Clinical Research industry was moving with its pace until recently when COVID-19 suddenly caused major disruptions to clinical trials operations. The disruptions forced the industry to find ways to design and run clinical trials more efficiently so that the disruptions could be minimized.
As per the data available on clinicaltrials.gov, there is a big drop in the number of clinical trials that were started in the current year when compared with the same period in the last year. The main reason for the inability to start a clinical trial is the restrictions posed by COVID-19. The patients or study participants are not able to visit the study sites. Disruptions in the business for a longer period of time is unsustainable. So, the industry is engaged in finding alternative ways to continue clinical trials.
Virtual Trial (e-Trial) eliminates the need for the patient to visit the study site or hospital physically. Instead, methods used in telemedicine such as phone and virtual conferences are being used to communicate with the patient. Digital medical and health devices are being given to the patients to record their health outcomes. The mobile apps record the data and send it over to the study sites. The study drug is being sent over to the patients through special courier services. Laboratories are providing mobile services to visit patients’ homes to do collect samples or do the lab work. The industry is also revisiting the clinical trial design and eliminate the unnecessary procedures that will reduce the number of visits a patient will have to make to the study site.
This does not necessarily mean that virtual trials are going to replace or eliminate the traditional trials completely. There are many clinical trials that simply cannot be executed virtually. However, there are certain aspects of clinical trials where virtual technology can be used or the equipment can be made available at a patient’s home or at a more convenient location or to consult a patient virtually. There are more chances of the industry using such a hybrid type approach. It may not be too optimistic to predict the majority of trials being conducted virtually in the near future. We have enough examples of technology disrupting businesses and making them obsolete. The biggest example is the retail industry where technology eliminated many brick and mortar businesses.
These transformations in the industry are creating new business opportunities. Virtual technology eliminates certain businesses but then it opens door to some new types of businesses. The early adopters will reap the maximum benefit from the shift, however, they will also carry the maximum risk of failure.
The virtual trials will require more integration of mobile and wearable technologies. It will require new types of software systems and applications. These applications would be required to help patients configure their medical devices and communicate with their physicians about their health. The applications are required to be integrated with existing traditional applications. This would require data to be shared across these systems creating a web of complex systems.
The health and IoT devices would generate large amounts of streaming data in different formats including pictures, video, and audio files. Most of the clinical trials businesses do not have the necessary infrastructure to process this kind of data. Storing and processing this kind of data requires different kinds of systems and processes. Owning these new systems requires a lot of investment in the form of upfront license and support services. Many small and mid-size clinical trial companies may opt for subscribing to cloud-based platforms. Therefore, there would be a demand for such platforms that allow companies to get up and running to start with a virtual trial in a few hours.
The methods companies are using to analyze the clinical data today, will also change. The streaming data would open doors for analyzing the data through a different kind of technology and mindset. The data warehouse and data marts need to be designed differently. The data volumes would require to make changes in the data archiving strategy to keep the cost under control. There will create a demand for data and analytics companies that can provide specialized advisory and implementation services to the clinical trial companies. There would be a demand for pre-built solutions that companies can start using with minimal customizations. The data would open doors for building advanced Artificial Intelligence and Machine Learning based analytical solutions.
The streaming data would allow more real-time based monitoring of patient health. The outliers in the data that could be due to an abnormal condition or an adverse event would require the physicians to be notified as soon as the alerts are triggered. There would be a sense of urgency to act to avoid any delays that could pose a risk to the patient life. This creates a need for a centralized support center that would monitor the data in real-time, and coordinates between patients and physicians. Companies specializing in operating such support centers would benefit greatly by providing services to sponsors and CROs.
Virtual Trials also creates business opportunities for specialized medical couriers, mobile clinics, mobile labs. These businesses would require specialized knowledge about handling and operational procedures used in life-sciences. Mobile medical couriers will have specialized temperature-controlled containers to carry the research drug to the patient’s home. The mobile clinics would be equipped with various health measurement and monitoring devices. It may not be uncommon for nurses and physicians to consult patients inside the mobile van.
It remains to be seen how quickly the clinical research industry adopts the changes and transforms itself. The leaders would take the leap through partnerships and acquisitions. Early adopters would establish themselves as industry leaders. The startups that will come up with innovative and useful solutions can greatly help in accelerating the pace of technology adoption.
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