What is the magnitude of risk from making the wrong choice?

First of all, I need someone with experience and background in clinical research for this paper.

Write up a plan for how you will
assess and make decisions around getting
enrollments for the study back on
track. Your plan should include the steps you will take, the tools you will
use, and what you will need to consider in the process. You should incorporate
any information you need not included in the Background
below into your plan.

Background:
You are a new Clinical Trial
Manager at an established company. The company is running a post-market
clinical trial designed to generate data to support marketing claims for a
spinal cord stimulator indicated to treat lower back pain. The device has been
on the market for 5-7 years in the United States, Europe, Australia, China,
Japan, and Brazil. Anecdotally the functional and quality of life outcomes have
been amazing. However, there has been no clinical data available to support
claims that the marketing team can use in marketing materials. The Sales and
Marketing department had allocated over 2 million dollars a year for three
years to the clinical research team to run this study. The company predicts a
significant increase in revenue once the marketing team can access the clinical
data.
The study has 20 sites in
the United States. The design of the study includes 300 patients followed for
one year. The team had projected that the study would enroll 150 patients by
the end of the first year. Unfortunately, ten months in, the enrollment is only
at 75 patients. Your senior leadership is looking to you get enrollments back
on track. Your finance partners have stated that they might provide a little
more funding if you have a solid plan to increase enrollments. It is your
responsibility to develop a plan and present it to your leadership team within
the next three weeks. Before you initiate your decision-making process and make
a final recommendation, your director wants you to run the plan by her and
explain the decision-making process you plan to take. She wants to make sure
you are thinking it through before you start working on the problem.

Consider options you could take to accelerate enrollments.
(examples are below)

Add sites

Incentivize
sites

Revise protocol

Identify and
repair other enrollment issues
Consider the stakeholders you could consult while
making your decision and the stakeholders you will impact.
Consider the decision-making topics . ( I have a slide deck that I can send you )

Decision-making strategies and tools

Ladder of inference

Intuition

Risk-taking

The assignment isnt about making the right decision. It
is about thinking through
your decision-making process. You can use any format
you wish, but your thought
process should flow clearly through the paper.
Questions to ask yourself for writing this paper are:-

What is my ultimate goal?

What data do I have, and what data do I
need to obtain?

What are all the possible options to solve
this problem?

Do I know all the options, or do I need
help?

Am I trying to minimize risk, maximize
output, or optimize the outcome?

What is the magnitude of risk from making
the wrong choice?

How would other stakeholders with
different perspectives view this issue?

Am I looking at this problem objectively?

What does my intuition tell me?

Is there an innovative (but risky) option
that could have a significant impact?

What tools could I use to help with this
decision?

Last Completed Projects

topic title academic level Writer delivered