As a part of Cytel’s 10 Year Anniversary of the Promising Zone Design, Cytel hosted a quiz on “Keeping the Promise” – to test trivia knowledge about the Promising Zone. Success required demonstrating both methodological and industry knowledge. The Cytel Blog congratulates Benjamin Esterni, Director of Biostatistics at Cytel, for receiving the highest score amongst all who participated.
See below for answers on the quiz:
1: When using a PZD Which of the Following Are Acceptable Decisions at the Interim look?
A: Early Stopping
B: Increase Sample Size
C: Decrease Sample Size
D: Add New Trial Arm
Answer: A and B
Early stopping and sample-size re-estimation are perhaps the most familiar elements of adaptive designs. Both are also features of the promising zone. Adding a new trial arm can be combined with a PZD design, to form a new advanced design, but is not a feature of the PZD itself.
2: A PZD can be tactically used for which of the following:
A: Allocating more resources to promising studies.
B: Improving the power of a clinical trial.
C: Aligning funding with trial risk.
D: Mitigating trial risk.
Answer: All of the above
Most respondents knew that a PZD had many tactical advantages, including the management of resources, power and trial risk. It can also align funding with trial risk, by a stage-gated funding process where investors get higher returns for riskier trials. To learn more about stage-gated funding read our new case study.
3: Which year did the first trial with a PZD unveil its results?
A: 2014
B: 2015
C: 2018
D: 2019
Answer: A
The first PZD trial results were unveiled by Sunesis Inc., in 2014. The VALOR Trial used a PZD to help obtain funding from Royalty Pharma. To learn more click here.
4: How many PZD designs have been approved by FDA?
A: Fewer than 10
B: More than 20 but fewer than 26
C: More than 25 but fewer than 31
D: More than 30
Answer: D
Dr. Julia Edwards gave a recent talk on a meta-analyses of all of the PZD designs approved by FDA. There are over 30! Find her webinar and all the other PZD webinars here.
5: In 2021 Cyrus Mehta and co-authors Unveiled Which PZD Innovation?
A: Convex Hull Promising Zone
B: Constrained Promising Zone
C: Jennison & Turnbull Gold-Standard for Optimality
D: Promising Zone Designs for Historical Borrowing
Answer: Constrained Promising Zone
Cyrus unveiled the Constrained Promising Zone in 2021 with a webinar at PSI. Find his webinar here.
6: Which of the following are not features of stage-gated funding?
A: Investors receive a greater expected return when a study is riskier.
B: A study in the promising zone that is successful will yield investors more than a study that completes on time.
C: A study that stops for efficacy will sometimes yield less to investors than a study in the promising zone.
D: A study that stops for futility will sometimes yield a greater return to investors than an unsuccessful promising zone study.
Answer: D
Stage-gated investment aligns risk with reward. Hence, A and B are typical features of stage-gated funding involving PZD. This also means that a study that stops for efficacy will occassionally yield less than a study in the promising zone (as a successful study in the promising zone was riskier and will yield more reward). Still, if a study is unsuccessful, stopping earlier is always more worthwhile.
7: Which Modules are necessary to conduct Promising Zone Designs in East
A: East Adapt
B: East SurvAdapt
C: East Predict
D: East Exact
Answer: A and B
East Adapt and East SurvAdapt would be necessary to create PZD designs in East. You can learn more from Cytel’s KnowledgeBase. Contact us to get an account.
8: A PZD Cannot Be Combined with which of the Following?
A: Seamless Adaptive Designs
B: Enrichment Designs
C: Bayesian Designs
D: Group Sequential Designs
Answer: None of the above
A PZD is a highly flexible design that can be combined with all of the above.
About the Author of Blog:
Dr. Esha Senchaudhuri is a research and communications specialist, committed to helping scholars and scientists translate their research findings to public and private sector executives. At Cytel Esha leads content strategy and content production across the company's five business units. She received a doctorate from the London School of Economics in philosophy, and is a former early-career policy fellow of the American Academy of Arts and Sciences. She has taught medical ethics at the Harvard School of Public Health (TH Chan School), and sits on the Steering Committee of the Society for Women in Philosophy's Eastern Division, which is responsible for awarding the Distinguished Woman in Philosophy Award.
