• 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

  • Dealing with Data Over-Collection in Clinical Trials

    Clinical Research News | Can you have too much of a good thing? Or perhaps, can you gather too much of a good thing? When it comes to clinical trials, it looks like the answer is yes. The industry has seen an exponential increase in the volume of data collected in clinical trials. When one considers all the talk of AI and what might be possible with more and more quality data, this growth in data gathering seems to make sense.

    Dec 10, 2024

  • Diversity, Equity, and Inclusion Guidelines Still Not Optimal for HIV-Positive Patients

    Clinical Research News | While randomized clinical trials (RCTs) have rightly long been considered the gold standard for establishing the safety and efficacy of new medications, their strict inclusion and exclusion criteria narrow participant types. For example, RCTs tend to exclude certain patient sub-groups, especially those with specific comorbidities. The scientific rationale behind these practices results from a desire to assess the benefit/risk ratio in a stepwise fashion, starting with the most homogenous population to more heterogeneous ones as development of a therapeutic progresses.

    Dec 6, 2024

  • PAN Foundation Taking Health Literacy Approach to Improve Trial Access

    Clinical Research News | The PAN Foundation, a nonprofit that has been providing financial assistance to patients with life-threatening, chronic, and rare diseases since 2004, has just launched an Opening Doors to Clinical Trials initiative aiming to improve equitable access to studies. Assistance is now freely available to people everywhere in the form of basic education about trials, a user-friendly trial finder tool, and a live person who can answer questions and direct them to needed resources.

    Dec 4, 2024

  • Diversity Begins at the Bench: Walking Back a Patient-Centered View of Trial Design

    Clinical Research News | At the SCOPE Europe conference held in Barcelona last month, clinical trials leaders highlighted transformative shifts toward diversity, inclusion, and patient engagement in study designs. Liz Bristow, director of patient recruitment and retention at AstraZeneca, and Jodie Allen, global senior director of clinical trial diversity at AstraZeneca UK, outlined key advancements and persistent challenges in achieving equitable patient representation across clinical trials.

    Dec 3, 2024

  • Follow the Money: Alpha-9 to Advance Radiopharmaceuticals, Dermatitis, Crohn’s Disease Studies, More

    Clinical Research News | Alpha-9 funds targeted radiopharmaceuticals; Evommune pursues chronic urticaria and atopic dermatitis; Agomab Therapeutics advances lead candidate in Crohn’s disease (FSCD); and more.

    Nov 26, 2024