The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them

FOREWORD

When Débora S. Araujo pulled me aside at an industry conference, I had no idea just how involved she was in one of the most important areas of clinical research—getting a trial started. It is the one moment in a clinical trial when all stakeholders are on the same page, but getting there takes quite a bit of navigation, negotiation, and compromise.

After she mentioned she was putting the final touches on a new book, The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them, she asked if I would write the foreword. I ecstatically agreed. As a blogger and a clinical trial advocate, I often get the chance to relay to the pharmaceutical and clinical research industry the ups and downs I faced in participating in two separate late-stage cancer trials. Nowhere would this story be more appropriate than to kick off a book that addresses the delays that myself and many other patients face in finding and enrolling in a trial.

When I was diagnosed in 2012 with stage IV melanoma, my first oncologist offered standard-of-care chemotherapy and a measly twentyfour-month prognosis. Determined to watch my family grow up—my son was only four weeks old at the time, and my daughter was just two years older—I looked for hope, which came in the form of clinical trials for new immunotherapies. That glimmer of hope was nearly dashed, along with my chance to participate in a potentially life-saving trial, when the execution of the clinical trial agreement (CTA) was continually delayed for more than a month.

Five years later, after telling my story at that industry conference, Débora followed my presentation with one of her own—on the four villains of clinical trial agreements. The timing couldn’t have been more perfect. She was able to cite several examples used in the keynote while walking the audience through a subject that is not easy to digest.

Making legal documents captivating is certainly a challenge, but when a comic storyline like the “four villains” is intertwined with real-world examples, this book becomes more than just a series of chapters. Yes, you will learn about the pitfalls of the clinical trial agreement and strategies for addressing them. You will also get context on what happens when issues cause delays and push out the contract execution.

Estimated times for clinical trial agreement execution vary from ten to eighteen weeks, but even with an optimistic thirteen-week timeframe, that is still a full three months. In that quarter, 150,000 cancer patients will die; over 400,000 people will pass away from the top six disease-related causes of death. Countless others will suffer with serious, chronic, or untreated conditions.1 Yet a piece of paper waiting to be signed will likely deny someone, somewhere, the chance to live a longer, healthier, or better

life through a clinical trial.

With more than a decade of clinical trial experience, Débora has intimate knowledge of clinical contracts, budgets, and payment management. Having worked for and with multiple pharmaceutical sponsors and investigator sites, she utilizes her robust knowledge and experience to drive practical change in the industry via thought leadership material, presentations, and consulting engagements.

Readers will find a wealth of practical ways to improve clinical trial agreement negotiations and avoid delays from the sponsor, CRO, and investigator site sides. Additionally, you will see how tackling the “villains” of clinical trial agreement delays simultaneously can surpass the results they would have if tackling any one of them in isolation.

The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them gives an animated view of navigating the real-world obstacles faced while kicking off a clinical trial through the CTA. I am honored to be able to provide the foreword for this endeavor, and I trust you will glean plenty of villain-crushing information from these pages. After all, there are patients out there who are waiting for a superhero to bring them a treatment to improve, extend, or even save their lives.