• 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

  • GeneDX Novel Data Visualization Tool, New Landmark Parkinson’s Initiative, More

    Clinical Research News | GeneDx announced GeneDx Discover, a first-of-its-kind data visualization tool, which provides biopharmaceutical companies access to deidentified and aggregated genetic data—powered by GeneDx’s database—to improve all stages of drug development; Critical Path Institute announced a landmark initiative, Gender Equitable Medicines for Parkinson's Disease, dedicated to globally advancing actionable research on how Parkinson's disease uniquely impacts women and individuals across the sex and gender spectrum; and more.

    Nov 25, 2024

  • Trends in Biosimilars

    Clinical Research News | The global biosimilars market is experiencing substantial growth, valued at $29.45 billion in 2023, it is projected to reach $150.3 billion by 2033 (CAGR of 17.7%). This upward trajectory is primarily driven by the ability of biosimilars to offer safe, clinically effective, and cost-effective alternatives to reference biologics, expanding patient access to treatments for the ever-rising number of chronic and severe illnesses.

    Nov 22, 2024

  • AI Drug Repurposing Tool Offers Suggestions Based on Disease Networks

    Clinical Research News | arvard scientists, led by Dr. Marinka Zitnik, have developed an AI-based tool, TxGNN, to identify drug repurposing opportunities for diseases lacking effective treatments. The AI model harnesses a novel approach by focusing on multiple diseases simultaneously, allowing insights from well-documented conditions to be applied to rare diseases with sparse data.

    Nov 20, 2024

  • Pharma Leaders Tackle Persistent Quality Challenges and the Future of Clinical Trials

    Clinical Research News | Pharma leaders took on clinical trial quality in a panel discussion at the SCOPE Europe conference last month in Barcelona. While technologies change, the conversation underscored a central truth: the push for quality in clinical research remains as vital, yet as challenging, as ever.

    Nov 19, 2024

  • The Case for Integrating Placental Pathology into Prospective Clinical Trials

    Clinical Research News | Perinatal pathologists are calling for placental pathology to be incorporated into prospective clinical trials so they can start telling clinical providers what the findings in their reports mean. For want of funding and the relevant diagnostic expertise, the placenta has long been a woefully under-investigated organ that could be providing critical insights on pregnancy-related conditions like preeclampsia and preterm birth that are currently defined solely based on a clinical diagnosis.

    Nov 14, 2024

  • AI Regulation Sparks Debate at Scope Europe Conference: Industry Leaders Weigh In

    Clinical Research News | Last week at SCOPE Europe, industry leaders took on the impact of AI regulation—particularly the European Union's AI Act—on the clinical research and life sciences sectors. Moderated by BioSpace’s Lori Ellis, the panelists included Firas Abdessalem of Sanofi, Christopher Hart of Foley Hoag, Ricardo Gaminha Pacheco of InSilico Medicine, and Artemy Shumskiy of Latvian VC company LongeVC. Together they discussed how the EU’s AI Act is likely to impact innovation, funding, and partnerships in the life sciences.

    Nov 12, 2024

  • Ensuring Study Participant Adherence: Strategies for Successful Remote Data Collection in Clinical Trials Using Wearable Technologies

    Clinical Research News | Ensuring clinical trial participants adhere to study protocols is essential for reliable clinical trial results. If participants aren't consistent with their participation, the data collected won't accurately reflect the effectiveness of a treatment or therapy. Poor adherence can slow down or even derail clinical breakthroughs.

    Nov 8, 2024

  • Scope of Things: SCOPE Europe 2024, AI in Clinical Trials, Rising Stars, More

    Clinical Research News | In this month’s episode of the Scope of Things, host Deborah Borfitz gives you the latest news on a study for AI system for drug repurposing, a window trial for a new triple-negative breast cancer treatment, Jill Pellegrino’s transition from CVS to AutoCruitment, publication bias with industry sponsored studies for psychiatric drugs, and more.

    Nov 7, 2024