Biostatistics is IDDI’s core competence
IDDI CAN ASSESS THE INHERENT RISK IN STUDY DESIGN
AND IMPROVE ROBUSTNESS AND CONSISTENCY OF CLINICAL TRIAL RESULTS.
IDDI was started by a Biostatistician, Dr. Marc Buyse, ScD (Doctor in Biostatistics – Harvard). The company is scientifically driven (5% of our costs are devoted to R&D) and, as a result, our philosophy tends to be different from companies that are purely business-driven. Our numerous publications reflect this scientific depth. Increasingly, drugs fail to be approved because of statistical issues (such as poor input and poor usage of statistical methods). Biostatistics is a highly specialized activity, requiring recognized, confident experts.
As such, IDDI is recognized as a partner who provides advanced statistical designs via our highly skilled professionals who focus on the critical data to be collected, analyzed and reported.We have proprietary cost-effective and adaptive web systems to randomize patients and to collect clinical data.
- In terms of innovative statistics, IDDI offers advanced statistical methods wherever needed thanks to its biostatistics competence which is the backbone of the company. IDDI commits to deliver clinical study results that are scientifically accurate, validated and reproducible.
- Moreover, IDDI assists its sponsors with the FDA/EMA through joint regulatory, clinical and statistics excellence in supporting contacts with the FDA/EMA and other main regulatory bodies.
- We have the ability and experience to deliver data following SDTM and ADaM standards, and have specialists with several years’ experience in this domain.
- Expertise in biostatistics has lead to development of new statistical methodologies (e.g. Bayesian method for the validation of biomarkers). To address regulatory guidelines regarding a risk-based approach to monitoring, IDDI has developed a new service: Central Statistical Monitoring (CSM) using advanced statistical tests, provided by IDDI’s affiliate “CluePoints”. These tests are based on non-predefined criteria and as such, they are complementary to Key Risk Indicators.
Biostatistics is IDDI’s core competence and supports the whole service offering.
- Thanks to its advanced statistical methodologies, IDDI is able to offer an optimal design for each clinical trial.
- A statistician will produce the most efficient algorithm for each randomization schedule, and makes a regular cyclic check of the global randomization balance and the balance within every minimization/stratification factor or according to the randomization list. This statistician will verify the acuracy of each subject’s treatment allocation.
- The (e)CRF will be reviewed by the study Statistician before production starts, in order to keep the CRF at the optimal size and with the right structure (to avoid the collection of useless data).
- Two statisticians are involved in the study data analyses: one for programming/producing the analyses and one for quality control.
- IDDI ensures data quality during the data collection process which guarantees that the statisticians are able to work on clean, consistent, non missing data.
IDDI is unique in the size and quality of the statistical team with respect to the rest of the company. We are committed to providing high quality statistics, and can also provide support in advanced statistical methods, biomarkers validation, meta-analyses. Also, our proprietary eClinical suite of EDC and IWR allows us to bridge the statistical expertise gap that exists at the majority of most eClinical dedicated vendors. In addition, we provide comprehensive IDMC support.
Experience, Expertise, Know-how:
Because figures speak louder than words:
- Biostatistics and Statistical Consultancy in 600+ Phase I-IV clinical trials
- 16 FDA EMA Approvals – 35 FDA/EMA meetings
- 7 Rescued studies - 120 DMCs
- 600+Scientific Publications
- 550+Scientific Conferences
- Authorship of 9 statistical books and collaboration on 80+ book chapters
3 FDA quoted papers:
· Buyse et al. The Role of Biostatistics in the Prevention, Detection and Treatment of Fraud in Clinical Trials. Statistics in Medicine. 18: 3435-51 (1999).
· Venet et al. A Statistical Approach to Central Monitoring of Data Quality in Clinical Trials. Clin Trials. 0: 1-9 (2012).
· Baigent et al. Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods. Clin Trials. 5: 49-55 (2008)
2 indirect references through the article of Cortazar P et al., 2014, Pathological Complete Response and Long-Term Clinical Benefit in Breast Cancer: The CTNeoBC Pooled Analysis, Lancet, 384:164-172 in :
Guidance for Industry Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm305501.pdf
· Buyse M, Burzykowski T, Michiels S, Carroll K. Individual- and trial-level surrogacy in colorectal cancer. Stat Methods Med Res 2008; 17:467–75
· Burzykowski T. An ordinal surrogate for a survival true endpoint. In: Burzykowski T, Molengerghs G, Buyse M, eds. The evaluation of surrogate endpoints. New York, NY: Springer, 2005