Long roads, artificial intelligence and mobile medical software in clinical research

Obviously, artificial intelligence (AI) and mobile health software (mHealthapp) can improve the participation and efficiency of clinical research. However, the industry's ancient inertia and the analytical tools still to be developed have slowed down the further application of new technologies.

According to a Deloitte research report, artificial intelligence (AI) and mobile health software (mHealthAPP) can accelerate innovation in clinical research by increasing patient engagement and optimizing process efficiency. However, the industry's inertia and data analysis methods have yet to be improved, which has caused the relevant parties to hesitate and linger.

As consumption expectations increased, subjects gradually demanded a more friendly participation experience. However, the report pointed out that the industry's slow adoption of technology has made it difficult to meet even the basic needs of the subjects. For the subjects, the inconvenience of transportation to the center greatly reduced their willingness to participate. According to the analysis, 70% of potential subjects in the United States are more than two hours away from the nearest center. This situation makes the potential participants' willingness to participate no longer strong.

However, virtual trials provide a solution to this problem, enabling participants to participate in research and eliminate the burden of inconvenient transportation in a comfortable home. According to the report, “Virtual clinical trials can streamline the recruitment process for participants through social media, e-licensing, telemedicine , applications and biosensors, enabling direct communication with subjects and supporting passive and proactive data collection.”

In addition, virtual clinical trials continue to attract participants to participate in clinical research by using text messages and smartphone apps to alert subjects to take medication, record their health data, and respond to their questions in real time.

Recruitment methods for traditional clinical trials have failed due to the inability to recruit a diverse representative research population. Virtual clinical trials through social media and artificial intelligence can do this, and this approach can also help sponsors better analyze the therapeutic effects of their research products in different subgroups.

Integrating digital participation and health-related Internet (IT) tools into traditional clinical trial recruitment and management processes may help researchers overcome some of the inefficiencies of current systems. For example, in traditional clinical trials, standard periodic clinical assessments do not always collect data from subjects, and repeated manual and administrative tasks only reduce the productivity of researchers.

According to the report, smartphone sensors, wearables and mobile health software (mHealth APP) can more effectively collect clinical research data from subjects and produce more sensitive measurements, which allows the sponsor to evaluate the efficacy of the product. Short studies, fewer subjects, and less time and money can be verified.

Smartphone apps can also help capture key data points related to the subject, such as a quality of life measurement tool or a specific day-to-day activity that will facilitate their application in the marketplace. .

In addition, tools that are driven by artificial intelligence (AI) methods, machine learning, or natural language processing can automate repetitive tasks, such as drafting standardized contracts or examining missing or inconsistent subject research data.

Although artificial intelligence (AI) and mobile health software (mHealth APP) have a positive potential impact on subjects' participation in clinical research and operational efficiency, many stakeholders remain hesitant to succumb to it.

The report states: "We have found that the industry's application in digitizing its clinical development processes is slow, which is very different from other digital applications in the industry."

“Even the most advanced organizations have only tried several technologies in different areas of clinical development, and these technologies are concentrated on fragmented solutions or new tools that support existing processes.”

All clinical trial sponsors agree with the idea that artificial intelligence (AI) must address its safety and reliability issues before it can be applied to the market. However, some believe that the developer's budget is only enough for pilot innovation. In this case, it would be even more difficult to convince the clinical trial sponsor to use the funds on these unproven artificial intelligence (AI).

The report recommends: “Strict change management can help overcome many organizational and cultural barriers.” Training on how new technologies and processes affect clinical research outcomes and daily life will be part of change management initiatives. ”

Insufficient IT infrastructure and yet-to-be-developed analytical tools are the main reasons for other aspects of artificial intelligence (AI) not being applied.

The report also pointed out that for clinical trials, obtaining external data from electronic medical record (EHR) management systems and genome databases is critical, but it is difficult to obtain. “Academic researchers, researchers, contract research firms (CROs) and sponsors need to share data efficiently with each other. However, due to differences in data privacy rules for subjects in different regions, if you want to use these data outside of clinical trials, Additional consent is required."

To alleviate these problems, the report recommends that stakeholders develop a data infrastructure and management plan to analyze their internal data across multiple studies. At the same time, clinical development leaders should ensure that subject data is available for secondary analysis and to ensure that data sharing protocols are signed between researchers.

The report said that in the future, the use of artificial intelligence (AI) and mobile health software (mHealth APP) will become a necessary condition for the success of the clinical trial industry.

The report concludes: "Digital technology can fundamentally improve the subject experience by integrating valuable insights from multiple data sources, improve clinical trial productivity, and increase the amount and quality of data collected during trials to further Change the way the company develops clinically."

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