Traditional clinical trials take about 10-15 years to develop a drug and introduce it to the market. The entire process, from choosing the correct patient group to screening their clinical data to obtaining approvals, involves a fair amount of human interference.
Pharmaceutical companies are witnessing a surge in the implementation of AI for their drug testing and patient trials. AI-based technology is used to recruit patients for clinical trials by preventing unnecessary screening.
The eligibility criteria are fed into an AI-based system to scan the hospital database and generate a list of potential patients. It also allows the system to contact eligible patients directly.
Another major implementation of AI in clinical trials is data analysis. Machine Learning algorithms are employed to identify trends and data patterns used in decision-making. It can be combined with AI to conduct predictive analysis and monitor patient safety during trials.
AI further enhances patient safety by collecting data from wearable health devices. It can also be used to develop prediction-based models to determine which patients are more likely to benefit from a particular treatment.
Using AI in clinical trials has excellent potential. However, it comes with its own set of challenges. Some of those challenges include data privacy and compliance.
Challenges Posed by AI in Clinical Trials
Artificial Intelligence is likely to transform how clinical trials are conducted. Collaboration between AI, ML, and Data Analytics can help researchers detect candidates, optimize trials, and boost the drug development process.
That being said, several issues arise with AI, which must be fixed to utilize its fullest potential.
1. Data Quality
One of the pressing issues faced by AI in clinical trials is that of data quality. The data used in clinical trials is inconsistent and heterogeneous. Such data gives biased results when used in AI-based algorithms.
To prevent this issue, researchers must ensure that the AI model’s data is accurate, complete, and error-free. This can be done by employing a practical approach to data collection.
2. Ethical Considerations
Another issue that arises is that of ethical considerations. Using AI algorithms in clinical trials causes security concerns such as data privacy and informed consent.
For instance, AI algorithms that are being used to identify clinical trial patients can end up excluding specific populations, causing a bias in the study. Researchers must use AI in clinical trials transparently and ethically with clear data privacy guidelines to curb that.
Secondly, there is also the issue of transparency of AI algorithms used for clinical trials. Because AI algorithms are complex and harder to interpret, validating their results or detecting errors can be challenging for researchers.
To resolve this issue, researchers need to ensure that the AI algorithms used in clinical trials are transparent and clearly documented in accordance with all the procedures.
3. Retrospective Data
The existing clinical practice studies include a large number of patients. Most of these studies use historical data to test algorithms. This means that real-world patient data differs from retrospective data being utilized, which poses a challenge in AI adoption.
4. Data Bias
AI algorithms work based on the data they are trained to interpret. That means if the data fed into the AI algorithm is biased, then the predictions given by the AI would be biased too.
This creates an issue during clinical trials because data that is biased based on factors like race, gender, socio-economic status, or any other similar data may affect the results.
5. Data Interpretability
Data collected by AI algorithms is debatable. It is difficult to understand how AI algorithms arrive at their predictions. This creates a difficulty for researchers when it comes to interpreting the trial results and understanding how the AI-backed algorithm arrived at a specific conclusion.
6. Data Regulation
The adoption of AI in clinical trials is comparatively new and continuously tested. This creates uncertainty for researchers who need help with how to comply with specific regulations or obtain approval for AI-powered clinical trials.
7. Integration of AI With Existing Systems
It can be challenging to incorporate AI into the existing clinical trial management systems. Especially if the system was designed in a manner without taking AI into consideration. To successfully adopt AI in a part of a clinical trial, it is imperative to ensure seamless integration.
8. AI Has Technical Limitations
AI can improve the efficiency and accuracy of clinical trials. But it also has some technical limitations. Some algorithms may require special hardware or be resource intensive. This may affect its scalability.
The Future of AI in Clinical Trials
AI has a promising future in clinical trials. AI can change the drug trial and development process through constant research and development. It can also improve patient enrollment and offer newer insights.
a. AI Can Predict Trial Failure
AI-based devices can analyze data from multiple sources, such as patient records, laboratory test results, and data from previous trials, to predict a failure in clinical trials.
It identifies patterns and data that led to the trial failure so that researchers can make informed decisions to improve their accuracy and efficiency. This accelerates the development of newer treatments and reduces costs incurred due to trial failure.
b. AI Can Predict Trial Success
Just like in the case of trial failure, AI can analyze data such as patient demographics, medical history, and data on treatment to predict the likelihood of failure of a clinical trial. It can also interpret factors that contribute to the success of the trials so that the researchers can design effective trials and allocate resources aimed toward improved patient outcomes.
c. AI Can Predict Delay in Trial
AI can review data on patient registration, safety standards and protocols, and regulatory compliance to assess the likelihood of delay in clinical trials. AI-based algorithms can process and analyze factors likely to contribute to a delay in trials.
It also helps trial managers obtain actionable insights to minimize risks and prevent trial delays.
d. AI Can Predict Termination of Trials
AI algorithms can predict whether a clinical trial will fail to meet its endpoints. It can predict the likelihood of termination of a clinical trial.
Using Machine Learning algorithms, AI can discover factors likely to contribute to the termination of a clinical trial. It does so by analyzing factors such as trial design, patient data, patient demographic, treatment protocol, and adverse treatment conditions to determine the chances of success or failure of a trial.
Data collected from electronic health records, wearable devices, and other similar sources significantly boost AI adoption in healthcare. AI-based algorithms analyze this data to produce insights into the patient population and optimal trial designs and to predict outcomes.
AI-backed automation tools can improve the accuracy and efficiency of clinical trial management by automating routine tasks such as data entry and analytics so that researchers and trial managers can focus on strategic tasks like designing trials.
It also allows participants to participate easily in research studies, reducing recruitment costs and improving communication between research teams and external stakeholders.
As there is an increase in data availability and access, it becomes easier for AI to generate insights on trial designs and predict outcomes.
These factors significantly impact AI adoption in clinical trials over the next few years and will lead to more efficient, effective, and accurate clinical trials.