- 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.
It's free to run up to 10 simulations for a scenario of any design!
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).
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.
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.
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.
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
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 email@example.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
- If you are not registered yet, please go to Registration page to complete registration. Registration is completely free.
- Log into your account
- Choose from below list of subscription plans and click "Get It" button of the chosen one
- 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
- Once on My Cart page, follow instructions to fill in all necessary information and submit your credit card information to complete the purchase
Full access to all designs
- Single Agent
- Dual Agents
- Decision & MTD
Please contact firstname.lastname@example.org 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).
And many more ...
FREQUENTLY ASKED QUESTIONS
Why do I need to register?
After registration, you will have created an account on U-Design website. Once logged into your account, you will be able to access all the tools and utilities, such as does-finding designers and decision tables. A complete history of running simulations for dose finding designs will be stored in your account.
Is registration free and how do I register?
Yes, registration is completely free. Please go to Registration page to register.
Are tools and utilities provided by U-Design free to use?
Yes, you could run up to 10 simulations at a time for a scenario of any design. However, you need to purchase a subscription plan to be able to run more simulations and generate decision tables.
I want to learn more about U-Design. Are there demos or tutorials?
Yes, please go to HOW IT WORKS section for a quick demo and tutorials.
- How do I purchase a subscription?
Can I cancel my subscription?
Yes, you could cancel your subscription at any time. Please go to My Orders page, at the top of which you will find your current subscription and then click the "Cancel" button next to it.
Do you offer a one-month only subscription so that I could give it a try?
Technically, we don't offer such a plan. However, you could purchase a monthly subscription and then cancel it, following steps listed in the previous question, at any time within the first month of your subscription. Your subscription will remain effective till the end of that month.
I received a notice that my subscription payment failed. What should I do?
By purchasing a subscription plan, your credit card on file will be charged periodically depending on the type of subscription you have. If you received a notice regarding payment failure, it's possible your card has expired or something happened to it that the charge on it was denied by your card issuer. Please contact your card issuer to see what might have happened. You could update your card information by going to My Profile page and scroll down to "Credit Card On File" section.
Do you keep my credit card information at your site?
No, we don't keep your credit card information. We use a reputable, PCI compliant third-party to process your credit card. We encrypt your card information and send it over. You could always remove your credit card information completely by going to the Profile page and scroll down to the bottom. Then click the "Remove Card" button.
Do you have plans to add new functions to your site?
Yes, our dedicated and talented team of statisticians will continue to improve U-Design and add more functions to it. Please go to the Upcoming Products section for details.
What do I do if I encountered a problem?
Please let us know the problem you encountered by either emailing us: email@example.com or filling out the contact form at the bottom of each page.
- 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.
- 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.
- 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.
- 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.
- O′Quigley, J., Pepe, M., & Fisher, L. (1990). Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics, 33-48.
- Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 925-937.
- 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.
- Ivanova, A., Flournoy, N., & Chung, Y. (2007). Cumulative cohort design for dose-finding. Journal of Statistical Planning and Inference, 137(7), 2316-2327.
- 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.
- 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.
- 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.
- 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.