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

    Dec 06 | 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. More

  • PAN Foundation Taking Health Literacy Approach to Improve Trial Access

    Dec 04 | 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. More

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

    Dec 03 | 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. More

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

    Nov 26 | 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. More

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

    Nov 25 | 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. More

  • Trends in Biosimilars

    Nov 22 | 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. More

  • AI Drug Repurposing Tool Offers Suggestions Based on Disease Networks

    Nov 20 | 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. More

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

    Nov 19 | 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. More

  • The Case for Integrating Placental Pathology into Prospective Clinical Trials

    Nov 14 | 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. More

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

    Nov 12 | 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. More
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SOT

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior writer Deborah Borfitz welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

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