Work hard to avoid protocol amendments as they consume a great deal more resource than one imagines in staff time to prepare, review and implement them. Some vendors have systems to minimize the numbers of amendments a company will need, by subjecting protocols to multiple internal checks of consistency, and comparisons with other protocols that have been conducted.
The number of patients available to join a trial drops by about 90% the day a trial begins. This is referred to as “Lasagna’s Law” and is mitigated by using only inclusion criteria that are truly required and by reviewing potential enrollees prior to choosing the site investigators.
Locate world class experts through professional associations, trade associations, local experts who can tell you the world’s top people in his area, FDA reviewing divisions, FDA Advisory Committee members, other companies in the therapeutic area, and/or literature citations of those quoted most often.
Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).
