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Has Digital Clinical Trials Passed the Test?

Like those conducted by companies such as Clinical Ink, clinical trials are an essential technique for determining the efficacy and safety of novel medications, medical devices, and other healthcare interventions. In addition, traditional clinical trials serve as a quality funnel for the development and deployment of new medicines, equipment, and healthcare initiatives.

Clinical trials are the primary means of evaluating projected breakthroughs in health and healthcare and comparing different approaches to prevention, diagnosis, and treatment. Therefore, the environment of trials should be compatible with clinical practice. Participants should represent the people who would utilize the novel medicines or delivery modalities. Unfortunately, the existing clinical research infrastructure is changing slowly, resulting in clinical trials that are both logistically and financially demanding.

The idea behind a "digital clinical trial" is to use digital technology to improve participant access, engagement, trial-related metrics, and interventions. This allows for hidden randomized intervention allocation, which has the potential to change and reduce the cost of clinical trials.

Several National Institutes of Health are interested in reducing clinical trial costs and efforts while moving closer to a patient-centered trial experience by utilizing digital technology. Trialists are urged to carefully use digital technology and other pragmatic aspects that disrupt and produce efficiency while maintaining the randomized clinical trials enterprise's strength.

There is a great opportunity to employ digital technology to accelerate the creation of evidence in clinical trials. Digital technology can improve trial efficiency by strengthening and complementing the function of investigators and study teams. Many studies can be done without in-person visits, and study participants may never see their research personnel. On the other hand, trials involving significant illnesses, extensive procedures such as advanced imaging and biopsies, and therapies having high risk will demand close monitoring and oversight by expert doctors and investigators.

Over the last decade, digital technologies have changed practically every area of our lives, including how we interact, purchase, and read. Despite a reputation for over-promising and under-delivering, digital health technologies have the potential to revolutionize clinical trials provided they are backed by sound investment and regulatory support.

However, this cannot be accomplished by simply reproducing present research techniques and converting them to digital form. Instead, a thorough re-engineering of the clinical trial experience centered on the participant rather than the research facility is required. While some trials could be conducted wholly online in a virtual environment, the majority will require a combination of online and clinical site-based activity.

To handle and make sense of the massive amounts of data that these revolutionary tools may collect, another digital technology will be used extensively: artificial intelligence. When used in conjunction with established biostatistical methods, AI will effectively address the problematic issues of missing data and artifacts, which raise difficulties in interpreting digital data.

There are significant but unquestionably solvable obstacles. Digital technologies' pervasiveness and depth of easily obtained information, making them appealing for use in health research, also make the data they generate helpful to commercial companies and malicious individuals. In addition, the frequent news of significant data breaches, or instances of hidden app trackers exchanging personal data without the user's knowledge, exacerbates researchers' and participants' security and privacy worries.

So, what are the requirements for overcoming current obstacles and driving innovation using digital technologies? First, as previously stated, it is vital to define standards and procedures that guarantee transparency and protection of participant data. The next step is to create incentives for clinical trials that need to discover novel solutions to current challenges in health research.

Both patients and professionals agree that more significant and faster evidence is required to make decisions. While market forces have disrupted many other industries, the clinical research community, funding agencies, and regulators will need to collaborate to stimulate methodological innovation and establish a digital clinical trial economy.

In comparison to today's clinical trial research teams, the clinical trial research team of the future will be different. Computer scientists and engineers will be integral members of research teams for technology creation and data collecting, analysis, security, and privacy. These new teams will also have more technology and data science understanding among everyone participating in conducting trials, so they can speak the same language as their technical counterparts and ask the right questions.

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