Reflect on all the information learned in this course so far( see attachment for previous grants and letters). Discuss the content/topic area from which you learned the most. Conversely, discuss the content/topic you feel you need to review.
An Introductory Summary of My Grant Proposal
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1. Do you have an idea for a project? Is yes, what is it? If no, what area of your specialty interests you the most?
Yes. My research topic will be, “Avoiding failure in clinical trials.”
2. Is your project idea(s) compatible with your organization’s current mission and purpose? In what way? If no, can the idea be revised to better fit the organization’s current mission and purpose?
Yes, it is compatible with my organization’s current mission. This topic is compatible because the organization’s main aim is to carry out clinical trials and roll out to the market and ensure minimal failures, including minimizing adverse side effects to the subjects.
3. Is your project unique? Are there other organizations or groups doing this same work? Is there a way to revise the project idea to make it more unique?
My project is not unique. For example, Global Development Amgen-a biotechnology company focused on clinical research-has outlined what needs to be done to reduce clinical trials’ failures. I, however, used the word ‘entirely’ to mean that there is uniqueness based on how I intend to carry out my research and address unanswered questions despite there being existing topics. Additionally, I plan to share my research with adoption organizations. It is important to maintain a philosophy of continual improvement in clinical trials broadly and specifically to optimize every aspect of the development process (Fogel, 2018).
4. What need does your idea address? (The answer to this question will become the framework for the proposal’s need statement).
My idea addresses the tendency of researchers to rush to phase 3. This rush is a significant contributor to failures, as it renders researchers unable to review their progress and proactively anticipate any challenges adequately. Rushing studies into phase 3 after successful phase 2 trials may not provide time for reflection on how best to address safety in phase 3 (Fogel, 2018).
5. How would your idea improve the situation? (This answer will become the basis of the proposal’s goals and objectives).
Upon ensuring there is no rush to phase 3, I will have addressed the need for an exhaustive review of the previous phase. This will involve not only the research team but also external consultants to audit the project. As a result, any unidentified areas, inadvertently skipped objectives, tests, and other vital pointers will be identified and addressed proactively.
To boot, there will be a thorough review of the associated costs and any anticipated costs. Through this, necessary trials will not stall in the future due to funds exhaustion midway. Optimizing for cost by staging investment also slows down, while optimizing for speed tends to drive up the cost (Amgen Science, 2021). This means that a rush to phase 3 may achieve speed but yield more costs upon failure. Further, on successful completion of phase 3 because of a meticulously executed phase 2, there will be an increased likelihood of financiers’ willingness to fund future projects, hence creating a more successful research industry.
6. What do you plan to do to improve the situation? (This answer will become the basis of the proposal methodology).
To improve the situation, I will conduct a study of organizations with recorded failures in their previous research to obtain first-hand information on best and worst practices, consequences, and solutions, which I will share with all relevant bodies and regulators.
7. How will you know if your idea worked? (This answer will become the basis of the evaluation section of the proposal).
To know if my idea worked, I will evaluate the organizations’ and industry’s rate of new drugs’ approval before and after the implementation of my recommendations. The cost of success is so enormous because of all the money invested in drugs that fail: 90 percent of test drugs that enter clinical trials never get approved (Amgen Science, 2021). Into the bargain, I will review the availability of willing future financiers for the next phases, to determine the project’s potential for future advancement and industry-players’ support. Each researcher’s reputation and future grant funding depend on the success of each project (Halcomb, 2016).
8. How much will your idea cost? (This answer will become the basis of the budget). My idea is estimated to cost approximately USD. 100,000.00
9. Is there support within the organization for the project? Consider if the idea might need internal support of organization leadership/administration or perhaps external support from community leaders, school board, or church leaders.
Yes, the organization is supportive as the project will help address some of the industry’s most pressing challenges and reduce the rejection of new drugs’ rollouts. I am seeking approval from the local community and church leaders and local governments, as some of the data collection and trials may fall within their jurisdiction or violate individual rights given religious or traditional beliefs.
10. Is there a way in which these services might be funded in the future once the grant money runs out? (Think sustainability).
Yes, if the grant money runs out, the project can be funded by income generated from community-based initiatives that will be developed in the course of the research. Secondly, once the project has started, I will continuously search for additional grants by sharing our progress and success milestones to have new partners on board for emergencies.
References
Amgen Science. (2021). A Strategy for Making Clinical Trials More Successful. https://www.amgenscience.com/features/a-strategy-for-making-clinical-trials-more-successful/
Fogel, D. B. (2018). Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemporary clinical trials communications, 11, 156-164.
Halcomb, E. (2016). Measuring research success. Nurse Researcher.
2
2
Nneamaka Ajaero
Dr. Elizabeth Adamson
Grant Watch Public Company
https://www.grantwatch.com/
Avoiding Failure in Clinical Trials
According to current research carried out, about ninety percent of drugs that reach the clinical stage of development never make it to the FDA’s commercialization and confirmation. I might think it could be because of the FDA’s stringent review process designed to ensure that only products that deliver a good effectiveness and safety profile ever reach customers. Only half of all drugs which are rejected during the process fail because of a lack of effectiveness. The rush to phase 3 is a significant contributor to failure because it renders researchers unable to review their progress and proactively accept any challenges adequately (Query Sample Size Software Team, 2017). The importance of avoiding failure in clinical trials is to ensure that there is no more cost used since when a clinical trial fails, it costs a lot of money, and avoiding it will cut the cost.
Specific Aims
One of the aims of this proposal is to reduce the costs incurred if a clinical trial fails. Upon the clinical trial failure, the company yields more costs. If a clinical trial’s failure is avoided, then these costs will be reduced. Another aim is to reduce the risks associated with the collapse of clinical trials. When the loss of a clinical trial is avoided, then these risks can be avoided.
Significance of the Proposal
The clinical trial’s impact, mostly in phase III, is significant, with the most affecting being the effect on the financial cost and the human lives. The failure impacts thousands of patients who enroll in clinical studies hoping to find a workable treatment option. When the clinical trial fails, most patients have cancer, cardiopulmonary diseases, or diabetes mellitus. Those patients who participate in these trials mostly have a later stage or difficulty treating conditions with less standard treatment options. Thus, the effect of failed drug trials may be worldwide and may make worse the expectation of the patient, the life quality of the patient, and their emotional well-being.
Thus, if my proposal works well, it will help these patients who suffer due to clinical failure. All these impacts that the clinical negligence has on these patients will be eliminated (Sy Pretorius, 2016). That is one of the essential things for my project. The clinical trial’s failure, mostly in phase III, resulting in material financial distress to the organizations, and they are the contributors to low capital productivity. Weighing the trial’s extensive financial investment, several new drugs are accepted by the regulators. The financial results of a failed drug development mostly exceed R$D. My project will also be significant to help these organizations from having extensive financial losses.
Relevant Article Summary
The failure of many drug candidates to win approval is a vast concern in pharma organizations, specifically as this drives the entire cost of developing the drug. To prevent failures and set up a secure phase II trial, the organizations should improve their method during the early stage and think of the data. There has been an innovative design that uses data to predict clinical trials’ failures and success. This kind of method could aid clinical trials whose failures have significantly risen (IVIDATA, 2020). This tool could prevent drug development failures at the advanced stages in development and allow the stakeholders to readapt the trial strategy to avoid the waste of money and time. This method could be used at the time of post-approval surveillance of drugs.
Innovation
My idea is not new because there have been explanations on what should be done to prevent other people’s clinical trial failures. Still, my idea is different from the others since I will carry my research different from what other people do. I will also be addressing some questions that have not been answered by others.
Conclusion
Only half of the new drugs make it to phase III; collaborating more closely with contract research companies and adopting best practices can help ensure success. One of the main reasons for the failure is the rush by manufacturers to phase II once an exciting signal appears at phase II. For the pharmaceutical organizations, this issue has also become very wasteful, though not only for the companies but also for the patients who may waste time participating in the studies they hope will result in new cures for their ailments. Finding ways to try and avoid these clinical failures is a very important thing that people should embrace.
References
IVIDATA. (2020, January 29). How to avoid failures in clinical trials using machine learning. Retrieved from https://medium.com/ividata-et-ses-business-managers/how-to-avoid-failures-in-clinical-trials-using-machine-learning-f8d852e582c2
NQuery Sample Size Software Team. (2017, May 19). Why do phase III clinical trials fail? Retrieved from https://blog.statsols.com/why-do-phase-iii-clinical-trials-fail
Sy Pretorius. (2016, August 1). Phase III trial failures: Costly but preventable. Retrieved from https://www.appliedclinicaltrialsonline.com/view/phase-iii-trial-failures-costly-preventable
2
2
Nneamaka Ajaero
Dr. Elizabeth Adamson
Grant Watch Public Company
https://www.grantwatch.com/
Avoiding Failure in Clinical Trials
According to current research carried out, about ninety percent of drugs that reach the clinical stage of development never make it to the FDA’s commercialization and confirmation. I might think it could be because of the FDA’s stringent review process designed to ensure that only products that deliver a good effectiveness and safety profile ever reach customers. Only half of all drugs which are rejected during the process fail because of a lack of effectiveness. The rush to phase 3 is a significant contributor to failure because it renders researchers unable to review their progress and proactively accept any challenges adequately (Query Sample Size Software Team, 2017). The importance of avoiding failure in clinical trials is to ensure that there is no more cost used since when a clinical trial fails, it costs a lot of money, and avoiding it will cut the cost.
Specific Aims
One of the aims of this proposal is to reduce the costs incurred if a clinical trial fails. Upon the clinical trial failure, the company yields more costs. If a clinical trial’s failure is avoided, then these costs will be reduced. Another aim is to reduce the risks associated with the collapse of clinical trials. When the loss of a clinical trial is avoided, then these risks can be avoided.
Significance of the Proposal
The clinical trial’s impact, mostly in phase III, is significant, with the most affecting being the effect on the financial cost and the human lives. The failure impacts thousands of patients who enroll in clinical studies hoping to find a workable treatment option. When the clinical trial fails, most patients have cancer, cardiopulmonary diseases, or diabetes mellitus. Those patients who participate in these trials mostly have a later stage or difficulty treating conditions with less standard treatment options. Thus, the effect of failed drug trials may be worldwide and may make worse the expectation of the patient, the life quality of the patient, and their emotional well-being.
Thus, if my proposal works well, it will help these patients who suffer due to clinical failure. All these impacts that the clinical negligence has on these patients will be eliminated (Sy Pretorius, 2016). That is one of the essential things for my project. The clinical trial’s failure, mostly in phase III, resulting in material financial distress to the organizations, and they are the contributors to low capital productivity. Weighing the trial’s extensive financial investment, several new drugs are accepted by the regulators. The financial results of a failed drug development mostly exceed R$D. My project will also be significant to help these organizations from having extensive financial losses.
Relevant Article Summary
The failure of many drug candidates to win approval is a vast concern in pharma organizations, specifically as this drives the entire cost of developing the drug. To prevent failures and set up a secure phase II trial, the organizations should improve their method during the early stage and think of the data. There has been an innovative design that uses data to predict clinical trials’ failures and success. This kind of method could aid clinical trials whose failures have significantly risen (IVIDATA, 2020). This tool could prevent drug development failures at the advanced stages in development and allow the stakeholders to readapt the trial strategy to avoid the waste of money and time. This method could be used at the time of post-approval surveillance of drugs.
Innovation
My idea is not new because there have been explanations on what should be done to prevent other people’s clinical trial failures. Still, my idea is different from the others since I will carry my research different from what other people do. I will also be addressing some questions that have not been answered by others.
Conclusion
Only half of the new drugs make it to phase III; collaborating more closely with contract research companies and adopting best practices can help ensure success. One of the main reasons for the failure is the rush by manufacturers to phase II once an exciting signal appears at phase II. For the pharmaceutical organizations, this issue has also become very wasteful, though not only for the companies but also for the patients who may waste time participating in the studies they hope will result in new cures for their ailments. Finding ways to try and avoid these clinical failures is a very important thing that people should embrace.
References
IVIDATA. (2020, January 29). How to avoid failures in clinical trials using machine learning. Retrieved from https://medium.com/ividata-et-ses-business-managers/how-to-avoid-failures-in-clinical-trials-using-machine-learning-f8d852e582c2
NQuery Sample Size Software Team. (2017, May 19). Why do phase III clinical trials fail? Retrieved from https://blog.statsols.com/why-do-phase-iii-clinical-trials-fail
Sy Pretorius. (2016, August 1). Phase III trial failures: Costly but preventable. Retrieved from https://www.appliedclinicaltrialsonline.com/view/phase-iii-trial-failures-costly-preventable
T.Forman, PhD, RN-BC, CNE 1
HSCI 7302 Professional Proposal Writing
Proposal Development Part 1 Assignment Instructions and
Grading Rubric
After reviewing all the required course content, please compose the elements of the proposal
requested for the Proposal Development Part 1 Assignment.
Private = Educational/Foundation Public = (NIH) Brief Description
Title/Cover Page Title/Cover Page Title may be created at any point in
time during the project. However, the
funding source and a designation of
whether it is private or public is required
for the Proposal Part 1 submission.
This is necessary for the instructor to
be able to capably grade the
submission.
Introduction/Problem Statement Introduction/Problem Statement One introductory paragraph should
provide the grant reviewed a general
overview of the main idea of the project
and its important.
Goals/Objectives Specific Aims Goals are clear, concise, statements
representative of what will be achieved
upon completion of the proposed
project.
Each goal should have underlying
specific objectives. Objectives need to
be measurable. Objectives usually
include words such as increase,
describe, reduce, or enhance.
Specific aims are used for a research
proposal submitted to the NIH. Aims
are similar to objectives in that they
stem from a statement about the
purpose of the research and concisely
describe what will be tested or
evaluated and should be measurable.
Background/Significance Significance This section should provide a clear,
compelling description of the
importance and significance of the idea
being proposed.
Literature Review/Theoretical
Foundation
Significance In this section other published literature
relevant to the proposed idea needs to
be summarized. It should include only
the most pertinent and current
literature.
Innovation Innovation The innovation section should address
the ways in which an idea is innovation.
Explain how the idea is new and
different from anything that has been
done before.
References References Should be created and updated
throughout the duration of the proposal
preparation process.
T. Forman, PhD, RN-BC, CNE 2
Assignment Instructions
1. Create a title/cover page.
2. Include on the cover page the name and link of the funding source (identified in Week 2).
Inclusion of the title on the cover page is optional for this submission.
3. Make sure to clearly identify the funding source as private or public. This information will
indicate to the instructor which proposal format you have chosen.
4. Instructors reserve the right to not grade any submissions without the private or public
designation information included.
5. Confirm inclusion of all required elements (found in the table above) for the type of
proposal being submitted (private or public).
6. Verify accuracy of APA formatting. For the purposes of this assignment, please follow
the guidelines of the APA 7th Edition Student Paper Checklist.
7. Make sure to use APA formatted heading and subheadings throughout the document.
8. After final review of the grading rubric, please upload the completed document into the
assignment link.
*This assignment is eligible for revision, resubmission, and regrading, if the
initial score earned is less than 90%. However, to meet the eligibility
requirements, the original version of the assignment must have been complete
and submitted on or before the due date/time. In other words, if the
assignment is submitted late or is incomplete, the option to revise and
resubmit for regrading has been forfeited.
Grading Rubric
Element
(Private OR Public)
Exemplary (4 points)
Proficient (3
points)
Developing (2
points)
Needs
Improvement (1
points)
No Credit
(0 points)
Title/Cover Page Finding source information
on title/cover page
includes:
1. Link
2. Private vs. public
funding source noted.
Title is not necessary until
the Week 6 submission.
Funding
source
information is
missing the
link.
Funding source
information is
missing the
private vs.
public funding
source
notation.
Neither link nor
private vs.
funding source
noted; therefore,
the instructor has
no idea what
format the
student has
chosen to follow.
Title/cover
page not
included.
Introduction or Problem
Statement
Introduction providing a
clear overview of the main
idea(s) of the project and
its importance included.
*Information included in
this section is essentially
Introduction
providing an
overview of
the main
idea(s)
included but
the
Importance of
the project
discussed in
the introduction
but the
overview of the
main idea(s) of
Introduction is
lengthy, off topic,
and does not
make it clear to
the reader what
problem this
proposed project
Not
included.
https://apastyle.apa.org/instructional-aids/publication-manual-formatting-checklist
https://apastyle.apa.org/instructional-aids/heading-template-student-paper
T. Forman, PhD, RN-BC, CNE 3
Element
(Private OR Public)
Exemplary (4 points) Proficient (3
points)
Developing (2
points)
Needs
Improvement (1
points)
No Credit
(0 points)
the same regardless of
private vs. public funding
source.
importance of
the project
was not
made clear to
the reader.
the project
were not made
clear to the
reader.
is seeking to
solve.
Goals/Objectives OR
Specific Aims
Clear, concise, goals
stating what will be
achieved by project. Each
goal has at least one
underlying, measurable
objective included (private
funding source format).
OR
Specific aims concisely
describe what will be
tested or evaluated and
are measurable. The
specific aims also address
the hypothesis if there is
one, and the way in which
the aim will be approached
(public funding source
format).
The goals
with
measurable
objectives
stating what
will be
achieved by
the project
are included
but improved
clarity
needed
(private
funding
source
format).
OR
Measurable
specific aims
are included
but improved
clarity
needed
(public
funding
source
format).
The objectives
(of the goals)
OR the specific
aims for the
project included
but some of
them are
immeasurable
(for both private
and public
funding
sources).
The
goals/objectives
OR specific aims
for the project are
either unclear to
the reader or
complete
immeasurable
(for both private
and public
funding sources).
Not
included.
Background/Significance
OR Significance
Clear, compelling
description of the
importance and
significance of the idea
being proposed provided.
*Information included in
this section is essentially
the same regardless of
private vs. public funding
source but the correct
heading must be used.
Private funding source =
Background/Significance
Public funding source =
Significance
An adequate
description of
the
importance
and
significance
of the idea
being
proposed
provided.
An incomplete
or inadequate
description of
the importance
and
significance of
the idea being
proposed
provided.
After reading this
section of the
proposal the
reader asks
themselves “so
what?” –
indicating that a
clear, compelling
case for the
proposed idea
has not been
made.
Not
included.
T. Forman, PhD, RN-BC, CNE 4
Element
(Private OR Public)
Exemplary (4 points) Proficient (3
points)
Developing (2
points)
Needs
Improvement (1
points)
No Credit
(0 points)
Literature Review OR
Significance
Summarizes and
insightfully synthesizes the
most pertinent and current
literature related to the
proposed project, including
an analysis of any noted
gaps and/or limitations in
the research.
*Information included in
this section is essentially
the same regardless of
private vs. public funding
source but the correct
heading must be used.
Private funding source =
Literature Review
Public funding source =
Significance
Both a
summary and
synthesis of
the literature
provided.
A summary of
the overall
picture of the
literature is
provided but
there is no
synthesis of the
information or
knowledge
gained.
There is no
summary or
synthesis of
information
discovered in the
literature
included. Each
article is reported
as a standalone
piece of
information.
OR
The information
included seems
to misinterpret
the literature.
Not
included.
Innovation A complete, detailed
explanation of how the
proposed project is new
and different from anything
that has ever been done
before is provided.
*Information included in
this section is essentially
the same regardless of
private vs. public funding
source.
The reader
can see the
innovative
potential of
the proposed
project after
review of the
provided
explanation.
The reader is
unclear if the
proposed
project is
innovative or
not after review
of the provided
explanation.
The innovation
section provides
no information to
the reader about
why or how the
proposed project
is different from
anything else
already done.
Not
included.
References Reference list contains
comprehensive list of
scholarly academic
resources.
Most of the resources are
from empirical peer-
reviewed journals
published within the last
five years.
Reference list
contains an
adequate list
of scholarly
academic
resources.
Some of the
resources are
from
empirical
peer-
reviewed
journals
published
within the last
five years but
some non-
scholarly
resources
Reference list
contains some
scholarly
academic
resources.
Several non-
scholarly
resources
cited. For
example,
websites,
blogs,
newspapers, or
article from
non-peer
reviewed
journals.
Reference list
contains no
resources that
would not be
commonly
considered
scholarly
academic
resources.
Not
included.
T. Forman, PhD, RN-BC, CNE 5
Element
(Private OR Public)
Exemplary (4 points) Proficient (3
points)
Developing (2
points)
Needs
Improvement (1
points)
No Credit
(0 points)
have been
cited as well.
More than ½
of the
references
listed were
published > 5
years ago.
Most of the
journal articles
cited were
published > 5
years ago.
APA Formatting Free of any APA formatting
errors.
One to three
APA
formatting
errors.
Four to five
APA formatting
errors.
Six APA
formatting errors.
Seven or
more APA
formatting
errors.
Grammar and Spelling Free of any grammar and
spelling errors.
One to three
grammar or
spelling
errors.
Four to five
grammar or
spelling errors.
Six spelling or
grammar errors.
Seven or
more
spelling
and
grammar
errors.
