Mihaela Munteanu Assignment 3 #A: DIA/FDA Statistics Forum: Visual Overview For Its Evaluation Plan by Mihaela C Munteanu

9. Analysis of Data -Preliminary Ideas

mihaelamunteanu — 2014-11-09 22:51:41 UTC

Descriptive statistics with frequency and percentage from the survey
Provide a pie chart with results from the survey if possible
Report on the number of surveys distributed and the number of surveys answered/completed to see if there is a good data pool to analyze; report on non responses and possible biases
For focus interviews: understand what data trends or themes evolve that will help with key evaluation question 3, and also set up questions in more detail for the next program evaluation.
Report if these interviews took place as designed and shown in Evaluation Matrix.

Note: This evaluation plan is used first as pilot.

2. Program Description

mihaelamunteanu — 2014-11-09 22:51:41 UTC

The DIA/FDA Statistics Forum is given every year in April. FDA stands for Food and Drug Administration and it is an agency within the U.S. Department of Health and Human Services responsible to approve safe and efficacious drugs. It is important to note each time the presentations are different. The presenters are different as well but there are exceptions. The forum facilitates open discussions of topics of practical and theoretical interest to statisticians, clinical trialists and clinical leaders involved in research and development of drugs and medical devices.

The forum takes place over two days as follows: (OPEN SLIDE)

4. Key Evaluation Questions

mihaelamunteanu — 2014-11-09 22:51:41 UTC

The key evaluation questions are related and focused to the overall rationale of the evaluation. The outcome of the evaluation plan is to use the information gathered from the data collection methods to improve the program and ultimately make decisions. Additionally, the stakeholders’ input, was taken in consideration in the development of these questions. Consequently the questions are as follows:

1. To what extent are the participants satisfied with the program and what recommendations for the next year do they have?

2. In what ways do the participants use the knowledge or awareness learned in the program?

3. To what extent were activities (i.e., the planned communication exchanges among participants, speakers, and FDA speakers and FDA participants) described in the program helpful and allowed?

8. Survey Template

mihaelamunteanu — 2014-11-09 22:51:41 UTC

Appendix B

5. Stakeholders

mihaelamunteanu — 2014-11-09 22:51:41 UTC

1. Introduction

mihaelamunteanu — 2014-11-09 22:51:41 UTC

This evaluation plan is for the program called DIA/FDA Statistics Forum organized by Drug Information Association (DIA). DIA is a non-profit international organization. There are other associations for non-profit and for profit that conduct these types of workshops. Some of these training programs differ in their costs and some differ in how often they are offered to keep the costs low. Due to increasing pressure from the industry, academia, private sector, and government on knowing which ones to attend evaluation designs of these educational and professional programs are extremely warranted and sought out.

The learning objectives for the forum were given as the following:

Recognize statistical solutions to issues associated with the evidence and regulatory review
Describe application of statistical methodologies and thinking to the development of new products
Assess the impact of regulations and guidance on statistical practice
Discuss ideas for improving the communication between industry statisticians and FDA reviewers

7. Evaluation Matrix

mihaelamunteanu — 2014-11-09 22:51:41 UTC

How the Data Collection Methods and the Sources of Information Support Each Key Evaluation Question Visually

Concerns of the Plan

mihaelamunteanu — 2014-11-09 22:51:41 UTC

Some of concerns I have are as follows:

(a) respondents will not fill in the survey

(b) respondents will not fill in entirely the survey

(d) not confident that respondents (i.e attendees and speakers) will be entirely truthful in their answers

(e) not able to identify trends from the focused interviews

Note: Consider incentives for respondents to have a higher return of the completed surveys.

6. Data Collection Methods

mihaelamunteanu — 2014-11-09 22:51:41 UTC

The data collection methods were chosen to fit the evaluation questions. There are mixed methods of qualitative and quantitative data to help with multiple sources of information (i.e., triangulation). For a brief summary and at-a-glance view, please refer to the Evaluation Matrix below that shows how the sources of information, and data collection methods attempt to serve the key evaluation questions. A sample Survey is also attached as Appendix B.

3. Purpose of the evaluation

mihaelamunteanu — 2014-11-09 22:51:41 UTC

The proposed evaluation hopes to identify strengths and weakness of the learning objectives of the forum. These findings could assess to what extent the program met its outcomes, and the needs and expectations of the target audience. Additionally, it is sought to identify the appropriate topics for the next training to refine the forum. It is a pilot evaluation at first that could be the basis for a larger evaluation plan later.

Audio Narrative of the Visual Overview

mihaelamunteanu — 2014-11-11 02:45:08 UTC