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Clinical Trials Methods Course

Clinical Trials Methods Course

Course Description and Objectives

The Clinical Trials Methods Course provides a five-day, intensive course based on four successfully conducted and published clinical trials that are used to teach the methodology of design and implementation of a controlled clinical trial. The course is recommended for surgeons who plan to engage in clinical research at a leadership level.

The course is designed to provide surgical investigators with the concepts necessary to:

  • Develop a protocol for a clinical trial that is fundable by a peer-reviewed agency
  • Understand the statistical concepts necessary to design a clinical trial
  • Understand the design and implementation issues unique to performing surgical trials
  • Foster collaborative efforts necessary to conduct a clinical trial

Expert faculty use a combination of didactic lectures and hands-on approaches, such as break-out sessions, to apply concepts learned throughout the course, including the development of concepts and skills in the design, implementation, and analysis of randomized clinical trials’ funding mechanisms and budget development; outcomes (medical, patient-centered); and dissemination of results through publications. Small teams work closely with experienced surgeons and biostatisticians to develop group proposals for a clinical trial.

What Previous Attendees Have to Say

“Gaining tools not only to write proposals but also to critically review literature was key. Despite countless lectures on critical review in the past, I feel like I finally get it with this course. Maybe it’s me but I think it is more a tribute to an excellent course. Thanks!”

“This course is in the top 5 percent of any I have attended.”

“This course was instrumental in showing me what is necessary to conduct a successful clinical trial. I now know how much I grossly underestimated what I thought I knew about clinical trials.”

“I have augmented my research skill set with this course and I feel confident that it will have an impact on my career.”

“Meeting other leaders in the field and developing potential collaborations with other surgeons in my specialty was very beneficial.”

Find Out More

Course Chair Kamal M.F. Itani, MD, FACS, wrote about the course in the August 2011 Bulletin article titled “The ACS Clinical Trials Course: Overview and assessment.”


The American College of Surgeons is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

AMA PRA Category 1 Credits

The American College of Surgeons designates this live activity for a maximum of 38 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The course will hold a self‑assessment component toward Maintenance of Certification (MOC) Part 2. All requirements must be completed to receive AMA PRA Category 1 Credits™ and hours toward self‑assessment. Verification of completion of the course will be posted to ACS members’ My CME Transcript.