May 5, 2022
According to ACRP, 30% of individuals withdraw from a clinical study prior to completion, and recruiting a replacement costs an average of $19,533. Psychiatry has been poised for disruption for decades, and pharmaceutical companies are looking for solutions to bridge the gap between participant recruitment and drug research and development. This blog highlights a modernized approach to patient recruitment strategies to increase the volume of qualified participants that are more likely to remain active and engaged throughout the duration of the study.
Conducting decentralized clinical trials is by far the most strategic and inventive avenue for pharmaceutical companies to distinguish themselves in a space that struggles with quick and thoughtful recruitment. Traditional clinical trial settings do not allow for convenience and significantly limit the pool of qualified participants simply due to the physical location of the study site, whereas the modern approach allows pharma companies to collect data remotely, from wherever the patients are located.
There are four major obstacles that traditional, in-person clinical studies fail to achieve:
TechCrunch reported nearly 70% of participants live more than 2 hours away from the clinic center, and 80% of clinical trials are canceled because they fail to meet the deadline to enroll patients on time.
In December 2021, Alto Neuroscience and Cerebral announced a first-of-its-kind partnership for a decentralized study in precision psychiatry that will change pharmaceutical trial recruitment forever. Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience said:
“The introduction of this first-ever decentralized clinical trial in precision psychiatry broadens our formerly narrow view of drug discovery and development in mental health, allowing us to quickly deploy effective, accessible treatments in a way not previously possible.”
This study has leveraged Cerebral’s 200,000+ member network to recruit 200 eligible participants to undergo in home-evaluations using EEG, remote assessments at milestones of the study, clinical outcomes (i.e. depression scales), and at-home visits.
Logistically speaking, considerations around the participants’ needs are not at the forefront when traditional clinical trials are designed. Whether it's commuting to the study sites or paying out-of-pocket for expenses, site-based clinical trials burden participants and hinder the possibility of successful recruitment. In other words, patient-centricty could be significantly enhanced beyond the current traditional clinical study design.
As noted by a recent PubMed article aimed to define patient centricity for patients as it related to clinical research studies, patient-centricity was outlined as“'Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family. Important principles for patients focused on education/information, cocreation, access, and transparency.”
Patient engagement is an essential aspect of all healthcare avenues, including the research and development of biopharmaceutical products. Patient-centric clinical trial frameworks are designed with a deep understanding of medical conditions, experiences, needs, and patient priorities (i.e. convenience, compensation, accessibility).
Traditional clinical trial recruitment strategies partner with labs and EHR systems to collect data on patients that could potentially qualify to participate in clinical trials.
Reaching out to patients that meet trial eligibility criteria by using these third-party databases is a step in the right direction, but leaves your team with the responsibility to create and maintain the time-intensive recruitment campaign with quick deadlines, and participants can still be disqualified based on more specific eligibility requirements.
Clinical trial recruitment tools like Cerebral with proprietary EHRs offer an immensely competitive edge to pharmaceutical companies because of the incredibly refined data slicing and reporting capabilities. Cerebral’s structured data aggregated across prescriptions, diagnoses, labs, self-report surveys, medication fill rates, and better enables Cerebral to more rapidly and accurately identify candidates that likely meet trial eligibility criteria.
For example, in the Alto precision psychiatry study, Cerebral searches its patient pool for potential participants who are taking specific antidepressants, yet haven’t seen improvement in their major depressive disorder symptoms. To support further in-depth analysis of whether an individual will be a strong candidate for participation in the trial, Cerebral is able to pull details on individuals’ prescriptions, therapy frequency, comorbidities, and more. Cerebral is able to target individuals who are more likely to meet trial eligibility criteria, enabling individuals who have historically not seen any improvement in their depression systems to try a new approach to treatment, while also enabling Alto to analyze how an individual's distinct biology impacts their response to treatment.
A decentralized clinical trial program will rapidly advance the time to development of novel targeted medicines, specifically within psychiatry, a vertical in healthcare ripe for change and evolution.
By leveraging an existing database of patients and structured patient data, you can recruit quickly by creating a customized list of individuals that meet trial criteria within hours.
Software for recruitment of patients for pharma trials has the capability to tap into proprietary patient databases, to select pre-qualified patients that meet the eligibility parameters of the clinical trial. Utilizing an EHR to identify relevant medical history, diagnoses, etc, allows pharmaceutical companies to target outreach to individuals who might be a good fit for a trial.
Building a digital recruitment campaign comes with its own set of challenges. You have to know what it takes to raise awareness and educate around clinical research, which marketing channels and formats to leverage based on your audience, and how to strategically target audiences to participate in studies.
In Cerebral’s case, our proprietary EHR and data collection capabilities enable powerful internal recruitment by having granular, detailed data about the patient base for pharmaceutical clients. Internal recruitment as one avenue in your marketing strategy leads to much more relevant outreach and ultimately faster recruitment.
Here is an example of a marketing campaign you might launch within your digital recruitment strategy:
You want to target individuals who are currently diagnosed and taking medication for bipolar I or II. Your company is conducting a clinical study for a new bipolar medication that could ease the side effects that these individuals are experiencing. You need to consider what and where individuals are searching for when looking for alternative solutions to the current medication they are taking. Maybe they are using Google and searching “new medication for bipolar I” or “best medication for bipolar disorder”). You launch ads on Google targeting these keywords to drive individuals to the recruitment sign-up page.
This is just one example of what could be part of a comprehensive digital recruitment campaign. Cerebral deeply understands the relationship between a robust data infrastructure and how it can be leveraged to strategically recruit participants.
To learn more about the capabilities and partnership opportunities with pharmaceutical companies, visit our pharmaceutical services page.
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