• 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

  • What Will It Take—And What Does It Look Like—For Clinical Care and Clinical Research To Converge?

    Clinical Research News | A profound shift is underway: one that positions patients not merely as recipients of clinical care but as active participants and collaborators in clinical research. A panel at last week’s SCOPE Summit Europe took on this challenge.

    Nov 4, 2024

  • SCOPE Europe 2024 Announces Best of Show Winners

    Clinical Research News | Clinical Research News and ClinEco announced three Best of Show winners today at the 2024 SCOPE Europe conference in Barcelona, Spain. The winning companies that submitted their products include Anju Software, Greenphire, and Medidata.

    Oct 30, 2024

  • IQVIA Introduces New AI Assistant, DHL Express, Thermo Fisher Partnership, Novel Cellular Blood Pressure Monitor, More

    Clinical Research News | IQVIA introduces IQVIA AI Assistant; DHL Express and Thermo Fisher Scientific join forces to drive more sustainable clinical research services; Withings Health Solutions announces a first-of-its-kind cellular blood pressure monitor; and more.

    Oct 30, 2024

  • Follow the Money: Trials for Major Depressive Disorder Therapies, Kidney Disease Treatment, More

    Clinical Research News | Seaport Therapeutics plans to advance their therapeutic candidate SPT-300, an oral prodrug of allopregnanolone; Purespring Therapeutics will initiate a clinical trial for IgAN, a common, chronic kidney disease primarily affecting young adults; and more.

    Oct 29, 2024

  • Advancing Health Equity: Community-First Approach to Drive Diversity in Clinical Research

    Clinical Research News | In clinical research, one ongoing challenge continues to persist: a lack of diverse representation. While the root cause stems from a combination of limited access and endemic mistrust of the health care system among certain communities, the outcome is that large pockets of communities are often excluded from studies, even in key areas where they are disproportionately affected by diseases such as diabetes, heart disease, and certain forms of cancer.

    Oct 25, 2024

  • SCOPE Europe 2024 Best of Show Entries

    Clinical Research News | The results are in: there are twelve new product finalists in the 2024 SCOPE Europe Best of Show awards that will be on display next week in Barcelona. Starting at the opening reception, the SCOPE Europe community is invited to identify exceptional innovation in technologies used by life science professionals, voting on the most impactful new products of the year.

    Oct 24, 2024

  • Drug Developers Eying Rollout of AI Legislation in the EU

    Clinical Research News | Eyes around the globe are on the EU Artificial Intelligence (AI) Act—the first comprehensive legal framework on AI anywhere—which will likely influence the direction of regulatory oversight measures adopted elsewhere, include other major markets such as the United States. Differing perspectives on the Act, including if and to what extent it could be a “death knell” for innovation, will be aired during a panel discussion being staged at the upcoming Summit for Clinical Ops Executives (SCOPE) Europe in Barcelona, Spain.

    Oct 22, 2024