Written by Gerald L. Klein, MD & Roger Morgan, MD
Drug Development
Informed consents have grown much larger, more complex, and oftentimes uses terminology that may be difficult to understand for persons with limited language skills. [1] It is imperative to make these forms shorter, simpler, and easier to understand. Studies have demonstrated poor patient comprehension of the essential elements of the informed consent process not just in the United States but globally. [2] [3] [4]
The definition of a laboratory adverse event is usually described in the protocol as a value that is clinically significant in the investigator’s judgment. One frequent protocol guidance for this is having a lab test reported as clinically significant if repeated. However, many results are repeated just to ensure that the results are insignificant or are due to a procedural error (hemolyzed blood). We recommend removing “repeat laboratory testing” as an indicator of a significant adverse event.
Removing all patient identification is important for sites to remember when they send patient hospital records or other medical records to the sponsor or CRO. In addition to name, it also includes items such as home address, telephone number and medical record number.
Medical Affairs
Making the most out of poster presentations
Place on social media
Solicit comments and questions
Answer appropriate questions and communicate these to a wider audience
Broadcast current and future work in this area when applicable
Write up and disseminate pertinent questions and answers
Create a white paper and journal articles from the data
Commercial booths at scientific conferences
Verify that a promotional committee consisting of legal, medical, and regulatory (LMR) has reviewed your booth and all material in detail. This includes the following:
Booth location
All banners
All printed material, videos, handouts, etc.
Labels, headers, designs, etc. on the booth wall
Location of medical science liaisons (MSLs) in relation to the commercial team
Detailed examination of all items is critical to maintain compliance with the regulations.
Product feedback is an important way to learn how health care providers are actually using your product
Having MSLs talk directly to clinicians is a way to gather this information. In addition, you can learn why and when they are actually using the product in this manner.
What difficulties or drawbacks are there to the product?
Can the patient experience be improved, such as administering a drug at bedtime?
[1] Schumacher A, Sikov WM, Quesenberry MI, Safran H, Khurshid H, Mitchell KM, Olszewski AJ. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS One. 2017 Feb 24;12(2): e0172957. doi:10.1371/journal
[2] Ibid
[3] O'Sullivan L, Sukumar P, Crowley R, et al. Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK: a retrospective quantitative analysis. BMJ Open 2020;10: e037994. doi:10.1136/bmjopen-2020-037994
[4] Wen G, Liu X, Huang L, Shu J, Xu N, Chen R, et al. (2016) Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China. PLoS ONE 11(10): e0164251. https://doi.org/10.1371/journal.pone.0164251