Phase Clinical Trials: Multiple Deliveries in Drug Development Projects

PMBOK v8 Definition

A project may have multiple components or elaborations delivered at different times throughout the project. For example, a project to develop a new drug may have multiple deliveries, such as preclinical submissions, Phase 1 clinical trial results (safety, side effects, optimal dose, and timing), Phase 2 clinical trial results (effectiveness for 100–300 human volunteers), Phase 3 clinical trial results (tests efficacy against standard treatments), registration and regulatory approval, and then launch. In this example, the deliveries are sequential.

This concept falls under Delivery Cadence (Section 4.4) within the Project Delivery Principles, not a specific Process Group or Knowledge Area.

Why It Matters for the Exam

The PMI exam frequently tests your ability to distinguish between single delivery, multiple deliveries, periodic deliveries, and continuous deliveries. Questions often present scenarios describing phased or incremental project outputs and ask you to identify the correct delivery cadence type. You will also see questions linking delivery cadence to development approaches (predictive vs. adaptive).

Key Points to Remember (for the exam)

• Multiple Deliveries Definition: Projects that produce outcomes at different times throughout the project lifecycle, not just at the end
• Sequential Example: Drug development phases (preclinical → Phase 1 → Phase 2 → Phase 3 → regulatory approval → launch)
• Parallel Example: Building security updates (physical barriers, badges, key code pads developed separately without specific order)
• Key Distinction: Multiple deliveries ≠ periodic deliveries; periodic deliveries follow a regular, fixed schedule (e.g., biweekly releases)
• Common Confusion: Do not confuse "multiple deliveries" with "incremental delivery" (incremental is about partial product delivery where each increment builds upon previous ones)
• Delivery Types: Single delivery (all at end), Multiple deliveries (various times), Periodic deliveries (fixed schedule), Continuous deliveries (ongoing)
• Business Objective: All deliveries must conclude to meet or exceed target business objectives

Typical PMI Exam Example

A pharmaceutical company is developing a new cancer treatment. The project plan includes preclinical submissions, Phase 1 results (safety), Phase 2 results (effectiveness in 200 volunteers), Phase 3 results (comparison with standard treatment), and regulatory approval submissions. Which delivery cadence does this project represent?

Answer: Multiple deliveries (sequential)

PMI Exam Traps

• Trap: Confusing "multiple deliveries" with "periodic deliveries"

  • Reality: Multiple deliveries occur at different times based on project needs; periodic deliveries occur on a regular, fixed schedule (monthly, biweekly)

• Trap: Assuming all multiple deliveries must be sequential

  • Reality: Some multiple deliveries can be developed separately and performed in parallel (e.g., building security updates)

• Trap: Thinking multiple deliveries means the project is adaptive

  • Reality: Multiple deliveries can occur in predictive projects (like drug development) where overall scope is planned upfront but phased delivery offers advantages

• Trap: Confusing "multiple deliveries" with "incremental delivery"

  • Reality: Incremental delivery delivers parts of the product progressively, with each increment building upon previous ones; multiple deliveries can be independent

Important PMI Connections

Quick Review Questions

1. A construction project delivers the foundation in Month 3, framing in Month 6, and final occupancy in Month 12. What delivery cadence is this?

2. A software team releases new features every two weeks on a fixed schedule. Is this multiple deliveries or periodic deliveries?

3. A hospital security upgrade includes installing cameras (independent), new locks (independent), and access control software (independent). Can these be delivered in parallel?

4. What is the key difference between "multiple deliveries" and "incremental delivery" regarding how each delivery relates to previous ones?

5. In the drug development example, what makes the deliveries "sequential" rather than "parallel"?

PMBOK v8 Reference

Section 4.4 - Delivery Cadence (pages 69-70 in PMBOK v8)

This concept is part of the Project Delivery Principles, specifically addressing how and when project outcomes are delivered to stakeholders.