FEATURED CONTENT

• Targeted Recruitment For Monkeypox Vaccine

  See how one late-stage biotech company leveraged Citeline Connect to recruit a diverse population of patients for a monkeypox vaccine trial, accelerating enrollment and targeting impacted communities.

• Diversity At The Start: Best Practices For Clinical Trial Planning

  Claire Riches, Citeline's VP of Clinical Solutions, emphasizes that clinical trial diversity must start with a fit-for-purpose protocol, incorporating the patient voice early on to ensure success in reaching diverse populations.

• Clinical Trial Diversity From A Disclosure Perspective

  Although the FDA mandate on diversity action plans won’t come until 2025, sponsors should start planning how to be inclusive, increasing the representation of underrepresented groups in clinical trials and reporting that data.

• Diversity In Clinical Trials: LGBTQIA+ Community Needs Not Just Allies, But Crusaders

  In an ACRP webinar on LGBTQIA+ diversity in clinical trials, industry panelists came together to discuss FDA action plans, SOGI data, advocacy efforts, challenges of transgender patients, and more.

• Practical Approaches To Clinical Trial Diversity

  Gain insights on FDA diversity action plans, and the important role that data points play in ensuring inclusion of underrepresented populations.

• Outlook Good For 7 Drugs Up For Q3 Review

  A total of 24 drugs, devices, diagnostics, and deals are expected to progress in the third quarter of 2024, including approval applications for 17 drugs. The estimated overall likelihood of approval is 90% or higher for seven of those drugs, including revumenib for acute myelogenous leukemia and KarXT for schizophrenia.

• Crafting A Successful Clinical Trial Diversity Action Plan

  Ensure your clinical trial meets FDA diversity requirements by clearly defining your enrollment goals and strategies in a comprehensive diversity action plan.

• Cell And Gene Therapy Field Quiet In Q2

  While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

• The Perfect Solution For Recruitment, Retention, And ROI

  See how Citeline Connect was deployed to advance enrollment six months ahead of schedule for a sponsor’s Phase IV atopic dermatitis trial and build a community of engaged patients who can enroll in future studies.

• Deciphering The FDA's Diversity Plan Updated Guidance

  Updated FDA guidance from June outlines the format and content of Diversity Action Plans, the products and studies requiring a plan, and the submission process. Learn about the changes and what to expect.

• The Promise And Peril Of AI In Clinical Trials

  In clinical research, as with many industries, AI is met with both excitement and trepidation. The impact of AI and machine learning is starting to be felt across the pharmaceutical industry.

• Billion Dollar Blueprint: The Journey To Blockbuster Status

  The allure of a blockbuster drug lies not only in its ability to generate billions in revenue but also in its potential to spur additional R&D investment.

• 10 Ways To Set Up Your Sites For Recruitment Success

  Selecting the right trial sites is key to success. Choose sites with the right experience, patient population, diversity mix, and timelines. See these nine tips to boost recruitment and retention.

• Including Diversity At The Onset

  Designing a clinical protocol that is fit for purpose can incorporate diversity into clinical trial planning early on. Explore strategies for incorporating diversity into clinical planning and study protocols.

• Cell And Gene Therapy Field Gains Momentum

  Discover how the dynamic growth trajectory of this field underscores its potential to revolutionize medicine and deliver innovative treatments to patients worldwide.

• Completed Clinical Trials, Terminations Both Rose In 2023

  This white paper highlights how the widespread growth in completed trials is coupled with higher success rates across multiple therapeutic areas, signaling the end of pandemic-related disruptions and infectious disease-related activity after three years of fluctuations.

• Pharma R&D Review 2024: Pleasant Weather Ahead

  Gain insights from the 2024 pharma landscape, which reports a record-breaking 22,825 pipeline drugs, led by Pfizer's 32 new candidates and a strong focus on oncology and neurological treatments.

• Optimizing Recruitment For Urgently Needed Vaccine

  Uncover how Citeline Connect helped a late-stage biotech sponsor expedite enrollment of a diverse population of eligible patients impacted by monkeypox for a large Phase 1 and Phase 2 trial of a next-generation vaccine.

• Deal-Making Volume Slowed In 2023

  This report provides an overview of alliance, merger and acquisition, and financing deal activities across the global biopharma, medical device, and in vitro diagnostics industries in 2023, as reported by Biomedtracker.

• Backup Sites: The Closers Of Clinical Trials

  Backup or coverage sites are usually brought in at the same time as others but are not activated. These sites become add-on or rescue sites, or the clinical equivalent of baseball’s ninth inning.