Generative AI for Protocol Authoring in Life Sciences

Introduction

In clinical trials, well-defined research protocols serve as the cornerstone for ensuring scientific rigor, regulatory compliance, and the safety and efficacy of investigational treatments. These protocols outline every aspect of a clinical study, from objectives and methodologies to participant eligibility and statistical analyses. Given their critical role, the creation of research protocols is a meticulous and time-consuming process. Traditional protocol authoring involves repetitive tasks and extensive collaboration among various stakeholders, which can lead to delays and inconsistencies.

Challenges in Traditional Protocol Authoring: A Few Insights

• Most clinical trials require substantial financial investments, extended timelines, and significant resources. An analysis of randomized clinical trial studies in Switzerland revealed that the average cost to complete a clinical trial is approximately 72,000 USD.
• Approximately two-thirds of clinical trials fail to achieve their primary objectives due to poor design, flawed statistical strategies, unrealistic operational requirements, lack of stakeholder involvement, and regulatory challenges. A well-designed clinical trial protocol can mitigate most of these failure causes.

That being said, the advent of Generative AI in clinical trials presents a groundbreaking solution to these challenges. Gen AI leverages advanced machine learning algorithms to generate text and other content, offering the potential to streamline the protocol authoring process significantly. By automating the generation of standard protocol sections and providing intelligent assistance to researchers, Gen AI in clinical trials can enhance the efficiency, consistency, and innovative capacity of clinical trial design.

How Gen AI Streamlines Protocol Authoring

Automating Standard Protocol Sections

One of the most significant advantages of Gen AI in protocol authoring is its ability to automate the generation of standard protocol sections. These sections include:

• Background: Providing the scientific rationale for the study, summarizing existing research, and justifying the need for the trial.
• Objectives/Goals: Clearly stating the primary and secondary objectives/purpose/goals of the study.
• Methods: Detailing the study design, including participant selection, intervention, and outcome measurement.
• Study Design: Outlining the structure and methodology of the trial.
• Selection and Exclusion of Subjects: Specifying criteria for participant inclusion and exclusion.
• Treatment of Subjects: Describing the interventions and treatments administered to participants.
• Assessment of Efficacy: Detailing how the effectiveness of the intervention will be measured.
• Assessment of Safety: Explaining the methods for monitoring and evaluating participant safety.
• Adverse Events: Reporting procedures for adverse events encountered during the study.
• Statistical Considerations: Describing the statistical methods and analyses planned for the study.
• Quality Control and Assurance: Ensuring the reliability and accuracy of the study data and processes.
• Ethical Consideration: Addressing ethical issues and ensuring compliance with regulatory standards.
• Supporting Documentation: Providing additional materials and references to support the protocol.
• Project/Trials Timeline: Presenting a schedule of key milestones and timelines for the trial.
• References: Citing sources and literature relevant to the study.

Large Language Models (LLMs) and Gen AI can be deployed to extract the trials data from relevant sources and accurately filling the necessary sections of the protocol document thus reducing the manual effort, time and resources spent.

Benefits of Gen AI

Increased Efficiency and Faster Turnaround Times

Gen AI significantly accelerates the protocol authoring process. Tasks that traditionally took weeks or months can now be completed in days or even hours. This speed is particularly crucial in the fast-paced world of life sciences, where timely protocol development can expedite the entire clinical trial timeline, from initiation to completion.

Improved Consistency and Reduced Errors

Manual protocol writing is prone to inconsistencies and errors, especially when multiple authors are involved. Gen AI ensures a high level of consistency across different sections of the protocol by adhering to predefined templates and guidelines. This uniformity enhances the protocol’s quality and facilitates easier review and approval processes.

Exploration of New Trial Designs

Gen AI’s capabilities extend beyond traditional protocol generation. It can assist researchers in exploring innovative trial designs, such as decentralized and virtual trials. These modern approaches to clinical research can improve participant recruitment and retention, reduce costs, and enhance the overall patient experience. Gen AI provides the flexibility to incorporate these novel designs into protocols seamlessly.

Real-World Applications and Examples

Here are several real-world use cases of Generative AI for protocol authoring for clinical trials in the life sciences sector:

1. Oncology Trials

Case: Streamlining Complex Cancer Protocols

Challenge: Oncology trials often involve complex protocols due to the diversity of cancer types, stages, and treatments.

Gen AI Solution: Researchers can input specific parameters such as cancer type, treatment regimens, and patient demographics. Gen AI generates detailed sections on study background, objectives, and methodologies, tailored to the specific oncology study.

Outcome: Significant reduction in the time needed to draft protocols and increased consistency across documents, facilitating quicker regulatory approvals and trial initiation.

Example: Roche uses Gen AI to manage the complexities of cancer trials, ensuring faster and more consistent protocol development.

2. Rare Disease Studies

Case: Accelerating Protocol Development for Rare Diseases

Challenge: Rare disease studies require highly specialized and precise protocols due to limited patient populations and unique disease characteristics.

Gen AI Solution: Gen AI models trained on extensive rare disease data can create comprehensive protocol drafts, including patient eligibility criteria, study endpoints, and   These models incorporate the latest research and regulatory guidelines specific to rare diseases.

Outcome: Faster clinical trial protocol development and improved quality, enabling researchers to initiate studies more rapidly and attract rare disease patients more effectively.

Example: Novartis uses Gen AI to draft detailed protocols that meet the unique requirements of rare disease studies, helping to accelerate the initiation and execution of these critical trials.

3. COVID-19 Vaccine Trials

Case: Rapid Clinical Trial Protocol Authoring During a Pandemic

Challenge: The urgent need for COVID-19 vaccines required rapid development and approval of clinical trial protocols.

Gen AI Solution: Pharmaceutical companies used Gen AI to draft multiple protocols for various phases of vaccine trials. The AI-generated sections on trial design, dosing regimens, and safety monitoring procedures based on real-time data and evolving regulatory requirements.

Outcome: Rapid development of high-quality protocols in clinical trials, leading to expedited regulatory reviews and the launch of critical vaccine trials at an unprecedented pace.

Example: Pfizer and Moderna utilized Gen AI during the COVID-19 pandemic to rapidly develop protocols for their vaccine trials, incorporating real-time data and evolving regulatory guidelines.

4. Decentralized Clinical Trials

Case: Designing Virtual and Remote Trial Protocols

Challenge: Decentralized trials, which include remote patient monitoring and telehealth visits, require novel protocol designs that differ from traditional in-person trials.

Gen AI Solution: Gen AI can create protocols that incorporate virtual trial methodologies, such as remote consent processes, digital health technologies, and patient engagement strategies. The AI ensures all sections align with the decentralized trial model.

Outcome: Streamlined creation of decentralized trial protocols, promoting increased patient participation, reduced dropout rates, and enhanced data quality through continuous remote monitoring.

Example: Johnson & Johnson uses Gen AI to create protocols that include virtual and remote trial methodologies, allowing for increased patient participation and better quality through remote monitoring.

Conclusion

Generative AI represents a transformative tool for protocol authoring in the life sciences sector. By automating the generation of standard protocol sections, improving efficiency and consistency, and enabling innovative trial designs, Gen AI addresses many of the challenges associated with traditional protocol development. While human expertise remains essential, the synergy between researchers and AI can lead to more precise, timely, and effective clinical trials.

As technology continues to evolve, the adoption of Gen AI in protocol authoring is likely to become increasingly widespread. Life sciences organizations that embrace Gen AI will be well-positioned to accelerate clinical research, enhance patient care, and drive the next wave of medical breakthroughs. Researchers and stakeholders are encouraged to explore the potential of Gen AI further, as it holds the key to unlocking new levels of productivity and innovation in clinical trial design.

Partner with Hexaware to unlock the transformation potential of Gen AI in life sciences. Contact marketing@hexaware.com now.