November 30, 2021
The COVID-19 pandemic triggered a sea of challenges, clinicians carrying out research were not spared the brunt. The social distancing and lockdown measures that had been instituted to forestall the pandemic made it difficult to enroll and retain clinical research participants. While high attrition rates have always been a setback for clinical research, with the pandemic, things got even worse.
By the beginning of April 2021, 1773 clinical trials had been listed as suspended on the ClinicalTrials.gov website. Ongoing trials were also experiencing challenges, with researchers citing the pandemic as a major setback.
Decentralized research is serving as a critical tool in enhancing research in this era. Instead of bringing patients to the research site, the research site is transported right to where the patient is. In-person interactions were replaced with remote interactions from 9% to 57% in the first half of 2020. Remote interactions allow researchers to recruit participants remotely and oversee trials from a distance.
With the global consensus that the COVID-19 virus will become endemic, it appears that most of these interventions will remain as permanent fixtures. One survey showed that 98% of patients were satisfied with remote management, while 72% of physicians reported satisfaction with remote patient monitoring.
This has prompted the need to meet patients right where they are. Decentralization of clinical research allows greater participation and retention. This also reduces the researchers’ workload.
Decentralization of research has been made possible by a myriad of technological tools supporting electronic consent management, telehealthcare, remote monitoring of patients, and electronic assessment of clinical outcomes.
Drivers for Decentralized Research
The FDA has approved remote settings for conducting clinical trials whenever this is feasible. This has paved the way for electronic consent and remote source data verification, where a specialized team verifies data remotely at a centralized location. There is also the provision to conduct over-the-phone interviews and allow patients to email responses to the clinicians.
Remote trials coupled with risk-based monitoring enhance the protection of subjects and the integrity of the collected data. At-home monitoring reduces patients’ exposure to risk and thereby enhances their safety. It has also made it possible to revive clinical trial enrollment and participation, which was grinding to a halt due to the pandemic. This has dramatically benefited clinical research.
Clinical researchers can now use integrated technology in smart devices to collect data from study participants. Data is collected through smart wearables that are given to the patients. This data is sent to a central database. Fluctuations and deviations in this data are also noted. Health questionnaires can also be completed on a tablet, and the responses sent to a central database where researchers can review them remotely.
This model improves the communication between clinical researchers and their patients and allows better monitoring. It also saves time and resources by reducing the number of physical trips made to research sites. Lastly, remote monitoring offers convenience to the patient, and this reduces study dropout rates.
Clinical research staff should be adequately trained on remote recruitment and data monitoring to ensure data integrity and the successful completion of clinical trials in a projected time.
Staff should be trained on ICH GCP requirements. The training program should cover role-specific training required for all staff cadres. The training should be inclusive of COVID-19 specific guidelines for conducting clinical research in decentralized settings. The training should be created by industry specialists who are abreast of ICH GCP E6 compliance requirements.
Emerging technologies such as artificial intelligence (AI) and machine learning (ML) can enhance clinical research in the future.
AI offers the following benefits:
Clinical research usually generates a lot of sensitive data that needs to be maintained in the highest security, integrity, and accuracy standards. Digitization can help a lab keep up with all the changes triggered by the COVID-19 pandemic and are here to stay. A clinical laboratory management system, also known as a Clinical Research LIMS, plays a crucial role in managing the data generated from digitizing clinical research.
A clinical laboratory management system can help laboratories overcome the data overload in clinical research and day-to-day challenges that they encounter to maintain the integrity of biospecimens and their related metadata. A LIMS plays a crucial role in managing patient consents and other sensitive data, clinical trial results, maintaining follow up appointments, and flagging results that are out of the normal range. It also ensures compliance with regulatory guidelines such as HIPAA, EU GDPR, and GCP. Integrating a LIMS with EHRs and other electronic data capturing tools will help a laboratory cope with the new trends in clinical research that the COVID-19 pandemic has triggered. A LIMS offers a dashboard for keeping track of the ongoing projects in the laboratory as well as pulling out the data for depicting trends in the ongoing research.
The COVID-19 pandemic has set the stage for major changes in clinical research. Electronic consent recording, remote data collection through smart wearables, online questionnaires, and telephone conversations have helped to decentralize clinical research, and this process has proved to be of infinite worth. The future of clinical research will be based on decentralization, and AI technology will be instrumental in implementing the necessary changes. A Clinical LIMS can help a laboratory keep up with all the changing trends while remaining compliant with the regulatory requirements.