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Resources for Analgesia Trials

Clinical trials in pain indications present unique challenges. Rho has extensive experience addressing these challenges to set your program up for success. Here are some resources we have developed to help you:

Development of Successful Phase 2 Analgesia Protocols

EBOOK

Development of Successful Phase 2 Analgesia Protocols

Phase 2 is a critical make-or-break phase of product development.This ebook includes key points to consider for Phase 2 Analgesia protocol design, including a discussion of FDA guidance, defining objectives and clinical endpoints to demonstrate proof of concept, determining dosage to progress to phase 3, guidelines for optimizing inclusion and exclusion criteria, and developing effective statistical analysis plans

David Shoemaker, Ph.D.
Senior Vice President, R&D

In the past two years, Dr. Shoemaker has contributed to four successful marketing applications and has significant experience interacting with the Division of Anesthetics, Analgesia, and Addiction Products (DAAAP) at FDA and has obtained marketing approval for products
in the US, Canada and the EU. He works closely with medical, biostatistics, clinical operations, and regulatory authoring team members to ensure Rho’s effort reflects the advantages of his nearly 20 years marketing application experience.

Jack Modell, M.D.
Senior Medical Officer

Dr. Modell is a board-certified psychiatrist with 30 years of experience in clinical research, teaching, and patient care including over 10 years of experience in clinical drug development (proof of concept through phase 4), medical affairs,  successful NDA filings, medical governance, drug safety, compliance, and management in the pharmaceutical and CRO industries.

Ben Vaughn
Principal Statistical Scientist

Ben Vaughn has twelve years of experience in clinical research. He has participated in nearly 20 regulatory submissions, coproduced the ISE for two opioid products; and provided statistical consultation, display generation and submission work for four separate products for OA knee pain.

6 Things to Consider When Selecting a CRO for Your Next Pain Study

ARTICLE DOWNLOAD

6 Things to Consider When Selecting a CRO for Your Next Pain Study

Selecting a contract research organization (CRO) for your next pain study is a critical decision in your development program.  This article provides considerations for making the best possible selection, including enrollment, subject reported data, data monitoring, drug preparation, diversion and misuse, and FDA Approval.

Strategies for Analgesic Development and the New FDA Guidance for Analgesic Indications

FREE WEBINAR

Strategies for Analgesic Development and the New FDA Guidance for Analgesic Indications

CDER recently issued an updated draft guidance for Analgesic Indications. In this webinar, Brett Gordon and Ben Vaughn provide a high-level review of the agency’s guidance, offer strategies for analgesic product development and share experiences with PROs and paper vs. tablet collection.

Ben Vaughn
Senior Statistical Scientist

Ben Vaughn has twelve years of experience in clinical research. He has participated in nearly 20 regulatory submissions, coproduced the ISE for two opioid products; and provided statistical consultation, display generation and submission work for four separate products for OA knee pain. Last spring he attended an FDA advisory committee to represent the sponsor for an opioid product. He has authored responses to various FDA queries regarding NDAs, PMAs, IDEs, and SPAs. Additionally, he has represented sponsors in FDA teleconferences and face-to-face meetings for both OA knee pain products and opioid products. His analytic experience includes cross-over studies, survival analysis, non-parametrics, and extensive work with linear and non-linear repeated measure models.

Brett Gordon
Project Director

Brett Gordon has more than fifteen years of overall clinical development experience, including eleven years in project management, encompassing trials of varying sizes and complexity, both domestically and internationally. He has extensive knowledge of clinical development including initial development plan formulation, protocol writing, trial implementation, monitoring and delivery, clinical study report writing, and regulatory submission to support of marketing applications. Brett has worked across numerous therapeutic areas and in particular possesses in-depth CNS experience, including four years at an orthobiologics company supporting clinical development activities for ultrasound bone healing and two hyaluronate products for osteoarthritis.

White Paper: Considerations for Development and Approval of Analgesic Products

Dr. David Shoemaker, Senior Vice President R&D, provides an overview of the regulatory landscape for analgesic product development.

White Paper: The Minimal Clinically Important Difference in Efficacy Trials of Analgesics

Dr. Brian Boehlecke, Medical Officer, provides an overview of the literature around minimal clinically important difference as it applies to clinical trials for analgesic products.

FREE WEBINAR

Stop the Pain: Tips for increasing patient retention and decreasing missing data in analgesia clinical trials

Lynn King, Assistant Vice President Operations, and Karen Kesler, Senior Statistical Scientist, share real-world solutions for trial design, execution, and analysis that will increase patient retention, minimize missing data, and help you successfully navigate FDA’s new paradigm for clinical trials in pain.

Karen Kesler, PhD

Senior Statistical Scientist

Karen Kesler has a Doctoral degree in Biostatistics from the University of North Carolina and over 15 years of clinical trial experience. A recognized expert in adaptive design, she is involved in researching more efficient Phase II & III trials.