• 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rationale, and means of achieving those intentions, as the agency spells out in some detail in its much anticipated draft guidance issued in June.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