What Is Patient Centricity and What Is It's Role in Clinical Trials?
Within the past few years yet another industry buzzword has emerged, this time it is "patient-centricity". What is patient-centricity? Well it seems to mean putting the patient at the forefront of the healthcare conversation between pharmaceutical sponsors, physicians, and from a clinical research perspective at least, drug researchers. Why does this not sound very innovative you might be asking yourself? Perhaps because every other industry in history has always put their end consumer first, that is after all the true nature of finding and selling to your target market. It seems like we had to wait until the 21st century for the pharmaceutical industry to understand this, or have they?
To keep this article short and sweet I'm just going to focus on the clinical research aspects of patient-centricity, however patient-centricity spans other facets of the healthcare industry affecting stakeholders such as providers, regulators, insurance payers, and advocacy groups (as we've written about before here).
With the emergence and rising popularity of social media, pharmaceutical companies have never had a greater opportunity than they have today to put patients first. There is an entire movement of highly informed and empowered patients, the e-patient movement, who have attempted to take on a greater control over their own health (as we all should). Many of these patient advocates have gained a tremendous amount of influence with other patients in their respective spaces. Pharma companies have recognized this and have attempted to make inroads with some of these patient advocates in hopes of including patients into the healthcare discussions that were usually made about them but not with them. Furthermore, The Internet and social media have allowed for patients to form real world and online support groups where they can discuss their medical conditions, treatments, and alternatives such as clinical trials. The opportunity for Pharma companies to listen to these sometimes public conversations that patients are having with one another exists and some have tapped into this ability. The insights that they gain from understanding the issues from the perspective of the patient, could in theory allow them to adjust study protocols to include the real world patients, which in many cases are excluded from the majority of clinical trials due to very rigid inclusion exclusion criteria.
This leads us to another issue. If Pharma companies say they are patient-centric, at what point do we need to start having their actions prove it? When will real world patients finally be included in studies? Currently the vast majority of studies restrict enrollment to patients who do not necessarily have the most severe forms of the medical conditions being studied. Furthermore, when they do allow patients with the most severe forms of the medical conditions to be studied in certain trials, other exclusion factors kick in such as excluded concomitant medications or other excluded medical conditions the patients may have. This greatly limits the true number of patients that can actually qualify for the studies that are testing the medications that these actual patients will end up using one day should the drug ever get approved. It also increases the cost of clinical trials, and ultimately of the medications once they're approved because of the slow enrollment rates in these clinical studies. The reason for these exclusion criteria are to skew the results in favor of the study drug by limiting certain medical conditions that may exacerbate during the course of a long trial, or side effects from other medications that may adversely impact some of the adverse events being reported in the study. Finally the question of drug efficacy comes in the play. With healthier study patients, the experimental drug is more likely to separate from placebo or from a comparative drug as opposed to a more chronically ill patient. As a general rule the sicker the patient the more difficult it is to prove efficacy of any drug including the study drug.
Finally there is the issue of raising awareness for clinical trials. Probably the lowest hanging fruit is using the patient influencers such as the aforementioned e-patients, to increase awareness about clinical trials to the general population of those medical condition sufferers. We have seen how advocacy groups could potentially become compromised by Pharma companies and run trials that are actually the opposite of being patient centric.
To summarize, if pharma companies truly want to be patient-centric and create better treatments and even possibly cures, they will need to make their clinical trials more inclusive of the patient population that they are aiming to serve. Secondly, they need to raise awareness of clinical trials in order to cut down on the costs associated with having clinical trials that lack adequate patient enrollment as is the case 90% of the time.