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Testing Drugs Better with Quality Assurance in Place

December 20, 2016
Posted by: Jamie Zacher, PharmD

The goal in any clinical trial is to test a drug or therapy to find out what the benefits and risks are to the patient, and if that therapy should ultimately be made available to the general public. In order for this to happen, the Sponsor Company, clinical investigators and clinicians need accurate, unbiased and reliable clinical data. Checks and balances must be in place to ensure the study has been conducted correctly, that data is collected and reported accurately and all is in compliance with the appropriate regulations. This is where Quality Assurance comes in to play. Please read on…

The ICH (International Conference on Harmonization) E6 document is recognized and used globally as a guideline for good clinical practice (GCP). This document defines quality assurance as “all those planned and systemic actions that are established to ensure the trial is performed and the data generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s)”.[1]

Quality assurance is used throughout a clinical trial, from beginning to end. This includes when creating a protocol design, setting up clinical sites, performing medical procedures, collecting patient data, validating data input, and closing a study database. It is important to have steps in place to make sure everyone involved in the study follows the protocol so that all data collected is reliable and acceptable. All members of the clinical trial team want a valid study in order to provide robust data for regulatory review and product approval.

Each step in a study will have its own quality assurance standards. These standards are in place to make sure everyone is conducting the study in the same way in order to have consistent data across the entire study. Audits, including internal audits, should be conducted with clear parameters laid out beforehand to ensure everyone involved in the study is performing their tasks consistently.

Quality assurance allows for the sponsor company and clinical sites to watch for data outliers, identify the data input in question, and verify any data inputs for accuracy. For example, if a patient is self-reporting blood glucose levels and they transpose numbers, recording a 410 reading instead of a 140 reading, the clinical team may observe and question that this level does not seem correct when the patient’s other readings have all been in the low 100s. By catching this error through good quality assurance procedures, the clinical site can follow-up with the patient to verify the correct blood glucose reading and correct any errors, thus ensuring quality data. If quality assurance is not done, and multiple patients make this type of error, the data for the study will be inaccurate and not reflective of the true therapy efficacy, leading to incorrect study results and conclusions.

Quality assurance is an important part of every clinical trial and must be in place in order to get most accurate and reliable data results possible. If errors occur and they are not corrected, the entire clinical trial may be in jeopardy and need to be redone, potentially costly millions of dollars and months or years of time.

1. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(R1). Current step 4 version dated 10June1996.

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