Review Evaluates How AI could Boost the Success of Clinical Trials

Big pharma and other drug developers are grappling with a dilemma: the era of blockbuster drugs is coming to an end. At the same time, adding new drugs to their portfolios is slow and expensive. It takes on average 10-15 years and $1.5-2B to get a new drug to market; approximately half of this time and investment is devoted to clinical trials.

Although AI has not yet had a significant impact on clinical trials, AI-based models are helping trial design, AI-based techniques are being used for patient recruitment, and AI-based monitoring systems aim to boost study adherence and decrease dropout rates.

"AI is not a magic bullet and is very much a work in progress, yet it holds much promise for the future of healthcare and drug development," says lead author and computer scientist Stefan Harrer, a researcher at IBM Research-Australia.

As part of the review and based on their research, Harrer and colleagues reported that AI can potentially boost the success rate of clinical trials by:

  • Efficiently measuring biomarkers that reflect the effectiveness of the drug being tested
  • Identifying and characterizing patient subpopulations best suited for specific drugs. Less than a third of all phase II compounds advance to phase III, and one in three phase III trials fail-not because the drug is ineffective or dangerous, but because the trial lacks enough patients or the right kinds of patients.
  • Start-ups, large corporations, regulatory bodies, and governments are all exploring and driving the use of AI for improving clinical trial design, Harrer says. "What we see at this point are predominantly early-stage, proof-of-concept, and feasibility pilot studies demonstrating the high potential of numerous AI techniques for improving the performance of clinical trials," Harrer says.

The authors also identify several areas showing the most real-world promise of AI for patients. For example:

  • AI-enabled systems might allow patients more access to and control over their personal data.
  • Coaching via AI-based apps could occur before and during trials.
  • AI could monitor individual patients' adherence to protocols continuously in real time.
  • AI techniques could help guide patients to trials of which they may not have been aware
  • In particular, Harrer says, the use of AI in precision-medicine approaches, such as applying technology to advance how efficiently and accurately professionals can diagnose, treat and manage neurological diseases, is promising. "AI can have a profound impact on improving patient monitoring before and during neurological trials," he says.

The review also evaluated the potential implications for pharma, which included:

  • Computer vision algorithms that could potentially pinpoint relevant patient populations through a range of inputs from handwritten forms to digital medical imagery.
  • Applications of AI analysis to failed clinical trial data to uncover insights for future trial design.
  • The use of AI capabilities such as Machine Learning (ML), Deep Learning (DL), and Natural Language Processing (NLP) for correlating large and diverse data sets such as electronic health records, medical literature, and trial databases to help pharma improve trial design, patient-trial matching, and recruiting, as well as for monitoring patients during trials.

The authors also identified several important takeaways for researchers:

  • "Health AI" is a growing field connecting medicine, pharma, data science and engineering.
  • The next generation of health-related AI experts will need a broad array of knowledge in analytics, algorithm coding and technology integration.
  • Ongoing work is needed to assess data privacy, security and accessibility, as well as the ethics of applying AI techniques to sensitive medical information.

Because AI methods have only begun to be applied to clinical trials in the past 5 to 8 years, it will most likely be another several years in a typical 10- to 15-year drug-development cycle before AI's impact can be accurately assessed.

In the meantime, rigorous research and development is necessary to ensure the viability of these innovations, Harrer says. "Major further work is necessary before the AI demonstrated in pilot studies can be integrated in clinical trial design," he says. "Any breach of research protocol or premature setting of unreasonable expectations may lead to an undermining of trust-and ultimately the success-of AI in the clinical sector."

Stefan Harrer, Pratik Shah, Bhavna Antony, Jianying Hu.
Artificial Intelligence for Clinical Trial Design.
Trends in Pharmacological Sciences, July 17, 2019. doi: 10.1016/j.tips.2019.05.005.

Most Popular Now

Unlocking the 10 Year Health Plan

The government's plan for the NHS is a huge document. Jane Stephenson, chief executive of SPARK TSL, argues the key to unlocking its digital ambitions is to consider what it...

Alcidion Grows Top Talent in the UK, wit…

Alcidion has today announced the addition of three new appointments to their UK-based team, with one internal promotion and two external recruits. Dr Paul Deffley has been announced as the...

AI can Find Cancer Pathologists Miss

Men assessed as healthy after a pathologist analyses their tissue sample may still have an early form of prostate cancer. Using AI, researchers at Uppsala University have been able to...

New Training Year Starts at Siemens Heal…

In September, 197 school graduates will start their vocational training or dual studies in Germany at Siemens Healthineers. 117 apprentices and 80 dual students will begin their careers at Siemens...

AI, Full Automation could Expand Artific…

Automated insulin delivery (AID) systems such as the UVA Health-developed artificial pancreas could help more type 1 diabetes patients if the devices become fully automated, according to a new review...

How AI could Speed the Development of RN…

Using artificial intelligence (AI), MIT researchers have come up with a new way to design nanoparticles that can more efficiently deliver RNA vaccines and other types of RNA therapies. After training...

MIT Researchers Use Generative AI to Des…

With help from artificial intelligence, MIT researchers have designed novel antibiotics that can combat two hard-to-treat infections: drug-resistant Neisseria gonorrhoeae and multi-drug-resistant Staphylococcus aureus (MRSA). Using generative AI algorithms, the research...

AI Hybrid Strategy Improves Mammogram In…

A hybrid reading strategy for screening mammography, developed by Dutch researchers and deployed retrospectively to more than 40,000 exams, reduced radiologist workload by 38% without changing recall or cancer detection...

Penn Developed AI Tools and Datasets Hel…

Doctors treating kidney disease have long depended on trial-and-error to find the best therapies for individual patients. Now, new artificial intelligence (AI) tools developed by researchers in the Perelman School...

Are You Eligible for a Clinical Trial? C…

A new study in the academic journal Machine Learning: Health discovers that ChatGPT can accelerate patient screening for clinical trials, showing promise in reducing delays and improving trial success rates. Researchers...

Global Study Reveals How Patients View M…

How physicians feel about artificial intelligence (AI) in medicine has been studied many times. But what do patients think? A team led by researchers at the Technical University of Munich...

New AI Tool Addresses Accuracy and Fairn…

A team of researchers at the Icahn School of Medicine at Mount Sinai has developed a new method to identify and reduce biases in datasets used to train machine-learning algorithms...