Here’s a good-science headscratcher… The lack of racial diversity in clinical trials is well documented, even in trials for diseases that disproportionately affect ethnic minorities. To the extent Caucasians and ethnic minorities respond differently to drugs, this is bad science. But here’s the headscratcher: minorities more often present with comorbidities (e.g. stroke, hypertension, diabetes) that disqualify them from participation. It seems like these are the drug development and regulatory community’s options: (1) mandate greater minority participation into existing study protocols and likely slow down trials and approvals, (2) mandate greater minority participation and loosen exclusion criteria—making scientific conclusions fuzzier because of comorbidities, (3) change nothing and hope minorities aren’t harmed by the underrepresentation. Send your thoughts here. It’s not an easy topic.
For those InsightCity readers who live in the clinical development space, this will be interesting. For everyone else, sorry. The biggest barrier to on-time completion of clinical trials is patient recruitment. Getting enough patients to enroll in and then stay with a trial is quite difficult. PPD, a top-5 private CRO, is thinking outside the box. Typically, in a clinical study, the pharma company or CRO will recruit clinical sites (think doctor’s offices/ hospitals) to participate and then try to recruitment patients. Well, PPD has flipped the script and is trying to find the patients first, then show them where they can go to participate in the trial. PPD’s PatientAdvantage program has shown some impressive improvements against industry norms for recruitment timelines and you know it’s big when Drake weighs in on recruitment (albeit basketball). Sorry Rick Pitino.
While Mr. Watson did answer Alexander Graham Bell’s first telephone call, what we’re talking about here is IBM’s Watson. The Mayo Clinic recently released results from a study whereby Watson “in the 11 months after implementation, there was on average an 80% increase in enrollment to Mayo’s systemic therapy clinical trials for breast cancer.” That’s a huge increase given that ~3-5% of cancer patients participate in clinical trials. There’s also a Mayo Clinic radio (yes, there is such a thing) podcast for your listening enjoyment. For those in the clinical development industry, this could be a substantial step in using technology to increase clinical trial participation rates. DYK that IBM’s Watson is named after their first CEO, industrialist Thomas J. Watson? You do now and you’re now less likely to lose on Jeopardy.
It is estimated that the number of clinical investigators required annually is in the range of 1-7 million! Yes, that’s a wide range but considering there are just over 800,000 practicing physicians in the US, that leaves a big gap. Katherine Vandebelt, global head of clinical innovation for Eli Lilly, thinks the case is clear and wants pharma to stop being the biggest barrier to physicians becoming clinical investigators. She and Lilly are creating a program to tear down institutional barriers that limit participation in clinical trials (i.e., within hospitals). The program also provides hands-on training to investigators new to clinical trials, recognizing that these investigators might not be the highest recruiters on day one. It’s a tough job and more companies have to do it.
How nice would it be for your study coordinator to sit back and receive contact details from people who want to join your trial? Well, now there’s a smartphone app designed to do just that. Peter Elkin, MD, a University at Buffalo researcher, has developed an app that essentially allows patients to self-recruit. Patients can search for trials near them that cover the disease/indication that interests them and with the press of a button, send their contact information to the appropriate study coordinator. If this takes off, not only will patients have the option to actively participate and have access to medical innovations, but the lengthy clinical trial recruitment process has the potential to be significantly reduced.