The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

RWE and the FDA (Part 1)

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What are RWEs or Real World Evidence about?
How are Real World Evidence used in determining the value of clinical trials on how they are applied in real-life settings?
How are RWEs validated and how are they used in actual medical cases as healthcare procedures are applied in hospitals?
What variables tend to affect the way RWE data is managed and used as a reference to actual medical developments?
How does accurate reporting affect the value of collected RWE data?

Clinical trials accomplished to support the development of healthcare industries around the globe are critically defined to the references on how health conditions are diagnosed and treated.

In the end, the real target end-users of the medicines and other medical procedures are the patients. Hence, creating a more patient-centered approach in handling clinical trials is an important part of defining the success of one study.

One way of making sure that the clinical trials reflect real-world situations is through inculcating Real World Evidences or RWEs. Often, these evidences are garnered through observing samples that are free from the manipulation of the researchers. Through EHRs or Electronic Health Records, statisticians are able to collect data without necessarily influencing the sample population that they have chosen to observe. How does the FDA consider these factors of evidence?

Listen to Josephine Wolfram, an expert in RWEs, and me, and learn more about the way the FDA sees the value of RWEs and how this factor affects the overall procedures considered when approving new medicines and medical procedures that are offered for patients to consider.

Here are some key takeaways to look forward to when listening to this podcast:

Adherence – what is state of the art now?

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How does patient adherence affect the results of clinical trials?
Are there ways to improve patient adherence to medication and treatments not only in clinical trials but also in real-life situations?
What is the future of the value of clinical trials in terms of inclusive technological innovations?

Clinical trials are designed to test whether a medication would be best for the target population. While these approaches are considered critical to healthcare development strategies, their value for applicability still remains dependent on how the participants cooperate with the process of treatment which involves their attitude towards adherence to the trial.

In this podcast, join me and Lina as we talk about the most effective ways to get patients to adhere to treatments they are offered in clinical trials. With her background in psychology, Lena’s insight is on point especially when it comes to determining the role of human behavior in terms of determining the applicability of the results garnered from clinical trials.

While there are several problems that arise from the lack of patient adherence, this podcast highlights some of the most effective ways that are available today for researchers and statisticians to consider when handling patient-centric clinical trials-therefore ensuring a high rate of patient adherence.

Here are some of the important learnings you can get from this episode:

Stepping outside of our co-functions as statisticians with your career

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Why would a person working under the rules and purpose of statistics for 30 years want something more than what she has been an expert with for many years?
Do you want something more out of your statistician background?
What could statisticians offer outside of the field of statistics in healthcare?
How does leadership in statistics bring you to embrace more exciting journey outside of statistics?
What does passion have to do with making statistics work for statisticians trying out new avenues of opportunities?

No matter how boring it may seem to others, statistics is certainly an exciting field for those who enjoy numbers and the analysis of the data collected from samples that are worked on. From the point of collecting data to studying what they mean, statisticians are certainly considered leaders who are able to utilize data to drive change for the benefit of the patients and the general public. But there is more to statistics than simply dealing with the numbers. It gives statisticians a direct connection with the issues giving them a chance to see things more clearly. In this podcast episode on steeping outside of statistics, Alex sits down to connect with Liz Thompson who has a strong 30-year background in statistics to understand why statisticians embrace the option of stepping outside of their expertise in the hope of bringing more value to what they do.

In this discussion, Liz presents some of the most distinct reasons as to why a statistician may want to embrace other options of growth in the healthcare industry as an advocate for distinct purposes.

Here are the bullets of lessons you will get from this TES podcast episode:

Leaders invest in themselves

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Why should statisticians aim for becoming good leaders?
How do you invest in yourself to become a good leader?
How does perseverance change the path taken by a leader in the field of statistics?

Gary Sullivan and I team up together to discuss the importance of leadership among statisticians. Understanding the basic factors of leadership and how it makes an effective statistician is important for every professional in the field of statistics to master.

Statisticians do more than just collect data and analyze the information they have collected. In many ways, statisticians, being the first-hand handlers of the data, also find solutions to problems at a much earlier time compared to other specialists in specific fields. Hence, beyond just relaying the facts, statisticians are also expected to provide first-hand solutions that they think may be capable of resolving the issues they find critical as they go through the data they have collected.

This is where leadership comes in. In our discussion, Gary and I exchange thoughts, and experiences and learned lessons through the years and how they can be applied in actual situations that statisticians face at work.

Here are some of the important realizations that we gathered during our conversation:

Publications in launch and lifecycle

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Publications are part of the bigger communication plan which also covers PR, scientific dialog, promotion, training, and internal communications. Writing publications should follow an overall strategy for the compound or therapeutic area. They are necessary for further steps like having promotional material, HTA submissions, scientific/medical dialog, etc.
They should not be an afterthought or seen as a pure incentive.

In this episode, Jenny Devenport and I talk about these publications as critical part of the scientific process We also cover how creating these helps establishing credibility with various stakeholders.

We also discuss the following points:

What makes a great secondary paper?

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What is a secondary paper?
What is its typical content?
Where is the content coming from?
A secondary paper is a paper you do once you are done with your primary paper. I've been working on this for a long time and always have fun doing it.

Together with Benjamin, we discuss the following points:

What makes you feel comfortable is what keeps you stuck

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Feeling comfortable does not lead to growth.

But why do most people stay in their comfort zone?
Are your own expectations holding you back?

In this episode, I am talking about the reasons why people stay in their comfort zones and always choose the “safe side”. And why choosing this hinders you from your personal and career growth.

Building organisations of leaders

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I am really passionate about leadership and Claude Petit is also passionate about building leaders and being an effective leader. Together, we will share with you how to become a statistical leader and how to build such an organization.

So stay tuned!

About this podcast

The podcast from statisticians for statisticians to have a bigger impact at work. This podcast is set up in association with PSI - Promoting Statistical Insight. This podcast helps you to grow your leadership skills, learn about ongoing discussions in the scientific community, build you knowledge about the health sector and be more efficient at work. This podcast helps statisticians at all levels with and without management experience. It is targeted towards the health, but lots of topics will be important for the wider data scientists community.

by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry


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