Assisting pharmaceutical companies with clinical trials has one of the oldest areas of CRO (Clinical Research Organization) operation. In the current scenario, clinical trials CRO can handle a bulk of the process, including running the entire clinical trial.
There is a lot at stake during clinical trials. The involved pressures can be regulatory, monetary, logistical, scientific, etc. In this high-stakes and high-pressure environment, adhering to best practices for clinical bioanalysis in drug development is important. Regulatory requirements related to GCP and bioanalysis focus on safety and potential risk exposure for the subject.
A Clinical CRO must align its goals for medical/pharmaceutical requirements with regulatory requirements and subject safety. As applicable, these include guidelines from the FDA and EMA’s (European Medicine Agency) E6 (R2) update for the ICH guidelines for GCP (Good Clinical Practices).
Risk Management and Risk-Based Monitoring
ICH guidelines focus on risk-based monitoring and creating a robust risk management system. Ideally, this should be accomplished before heading into clinical trials. Establishing the position of a risk manager can be useful. Collecting and managing adequate data for decision making and risk-based monitoring is crucial to a trial’s success.
The clinical trials CRO essentially works on behalf of the sponsor. Therefore, a sponsor should maintain a mechanism for oversight. The organization can use a risk manager to look further into the expected risks from the trial.
Ideally, a candidate drug shouldn’t have any adverse effects on humans. However, this isn’t always true and a risk manager should evaluate therapeutic and possible negative effects to make go or no-go decisions.
Employed correctly, risk management helps unravel the complexities of the modern clinical trial. It can encourage efficiency by focusing on relevant activities.
Centralized monitoring and risk-based monitoring are the most prominent parts of the best practices and GCP expectations for clinical bioanalysis in a trial. Generally, it encompasses the following elements:
- Critical process and data identification
- Identification of risk
- Risk evaluation and control
- Risk communication
- Review and reporting of the risk
Defining Goals and Setting up Thresholds
Defining goals that represent the success of a trial form an integral part of protocol development. This also represents guidelines for the protection of human subjects of the trial. Gathering data and proper documentation is necessary. Original records or certified copies of original records for findings, observations, and other activities in a clinical trial are necessary for evaluation.
One aspect of this involves the pharma cro avoiding unnecessary complexity and focusing on operational feasibility. Setting up thresholds that signal achievement of goals should happen before starting the trial.
The presence of pre-defined Quality Tolerance Limits (QTLs) can help identify systematic issues in the trial. Often, statistical characteristics of variables help identify safety and reliability issues related to trial results.
A Comprehensive Communication System
Even if the clinical bioanalysis is carried by a CRO, adequate protocols and systems should exist for communication with other stakeholders. The sponsor is an obvious party that should have unfettered access to the data and analyses.
Lines of communication should be available for any situation concerning patient safety. For example, the presence of anomalous results should be communicated without delay.
A good communication system should include other stakeholders like vendors, regulatory agencies, and others, as necessary. A regular flow of communication internally and externally should be unimpeded and easily accessible.