The FDA is bringing to the table draft recommendations on innovative trial designs and health technologies to be incorporated into clinical trials.
On June 06, 2023, the U.S. Food and Drug Administration (FDA) revealed the presence of a draft guidance that offers updated suggestions for good clinical practices (GCPs). The purpose of these recommendations is to modernize the methods and organization of clinical trials, making them more adaptable while ensuring the preservation of data reliability and the protection of participants.
These updates aim to smooth the path for more effective clinical trials, thereby accelerating the production of medical products. The provisional guidance draws upon the International Council for Harmonisation’s (ICH) latest E6(R3) draft guideline, which was formulated to allow the integration of swiftly evolving technological and methodological advancements into the realm of clinical trials.
The FDA Commissioner Robert M. Califf, M.D. said:
“These draft recommendations propose a major step forward in this work. Building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to truly advance clinical trials and generate meaningful results.”
Why is there a desperate need for innovation?
The COVID-19 pandemic brought to light several primary challenges within the realm of clinical trials. Clinical trials are often seen as expensive and inefficient processes. For new drugs in the United States, the probability of phase two success is less than 50 percent in almost every disease area.
Resources, time, and effort are frequently expended on tasks that may not directly contribute to the study’s success or the safety of its participants. The number of endpoints in a typical phase three protocol has increased over time, making planning and testing more challenging, and this can lead to false conclusions. This inefficiency can lead to higher costs and longer timelines for drug development.
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The lack of adequate collaboration is a significant challenge, leading to duplicated efforts and slowed progress. This could refer to cooperation between different research teams, pharmaceutical companies, regulatory authorities, and even between different countries. There is often insufficient use of technology and data sources in the design and conduct of clinical trials. This can include everything from electronic data capture and remote monitoring technology to real-world data sources like electronic health records.
What does the ICH E6 (R3) add to the previous one?
The recently updated E6(R3) guidelines from the ICH reflect a modernized approach to GCPs for conducting clinical trials. This approach encourages innovation, focuses on quality, and establishes proportionate and risk-based methods for conducting clinical trials, aiming to reduce unnecessary complexities.
The guideline ensures the credibility and integrity of the data generated and the protection of trial subjects. Here are some of the things the latest update brings to the table:
- Focus on the quality of clinical trials. The updated guideline highlights the necessity of incorporating a software system for quality management to guarantee high-quality clinical trials. This involves executing risk management strategies, conducting regular monitoring, and promoting an ongoing culture of improvement.
- Risk-based approach. The guidelines explicitly encourage a proportionate risk-based approach to clinical trial design and execution. This approach is intended to ensure participant safety and data integrity, while also promoting innovation and minimizing unnecessary complexities.
- Patient centricity. The importance of input from patients and healthcare providers in trial design to facilitate trial feasibility and meaningful outcomes is highlighted.
- Electronic systems and data. The guidelines are intended to adapt to technological developments and the increasing use of electronic data sources.
- Enhanced clinical trial design. There is an emphasis on designing quality into a clinical trial and identifying factors critical to trial quality, as well as a focus on avoiding unnecessary complexity in trials.
- Flexibility. The flexible framework for trial conduct is intended to adapt to innovative trial designs and technological developments.
The impact of the revision
The guideline also delivers a comprehensive delineation of the roles and duties attributed to different entities involved in a clinical trial, including the sponsor, investigator, and contract research organization (CRO). It underscores the imperative for effective communication and harmonious collaboration among these parties to ensure the seamless operation of the trial.
The new approach offers stakeholders greater adaptability in tailoring the guidelines to their unique circumstances. Concurrently, the guideline promotes the employment of innovative techniques and technologies aimed at enhancing the efficiency and effectiveness of clinical trials.
Furthermore, the guideline emphasizes the significance of focusing on the participants in clinical trials. It advocates for the consideration of the needs and preferences of trial participants during the design and implementation of trials. This encompasses the provision of clear and thorough information about the trial to participants, guaranteeing their privacy and confidentiality, and reducing their burden.
The FDA recently issued other documents that complement the draft guidance:
In May, the agency released draft guidance focused specifically on decentralized clinical trials, a type of trial design that leverages technological advancements to allow for remote participation. Decentralized trials can reduce the need for participants to travel to specific locations, thereby increasing accessibility and convenience. This type of trial can be particularly beneficial in reaching broader and more diverse patient populations and can potentially accelerate the clinical trial process. The new draft guidance provides recommendations for the implementation of these decentralized trials, offering direction on how to ensure data integrity, participant safety, and trial reliability in this novel context.
In addition, the FDA has issued a specific framework document concerning the use of Digital Health Technologies (DHTs). DHTs, such as wearable devices, mobile applications, and telehealth platforms, are becoming increasingly prevalent in healthcare and clinical research. They can generate a wealth of real-time data on patients’ health status and responses to treatments outside of traditional clinical settings.
The FDA’s DHT framework aims to guide the effective and appropriate use of data derived from these technologies in regulatory decision-making processes for drugs and biological products. By establishing a clear framework for DHT use, the FDA aims to ensure that DHT-derived data is reliable, valid, and useful in assessing the safety and efficacy of medical products. (5)
How does the draft guidance impact your organization?
In the wake of understanding the extensive implications of the draft guidance, it’s time to pivot our attention to how these transformative stipulations can significantly shape the trajectory of your healthcare venture. The ICH E6 (R3) guidelines are an influential determinant for numerous stakeholders in the realm of clinical research. Allow us to offer succinct yet comprehensive elucidations for each party involved:
Pharmaceutical startups and biotech
These companies often conduct clinical trials to test new drugs or therapies. The updated guidelines can offer a clearer path for startups to navigate the complexities of clinical trials. The risk-based approach to trial design and execution could allow for more efficient use of resources, potentially reducing the cost and time required to bring a new drug to market. Emphasis on technology and electronic data sources could also make it easier for startups to integrate new data collection and management tools into their trials, which could improve data quality and trial monitoring.
Contract research organizations
CROs are companies that provide support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. CROs will need to adapt their practices to align with the ICH E6 (R3) guidelines, particularly the emphasis on risk-based approaches and technology use.
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This could lead to CROs developing new services or offerings, such as risk-based monitoring solutions or technological platforms for trial data management. Furthermore, the emphasis on stakeholder engagement might lead CROs to form closer partnerships with their clients and other stakeholders, improving communication and collaboration.
Regulatory authorities
Authorities such as the FDA in the United States or the EMA in Europe will use the ICH E6 (R3) guidelines when reviewing clinical trial data submitted for drug approval. The guidelines can help these agencies ensure that trials are designed and conducted in a way that prioritizes participant safety and data reliability.
Healthcare providers and patients
The updated guidelines encourage the input of healthcare providers and patients into trial design, which could lead to trials that are more feasible and produce more meaningful outcomes. This could benefit providers and patients by leading to the development of new treatments that are more effective or have fewer side effects.
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Overall, the ICH E6 (R3) guidelines aim to modernize the design and conduct of clinical trials in a way that benefits all parties involved. By encouraging innovation and focusing on quality, these guidelines can help to ensure that clinical trials are efficient, effective, and ethical.
Sources:
- https://www.fda.gov/news-events/press-announcements/fda-announces-additional-steps-modernize-clinical-trials
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp
- https://www.fda.gov/media/169090/download
- https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf
