Challenges in Biostatistics Methodology in Clinical Research

2017 was a good year for drug approvals in both the U.S. and the EMA. The FDA approved 46 novel medicines which is more than double from the previous year. The EMA recommended 92 medicines. Regulatory approvals are based on strong statistical evidence which often leads back to the biostatistics methodology.

That being said, it should be pointed out that there are over 266K ongoing clinical studies worldwide, over 108K in the United States alone (according to The drug development failure rate is astounding.

Biostatistics is constantly playing a more important role in the drug development process. Our infographic points out some of the common challenges in statistics when it comes to clinical research.biostatistics methodology

Biostatisticians need to be involved from the beginning of a study to support with protocol and trial design. Since the new ICH GCP E6(R2) regulations were rolled out, Sponsors have been investing in vendor and CRO oversight. According to a recent study, 83% of Sponsors are looking to automate oversight and the key indicators they are looking for include milestone status and forecast as well as patient metrics. With the proper data analysis and visualization tools in place, statisticians play a key role in this analysis.

As a data-driven CRO, CROS NT can support with biostatistics methodology, analysis and reporting. Our statisticians can also provide expert consultancy in the following areas:

  • Adaptive Trial Design and Bayesian Methods
  • Special statistical considerations for oncology trials
  • DSMB Meetings
  • Regulatory Authority feedback on statistical considerations
  • Data Anonymization
  • Risk-Based Monitoring