Contract Research Organizations (CRO) play an essential role in clinical bioanalysis. The role of CROs has expanded beyond handling just a few aspects of clinical trials. Now, pharmaceutical companies often partner with (or hire) a full-service clinical trials CRO. The CRO still bound by regulations under federal laws and have to handle state law and international guidelines.
The sponsor and the CRO should have a clear understanding and communication related to the clinical trials and all the phases and steps involved in clinical bioanalysis.
Designing a comprehensive protocol is necessary to lay down the guardrails and framework of clinical bioanalysis. The objectives, design, statistical information, and data management are all parts of this protocol. A clinical CRO works the protocol into use for study and bioanalysis.
Phases of clinical trials and the steps involved in bioanalysis
A clinical trial is usually divided into several phases. The poor performance of the drug in any phase can lead to ending the trial. The initial phases (Phase 0 and Phase I) seek to ascertain the safety and correct dosage of the drug in humans. It is not until the drug reaches Phase II trials that efficacy is seriously considered. Here are the steps involved in clinical bioanalysis:
Method Development: Designing a comprehensive protocol as the guardrails and framework of the study and bioanalysis. The sponsor and CRO should set up clear and convenient communication channels. If the analysis is taking place at different bioanalytical laboratory, communication, sample management, and assay validation become important considerations.
Assay Development And Parameters: Assays used for human studies need to be more rugged and robust. They should be able to withstand the potentially long times a study can take to complete. Another consideration is reproducibility to manage assay use between multiple labs. Other important assay validation parameters are specificity, precision, accuracy, quantitation limit, etc.
Sample Management: A lot of samples and data are generated during these phases. A clinical CRO will often have plans for data management, and where necessary, storage of samples, etc. Sample collection, storage, and shipment will have to be considered. Long term storage has to be considered as well.
Drug Efficacy And Dosage: Effective clinical bioanalysis also includes PK (pharmacokinetic), TK (toxicokinetic), and biomarker sample matrices. Pharmacodynamics is required to consider the effectiveness of the drug while toxicological studies consider after-effects.
Study Endpoints: Study endpoints and length of study are especially important to ensure that the outcome can be measured objectively. This helps determine whether the intervention has been successful. Careful consideration is, therefore, necessary to form endpoints that are both practical and objective.
Length Of Study: It is important to consider the number of participants, their eligibility criteria, and the conduct of the study in general. The time duration of the study and for each phase of trials has to be set up as well.
Patient Safety: An essential part of clinical bioanalysis and the study is patient safety. Constant monitoring of the participants is necessary to ensure the safety of the participants. Additionally, constant monitoring is necessary for checking parameters like PK, PD, and TK profiles of the drug.