Newsletter | September 25, 2024

09.25.24 -- Changing Trial Design When Stepping Up From Second-Line To First-Line Treatment

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Webinar: From Crisis to Confidence in Medical Writing

The regulatory submission process is complex and filled with challenges that can jeopardize critical filings. In this session, we’ll explore the key obstacles medical writing submission specialists face today and share proven strategies to ensure successful submissions every time. Click here to learn more.

TRIAL MANAGEMENT

Changing Trial Design When Stepping Up From Second-Line To First-Line Treatment

Guest Column | A conversation with Fairooz F. Kabbinavar, MD, FACP, Cardiff Oncology

Chief Medical Officer Fairooz F. Kabbinavar, MD, FACP, explains how Cardiff Oncology moved its CRDF-004 into a first-line treatment and how conversations with consultants and the FDA made it possible.

Radiation Therapy Quality Assurance In Clinical Trials

White Paper | By Andrew Cowen and Scott Brame, Ph.D., Radialogica LLC; David Alsadius, MD, Ph.D., Kimberly Clarke and Forrest Anthony, MD, IQVIA Biotech

Here, the authors describe the crucial role of radiation therapy in oncology trials and how a robust quality management program can enhance treatment outcomes and research efficacy.

Oesophageal Cancer: Global Clinical Trial Landscape (2024)

White Paper | Novotech

Oesophageal cancer is the 11th most common cancer and the 7th leading cause of cancer deaths. Explore our report to discover the latest in treatments, clinical trials, and future innovations.

True Breakthroughs In Individualized Treatments For Cancer Patients

Podcast | Biorasi

Dr. Diana Azzam delves into the details of her work in guiding individualized patient treatments, from her functional precision medicine research into the future standard of care for oncology testing.

DECENTRALIZED TRIALS

The Importance Of Semantics: Decentralized Clinical Trials And A Shifting Industry

Guest Column | By Daniel J. Fox, MPH, Ph.D., Clinical Research Payment Network; Land of Lincoln Clinical Research; DiversiTrials; and Save Our Sites Conference and Alliance (former)

Has the term "DCT" fallen out of favor? And if it has — especially among sites — what should take its place? Daniel J. Fox, MPH, Ph.D., clinical site advocate and entrepreneur, advocates for a more accurate and equitable moniker: DCV.

Risk Mitigation In Direct-To-Patient Clinical Trials

Article | By Nicole Gray, Catalent

The DTP model can help alleviate risks in patient enrollment (including diversity), retention, and adherence to study timelines and budgets. Explore how to ease trial troubles through DTP.

Improving Studies In Vulnerable Populations With Mobile Nurses

Video | PCM Trials

Dr. Steven Cummings highlights the role of PCM Trials certified mobile research nurses in making possible large-scale home-based clinical trial.

How To Build A Hybrid Visit Strategy That Delivers High-Quality Results

Article | By Helen Marks, MRN - Medical Research Network

In-home clinical trial visits yield major benefits for patients, including increased access and convenience. As a result, hybrid trials are helping developers increase enrollment, engagement, and retention.

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You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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