Source: Insightcare
By Harsha Rajasimha, PhD, Founder and CEO, Jeeva Clinical Trials Inc. www.jeevatrials.com
To say that COVID-19 has been a challenge to healthcare systems around the world is a gross understatement. The pandemic has also been very effective at exposing gaps in the U.S. healthcare system. Front-line healthcare workers have been drastically overworked, hospitals ERs and ICUs have been filled to capacity, and innumerable other effects from the pandemic have been felt across the healthcare system. Medical trials, in particular, have experienced serious adverse effects.
As someone focused on accelerating medical trials, the complex processes of developing drugs and devices that are regulated at the international, national, and regional levels, I have seen the fallout first-hand.
The first phase of the pandemic quickly brought most ongoing clinical trials to a grinding halt as clinical trials relied on in-person face-to-face interactions between clinical researchers and patients. Patients were scared to go out of their homes and not to a hospital/clinic as there was significant risk of exposure to COVID-19. The clinical trial industry was caught unprepared to ensure continuity and integrity during the pandemic. Most new clinical trials had to be postponed indefinitely.
In addition, there was a lack of validated tools that could enable flexible remote clinical trial operations. Stitching together numerous a la carte tools on a per-clinical trial basis is not scalable. These gaps were already known to the life science industry but for far too long, there had been in action.
However, platform technology is helping to decentralize clinical trials by bringing them to patients’ homes rather than forcing patients to travel to the trial sites. That’s the paradigm shift we are witnessing in the life science industry:
- “Bring Your Own Device” (BYOD) apps work on any browser-enabled mobile devices.
- Cloud-based centralized real-time data collection is enabling remote patient screening, education, engagement, enrollment, remote electronic informed consent, and retention in clinical trials. The advantages are numerous.
- Telemedicine and video conferencing systems are enabling secure follow-up visits between trial sites and patients, further reducing the travel burden on patients.
- Continuous stream of clinical endpoints is collected from patients using wearable sensors in between episodic visits.
- Patient-reported outcomes are captured directly in electronic formats from questionnaires.
- Medication adherence and concomitant medications are captured in daily electronic diaries.
- Trial sites and patients can communicate with each other throughout the clinical trial via video, audio, SMS, and emails.
Furthermore, the emergence of integrated or a la carte and scalable technology platforms enable flexible options for patients with virtual or in-person participation in each aspect of clinical operations. Centralized monitoring enables trial sponsors, CROs, and sites to manage risks and take corrective action preventive action (CAPA) early on.
Decentralization of clinical trials improve recruitment, diversity, and retention by expanding the reach to patients living far away from the trial sites. This breaks the traditional paradigm where most patients lived within a 50-mile radius of the trial sites. AI-based algorithms operating on electronic medical records (EMRs) are enabling sites to match patients to complex inclusion/exclusion criteria of a clinical trial protocol. By utilizing telemedicine and digital health technologies, prospective patients are being identified via social media channels to refer them to sites.
In extreme cases, clinical studies are being conducted entirely on digital platforms without any face-to-face interactions. This is helping address a long-standing industry problem of lack of diversity in clinical trials. While less than 1% of patients had a chance to access traditional brick-and-mortar clinical trials, more than 82% of Americans and over 60% of the world’s population having Internet access are starting to have the opportunity to participate in clinical research.
It has been generally acknowledged there has been a lack of diversity, equity, and inclusion in clinical trials, particularly since 2014. However, there has never been a regulatory mandate on this matter. Doing what’s right is not always easy when incentives are not favorably aligned. However, with growing public awareness about this issue, we have seen negative impact on the stock performance of biopharmaceutical companies that showed a lack of diversity during the pandemic.
This means healthcare leaders must make this a priority at the board governance level and make strategic organizational upgrades at various levels. This includes hiring and maintaining a diverse workforce, responsible adoption of decentralized clinical trials, and uncompromisingly reinforcing commitments to uphold the moral and ethical principles of diversity, equity, and inclusion. Above all, they are now putting operational excellence as a top priority. Leaders at organizations such as the Association for Clinical Research Professionals (ACRP), Clinical Trials Transformational Initiative (CTTI), the recently formed decentralized clinical trials alliance (DTRA), and others can influence educational curricula, industry standards, best practices, and multinational declarations such as the Declaration of Helsinki and the Belmont Report.
It’s imperative that the C-Suite understands that public trust is hard to gain and easy to lose. There is historical mistrust among minorities with the healthcare systems in general and clinical research in particular. Life science organizations have to make efforts to earn the trust of minorities, women, and underrepresented populations in the geographies they serve.
As we saw with COVID-19, healthcare is a global issue. Clinical trial leaders should make it a priority to include the target populations proportionally in clinical trials as a way to earn back public trust.
As clinical trial leaders, we seek to address patient recruitment, patient retention, and quality of real-time evidence generation while adhering to national and international regulatory guidelines. I strongly believe through overcoming these obstacles, we will go far to accelerate clinical trials and allow all concerned stakeholders to make meaningful contributions to medicine, which is always the ultimate goal.
About Harsha Rajasimha, MS, Ph.D.:
Dr. Rajasimha is the founder and CEO of the decentralized clinical trials software company, Jeeva Clinical Trials Inc., based in Virginia. He is a precision medicine data scientist-turned social entrepreneur on a mission to accelerate human-centric clinical research through technology innovation and global advocacy.
