I’ve done a handful of videos on why I believe new clinical research investigators should look towards Phase 4 clinical trials to gain the experience typically necessary to begin conducting more studies. Not only are Phase 4 studies a great way for Principal Investigators to get their first taste of clinical research, they are also a great supplemental income for more experienced sites as there are often relatively simple inclusion/exclusion criteria as well as solid financial incentives for them to enroll their patients. We actually did a podcast on this topic here. While these two criteria make phase 4 studies a little interesting to me, the various ways that Pharmaceutical Companies can experiment with outside of the box marketing and lead generation initiatives is even more interesting.
Before we can look into how clinical trial sponsors can utilize phase 4 studies to invest in their long term branding strategy, we need to at least give some mention to some of the more unscrupulous companies out there whom unfortunately also find Phase 4 studies interesting. I do not want to spend too much time dwelling on these examples, in fact we already did a 30 min podcast interview with an expert on this matter. In a nutshell, there are some companies that will run clinical trials under the guise of “research” as a glorified way to bill patients’ insurance plans for unnecessary procedures such as genetic testings and other such assessments. You can find these trials on clinicaltrials.gov they are typically the ones looking for 100,000 patients or more to enroll. There are a handful of people making serious money from these Phase 4 studies and in these cases, they are the study sponsor themselves, not the sites. Listen to the podcast interview above to learn how to differentiate between a legitimate Phase 4 studies (most) and these borderline scams (a small minority).
When it comes to the vast majority of Phase 4 clinical trials, there are 3 reasons for conducting them: gaining additional data at the request of the FDA, gaining some additional data for internal or marketing purposes, and the most recently emerging strategy: building up a patient database to retarget for future studies that the Sponsors may have in their pipelines. All 3 could potentially be lucrative for sites that are both experienced and research naive, however only the latter 2 could provide residual benefits for the Sponsors and promote creative strategy implementation.
The first, FDA mandated Phase 4 studies, are not interesting to me at all as there are no creative initiatives for Sponsors to pursue. Typically the FDA is requesting additional data to collect and the Sponsor begrudgingly obliges. However, when sponsors utilize Phase 4 studies on their own accord, I believe this is where they are able to make a long term investment in the health of their future trials while also engaging with the clinical research investigator community.
Once a drug has reached Phase 4, it has already been approved by the FDA for marketing. At this point, a pharmaceutical sponsor may choose to run a variety of Phase 4 trials to obtain feedback from real world physicians who might be curious about participating in clinical trials and curious about the drug. Furthermore, the sponsor can create a registry study where they encourage investigators to enroll their patients into a database, gather some info on the patient cohort, and simply observe how the patients’ condition progresses over time; all while not making any medication changes to the current treatment the patient is receiving. This accomplishes 2 major things: sponsors can collect data on their competition, and they can build up a database of potential future trial participants for any other studies they may have in their pipeline. It will certainly be interesting to observe and also participate in what I think will be a new Phase 4 clinical trial gold rush over the next couple of years.
