First, many studies present a very narrow set of eligibility criteria to bring in the most ideal group of participants. However, if studies were geared more towards a broader set of real people, the trial data would become more representative of the target product population, who in the end won’t be excluded from a prescription because of a high BMI anyway.
Brad brought up another issue regarding protocol expectations. Often, the full protocol may not even be provided until after both parties are already deeply invested in start-up, which hurts sponsors if the site then struggles to deliver on its initial promises. Of course, sites will also suffer if they budgeted based on a protocol that appeared to have fewer procedures, with the reality being that they will simply stop conducting a study that loses money.
No protocol is perfect, of course, but having one cohesive workflow that consolidates the most essential central and vendor processes would streamline trial conduct considerably. This would then improve study recruitment, as sites always actively recruit studies that are simply easier to navigate.
Many companies also forget to account for variability amongst site preferences when they do not allow for flexibility within the conduct of their study. Presenting a well-developed, useful integrated workflow to sites as one possible option can go a long way in making the necessary support required to succeed more accessible to those who need it.
Despite these challenges, Brad affirms that he still loves his work because of the visceral effect of seeing these research programs change the lives of people who have been in pain for a long time. Moreover, it provides opportunities to improve inefficiency in clinical trial practices. Aside from his successes at Hightower Clinical, Brad is also active on LinkedIn, produces content on notetofilepodcast.com, and has a web forum for increased site-level transparency on clinicaltrialconfidential.com.