The study investigator- participant relationship may have changed due to COVID-19, forever, in more ways than one. There has been a conscious move towards virtual clinical trials, with remote monitoring and virtual trial participation becoming the norm. The subsequent acceleration in digital solutions has aided us in operating at a pace that may have been unimaginable before.
Multiple remote monitoring practices were put in place to run virtual clinical trials. Electronic data capture has been shown to reduce pre-screening time by 41%, reducing the need for research, increasing data accuracy, and reducing data collection time.
Though COVID-19 vaccines are slowly making their way into the market, there is still a long way to go before the pandemic ends and it ceases to be a global threat. There is still time before herd immunity is reached, which means that virtual clinical trials are the need of the hour.
Reimagining possibilities for greater efficiency
At Navitas Life Sciences, we have been investing in advancements in digital solutions, remaining focused and curious about evolving in an ongoing way.
The changes that were brought in by the pandemic need to be hardwired so they can help build better solutions for the future. Technological advancements are a lifelong learning process, and they could become obsolete if they are not routinely updated.
New Complications among familiar challenges
Drug development and the conduct of clinical trials have always had their share of challenges that experience and expertise aid in resolving. In the wake of the pandemic, a dramatic shift towards virtual clinical trials intensified certain challenges while also adding new ones.
Effective management of clinical trials includes addressing challenges and preparing for them pre-emptively. The risky launch environment of virtual clinical trials has been compounded by the uncertainty of the pandemic, with decentralized clinical trials bringing in certain operational challenges.
Remote Data Management Needs
Virtual clinical trials and remote monitoring measures result in the need for virtual data collection and management. According to a McKinsey report, the clinical trial industry has moved 5 years forward in terms of digital transformation over the past few months. Navitas Life Sciences has been investing in digital advancements and operational measures, that have helped in delivering virtually.
5 Ways Navitas Life Sciences Overcame Data Collection Challenges in Virtual Clinical Trials
Digital transformation is made possible by leveraging advancements in digital technology but, to sustain this transformative change, there is a need for enhanced support systems.
1. Technological capability: Investments in the right tools prior to the pandemic aided the use of digital tools to capture health data virtually. The use of this technology has required retraining and re-skilling staff and investigators about using the technology right, aiding in addressing gaps. Moreover, experts have helped in utilizing the existing technology in innovating essential patient communications as the pandemic progresses, with iterations and changes instituted across the virtual clinical trial.
2. Flexibility: Virtual data capture requires the flexibility to support the various data formats and the extensive data collected. There is a need to
- Include word limits to restrict human error during entry
- Ensure seamless integration across various platforms, including smartphones.
- Provide the necessary training for use
- Take proactive steps to ensure ease of set up
Extensive training and support extended to staff, and to study participants, has helped in ease of use of e-consent forms and health record submissions. Our use of technology has been purpose driven, with value for everyone involved.
3. Staying Patient Friendly: Study participant centric approach is needed to ensure that innovations augment benefits. The data collection tools were not seen as a tool to enter health records but as a platform for managing patient wellness during the course of the study.
As the COVID-19 pandemic continues, our customer centric approach to data collection has provided us with an opportunity to better serve our study participants.
4. Scalability and data literacy: Virtual data driven interactions between study participants and the investigators, across multiple sites, patients and trials require effective data literacy and scalability. The systems in place should withstand the heightened workload. Moreover, centralized data storage and analysis are key to fully utilizing the virtual data collection methods.
The use of Artificial intelligence and machine learning tools to enhance data analysis aid in intelligent clinical trial solutions.
5. Compliance and Data Security: The International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines has resulted in increasing the scale and the complexity of clinical trials. The E6 R2 addendum came into effect on 14 June 2017, with these measures brought in to improve trial oversight, conduct, and design while aiding in data integrity and study participant protection.
Navitas Life Sciences has been working towards improved clinical trial efficiency, and virtual data collection is an important measure that could help with risk-based monitoring (RBM). Our risk-based monitoring system is structured to identify and mitigate risks from the data collected, for improved decision making. Such risk-based monitoring is enabled with virtual data capture, with better safety and quality of clinical studies.
The data from study participants is collected, stored and analyzed ensuring compliance, data privacy and data security.
As an organization, Navitas Life Sciences has been agile in its approach to leveraging technology in developing intelligent and efficiently run clinical trials. We have nurtured a resilient ecosystem, and by capitalizing on existing technology and data platforms, our clinical trials have endured the uncertainty of the pandemic, stepping into the future with strength, wisdom and experience.