There is a second type of protocol quality that is focused around the quality of the execution of the clinical trials. "Execution" quality addresses issues such as whether effective practices and processes are being used in the protocol; whether the protocol can be executed within the time and cost specified; whether the inclusion/exclusion criteria, procedures, visit schedule, etc. are necessary for the achievement of the protocol's goals and endpoints; and whether any of those events will hinder execution tasks such as subject enrollment/retention or data collection. While execution quality doesn't deal with the protocol from a scientific standpoint, it is nonetheless critical to a successful outcome. No matter how good the science is, a protocol that can't be executed effectively has very little real value.

When considered together, these two types of quality complement each other: Scientific quality tends to expand a protocol's complexity in the name of good science, while execution quality tends to limit it in the name of efficiency and effectiveness. When they are in balance, the two work together to create an optimum protocol. Out of balance, the protocol becomes either too bloated to be executed effectively or too limited to achieve its scientific goals.

Left Out of the Equation

R&D's scientific experts clearly own a protocol's scientific quality. They have the responsibility, the expertise, the authority, and the accountability for creating a scientifically high-quality protocol. However, the scientific experts usually hand off the protocol to operations experts for execution.

It would be natural to assume that the operations experts own execution quality, but that's not the case. While operations experts have responsibility and expertise for creating execution quality, they generally only gain authority after the protocol is finalized. By then, the crucial execution-quality decisions have been made already.

Rarely do scientific experts bring operations experts in as partners during the development of the protocol. That happens for several reasons. Often, the scientific and operational experts are siloed into medical and operations departments, and the "throw it over the transom" mentality presides in which one group independently develops the protocol and then simply hands it off to the second group to execute. Team-based organizations attempt to address this gap by creating a single, unified team. But execution experts remain left out of the protocol-development process because their position often is seen as subordinate to the scientific experts when it comes to protocol decisions. Even in a team environment, scientific experts' opinions receive undue weight, thereby rendering team-based decision-making ineffective.

Furthermore, neither the scientific nor the execution experts have significant accountability for execution-quality failures. If a protocol runs late or over budget, management typically assumes external or other unknowable factors were to blame and no one is held responsible. And if the drug is successfully launched, virtually all execution problems are forgiven. The result is that poor protocol quality never gets resolved. Enrollment and site problems crop up again and again but the root cause – poor execution quality – is never addressed and a huge amount of waste is allowed to occur during the protocol-execution phase.

Steps to Success

There are four steps companies can take to bring scientific- and execution-protocol quality into balance.

1. Make the two types of protocol quality a management priority. R&D management tends to focus on big picture issues and schedules, while the actual protocol quality, execution times, and budgets are delegated to lower level groups in the organization. These lower-level groups, such as the clinical teams or medical management and clinical operations groups, often have conflicting priorities and goals that prevent them from creating the balance between scientific and execution quality. For example, one group may develop milestone dates, but a different group is responsible for the quality standards associated with that date.