Join to access to all OVN content. Join for Free
Professional Medical Writer Assistance in Oncology Clinical Trials
PMW usage phase III oncology trials professional medical writer assistance

Professional Medical Writer Assistance in Oncology Clinical Trials


Share This Article


Summary

  • The use of professional medical writers (PMWs) in oncologic phase III randomized controlled trials (RCTs) has been historically low, but recent data on their usage is limited.
  • This study aimed to quantify the usage of PMWs in cancer-specific phase III RCTs by analyzing trial manuscripts on ClinicalTrials.gov.
  • Out of 600 trials, 260 (43.3%) involved PMWs in writing the trial manuscript.
  • Industry-funded trials were significantly more likely to use PMWs compared to nonindustry trials (54.9% vs. 3.0%, p < .001).
  • PMW usage was higher in trials that met their primary endpoint (53.4% vs. 32.9%, p < .001) and those resulting in FDA approval (63.1% vs. 36.3%, p < .001).
  • Among treatment interventions, PMW use was most prevalent in systemic therapy trials (50.2%).
  • The study observed a significant increase in the use of PMWs over time (odds ratio: 1.11/year, p = .001).
  • The study calls for increased transparency in reporting the funding and use of PMWs.

Academic publishing remains the cornerstone of cancer research and scientific communication of clinical trials. Over the years, there has been increasing interest in the use of professional medical writers (PMWs) to help investigators improve quality of writing and/or reduce the time to publication. Use rates of such PMW services have historically been low, but contemporary data regarding PMW usage remain scarce. With an increasing role of industry sponsorship in cancer clinical trials, we sought to characterize the rate of PMW use among reports of phase III cancer clinical trial results, focusing on factors associated with PMW usage.

Click for Source Download PDF version
PMW usage, phase III oncology trials, professional medical writer assistance

Related Topics

Meet Our Innovation Partners

Loading partners...

You May Also Like

Article
Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis
OVN Avatar Jayson L. Parker, Sebnem S. Kuzulugil, Kirill Pereverzev, Stephen Mac, Gilberto Lopes, Zain Shah, Ashini Weerasinghe, Daniel Rubinger, Adam Falconi, Ayse Bener, Bora Caglayan, Rohan Tangri, Nicholas Mitsakakis

Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis

Article
Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
OVN Avatar Avi Cherla, MSc; Huseyin Naci, MHS, PhD; Aaron S. Kesselheim, MD, JD, MPH; Bishal Gyawali, MD, PhD; Elias Mossialos, MD, PhD

Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval

Article
Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review
OVN Avatar Vanessa Arciero, BS, Seanthel Delos Santos, Liza Koshy

Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review

Article
Clinical Educator Oncology Program Improves Adherence by 29%​
Partner Avatar iNIZIO

Clinical Educator Oncology Program Improves Adherence by 29%​

Article
New Book Unites Oncology’s Brightest Minds To Innovate Cancer Cures
OVN Avatar Forbes Books Press Release Official

New Book Unites Oncology’s Brightest Minds To Innovate Cancer Cures

Article
CheckMate-067: Raising the Bar for the Next Decade in Oncology
OVN Avatar Sarah A. Weiss, MD, and Harriet Kluger, MD

CheckMate-067: Raising the Bar for the Next Decade in Oncology

Explore OVN