Speed Matters, Quality Matters

Shaping The Future Of Drug Development

A pioneering Software-as-a-Service biostatistics design web platform that delivers innovative optimized statistical designs to improve the efficiency, speed, and safety of drug development

POWERED BY

A team of world-class Bayesian statisticians, including PhDs from University of Chicago, University of Texas, Fudan University and Rice University, specializing in Bayesian adaptive designs and implementation for drug and device clinical trials

ANSWERING THE CALL

WHY U-Design?

Why U-Design
  • Features best-in-class innovative Bayesian adaptive designs based on years of research and continuous refinement that will improve safety, efficiency, and speed of clinical trials, and increase the probability of successful drug development programs
  • Offers a simple user interface that allows both clinicians and statisticians to easily create and configure different designs side-by-side, run simulations and compare results with a few clicks of buttons
  • Automatically generates submission-ready statistical section with simulation results embedded for the clinical trial design protocol
  • Provides easy-to-use tools to generate decision tables for mTPI, mTPI-2, mCCD and 3+3 designs and estimate the MTD based on trial data

HOW IT WORKS

This is the simplified version of the single-agent cohort-based dose finding designer. Many inputs are preset, such as scenarios and the number of simulations to run. However, it produces and presents results the same way as that for the full version. It is intended as a quick demonstration of how U-Design works.

1. What is the maximum sample size (total number of patients to be enrolled) of the trial?
2. What is the toxicity rate of the MTD? For example, if the MTD is defined as the highest dose with no more than 1 patient out of 6 having DLT, the toxicity rate of the MTD is 1/6, or 0.17.
3. How many dose levels will be investigated in the trial?
4. What Dose-finding design(s) do you want to implement?





Go to user manual

Download PDF version of the user manual

CURRENT PRODUCTS

It's free to run up to 10 simulations for a scenario of any design!

Single
Agent

Cohort Based Designs

An integrated tool supporting the simulation-based comparison among 7 main-stream dose-finding designs. This module provides both the modern Bayesian model-based designs, including the i3+3 design (Liu et al., 2019), the mTPI design (Ji et al., 2010), the mTPI-2 design (Guo et al., 2017), the continual reassessment method (CRM) (O'Quigley et al., 1990), and the Bayesian logistic regression method (BLRM) (Neuenschwander et al., 2008), and the algorithm-based designs, including the 3+3 design and the modified cumulative cohort design (mCCD; the original CCD design was introduced in (Ivanova et al., 2007).

Single
Agent

Rolling Based Designs

Targeting the key point of time-consuming clinical trials, the module of Rolling-Based Designs is an innovative tool that allows users to compare how long a trial would take under different designs in real-life enrollment settings. This module includes rolling-based designs (rolling six (Skolnik et al., 2008) and R-TPI (Guo et al., 2019) that aim to accelerate phase 1 trials, and cohort-based designs (3+3 and mTPI-2 (Guo et al., 2017)). This module for rolling-based designs is the only tool on the market that incorporates the comparison of trial duration among different designs.

Single
Agent

Decision & MTD

A simple-to-use tool that allows users 1) to generate and examine the transparent dose-finding decision tables for four designs, mTPI, mTPI-2, mCCD and 3+3, 2) to make the mTPI-2 decision of MTD selection based on accumulated data for a real trial.

Dual
Agents

Dual Agents

Combination drugs are important in oncology. By attacking the cancer at multiple points on cell signaling pathways, or by attacking multiple pathways, combination drugs can overcome resistance and gain greater potency. This module provides simulation-based comparison of two Bayesian model-based dose-finding designs, dual-agent BLRM (Neuenschwander et al., 2015) and PIPE (Mander and Sweeting, 2015). These two designs only model the toxicity outcomes and aim to identify the Maximum Tolerant Dose.

UPCOMING PRODUCTS

We are working hard to bring these to U-Design. Stay tuned!

A simple and effective dose-finding design for CAR-T phase I trials

Subgroup enrichment designs and methods for precision clinical trials

Adaptive dose insertion allowing new doses to be inserted during the trial to increase the probability of success (for finding the best dose)

A sample size calculator for dose-finding trials

BEST The Bayesian Early-Phase Seamless Transformation Platform

The BEST platform provides a fast, efficient, and powerful solution for early-phase drug development. Currently, we offer BEST consulting services. We'll bring various designs and utilities under BEST to U-Design. Learn more about BEST

PRICING

It's free to run up to 10 simulations for a scenario of any design!

If you are an academic user, you could request a discount by sending an email to admin@laiyaconsulting.com from your organization email address with a subject line 'Academic Discount Request'. We will email you a discount code that you could enter at the checkout to enjoy a 30% discount off the regular subscription price, if you are eligible.

Individual Subscription Plans
Please follow below steps to purchase a subscription plan of interest:
  1. If you are not registered yet, please go to Registration page to complete registration. Registration is completely free.
  2. Log into your account
  3. Choose from below list of subscription plans and click "Get It" button of the chosen one
  4. In the resulting confirmation dialog box, click "Go To My Cart" button or later go to My Cart page directly by clicking "My Cart" menu item on the dropdown menu at the top right corner
  5. Once on My Cart page, follow instructions to fill in all necessary information and submit your credit card information to complete the purchase

Annual
Subscription

$2,160 /year

Full access to all designs

  • Single Agent
  • Dual Agents
  • Decision & MTD

Corporate Licenses

Please contact admin@laiyaconsulting.com to inquire about or purchase corporate licenses

We offer two options for corporate users – single user license and multi-user license.

  • A single-user license allows one user to log in with the registered email address simultaneously. A multi-user license allows a number of users to log in with one or more registered email addresses simultaneously, depending on the number of licenses purchased.
  • For a multi-user license covering up to 5 users, the price is 50% off regular price (please see above prices under "individual subscription plans") for each user in addition to the first user (the first user is charged at regular subscription price). For a multi-user license covering more than 5 users, the price is 70% off regular price for each user in addition to the first 5 users (the first 5 users are charged according the multi-user license covering up to 5 users as described above).

U-Design USERS


And many more ...

FREQUENTLY ASKED QUESTIONS

REFERENCES

  1. Ji, Y., Liu, P., Li, Y., & Nebiyou Bekele, B. (2010). A modified toxicity probability interval method for dose-finding trials. Clinical Trials, 7(6), 653-663.
  2. Ji, Y., & Wang, S. J. (2013). Modified toxicity probability interval design: a safer and more reliable method than the 3+ 3 design for practical phase I trials. Journal of Clinical Oncology, 31(14), 1785.
  3. Yang, S., Wang, S. J., & Ji, Y. (2015). An integrated dose-finding tool for phase I trials in oncology. Contemporary clinical trials, 45, 426-434.
  4. Guo, W., Wang, S. J., Yang, S., Lynn, H., & Ji, Y. (2017). A Bayesian interval dose-finding design addressingOckham's razor: mTPI-2. Contemporary clinical trials, 58, 23-33.
  5. O′Quigley, J., Pepe, M., & Fisher, L. (1990). Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics, 33-48.
  6. Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 925-937.
  7. Neuenschwander, B., Branson, M., & Gsponer, T. (2008). Critical aspects of the Bayesian approach to phase I cancer trials. Statistics in medicine, 27(13), 2420-2439.
  8. Ivanova, A., Flournoy, N., & Chung, Y. (2007). Cumulative cohort design for dose-finding. Journal of Statistical Planning and Inference, 137(7), 2316-2327.
  9. Guo W., Ji Y., and Li, D. R-TPI: Rolling Toxicity Probability Interval Design to Shorten the Duration and Maintain Safety of Phase I Trials. (Submitted) Journal of Biopharmaceutical Statistics.
  10. Skolnik, J. M., Barrett, J. S., Jayaraman, B., Patel, D., & Adamson, P. C. (2008). Shortening the timeline of pediatric phase I trials: the rolling six design. Journal of Clinical Oncology, 26(2), 190-195.
  11. Neuenschwander, B., Matano, A., Tang, Z., Roychoudhury, S., Wandel, S., & Bailey, S. (2015). A Bayesian industry approach to phase I combination trials in oncology. Statistical Methods in Drug Combination Studies, 2015, 95-135.
  12. Mander, A. P., & Sweeting, M. J. (2015). A product of independent beta probabilities dose escalation design for dual‐agent phase I trials. Statistics in medicine, 34(8), 1261-1276.