THE CHALLENGE: Budgetary Issues Bring Phase 2b Study to a Halt
To secure additional funding for continued business operations, a small pharmaceutical company was required to submit a Phase 2b study. However, during development of the study, the company encountered budgetary issues that forced them to discontinue the project. Making matters worse, their clinical research partner declined to participate in any further business activities without a significant operating budget. To get the study back on track, the company turned to MMS with only a few months left to meet their deadline.
MMS SOLUTION: Complete the Study Within the Remaining Time and Budget
Working with the limited funds available, MMS stepped in and immediately prioritized the project deliverables to maximize cost savings and to focus on the most relevant and impactful components of the study. We prepared key data displays and developed concise statistical reports. Instead of assembling as many tables as possible, we saved time and money by identifying only the tables that provided answers to the most pressing questions and cleaned only essential data. It was an exercise in efficient data mining and reporting and, when it was completed, we provided the client with additional biostatistical information to include in their messaging for the review board.
THE OUTCOME: Phase 2b Study Completed and Delivered Successfully
MMS, armed with experience from similar clinical trials and submissions data, was able to deliver the study on time and within the client’s budget. As a result, the company was successful in securing the venture capital funding required for future operations.
By Chris Hurley, MBA, Manager, Clinical Programming & Biostatistics
Monday Morning Mentoring is book on leadership by David Cottrell. This book tells the story of Jeff, a successful manager, who needs to work himself out of an uncomfortable region called “splat” which is located just over the horizon in management land. Desperate for answers, Jeff seeks advice from Tony, the father of one of his college buddies and a very successful entrepreneur. Tony agrees to help Jeff in a series of Monday morning meetings. The intent is not to solve his problems, but to help make Jeff a better person and leader. By doing so, Jeff will develop the skills and confidence to solve problems on his own. This book provides fundamental lessons in an entertaining story as we follow Jeff in his journey to get past “splat” and out of management land and back on the road to success.
In what I believe to be one of the core principles from the book, Tony states: “When you accepted your job, you were not chosen solely to fill a position on the organization chart; you were chosen to fill a responsibility.” A good manager will not place blame when something happens within an organization because by doing so the focus is on the past. By accepting responsibility, one sets the focus from that point forward. By accepting total responsibility, a good leader will be able to put plans in place to overcome issues and accomplish one’s goals.
One doesn’t have to be a manager to accept responsibility. Real leadership can come from anywhere in an organization. People perform necessary functions and make decisions every day that have some impact on the performance of an organization. Actions are taken and outcomes are reviewed either by those performing a function or someone on the receiving end. One accepts responsibility by taking ownership of an issue, making any necessary adjustments, and then moving forward with the solution. This is part of the learning process that we all go through. It is how we improve ourselves at the individual and organizational levels. It makes us better at whatever we do and helps us accomplish our goals.
In a related quote, Tony re-enforces this key principle as he states, “I have found success is ultimately realized by people who make more right choices and recover quickly from their bad choices.” Successful people often realize there is a greater purpose in doing some things, making the right choices, as they keep their eye on the goal. As a successful organization, MMS fosters a culture that enables us to make the right choices. We have a wealth of experience and have a philosophy of continuous improvement that keeps us all focused and moving in the right direction. People here make a difference and, on a daily basis, whether working individually or on teams, demonstrate the values that make MMS the very best in the business.
There are a number of other principles presented in the book’s chapters. Some are targeted towards managers, like “Getting Past Spat”, “Buckets and Dippers”, “Hire Tough” and “Escape from Management Land”. Other principles can apply across the board, like “Tough Learning”, the “Do Right Rule” or “Do Less or Work Faster”. Finally, there are thoughtful examples of simple things that can be put into practice immediately to enhance anyone’s leadership abilities.
In this book, the author takes us on a 10-week journey as we watch Jeff dig himself out of a management rut called “splat”. Along the way, Cottrell demonstrates some key principles that can be used in any environment to either help one get past “splat” or avoid it altogether. Of course, utilizing some of these ideas can help improve oneself as a person as well. This book is very easy to read in a day or so and I highly recommend it for anyone interested in improving their leadership capabilities.
Reference:
Monday Morning Mentoring – Ten Lessons to Guide You Up the Ladder – What You Don’t Know About Leadership Is What’s Holding You Back
HarperCollins Publishers, 2006, ISBN-13:978-0-06-088822-0
By Christopher Hurley, MBA, Justin Sjogren, MS, and James Zuazo, MS, Clinical Programming & Biostatistics
Ingredients: Raw Data (CDASH® brand if possible), CRFs, Protocol, SDTM Implementation Guide, WebSDM (or Open CDISC Validator if you’re on a tight budget), Client Input and 2 to 4 Programmers/Statisticians (4 to 6 for quicker results!).
Directions:
- Begin with a finely grated selection of CDISC SDTM implementation guidelines (for extra spicy, choose version 3.1.2!)
- Set up trial domains and sprinkle with a dash of consistency to other studies if integration is desired.
- Mix raw data, CRFs, Protocol and Sponsor input together and blend purposefully to create Specifications that capture the flavor of the study design and data that was collected.
- Assign programming teams to the mix and develop SAS-based SDTM data domains utilizing the savory Specifications from above.
- For best results, validate these domain datasets using double-programming. This is the preferred method and will enhance your stew with a hearty and satisfying flavor of quality.
- Reconcile all differences between the source and validation programming of the SDTM domains. Note: allow a little extra time for this step.
- Season the SDTM data domains with CDISC compliance using a pinch of Open CDISC Validator or WebSDM, and update your data domains based on the findings.
- Garnish your SDTM domain datasets with updates based on sponsor review comments. Repeat until a perfect blend is achieved then serve with confidence. Note: this is the ultimate taste test. If you slacked off in Steps 2-7, it will show here. Enjoy your Stew!
SDTM stew serves well on its own or as an appetizer to the analysis! Once the raw data is in SDTM format, the process of creating analysis datasets (ADaM) and/or tables will be a mouth-watering treat for your programming and statistics team! Bon appetite!