the past 200 years, the stethoscope and X-ray imaging, digital health technologies (DHTs) are giving “a whole new perspective” on human health. Earlier innovations enabled doctors to hear and see inside the human body, and the addition of digital measures of health offer a view into people’s everyday lives when they’re outside the clinic setting.

    Jan 21, 2025

  • The Roadmap for Analytical Validation of Novel Digital Clinical Measures

    Clinical Research News | Digital clinical measures that are truly novel and therefore lack a good reference measure for assessing their performance have been given overdue attention by a public-private partnership between the nonprofit Digital Medicine Society (DiMe) and the U.S. Food and Drug Administration (FDA).

    Jan 17, 2025

  • ‘Rebuttal Campaign’ Exposes Deficiencies in Study and Knowledge of Obesity

    Clinical Research News | Widespread misinformation about what obesity is and how it should be treated is finally getting the attention it deserves. The inconvenient truth is that obesity is a series of diseases, and the underlying culprit is malfunctioning adipose tissue.

    Jan 14, 2025

  • NVIDIA Announces Agentic AI Vision at J.P. Morgan Healthcare Conference, Partners with IQVIA

    Clinical Research News | Among the many partnerships and technical announcements made by NVIDIA during the company's Monday morning presentation at the 43rd Annual J.P. Morgan Healthcare Conference, NVIDIA focused several on innovation within the healthcare and life sciences industry.

    Jan 13, 2025

  • Sites, Participant Engagement Efforts Recognized as Award Finalists Before SCOPE

    Clinical Research News | Finalists have been named in two of the three awards programs slated for the SCOPE Summit, February 3-6, in Orlando, Fla. Entries in the Participant Engagement Awards and the Site Innovation Awards have been named finalists. Winners will be announced on site at the event.

    Jan 9, 2025

  • Trendspotting: Predictions for Clinical Research in 2025

    Clinical Research News | 2024 was full of innovative ideas and achievements. We spoke with industry experts and leaders about what to expect in the new year. Here are the full predictions and trends, including more information on patient recruitment and retention, patient perspectives in clinical trials, AI/ML’s impact on drug development, and more.

    Jan 7, 2025

  • Top Stories of 2024: Decentralized Clinical Trials, New Treatments, AI Automation, More

    Clinical Research News | In 2024, AI continued to help clinical research and trials by increasing efficiency and patient engagement, new drugs and treatments showed great potential for previously difficult-to-treat diseases, and decentralized clinical trials are heading to their “next phase.” The Scope of Things podcast also delivered news and exclusive conversations on improving diversity in clinical trials, enrollment challenges, patient centricity, and more. To kick off 2025, here are the top stories from Clinical Research News and top episodes from the Scope of Things podcast.

    Jan 3, 2025

  • Tracking Compliance in Ophthalmic Clinical Trials

    Clinical Research News | We have all heard it often noted that treatment outcomes in real-world practice don't always reflect those observed in clinical trials, largely attributing these differences to a lack of adherence to prescribed therapy. Yet the uncomfortable truth is that therapeutic nonadherence happens in clinical trials too—with far-reaching consequences.

    Dec 30, 2024

  • myTomorrows Expands AI-Powered Platform, MissionBio Collaborates With University of Miami, More

    Clinical Research News | myTomorrows adds the ISRCTN registry to the clinical trial search functionality on its platform; Mission Bio collaborates with University of Miami on Multiple Myeloma (MM) at an unprecedented level of clonal detail; and more.

    Dec 27, 2024

  • Follow the Money: Trials for Autoimmune Dysregulation, Advancing Trigeminal Neuralgia, Tuberous Sclerosis Complex, More

    Clinical Research News | Nuvig aims to deliver novel methods for reducing autoimmune dysregulation without immunosuppression; Noema Pharma plans to advance four active Phase 2 trials for trigeminal neuralgia, tuberous sclerosis complex, and other diseases; and more.

    Dec 23, 2024

  • Scope of Things: Clinical Trial Simulations Save Costs, European Union AI Act, ChatGPT Matching Volunteers, More

    Clinical Research News | In this year’s last episode of the Scope of Things, host Deborah Borfitz discusses concerns surrounding obesity studies and treatments, debate over the European Union AI Act, the first international-level clinical study using secure multiparty computation, the NIH’s ChatGPT tool that matches potential volunteers to relevant studies, and more.

    Dec 19, 2024

  • Secure Multiparty Computation Unlocks Cross-Border Research Potential

    Clinical Research News | European researchers have achieved a breakthrough in privacy-preserving clinical studies through the first international application of secure multiparty computation (MPC). This advanced cryptographic method enabled institutions across borders to collaborate without sharing sensitive patient data, paving the way for privacy-respecting global research.

    Dec 18, 2024

  • Inconvenient Truths Stall Progress in Achieving Clinical Trial Diversity

    Clinical Research News | The U.S. Food and Drug Administration (FDA) expects sponsors of certain clinical studies to submit a Diversity Action Plan outlining enrollment goals, their rationale, and means of achieving those intentions, as the agency spells out in some detail in its much anticipated draft guidance issued in June. At the same time, pushback against diversity, equity, and inclusion (DEI) initiatives has been ramping up in industry hallways across the land to the point where merely uttering the term “DEI” can evoke sneers.

    Dec 17, 2024

  • AI Beyond the Hype: A Game-Changer for Scaling Clinical Trials Without Sacrificing Quality

    Clinical Research News | In the past year, the rise of generative AI has created much buzz within the life sciences industry. This technology promises to shorten the lengthy timelines typically seen when bringing new therapies to market, providing a glimmer of hope (perhaps hype?) for an industry known for its methodical pace. The challenge is to harness AI’s capabilities safely, securely, and effectively to accelerate every phase of the drug discovery and development lifecycle.

    Dec 13, 2024