Optimizing clinical development planning consists of adjustments ensuring the development program achieves the best outcome whilst minimizing risks or costs. A clinical development plan needs a multidisciplinary team with experts in regulatory affairs, statistics, medical affairs, and other coinciding areas. Following are some steps that are required to create a clinical development plan:
1. Target Identification
The first step in clinical development strategy is identifying the disease the drug is manufactured to treat.
2. Preclinical Testing
A preclinical test is conducted in animals to assess the drug’s safety and efficacy and determine the correct dose levels in human clinical trials.
3. Phase I Clinical Trial Design
After biomarker identification, it is categorized into diagnostic, prognostic, Pharmacodynamics, or safety. Later, phase I of clinical trial design is determined, including the dose levels to be assessed, the number of subjects to be enrolled, and the endpoints to be measured. Clinical pharmacologists or toxicologists must optimize dosing evaluation and modelling for this clinical trial phase.
4. Phase II Clinical Trial Design
Based on the results, the design of the phase II clinical trial is fixed. Now, the efficacy assessments, endpoints, and applicable estimand are determined. The safety assessments are refined based on the information from the phase I study and pre-clinical information.
5. Phase III Clinical Trial Design
The structure for Phase III trial Phase III trial is determined from the outcomes of the Phase II study. The number of subjects that will be included, the criteria for endpoints to be measured, and the estimate are considered. Trials must present an argument that is clear and can convince people that it is effective to trigger a response.
Following these steps is the data analysis, where the plans are created to guarantee the quality of data. After that, the plan is to interact with regulatory agencies, including meetings with regulators and submitting regulatory submissions. The safety inspection is one of the crucial measures to ensure the security of the medication during clinical development, after which the drug is authorized to be used.
