The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and ultimately market approval.
Over the course of any development plan, new protocols, protocol amendments, and protocol concept sheets will be needed on an ongoing basis. Though they require similar information, protocols for Phases 1, 2, 3 and 4 require different writing approaches. As a writer of a protocol, you need to know what the agency expects to see at every development milestone to avoid the trial being put on clinical hold. Moreover, amendments, however unwelcome, are a necessary part of the development process. Amendments need to be managed efficiently to avoid costly implementation or delays to the ongoing trial.
Improve basic writing skills
Implement a style guide
Describe the overall structure of a protocol and regulatory requirements
Differentiate between the phases of investigation and how Phase 1-4 protocols differ in their content
Identify who contributes to the protocol development and amendments
Manage the timeline for protocols and their amendments
Manage the review and commenting process
Hold protocol review meetings
Describe the requirements for a protocol, including: Establishing the indication(s); Writing the Concept Sheet to guide research; Types of studies (prospective, observational, retrospective); Design (single blind, double blind, randomized, etc.);
How to conduct literature searches, organize the articles, and develop a background for the disease including the current standard of care (SOC); Using regulatory precedence and literature to establish metrics, and primary and secondary endpoints; What to do when there are no established metrics for a particular indication; Establishing the hypothesis; What is safety and efficacy and how do you establish either or both; Using the Synopsis as an outline for the protocol; Determining inclusion/exclusion criteria;
Determining the Schedule of Events; Determining the initial expected adverse events and serious adverse events and rate of occurrence (based on background disease and related compounds); Adverse and serious adverse event reporting; Statistics (sample size, etc.); External Key Opinion Leader review; How to manage the references;
QA and final sign off of protocol; Informed consent development based on final protocol; Case report form development based on the final protocol
Determine what happens next: distribution to regulatory agencies, sites, and IRB review: Who does the protocol get sent to and timing; IRB Do’s and Don’ts
Developing protocol amendments: how and when to do it and documentation needed. Amendments can be needed for: Drug dosage increase/decrease; Drug exposure duration; Change in the number of subjects; Significant protocol design change;
Statistical plan change; Additional test procedures; Indication change
Drug or device professionals looking to explore the mechanics of putting together a clinical protocol including: medical writers, clinical research associates, study coordinators, regulatory affairs personnel, engineers, pre-clinical personnel, or physicians.
The course will be led by one of the following instructors:
Cheryl Vitow
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Day 1: 8:30 a.m. – 5:00 p.m.
- Writing Basics
- Overview of the Protocol Requirements
- Building the Protocol
Day 2: 8:30 a.m. – 5:00 p.m.
- Building the Protocol, cont.: Past precedence and approved labels;Constructing protocol based on research; Informed Consent Form; Case Report Forms; Protocol Amendments
Mock drug will be researched
Protocol for a Phase 1, 2, or 3 drug will be constructed in a group activity
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-11-007-L01-P. Released 3/11.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.