What are the similarities and differences between clinical researches and clinical audits?
Quality is something that circulates around the clinical and pharmaceutical industry ever since they started evolving and progressing. We know that quality of services should be preserved, quality of pharmaceuticals should be guaranteed by means of quality storing and distributing practices. But the use of the term “quality” doesn’t end here. For instance, there is quality of care, quality treatment, quality data management planning/plans, quality control systems, quality management and so on. The list of quality-related basics in clinical research is just endless and can go on and on. In this regard, clinical audits and researches have a well-established reputation when it comes to quality evaluation and revision. Online published materials, existing literature and other sources have pointed out a numeral similarities between audits and researches. And yet, even though they share some similar functionalities and purposes, there are some really notable differences between these two processes.
- Aims at defining best practice
- Focuses on experiments performed on humans who take a completely new treatment or are given different treatments
- May involve assigning patients to different treatment groups randomly or blindly
- Has the goal to increase knowledge or create new knowledge
- It is based on theory and may try out different hypothesis which evaluate or compare treatments
- Involves extensive statistical analysis
- The results have to be publishable to the general public
- Requires ethical approval
- It takes a long time period and is carried out on a large scale
- Measures if already known best practices are being followed by complying to a set of standards and criteria
- Never involves experiments on patients who receive new treatments and doesn’t affect their normal treatment
- Doesn’t involve allocation of patients to different groups randomly
- Assesses already created knowledge of current clinical practices
- It is practice-driven
- May involve basic statistical analysis
- Results don’t need to be publishable or generalisable as they are relevant to the area being audited
- Doesn’t need ethical approval
- It happens in a shorter time period and is performed on a smaller scale
To sum up, quality has an integral role in the pharmaceutical and clinical field. Therefore, there are various procedures that aim to define if services being offered are actually quality services and whether they comply with pre-determined best practices. Clinical audits and clinical researches are part of these procedures. And despite the fact that they sometimes share similar aspects, they can have really different focuses indeed.
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