LIFE SCIENCES AND HEALTHCARE PULSE

Clinical and Regulatory Implications of COVID-19 and Potential Technologies

 
July 2, 2020

Amid the pandemic transmission of COVID-19, every industry vertical is engaged in finding transformative ways of working that are resilient, purpose-driven, and adaptable. The pharmaceutical industry, in particular, is facing additional pressures in ensuring patient safety during clinical trial phases. A set of new and advanced patient-centric approaches that are ethically, scientifically, and clinically relevant and compliant to regulatory requirements have come into the picture. However, the ripple effect of these changes go far and beyond.

Pharmaceutical companies incur huge losses even with a single-day delay to market a drug. And in the current pandemic situation, there are several factors contributing to delayed product launches. Some of the impact areas include:

Clinical trial recruitments and retention: There has been a decline in the rate of clinical trial recruitments and retention.1 While for existing trials, subject attrition seems to be increasing with more withdrawals and discontinuations, for new trials, patient reach-out and management has become a challenge.

Clinical operations: A majority of trials have been stopped and others continue remotely due to safety reasons. Hence, protocol violations and deviations can occur, which means we need necessary protocol amendments and detailed documentation.

Sample management: Logistical challenges have risen in the withdrawal of specimens from patients as per the study schedule and transfer of those samples to local or central laboratories for analysis.

IP supplies: Study drug dispensing with a no-touch mechanism from the site to the patient, while complying to study protocols, has become a challenge.

Data management: Additional complexities in data management are witnessed in:

Capturing, management, and analysis of data for missed visits/discontinuations

Ascertaining safety data based on disease transmission and/or investigational drug

Changes in the documentation and coding manuals such as CRF and ICD with the adoption of flexible study protocols (adaptive designs)

Analysis of data as part of sub-analysis/per-protocol analysis

Patient connect: Patient connect is critical as they are psychologically down with the uncertainties and fear of transmission. The challenge is to engage and keep them informed, compliant, and motivated.

Patient monitoring: Targeted patient monitoring and better remote mechanisms are required throughout the trial.

Reporting: New ways of report and record-keeping are required to ensure data security and integrity.

Industry Preparedness

The pharma industry has already embarked on the journey of remote monitoring and virtual trials. However, a lot has to be done to make these practices a norm. Based on these process changes, regulatory authorities (USFDA, EMA, MHRA) have released new guidelines, such as COVID-19 Risk Emergent Mitigation Strategy (REMS) policy, GxP Inspections, trial design considerations, etc. These will lead to the implementation of new policies, procedures, SOPs, and checklists. The pharma industry is also leveraging emerging technologies in diagnosis, treatment, and prophylaxis of such bio-transmissions, to develop new innovative diagnostic kits, repurpose drug real-world evidence (RWE) and develop vaccines using AR/VR.

In addition, the following disruptive technologies can provide potential solutions to carry out clinical development seamlessly:

Social media and m-health: Social media can be leveraged to advertise the various drug information sites or communities to navigate subjects for enrolment into the trials. Registered subjects will receive notifications and study-specific information on screening securely.

Online collaboration portals and solutions: Subjects can consent through e-ICD forms that can be sent to their registered phone numbers with digital signature features. Further, ethics committees can collaboratively review protocols and other study documents online by leveraging e-IRB platforms with workflows, notifications, etc.

Smart and virtual documentation: In order to mitigate risks and eliminate redundancies in documentation, smart documentation like SCM or XML authoring can be adopted.

IoT, sensors, and wearables:

Automated patient-controlled specimen collection kits: For sample collection, patients can be trained to collect specimens e.g. blood, sputum, etc., with user-friendly remote specimen collection kits, such as Neoteryx.

GPS-enabled drones: GPS-enabled drones with AI-driven temperature-controlled features can be used for pick-up and drop of samples or supplies.

Telemedicine and patient-monitoring devices: Physician consultation through telemedicine and IoT/sensor-enabled medicines, wearables, etc., can help listen, diagnose, treat, and train patients.

Patient-centric tools:

Patient engagement platforms: Patient engagement can be established through these platforms with constant dialogues, trainings, reminders, and notifications/alerts for safety.

Conversational bots/AR/VR: Answering queries of patients instantly with these technologies gives them the confidence to remain motivated and compliant.

ePros: Electronic patient-reported outcomes enable patients to collect and submit their data based on the study schedule in a user-friendly manner.

Blockchain: With decentralization and remote working becoming the norm, data integrity, traceability, and security issues can be resolved by leveraging blockchain technology. Apart from ensuring trust and auditability of the data, blockchain also paves the way for incremental reporting and digital signature features.

Conclusion

Staying resilient and being prepared for such biothreats in the future requires a complete recoding of the clinical studies along with the corresponding regulatory guidelines. This means that pharmaceutical companies will need to get on board this adaptive culture to ramp up their networking, collaboration, data exchange, and cybersecurity capabilities. While this transformation demands time, a new era of virtualization powered by emerging technologies will help accelerate the change for good.

 

1.https://www.outsourcing-pharma.com/Article/2020/05/05/Medidata-shows-COVID-19-impact-on-clinical-trials

 

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Rita Shah is a Clinical Research professional with over 21 years of experience in academic research in the Life Sciences and Pharma domain. She is actively involved in research and development of innovative conceptual solutions leveraging automation technologies. Rita has a PhD in Organic Chemistry from Council of Scientific & Industrial Research (CSIR) and has more than a dozen research publications in peer reviewed journals. She has also worked as a Postdoctoral Fellow and Assistant Research Professor (Molecular Biology) at the Indiana University School of Medicine, USA.