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Establishment of a Clinic-based Biorepository
Published on: May 29, 2017
Clinical research in dermatology: 10 steps to getting started
1Department of Dermatology and Skin Surgery, Roger Williams Medical Center, Providence, RI 02908, USA. pcarson@rwmc.org
Dermatologic Therapy
|January 4, 2007
Summary
Initiating clinical trials for drug and device development, especially in wound healing, involves complex regulatory steps. This review outlines the 10 crucial stages for researchers to successfully launch investigational trials.
Area of Science:
- Medical research
- Clinical trial management
- Wound healing therapeutics
Background:
- Clinical research is vital for advancing medical treatments and devices.
- Initiating clinical trials presents significant challenges due to complex regulatory requirements.
- Many healthcare professionals lack adequate training in clinical trial initiation.
Purpose of the Study:
- To provide a concise overview of the essential steps in initiating a clinical trial.
- To offer guidance for researchers, particularly those in wound healing studies.
- To demystify the process of clinical trial commencement for clinicians.
Main Methods:
- Review of key steps in clinical trial initiation.
- Focus on practical guidance for researchers.
- Applicability to various investigational trials, including wound healing.
Main Results:
- Identification of the 10 most critical steps for starting a clinical trial.
- A structured approach to navigating regulatory and logistical hurdles.
- Information tailored for both wound healing and broader clinical research.
Conclusions:
- Successful clinical trial initiation requires a clear understanding of procedural steps.
- This review serves as a practical guide for clinicians and researchers.
- Adherence to these steps can facilitate the development of new drugs and devices.
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