IDDI Newsletter – August 2022

IDDI ANNOUNCES RTSM PARTNERSHIP WITH CLARIO

By combining CLARIO RTSM know-how with IDDI’s statistical expertise, we ensure that your studies are configured in the most reliable and efficient way, securing your trial integrity.

The configurable nature of the software will allow us to bring studies to market much faster and will also allow us to manage mid-study changes more efficiently, with less effort. Read the full Press Release.

UPCOMING WEBINAR

The Benefit-Risk Assessment of new Treatments: The Health Technology Assessment (HTA) Process
September 21 | 17:00 CET – 11:00am EDT

The increasing cost of new treatments, notably of cancer medications, is prompting policymakers to ask if newer therapies are worth their cost. Most European nations use health technology assessment (HTA) to determine the value of new drugs, decide whether insurance should reimburse them, and determine payment.

• We will first describe the standard and ideal HTA process for a new drug, with a focus on the French process.
• Then the assessment of Basket Trial will be explained.
• Finally, the moving position of HTA organizations for the early or accelerated assessment of promising drugs will be detailed, with a personal position of the speaker. Read abstract here.

PAST WEBINARS

Conversation between a Sponsor and a Statistician about Phase II/III trials in oncology:
Learn on the features, advantages and disadvantages of adaptive designs and group-sequential designs and their regulatory aspects of Phase II/III trials. WATCH RECORDED WEBINAR.

Risk-Based Fraud Detection: How Centralized Monitoring Can Boost Data Quality:
This webinar presents the results of a new study that further demonstrated that risk-based monitoring is an efficient tool to detect fraud at clinical trial sites and early identify data quality and safety issues in clinical trials. WATCH RECORDED WEBINAR.

Assessing treatment efficacy in early-phase oncology trials:
– Historical overview of efficacy assessment in early-phase trials
– Highlights on some recent regulatory trends in that respect
– Discussion on the tension between the clinically appealing and statistically sound methods to assess the efficacy of novel treatments in phase 1 trials, single-arm phase 2 trials, and randomized phase 2 trials. WATCH RECORDED WEBINAR

ALL OUR RECORDED WEBINARS ARE AVAILABLE ON OUR YOUTUBE CHANNEL

GENERALIZED PAIRWISE COMPARISONS (GPC): AN INNOVATIVE STATISTICAL METHODOLOGY

Generalized Pairwise Comparisons (GPC) is an innovative statistical method that brings a new approach for the design and analysis of clinical trials. It allows for the use of multiple endpoints in a single analysis, addressing the specific needs of patient-centric medicine.

Learn on how GPC can decrease sample size to power studies and maximize chances of regulatory approval!

SHRUTI JITURI APPOINTED AS DIRECTOR BUSINESS DEVELOPMENT WESTERN USA AT IDDI INC.!

SHRUTI JITURI APPOINTED AS DIRECTOR BUSINESS DEVELOPMENT WESTERN USA AT IDDI INC.!

We are happy to welcome our new Director Business Development, Western USA – Shruti Jituri PMP. Shruti will help support our Western US clients to accelerate the delivery of their drugs. Set up a meeting with Shruti

JOIN OUR INNOVATIVE AND GROWING TEAM – WE ARE HIRING!