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Technology Being Challenged by Upsurge in Decentralised Clinical Trials

Clinical trials in certain common serious diseases are on track for their first year-over-year increase since the outbreak of the Covid-19 pandemic. Among areas slated for significantly increased testing are diabetes, hypertension and respiratory tract infection. Along with these activities will come a marked increase in decentralised clinical trial design, expected to increase 28% this year over 2021.1 “By joining forces to enable the increased growth of decentralised studies,” says Dr Harsha Rajasimha, founder and CEO of Jeeva Informatics, “technology companies are transforming the face of medical research. The remotely managed, decentralised clinical trial is the wave of the future.”

One reason for this, notes Dr. Rajasimha, is the ongoing lack of diversity among patients participating in traditionally structured clinical trials. Historically, clinical trials have tended to take place in close proximity to major medical research organisations; some 50% of FDA trials are conducted in 1-2% of all US zip codes,2 leading to under-representation of members of racial or ethnic minorities.3 The solution, says Dr Rajasimha, is to allow socio-economically and geographically diverse patients to participate in clinical trials independent of their location via a modular and flexible bring-your-own-device solution.

There has been, he notes, a growing awareness of the need for decentralised clinical trials for some time. A few years back, for example, the National Academies of Sciences convened a forum on transforming clinical trials through technology. Various speakers took note that:

  • The traditional research model requires a massive investment of resources before acquiring any feedback on study viability.
  • New technology such as wearable devices, remote monitoring, and virtual clinical visits could make clinical trials more patient-focused.
  • Social media offer increased opportunities for patient engagement.4

For decentralised clinical trials to work effectively, however, says Dr Rajasimha, it is necessary for the various technologies involved to work together effectively. Companies like Jeeva Informatics are developing the next generation of virtual platform technology that gives sponsors and CROs, greater flexibility with a modular eClinical platform for global trial operations.

Lessons learned

  • Over the course of the Covid-19 pandemic, says Dr Rajasimha, it has become clear in a number of ways that remote access to clinical trials is essential.
  • The pandemic has made many prospective enrollees unable or unwilling to travel to a hospital or other major medical facility to participate in a new drug study.
  • A large percentage of CTs will experience delays, costing the developers as much as $1m per day.5
  • Traditional trials have led to a serious lack of diversity.
  • The accelerated process used for Covid-19 trials has conclusively demonstrated both the need for and the efficacy of decentralised clinical trials.

Technology platforms partnered with a systems integrator, says Dr Rajasimha, can accelerate data collection and provide both better integration of the disparate software and data systems involved and platform-level unification of the entire CT process. What is needed, he says, is the ability to knit patient outcomes—from virtually any device—into an integrated 360o view.

In fact, adds Rajasimha, the last few years have seen an enormous increase in how technology is applied to clinical trials. The use of artificial intelligence technology in matching patients to clinical trials, in diagnostic devices, the proliferation of smartphone use in clinical data-capture, cloud services to store and access to electronic medical records and ‘many more examples have led to one inescapable conclusion: clinical trials can now be conducted entirely in a virtual format’. There are many challenges still to conquer, Rajasimha notes, but eliminating the need for in-person interaction coupled with real-time access to data are encouraging news for the future of clinical trials.

“On one level,” says Dr Rajasimha, “a clinical trial is a one-off project—a test of the response of X subjects to Y treatment. On another level, however, it needs to be a comprehensive digital data collection and processing platform. Being a part of the Amazon Partner Network (APN) and a recent partnership with a global IT systems integrator, enables us to achieve both data collection and process unification, thus delivering dramatic improvements in cost and performance-effectiveness to the sponsors of clinical trials.”

About Jeeva Informatics

The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology in itself is not the limiting factor and that patient-centred design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform.

By digitising and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them more than three times faster. The Virginia-based company’s modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device.

Sources

1: Castañeda, et al. “2022 Forecast: Diabetes, Cardiovascular, Respiratory Trial Activity Set to Rebound.” Clinical Trials Arena, 3 Feb. 2022, clinicaltrialsarena.com/analysis/2022-clinical-trials-diabetes-cardiovascular-disease-among-likely-winners/.
2: “Clinical Trials Have Far Too Little Racial and Ethnic Diversity.” Scientific American, 1 Sept. 2018, scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/.
3: “Why We Need to Improve Diversity in Clinical Trial Participants.” Mdgroup, 18 Dec. 2021, mdgroup.com/blog/why-we-need-to-improve-diversity-amongst-clinical-trial-participants/#:
4: Forum on Neuroscience and Nervous System Disorders. “Transforming Clinical Trials with Technology.” Neuroscience Trials of the Future: Proceedings of a Workshop., U.S. National Library of Medicine, 19 Aug. 2016, ncbi.nlm.nih.gov/books/NBK396107/.
5: “How to Avoid Costly Clinical Research Delays: Blog.” MESM, mesm.com/blog/tips-to-help-you-avoid-costly-clinical-research-delays/.

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