The new article describes how clinical data should be handled and highlights the key points to be considered in this respect.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the design considerations for pivotal clinical investigations for medical devices. The document provides additional clarifications regarding the applicable regulatory requirements and recommendations to be taken into consideration by medical device manufacturers, study sponsors, and other parties involved. At the same time, provisions of the guidance are non-binding, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation. It has been agreed with the authority in advance. 


Regulatory Background: The Importance of Data Quality 

The scope of the guidance covers, among other things, the matters related to sustaining the quality of clinical studies, including handling clinical data, study conduct, and analysis, as well as changes to pivotal studies. In particular, the document provides an overview of the approach and techniques to be applied to sustain the evidence level concerning clinical outcomes and diagnostic studies. 

As further explained by the FDA, the clinical evidence collected during a clinical study can be used to evaluate the safety and effectiveness of a medical device in question. According to the guidance, a key factor that contributes to the generation of this evidence is the selection of study design, which will hopefully also reduce the sources of bias; the use of sound scientific methods to carefully conduct the study and analyze the data should maximize how informative the study will be. The authority mentions that if the poorly-conducting clinical investigation will not provide accurate and reliable data to be used to analyze a medical device’s actual performance,  the proper quality of a study is vitally important to ensure the proper level of evidence. 

In accordance with the applicable legislation (21 CFR 812.40), study sponsors are obliged to ensure proper monitoring with respect to the studies they are responsible for. Therefore, the appropriate measures should be duly introduced at the stage of study design development to optimize the reliability and usefulness of data and information generation in the clinical study. According to the guidance, the said measures should cover the most important matters related to the clinical study, including handling clinical data, conducting the clinical study, planning the analysis strategy, and prospectively accounting for the changes that could be introduced during an investigation. The guidance describes the aspects mentioned above in detail and highlights the key points to be considered in this respect.

Handling Clinical Data

First, the guidance outlines the most important points related to handling clinical data. According to 21 CFR 812.150(a), study sponsors shall prepare and submit complete and accurate records containing specific information (e.g., case history of study participants). For this purpose, sponsors are encouraged to develop detailed enough data management plans and training programs to be implemented according to the principles set forth by the Good Clinical Data Management Practices (GCDMP). As explained further by the FDA, the data management plant becomes vitally important in establishing the level of evidence and minimizing bias with respect to the increasing volumes of data recorded and analyzed in electronic environments. It is important to mention that according to the appliance regulations, there is no requirement to submit a data management plan to the authority for review. However, the latter still encourages the parties responsible for clinical investigations to provide an executive summary (by including it in the clinical study protocol). Furthermore, it will be beneficial for a study sponsor to get in touch with the authority to discuss the questions related to these matters during meetings counted under the Pre-Submission pathway. 

With respect to the data collection process, the authority mentions that study sponsor are obliged to ensure that the study data is being collected in a consistent format and structure so that they may be easily interpreted, understood, and evaluated; while maintaining an efficient standard method of data collection across studies, sites and investigators can help to ensure high-quality data across the studies and facilitate the interpretation of protocol design across studies by comparing the associated metadata. In particular, to optimize the data collection process and improve the overall quality of data collected, standard vocabularies and requirements for data collection are to be used. 

In summary, the present FDA guidance describes the approach to be applied by study sponsors to ensure the proper quality of clinical data collected in the investigations they are responsible for. In addition, it is vitally important to ensure the accuracy and reliability of study results. The authority highlights the most important aspects to be considered in this respect and also encourages study sponsors to get in touch before commencing a study to discuss all the key points and concerns in advance. The document also outlines the scope of measures to be implemented by a study sponsor at the clinical study design development stage. 



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