When designing an In Vitro Diagnostic (IVD) clinical trial, there are three major areas that must be considered if manufacturers are to achieve optimal, accurate outcomes:
- Clinical research conduct
- Data management
While these three clinical research disciplines are interdependent on one other, equal attention should be paid to each of these functions, as outlined below.
The area of Biostatistics plays a critical role in achieving IVD clinical trial success, much of which is dependent on compiling evidence to effectively bring a product to market. Other considerations include:
- IVD studies should be designed in accordance with guidance documents that are applicable to a particular manufacturer’s IVD product, and based on target condition and region—all of which are critical for accounting for each facet of a diagnostic.
- It is suggested that the clinical trial Biostatistician work closely with the Clinical Study Manager to ensure that the population of interest is being successfully enrolled into the trial.
- Reasons to exclude data should also be pre-specified to mitigate bias.
- It should also be required that the Biostatistician collaborate with the Data Manager to ensure all necessary endpoints and covariates are being collected.
- It is also important that the assigned Biostatistician ensures that the study, and any subgroup analyses, is adequately powered by determining the following requirements:
- Sample size
- Proper statistical methods
- Results that are formatted properly for the intended regulatory authority
II. Clinical Research
Clinical research conduct requires effective trial management regardless of size, duration and complexity of a clinical trial. Many trials fail due to poor design, lack of documentation, inefficient data analysis, and the inability to support trial endpoints.
As such, a Clinical Study Manager plays a critical role in the trial design, planning and execution of a successful clinical study. For IVD trials, there are various clinical trial designs, such as procurement, method comparison, and reproducibility studies, which seek to answer various questions regarding the safety and efficacy of an IVD product. Also noteworthy is the fact that clinical trial results may influence physicians’ treatment plans or a patients’ decisions regarding healthcare options.
It is recommended that the clinical research phase should consider input from other disciplines, such as the Biostatistician, to determine:
- Trial sample size
- Number of trial sites needed
- Data management approach (to determine what data and how data will be collected)
Additionally, it is critical that:
- The Clinical Study Manager design a well-structured trial protocol, with a clear objective to capture study endpoints and to support the intended use of a particular IVD product.
- Site selection is carefully considered, as it greatly affects design and identification of a study’s target subjects for enrollment and sample collection.
As a trial progresses, frequent monitoring of clinical procedure results can also ensure timely collection of quality data to support study claims for IVD regulatory approval in varying geographies.
III. Data Management
Data is the primary focus of any clinical trial and proper management of this information can make or break the overall outcome.
The clinical study Data Manager must work closely with nearly every stakeholder involved in a study to help ensure that database specifications are met, users can seamlessly navigate the Electronic Data Capture system (EDC) and the integrity of the data being captured is maintained.
This requires a collaborative and interactive relationship between Data Management, Biostatistics, Clinical Affairs and study sites while developing the key data collection documents such as the:
- Data management plan
- Centralized data monitoring plan
- Case report forms (CRFs)
Careful consideration should also be paid when building a trial database and managing all aspects of the EDC—once active—as IVD studies present a unique challenge in terms of captured data type and volume
EDC customization, utilization of templates for IVD-specific trials and leveraging past experience with IVD trials can prove helpful in reducing development timelines, enhancing efficiencies for more productive data entry and decreasing training time for future IVD trials. (The functionality of an EDC should be maximized to perform efficient, and in some cases automated, monitoring to ensure that all data is accurately collected. Custom dashboards should be used to provide real-time enrollment metrics to track the progress of a trial.)
How Can NAMSA Help?
Getting your IVD innovation to market…faster.
NAMSA is a leading contract research organization (CRO) and the world’s only Medical Research Organization (MRO) that assists In Vitro Diagnostics (IVD) manufacturers translate great ideas into great medical products.
From point-of-care diagnostics to instrument platforms to companion and complimentary devices, NAMSA provides global expertise for the full product development continuum. Through our regulatory consulting, laboratory testing and clinical research services, we consistently deliver proven time savings and cost efficiencies to clients around the world, resulting in hundreds of successful IVD regulatory submissions.
Learn more about NAMSA’s IVD services here…or, check out our latest on-demand webinar, “IVD Clinical Trials: Essentials of Effective Product Launch in 2019 and Beyond.