Practical Pointers for Drug Development and Medical Affairs

Authors

  • Gerald L. Klein MedSurgPI LLC, 3700 Lark Farm Road, Franklinton, NC 27525, USA
  • Roger E. Morgan MedSurgPI LLC, 3700 Lark Farm Road, Franklinton, NC 27525, USA
  • Shabnam Vaezzadeh MedSurgPI, LLC and Exquisite Biomedical Consulting, NC 27525, USA
  • Burak Pakkal MedSurgPI, LLC and Exquisite Biomedical Consulting, NC 27525, USA
  • Pavle Vukojevic MedSurgPI LLC, 3700 Lark Farm Road, Franklinton, NC 27525, USA

Abstract

It is absolutely an essential part of the clinical research process in providing informed consent, and having the potential participant sign the forms (ICF).1 It may help foster enrollment by also explaining to potential study participants not only why the research is being conducted, but also how their individual participation will help in product development and what this product has the potential
to accomplish. It is more difficult than ever to enroll patients in Phase I oncology clinical trials.2 One partial solution, when feasible, is to make this a multi-center semi-decentralized clinical trial rather than one inhouse unit.

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Published

2024-04-06

How to Cite

Gerald L. Klein, Roger E. Morgan, Shabnam Vaezzadeh, Burak Pakkal, & Pavle Vukojevic. (2024). Practical Pointers for Drug Development and Medical Affairs. Clinical Trials and Practice – Open Journal, 7(1), 1–5. Retrieved from https://openventio.us/index.php/CTP/article/view/1262

Issue

Vol. 7 No. 1 (2024): Volume 7 Issue 1 2024

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Articles

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