Foundations of Early Clinical Development

What is Early Clinical Development?

Early Clinical Development often refers to Phase I and Phase II studies, which are a drug’s earliest human evaluations.

Clinical development stages are often shown as a succession of interrelated stages, as indicated in the diagram below:

The four clinical development phases have different aims and features.

The reasoning underlying the representation of medicine development as a succession of related stages is based on the assumption that the outcomes of previous research should impact the plans for subsequent studies; new information will frequently lead to revisions of the development strategy.

However, studies are also classified into phases based on their objectives and when they occur. Studies may have many phases with varying fundamental aims.

This means that while a medicine is being developed, new evidence may signal the need for trials that are typically conducted at a later stage. For example, although human pharmacology studies are often conducted in Phase I, many of these studies are also conducted in each of the subsequent phases (see picture below).

The reasoning underlying the representation of medicine development as a succession of related stages is based on the assumption that the outcomes of previous research should impact the plans for subsequent studies; new information will frequently lead to revisions of the development strategy.

What are the objectives of early clinical development?

Early clinical development studies focus on the safety and tolerability of the new medicine. They also seek to illustrate the potential of the intended consequence of the medicine.

Early clinical development must solve the following critical questions:

Phase I

Is the medication safe for human use? What are the qualifications? (Intolerance) What happens to the drug after it enters the body? Pharmaceutical Kinetics (PK): How does the medicine effect the body? (Pharmacodynamics) Does the drug work?

Phase 2

Is the medicine dangerous to users? What are the medication’s side effects on the body? Does the drug seem to be effective in patients? What dosage or dosages are you talking about? How should follow-up research be planned? (Endpoints, target population, concomitant drug usage, etc.)

What sorts of interactions are there? (Medication interactions, interactions with food and alcohol, and so forth.)

What are the prerequisites for preliminary clinical development?

Before beginning early clinical development, a medicine must have sufficient proof from non-clinical research to show its safety for usage in people. The next stage is to build a clinical development plan that comprises the following components:

The clinical program’s objectives are established.

Describes the parameters that must be satisfied before a Proof of Concept can be considered successful.
Describes how Phase I and Phase II clinical trials are designed and carried out.

How are decisions made in the early phases of clinical development?

Data informs development decisions. The outcomes of studies are thoroughly examined before development proceeds. Before any additional study can begin, the Proof of Concept must be completed, and a dosing regimen must be determined. If the results of a drug’s early phases of clinical development are favourable, further testing may be conducted. Uncertain early clinical development results need more testing and review before decisions can be made. Early clinical development of a treatment is discontinued if it yields unsatisfactory results, such as when the hypothesis is insufficiently verified or when unacceptably substantial safety issues emerge. At this point, it is vital to halt the development of a large number of potential drugs.

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