Clinical Trials & Medical Devices
Quantics is experienced at providing expert statistical guidance throughout the clinical trial process. From the first sample size calculations to long-term follow ups, we can help ensure you get the most out of every datapoint.
Study Design & Sample Size Calculations
Quantics is very experienced in supporting study design and sample size calculations for a wide variety of different clinical areas. This includes a specialisation in both invasive and noninvasive medical device trials.
Study Design
Quantics has supported study design for studies in fields as wide-ranging as respiration, oncology, dermatology, cardiovascular health and gastroentorology. We can provide a report on the pros and cons of particular designs including adaptive models and other complex designs to ensure that the trial gains the maximum information at minimum cost.
Adaptive Design
Quantics, as an independent statistical consultancy, can design, monitor analyse and direct changes for an adaptive trial without risk of un-blinding. Adaptive trials are often implemented when there is not enough historical evidence about the expected performance of a clinical trial to be reasonably confident in a standard study design. The outcomes of interest are then monitored as the trial progresses, and this information is used to adjust trial parameters such as sample size, prescribing schedule, dose selection, or patient selection criteria.
Project Insight
Quantics reviewed a draft protocol for a new wearable device. The manufacturer had included many subgroup analyses for the secondary endpoints, in the belief that these would be important for licensing submission.
Quantics advised that subgroup analyses for secondary endpoints are often not required by regulators, and with small sample sizes proposed could produce very misleading results. Based on this advice, the client reviewed the study protocol of the predicate device, found that this study had not included subgroups, and removed these analyses from their protocol. This substantially reduced the costs and time required for the data management and statistical analyses.
Sample Size Calculation
Quantics has extensive experience in performing sample size calculations for a wide range of studies. We can provide a comprehensive report on the impact of varying the assumptions on the sample size and likely trial success, enabling you to balance the risk of trial failure against cost and recruitment time. We can explain the options with risks and consequences in ways suitable for scientists and financial supporters. With average per patient costs of a Phase 3 trial of $40,000, ensuring the sample size for a study is optimised is a crucial component of clinical study design. Too big a sample wastes time and money, but reducing the number too far may result in the entire trial being wasted.
PK/PD Analysis
Quantics are experienced in Pharmacokinetic (PK) and Pharmacodynamic (PD) analyses. Our expert team of statisticians are on hand to ensure your knowledge of your drug’s PK and PD properties is sufficient to satisfy regulatory requirements. We can also directly support applications to regulatory bodies, both by conducting analyses, and presenting data/code to required standards.
Results and Reporting
Quantics have supported many clinical trials through to the latest stages of analysis and reporting, including final analyses, and regulatory submission. Quantics uses unique Diverse Self-Checking Pair (DSCP) programming to ensure our results meet rigorous GCP standards. DSCP drastically reduces the QA and QC time at the end of the study, minimising the time from database lock to final results.
Interim Safety Analysis
Interim analyses and data monitoring committee meetings need to be planned and defined in the SAP. In particular it is important to define what data is to be reported, whether it is to be unblinded, and how the consequences of any decisions made will be implemented, and what the implications may be on the power of the study and required sample size. Quantics can provide completely independent analysis, allowing unblinded results to to be examined without risk of unblinding of investigational staff. Quantics staff can also be part of the review group if required.
CDISC Reporting
Quantics can undertake full trial statistical analysis and provide appropriate reports for the Final Study Report, all to CDISC and GCP standards. We can work with SDTM data from Data Management companies, provide ADaM and define.doc data sets, and all required documentation.
Regulatory Submission Support
Quantics has extensive experience discussing statistical issues raised in the design stage or at NDA stage with regulators including MHRA, FDA, EMA, PMDA.
ISS and ISE
ISS and ISE stand for integrated summary of safety and integrated summary of effectiveness, respectively. These are not merely summaries, as the name might suggest, but rather documents comprised of integrated analyses of the safety and effectiveness of a study drug. In other words, the results from all clinical trials performed on the study drug are pooled together and analysed as a whole, producing combined statistical results. Quantics have a good understanding of the challenges and regularly work on projects in this area.
Independent Review
Are you planning to spend a fortune on your phase 3 pivotal clinical trial? The clinical side of the protocol is vitally important, but don’t forget that a trial can fail if the statistical design is wrong!
You will be expected to review and sign off on the two defining documents for the trial, the protocol and the statistical analysis plan (SAP). Someone at your company should be appointed to take responsibility for reviewing the statistical aspects of these. Who will that be? Are they sufficiently experienced to discuss these key components, up to date with what regulators want, and happy to take this responsibility?
If you have the right person great! If not, get an independent statistician to perform this role on your behalf.