With an increasing demand for drug discovery and development, the biopharmaceutical industry is relying on bioanalytical laboratories to fulfill these increased responsibilities. Bioanalytical laboratory services include assays such as qPCR assay development and testing protocols, including preclinical and clinical assessments. Clinical research is continuously evolving. With new expectations in clinical testing, the bioanalytical lab and pharmaceutical industry need to transform the concepts of clinical trials.
Adherence to clinical practices is crucial for robust study design, high-quality data, and enhanced patient safety. Hence, bioanalysis labs and drug developers are continuously evaluating study designs for conducting better clinical studies and accelerating drug development. The current article dives into good clinical practices for bioanalytical lab services.
Good clinical practices
Good clinical practices are quality standards given by the International Conference on Harmonization for conducting clinical trials and the responsibilities of monitors, investigators, and research sponsors. By following good clinical practices, clinical study teams and investigators can gather quality data while upholding patient safety standards. Hence, teams conducting clinical trials must focus on the efficacy, requirement, and safety parameters from a regulatory perspective. Besides, adhering to good clinical practices is critical for regulatory review.
Following are some good clinical practices for bioanalytical laboratories.
- Informed consent for study subjects
- Safety management of patients
- Generation and availability of quality source documentation
- Safe and effective administration of the investigational drug product to verify and confirm its efficacy and safety in supporting experimental claim
- Compliance with a predefined protocol, which is a crucial element for regulatory agencies
Bioanalytical laboratories and study sponsors should have an early discussion regarding clinical trials and optimization of the study protocol to ensure the success of the designed clinical trials. Ideally, bioanalytical laboratories should discuss the risk management of study designs with regulatory agencies before initiating clinical trials. Most importantly, researchers should ensure that the study set up for efficacy protocols is efficient to support market authorization.
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To generate the highest quality experimental results, bioanalytical laboratories should have well-defined criteria communicated to site staff, investigators, and sponsors before beginning a clinical trial. Besides, each patient should be met with accurate entry criteria before enrolling in a clinical study. Bioanalytical laboratories should have systems for documenting protocol-related methods, especially around efficacy parameters, safety data, and patient consent. Importantly, clinical trials should be designed in such a way that avoids the need to extract more data than needed from a submission and regulatory standpoint. Hence, bioanalytical laboratories should identify the appropriate degree of data before initiating a clinical trial.
Clinical trials are all about human subjects. Therefore, bioanalytical laboratories and sponsors should emphasize the role and characteristics of the study patients. In some therapeutic domains, patient advocacy teams are the voice of patients who need therapeutic intervention the most. Bioanalytical laboratories can design clinical trials and involve patient advocacy groups in the development process. This initiative is particularly beneficial for clinical studies on rare diseases where enrolling patients is challenging. With a rise in personalized medicine, traditional clinical trial approaches can become a thing of the past. Hence, the biopharmaceutical industry should evolve and incorporate the votes of these patients while designing clinical trials.
