Continuous Trials

Extracted Attributes

• Economic Goal

  Lowering drug prices by reducing development costs and increasing competition

• Key Proponent

  Marty Makary (FDA Commissioner)

• Primary Objective

  Accelerate drug approval process and shorten clinical trial timelines

• Pivotal Trial Reform

  Reduction of required pivotal trials from 2 to 1

• Post-Market Strategy

  AI-enhanced post-market surveillance

• Statistical Methodology

  Bayesian Statistics for real-time data analysis

• Monitoring Infrastructure

  Cloud-based endpoints for real-time regulatory oversight

• Technological Substitutes

  Computational modeling and organ-on-a-chip technology to replace animal studies

Timeline

• FDA Commissioner Marty Makary discusses the 'Continuous Trials' model and the need to cut 'idle time' at the Galien Forum in New York City. (Source: Web Search: Makary Talks Faster Drug Reviews)

  2025-10-30

• Industry analysis identifies continuous trials as a top trend for 2026, noting they require a total rethink of the traditional phased research structure. (Source: Web Search: Trends for 2026)

  2026-01-01

Clinical trial

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results. Costs for clinical trials can range into the billions of dollars per approved drug, and the complete trial process to approval may require 7–15 years. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical-device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. Only 10 percent of all drugs started in human clinical trials become approved drugs.

Web Search Results

• Trends for 2026: Targeted AI, continuous trials, and uncertainty

  Continuous trials require changes across clinical decision making, trial execution (including at the sites, with patients, and with clinicians), as well as in how protocols are written and data monitored. Other considerations include how sites are chosen, the ways participants engage, how to manage consent for trials, and the research structure. [...] The intention is to get products to the market more quickly. Instead of conducting clinical trials in phases to obtain regulatory approval for a product, trial participants would receive the treatments over a longer period and have their health closely monitored – potentially over decades. Wearables could play a key role within this, with the US Health and Human Services Secretary stating a long-term goal to have all Americans wearing such devices. Even though the continuous trials concept is not a new idea, given that the clinical trials industry was built around a phases model and continuous trials have been mostly used as experimental designs to date, a total rethink is required for continuous trials to be successful at scale. [...] It remains to be seen whether a large-scale shift to the continuous trials model is viable as there are additional risks with this approach, and it is not fit for purpose for all research needs. That said, continuous trials have been successful and aspects of the approach have already been implemented in adaptive trials, which are now more common in the industry. And it should be noted that technology should not be seen as a barrier as there are existing technology solutions that can handle requirements for continuous trials such as has been done on the Zelta platform.

• Makary Talks Faster Drug Reviews 'Continuous Trials' DTC Ads

  By way of analogy, Makary noted that students don’t apply for college after each year, producing a 500-page document detailing freshman year results in order to get accepted for a second year, and then doing that over and over again. “We can now with modern technology run more continuous trials with endpoints in the cloud, that the regulators look on to,” he said. “It's a longer-term project, but I think we're going to get there.” ## Direct-To-Consumer Advertising [...] Get more Life Science Leader insight with our FREE newsletter. sign me up Log In or Subscribe From The Editor | October 31, 2025 # Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads By Ben Comer, Chief Editor, Life Science Leader The FDA must “cut the idle time” that exists within the agency to bring drugs to market faster, said Commissioner Martin Makary, M.D., during a wide-ranging conversation at the Galien Forum in New York City on October 30. [...] Another pilot program called the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program, allows FDA “to do the CMC review and even the inspections before the clinical trial is complete,” said Makary. “I don't know if it's going to work, but we have to try new things.” Makary also noted that he has “asked Congress to renew” the Rare Pediatric Disease Priority Review Voucher program and is “optimistic that they will.”

• Phase I Clinical Trial Designs: Continuous Reassessment Method ...

  Skip to content Precision for Medicine Contact Us Early Access to Whitepaper Beyond Geography: A Former Regulator’s Perspective on Multiregional Oncology Trials Pre-Register Now Clinical Trials # Phase I Clinical Trial Designs: Continuous Reassessment Method (CRM) Kurt Preugschat ## How the Continuous Reassessment Method Works in Adaptive Clinical Trials Phase I clinical trials shape the future of drug development by establishing safe, effective dosing for new therapies. While the 3+3 design has long dominated these trials, the Continuous Reassessment Method (CRM) offers a smarter approach. CRM uses real-time toxicity data to update dose recommendations, protecting patients while finding the right dose faster. ### Step-by-Step CRM Process in Phase I Dose Escalation Trials [...] Explore ## Frequently Asked Questions hat is the Continuous Reassessment Method (CRM) in clinical trials? CRM is a model-based, adaptive design used in Phase I trials to identify the maximum tolerated dose (MTD) by updating dose decisions in real time based on patient toxicity data. Why isn't CRM used more often in early-phase clinical trials? Barriers include limited access to trained statisticians, unfamiliarity among research teams, and stricter regulatory requirements for adaptive designs. How does CRM differ from the 3+3 dose escalation design? Unlike the 3+3 method, which follows fixed rules, CRM uses Bayesian statistics to continuously reassess dose safety, allowing more accurate and ethical dosing. In what types of trials is CRM most commonly used? [...] Clinical Trials ### Best Practices to Streamline Development of Safety Update Reports (DSURs) + |Discover ## Why Choose CRM for Phase I Trials: Safety, Speed, and Precision The Continuous Reassessment Method represents a more precise and ethical approach to early-phase trials. While challenges remain, improved tools and growing acceptance are making CRM more accessible. For organizations committed to safer, more efficient trials, CRM offers a proven path forward. Explore ### Early Phase Expertise Navigate First-In-Human to Proof of Concept with aligned expertise & solutions. Explore ### Early Phase Expertise Navigate First-In-Human to Proof of Concept with aligned expertise & solutions. Explore Explore ### Clinical Trial Design

• What is an “ongoing” clinical trial? An analysis of different sources ...

  ### Table 1. Definitions of “ongoing” trials by different sources. [...] ### CONCLUSION: The concept of “ongoing clinical trials” lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial. KEY WORDS (MeSH terms): Randomized controlled trials as topic, Controlled clinical trials as topic, Clinical trial [publication type] AUTHORS’ KEY WORDS: Study classification, Study category, Ongoing studies ## INTRODUCTION [...] trial is one that is still recruiting and/or collecting outcome data. |

• Rule 3.1332. Motion or application for continuance of trial

  (c) Grounds for continuance Although continuances of trials are disfavored, each request for a continuance must be considered on its own merits. The court may grant a continuance only on an affirmative showing of good cause requiring the continuance. Circumstances that may indicate good cause include: (1) The unavailability of an essential lay or expert witness because of death, illness, or other excusable circumstances; (2) The unavailability of a party because of death, illness, or other excusable circumstances; (3) The unavailability of trial counsel because of death, illness, or other excusable circumstances; (4) The substitution of trial counsel, but only where there is an affirmative showing that the substitution is required in the interests of justice; [...] (7) The court's calendar and the impact of granting a continuance on other pending trials; (8) Whether trial counsel is engaged in another trial; (9) Whether all parties have stipulated to a continuance; (10) Whether the interests of justice are best served by a continuance, by the trial of the matter, or by imposing conditions on the continuance; and (11) Any other fact or circumstance relevant to the fair determination of the motion or application. (Subd (d) adopted effective January 1, 2004.) Rule 3.1332 amended and renumbered effective January 1, 2007; adopted as rule 375 effective January 1, 1984; previously amended effective January 1, 1985, January 1, 1995, and January 1, 2004. California Courts Judicial Branch of California Judicial Branch of California © 2026 [...] Judicial Branch of California California Courts Judicial Branch of California Previous rule Back to Table of Contents Next rule Back to top Print;) California Rules of Court 2026 # Rule 3.1332. Motion or application for continuance of trial (a) Trial dates are firm To ensure the prompt disposition of civil cases, the dates assigned for a trial are firm. All parties and their counsel must regard the date set for trial as certain. (Subd (a) repealed and adopted effective January 1, 2004; amended effective January 1, 1995.) (b) Motion or application