Scope Creep is a Potential Risk for Any EAP
Posted on 07/16/2018

Learn to Recognize Scope Creep within your Expanded Access Program

Scope Creep is continuous or uncontrolled growth in a project's scope, at any point after the project begins. Just as other clinical projects are susceptible to the concept, so is Expanded Access. In an Expanded Access program, scope creep can occur at any time.  The highest likely time occurs when additional stakeholders join a team.  Those countless weeks of planning leading to the development and launch of an Expanded Access program is when team members seek simplicity, minimal burden on patient and physician, minimal data collection, and low operational costs.  Keeping it simple takes a lot of planning.  As internal stakeholders engage in project conversation, they quickly identify potential opportunities to gather additional data during the program.  It’s easy to lose focus of the original streamlined base deliverable of an Expanded Access Program.  Opportunities for additional data collection are the most common seedlings of scope creep: historical comparisons to past studies, patient acceptability data of a product, or questionnaires on symptoms and progress of the disease. This data can be collected during a clinical program. Keep the Expanded Access Program simple and avoid taking on more than what the program’s original intent. From this you can see that scope creep has the ability to turn a simple inexpensive Expanded Access program with a simple treatment outcome into a program with a structure similar to a clinical trial.

Characteristics of Scope Creep

The four characteristic outcomes of scope creep include: increased cost, decreased manageability, increased burden, and decreased desirability.  

Increased Cost is self-explainable; more data is being gathered which calls for added expenses to the program.

Decreased manageability occurs when there are too many aspects of the Expanded Access program to monitor in a controlled manner. Additional sub-projects will aggregate to create an exaggerated version of the original program. The number of individuals on the team to navigate the Expanded Access program becomes more than what is necessary.

Because you are adding more parts to the program the burden is increased- additional layers to the Expanded Access Program can cause physicians, patients, and sites to become overwhelmed, stretched of resources, and frustrated because of the extensive amount of work involved in the process of requesting investigational drug. Keep in mind, most times physicians and sites are not being paid for their participation in an Expanded Access Program. If the group is adding additional components to the Expanded Access program, set a limit or consider compensation. This increased burden in turn, creates a sense of decreased desirability; physicians, sites, and patients will not want to be involved in the program because of the extraneous entailments of your Expanded Access program.

 

How to Avoid Scope Creep

The issue of scope creep will grow slowly and unnoticed and only recognized when the project outgrows its capacity. Why does it occur? Scope Creep occurs because the scope of a project is not properly defined, documented, or controlled. How do we avoid this concept in Expanded Access Programs?

Have a thorough project plan for your Expanded Access Program. What is your internal organization for your Expanded Access Program? Meaning: how will you create a process to handle each request from the time it is received to the time the drug is delivered to that patient? Have the project plan be the central structure for your program, this alignment will minimize drift from the goal. Ensure the internal structure of the program is coordinated within your Expanded Access program group to keep the program managed within the group that is involved in its administration. Another precaution is to define what data will and will not be collected and adhere to this defined set.

Define the deliverables. Lack of scope or definition can cause the program to follow an unintended pathway. The key is to define your targets and to stay focused on them. Once the treatment deliverables of the Expanded Access program are defined, proper execution of the program will come naturally.

Regardless of how cautious your group is, scope creep will occur. Keep it minimal and plan to accommodate it in a controlled manner. Keep in mind, the primary purpose of an Expanded Access program: treatment rather than data collection.

               

Sarah Alummootil, Expanded Access Coordinator