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[Industry Voice #21] Vaccine Development…
By this point it is widely understood that digital revolution is driving change across the healthcare industry. Beyond simply being important however, the way of managing clinical trials, having met new unfamiliar issues, has also transformed. The key to resolving multifaceted issues such as research sites being on lockdown and unavailability of patients for in-person visits, lies in technology, and Covid-19 might finally be an accelerant needed to help the healthcare industry and clinical development properly embrace new digital approaches.
Decentralized Clinical Trials with Remote Data Collection
With clinical trials participants unable to physically visit research sites, more than ¾ of industry players noted that the pandemic sped their adoption of decentralized clinical trial methods. Leveraging telemedicine and eHealth platforms such as mobile apps and wearable sensors, is a good way to mitigate the effects of the pandemic. Application of such new software tools help monitor patients remotely from their homes, without requiring physical contact, and without risk of further infection. Thus, it makes sense for pharma companies and contract research organizations to continue embracing and investing in existing and new technologies that besides cost-saving potential bring an opportunity to expand patient engagement. According to a recent report, the patient engagement solutions market is expected to reach a compound annual growth rate (CAGR) of 21.4% from 2021 to 2028.
Incentivized Blockchain Adoption
Another point is a little bit more of a prediction than an observation. There is, however, some logic to the idea that COVID-19 will ultimately incentivize more blockchain adoption in the context of clinical trials, as the healthcare industry is flooded with enormous amounts of data (clinical trials, patient medical records, complex billing, medical research and more. Concerning the U.S. healthcare system specifically, a Saint Louis University professor’s take on blockchain technology suggested that it is poised to solve significant problems in general data management. As said professor puts it, healthcare is simply too spread out to rely on accurate data management as is — whereas blockchain tech can keep information logged, orderly, and accessible.
The core principle of this technology is that it is a huge, public, secure and decentralized datastore of ordered records, or events, called blocks, which is hardcoded in the protocol via a complex cryptographic algorithm. As the industry is drowning in enormous amounts of data generated in clinical trials and from patient-physician interactions, blockchain could create a secure tracking system for it. System anonymity allows electronic health record (EHR) data, for instance, to be stored and shared transparently, yet still maintain patient privacy. Thus, all users have a high degree of control, autonomy and trust in its integrity. In sum, such an approach may be a key to building transparent and highly trustable clinical study management, and deserves attention from the whole clinical research community.
As the points above convey though, there are lessons to be learned from the pandemic that can make that practice simpler, more precise, and ultimately more effective. Digital innovations will definitely help to be better prepared and minimize the effects of future pandemics or similar crises on healthcare systems. With the rise of new software tools that make research faster, CRO services cheaper, and more accessible, and with a forward-looking FDA digital health team, it is time for a paradigm shift in clinical trials.