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.
Quantics is very experienced in many different types of study design, in many different clinical areas with a specialisation in both invasive and noninvasive medical device trials
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.
Quantics has also had experience of respiratory, oncology, dermatology, cardiovascular and gastro-intestinal studies.
We have particular experience in sample size estimation in complex study designs.
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 calculations are vital to clinical trials. With average per patient costs of a Phase 3 trial of $40,000, minimising the numbers required is very important. Too big a sample wastes time and money, but reducing the number too far may result in the entire trial being wasted.
Sample size calculations are based on a set of assumptions about what the trial is expected to show, based on historical data. Quantics has extensive experience in this field, and 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.
We have experience to help you in all of the following areas:
Exploratory studies / descriptive studies
Non-inferiority or superiority studies
Adaptive designs
Designs involving data monitoring committees and interim analysis
Interim analyses are common in medical device trials for a variety of reasons. Just having a look is fine, but if the outcome of the analysis could change the conduct of the trial, for example by early stopping for superiority, futility or safety, then there is a problem. If the analysis result does stop the trial, then all is well, but if the analysis does not show that the trial can be stopped early, then the fact of having undertaken the analysis might undermine the power of the trial to demonstrate the objective when the trial is finally complete.
If there is not enough historical evidence about the expected performance of a clinical trial to be reasonably confident in the design, an adaptive trial can be designed. An adaptive trial monitors the outcomes of interest as the trial progresses, and uses this information to adjust trial parameters such as sample size, prescribing schedule, doses used, or patient selection criteria.
If this is to be done, the adaptive process MUST be fully defined in the protocol prior to the trial start and can not be subsequently changed.
Details of the adaptive process need to be masked from investigators to maintain blinding and Quantics, as an independent statistical consultancy, can design, monitor analyse and direct changes for an adaptive trial without risk of un-blinding.
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.
Quantics uses unique Diverse Self-Checking Pair (DSCP) programming (note that DSCP is not the same as “double programming”).
DSCP drastically reduces the QA and QC time at the end of the study, minimising the time from database lock to final results.
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.
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.
Quantics can provide a completely independent review of CRO proposals to address your core concerns:
We are happy to represent you at face to face meetings if required.
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 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.
