Patient centricity is of importance for clinical trials because it drives the motivation to participate.
Pharmaceutical and Biotech Companies increasingly strive to engage with patients and provide the best patient experience in a way that is sustainable and leads to relevant improvements. Patient centricity plays a large role in achieving this goal by centering a medical treatment or clinical trial around the patient. Patient-centric solutions are based on the patient's needs and take into account the patient's perspective by actively involving the patient into their treatment process.
Patient centricity is of importance for clinical trials because it drives the motivation to participate. Patient enrollment and retention are key factors for successful completion of clinical trials and yet up to 80% of clinical trials struggle with patient enrollment¹ while up to 30% of patients drop out of clinical trials². It is therefore essential to keep the patient's perspective in mind at every stage of the clinical trial.
Although patient centricity has been called the “holy grail” of modern pharma, it is not yet the gold standard for every clinical trial. There are a variety of barriers as to why patient centricity has not been fully put into practice, ranging from downright scepticism about patients input and difficulties in communication with patients, to a reluctance to empower patients. 31% of the clinical trial industry indicated that a lack of resources was the main barrier for patient centricity, while 18% indicated that financial matters were the primary reason³. In addition, for decades people in medical affairs have been trained not to actively engage with patients, and this has proven difficult to change. Meanwhile, investigators tend to consider patients' inputs subjective and not reproducible, and therefore unreliable. Thus, in order to realize patient centricity the mindset of organizations and people needs to change.
There are several means to involve patients and other stakeholders early on in clinical trials. Cross-collaborations between stakeholders are rare but have shown to greatly improve clinical trial performance⁴. Hosting patient groups, trial simulations, surveys and interviews have resulted in over 60 recommendations to enhance the patient experience, for instance by simply making visits shorter⁵. In addition, patients are frequently organized in patient advocacy organizations that give input to industry and academia. These advocacy groups are usually well informed and know the patients they represent, so they can outline how patients should be instructed. For enrollment of trials it is important to keep in mind that patients are usually not “health literate”, in fact it has been shown to be the case for only 12% of Americans⁶. Technology needs to be adapted for utilisation by patients with low health literacy using layperson's language.
Patient centricity can help to increase patient retention. Patients may drop out because of a lack of coordination and information. As a result they may feel overwhelmed by requirements put forward by the investigators. In addition, it is important to follow through after the trial has been finished, as patients tend to feel abandoned. Therefore, communication of milestones and results is important to make clear to patients that their participation contributes to improvement of medical interventions.
To assess the efficacy in clinical trials, electronic patient reported outcomes (ePRO) have been used ever more frequently. Given that patients directly govern the quality of the data it is of the utmost importance to center this form of evaluation around the patient. That is why at PatchAi we have developed Co-PRO: conversational patient reported outcomes. Want to learn more about Co-PRO? Click here.
4. Gregg et al. “A Novel Collaborative Approach to Building Better Clinical Trials: New Insights From a Patient Engagement Workshop to Propel Patient-Centricity Forward.” Therapeutic Innovation & Regulatory Science, vol. 54, no. 3, 2020, pp. 485-491.
5. Lim et a,. “Simulating clinical trial visits yields patient insights into study design and recruitment.” Patient Prefer Adherence, vol. 11, 2017, pp. 1295-1307.
6. “Health Literacy Reports And Publications.” Health Literacy Reports And Publications, 2006, https://www.hhs.gov/surgeongeneral/reports-and-publications/health-literacy/index.html.
Patchai develops intelligent digital health engagement solutions for decentralized clinical studies. The company has received funding under the Smart&Start Italia program. The funding supported the company to develop its clinical research and standard care platforms and to internalize core functions (IT, business development, marketing&sales, medical affairs, clinical operations, human resources). The company will continue to advance the predictive capabilities of the CO-PRO® technology and the IoT integration of its products.