As we move into the future of clinical trials, artificial intelligence (AI) is playing a more integral role than ever. AI enables more accurate analyses of data points, faster results that can provide improved accuracy compared to older methods, and technology-driven improvements in identifying patterns within large datasets. In this 7-part series, we will explore how AI is revolutionizing the world of clinical research, from virtual trial design to patient recruitment and safety monitoring during trials through to post-marketing assessments for drug development teams. Alongside this information-rich series of blog posts – readers will gain all the necessary knowledge about AI’s impact on clinical trials that they need to be informed decision makers.

Part #1: Revolutionizing Clinical Trials: How AI is Streamlining the Drug Development Process
Part #2: How AI Can Improve Data Collection And Analysis In Clinical Trials

The Ethical and Regulatory Considerations Surrounding the Use of AI in Clinical Trials

Artificial intelligence (AI) is rapidly becoming a powerful tool in clinical trials. It allows researchers to automate tedious tasks and analyze data more accurately and efficiently than ever before. However, as with any new technology, there are ethical and regulatory considerations that must be taken into account when using AI in clinical trials. Let’s take a look at some of the key issues.

Data Privacy

Data privacy is an important ethical consideration for any clinical trial. In the case of AI-based clinical trials, patient data must remain secure throughout the entire process. This includes protecting it from unauthorized access, manipulation, or disclosure. To ensure this, researchers should take measures such as encrypting data stored on computers and networks and using strong authentication methods to protect access to sensitive information.


In addition to ethical considerations, there are also regulatory concerns surrounding the use of AI in clinical trials. For example, regulatory bodies may require additional documentation or evidence that an AI-based system works as intended before approving its use in a trial. Similarly, researchers may need permission from regulatory bodies or other authorities before they can use AI-based systems in their trials. This could include obtaining approval from government agencies or obtaining consent from individuals whose data will be used by the system.

Bias and Unintended Consequences

When using AI-based systems in clinical trials, it’s important to consider potential sources of bias that may lead to inaccurate results or unintended consequences. For example, if a system is trained on biased data sets—such as those containing racial or gender biases—it could lead to inaccurate results or decisions based on these biases rather than actual medical evidence. Therefore, researchers should make sure that their AI-based systems are trained on unbiased data sets and tested for accuracy before being used in a trial.


In summary, the ethical and regulatory considerations surrounding the use of artificial intelligence (AI) in clinical trials are complex but necessary for ensuring that research is conducted ethically and legally. Data privacy must be maintained throughout the process; regulations may need to be followed; and potential sources of bias must be identified and addressed before an AI-based system can be used in a trial safely and effectively. By taking these considerations seriously, researchers can ensure that they produce accurate results while still adhering to ethical standards and legal requirements related to their work.


Communications automation is the future of clinical trials, happening now. Use Mosio mobile messaging software to improve engagement, adherence, and data collection in your clinical trials, available on every mobile device. Get a quote for any current or upcoming studies you have or contact us for a demo.

Note: The titles, content and artwork for the articles in this series were all created by AI.