The Clinical Trials in Healthcare Training provides healthcare professionals with a comprehensive understanding of clinical research and trial phases. Participants learn about the regulatory framework, including the Investigational New Drug (IND) process, ethical considerations, and strategies for ensuring patient safety. By understanding the progression from early-phase studies to large-scale trials, professionals can support the development of safe and effective treatments while upholding ethical and regulatory standards.
What You Will Learn:
Key regulatory bodies that oversee clinical trials
Ethical considerations surrounding clinical trials
Strategies for minimizing patient risk during clinical trials
Details:
Course length: 45 minutes ; CME: 0.75
Languages: American English
Key features: Audio narration, learning activity, and post-assessment.
American Medical Compliance is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education to physicians. Our Continuing Medical Education (CME) program is committed to enhancing the knowledge, skills, and professional performance of healthcare providers to improve patient care outcomes. Through high-quality educational activities, we aim to address the identified educational gaps and to support the continuous professional development of our medical community. American Medical Compliance designates this activity for a maximum of 0.75 AMA PRA Category 1 Credits. Physicians should only claim this credit for their complete participation in this activity.
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Learning about Clinical Research
Clinical research involves studies conducted on people to evaluate medical treatments. Before beginning a clinical trial, drug developers must design their study based on the goals of each research phase and submit an Investigational New Drug (IND) application to the FDA. This application includes clinical protocols outlining study plans. Clinical trials progress through phases, from small-scale Phase 1 studies to large-scale Phase 3 trials, ensuring the safety and effectiveness of new treatments.
Understanding Clinical Data Management
Clinical Data Management (CDM) involves the collection, cleaning, and management of subject data while ensuring compliance with regulatory standards. Its primary goal is to provide high-quality data by minimizing errors and missing information, allowing for accurate analysis. Best practices, supported by advanced software applications, help maintain data integrity by tracking audit trails and resolving discrepancies efficiently.
With the increasing complexity of clinical trials, CDM systems have evolved to handle large-scale studies while maintaining compliance with regulations like 21 CFR Part 11. The pharmaceutical industry relies on electronically captured data for drug evaluation, necessitating strict adherence to good data management practices.
Recruitment and Retention in Clinical Trials
Recruitment and retention are critical challenges in clinical trials, with patient recruitment being the leading cause of delays. Up to 20% of trials either fail to meet enrollment targets or end prematurely due to recruitment issues. Barriers such as study design, physician and participant attitudes, accessibility, demographics, and socioeconomic disparities impact trial participation.
The COVID-19 pandemic further disrupted clinical research, halting ongoing trials and delaying new studies. In response, regulatory agencies like the FDA and the National Cancer Institute provided guidance to support decentralized clinical trials. These methods, including virtual visits, remote monitoring, and alternative data collection sites, have helped improve trial accessibility and continuity while reducing barriers to participation.
