What is the difference between clinical evaluation and clinical investigation?

 These terms used for medical devices are sometime misunderstood and used one for another, but both are distinctly different. Though clinical investigation data is often used in Clinical evaluation report, clinical investigation is one of the requirements of MDR like clinical evaluation. Let us further examine to understand the difference better.

 Though detailed discussion of clinical evaluation is not the subject of blog, it will be essential to briefly describe the process of Clinical Evaluation so that difference can be understood better.

Let us go to the brief definition of Clinical Evaluation Report (CER). Clinical evaluation of medical device is a continuous process of generating, collecting, analyzing, and evaluating clinical data under assessment to demonstrate conformance with general safety and performance requirements as per the manufacture’s intended use. This process starts with development stage and continues through life cycle of device.

 Clinical Investigation: This is systematic study performed on humans to access the safety and performance of medical device based on the comprehensive analysis of available pre-clinical (Safety) and post market data relevant to the intended purpose of the device.

Normally, clinical investigation is done on device which is new, and the device already put in the market. These data are very important back born data which assures the safety and performance of device. It is also termed as good clinical practice to conduct clinical investigation.

Please note that clinical investigation data goes to clinical evaluation report. This is how clinical investigation and clinical evaluation are related to each other. In-fact, clinical trials are nothing but scientifically designed clinical investigation. Clinical trials are almost end of R&D process and then the same is used for trial on human.

Clinical Investigation is carried out on premarket and post market assessment of medical device in designed manner considering,

 

1.       Adequacy of sample size and power calculation

2.       Adequacy and relevance of end points

3.       Adequacy of choice of control on study.

4.       Prospective randomisation of patients,

5.       Adequacy of inclusion and exclusion criteria for study,

6.       Distribution of prognostic factors

7.       Adequacy of follow up period

8.       Reliability of methods used for quantifying data

9.       Adequate reporting of serious adverse events and device deficiencies

       Adequate handling of medications and concomitant intervention

1   Adequacy of procedure for retrieving complete information (the procedure should cover incidents like, if patient is not contactable, if leaves study and reason for leaving, sensitive analysis where data is not sufficient)

 The evaluator’s role is to ensure that all above factors are considered while investigation data are evaluated. Evaluator also ensures that data is in sufficient quantity to make scientific conclusion.

 Though clinical evaluation report (CER) is an important document it comprises of clinical investigation data, hence it is essential to understand that clinical investigation data has highest relevance and contribution towards clinical evaluation because the clinical investigation is well designed and monitored randomized controlled clinical investigation. This is conducted under device under evaluation in its intended purpose with patients and users that are representative of target population. Clinical evaluation is the responsibility of manufacturer.

Clinical investigation is a valuable tool for capturing preliminary data at early stage so that design change if needed can also be done.

Once again specifying clinical investigation which is designed process of investigating using some known scientific methods specified in plan and generate data, while clinical evaluation is evaluation of this data as well as data obtained through other sources like PMS, complaint, adverse reactions etc.

The Evaluator will use this data using various established scientific methods including risk assessment and make evaluation report called clinical evaluation report called CER.