SMED Clinical Research is now operational

20/03/2024

A big thank you to everyone supporting us. 

Introducing SMED Clinical Research's Featured Feasibility Process.

26/03/2024

At SMED Clinical Research, we understand that successful clinical trials start with meticulous site selection. That's why we've developed our Featured Feasibility Process, a comprehensive approach designed to streamline site identification and ensure the success of your study.

Review on FDA meetings

08/04/2024

FDA meetings are critical for effective communication and collaboration between sponsors and regulators. Understanding the different types of FDA meetings and their purposes is essential to successfully navigate the regulatory pathway. By leveraging these meetings appropriately, sponsors can address key issues, receive valuable feedback, and ensure a smoother drug development and approval process. 

CTIS SUBMISIONS

12/04/2024

After publishing our review on FDA meetings, we had planned to delve into insights about the European regulatory environment, including how to request scientific advice and navigate the clinical trial application process. However, due to the vast scope and complexity of these topics—ranging from seeking advice from the EMA to individual country-specific processes—we decided to begin with a focused overview of the Clinical Trials Information System (CTIS), deferring other topics for subsequent discussions.

STATISTICAL DESIGNS FOR PHASE 1 TRIALS

15/04/2024

Optimizing phase 1 study designs in Oncology is crucial for efficient and effective clinical development, advancing new treatments while minimizing the time, resources, and sample size required for completion. Expedite dose selection and improve patient safety is key.

Overview of the 10 drugs that generated the highest revenue globally in 2023

2/5/2024

Within these pages, we show some insights into the development timelines of each drug, highlighting standout achievements such as the resounding success story of Keytruda and the swift progression through phase I-III trials for Comirnaty amidst the challenges posed by the global Covid-19 pandemic.
While our gaze does not linger on profit margins today, recognizing the multitude of factors at play, the data hints at a promising future discussion. Indeed, as we dissect these development trajectories, a clear pattern emerges – the expedited clinical timelines not only symbolize efficiency but also hold the key to significant cost savings.
As we eagerly anticipate our forthcoming review, let us reflect on the profound impact of accelerated development pathways, paving the way for transformative therapies to reach those in need with greater speed and efficacy.

Once upon a time…abiraterone, from the rejection to revolution.

8/5/2024

In our previous post, we look at the top 10 revenue-generating drugs of 2023, and their clinical development journeys. Yet, beyond these high-profile successes, there's a trove of other drugs that, for various reasons, have lingered in development limbo, been shelved, or perhaps haven't received the precise clinical attention they deserve. Some of these compounds harbor immense potential but remain stagnant, lingering in the shadows, probably because they haven't been approached in the right manner.
Something like this happened with the drug that revolutionized the prostate cancer treatment landscape many years ago: abiraterone (Zytiga)

Accelerated approval procedure for trials conducted solely in Spain.

28/5/24

Spain has been traditionally considered as an appealing country for running clinical trials, and it's not hard to see why, as it offers a highly favorable regulatory environment, generally short startup times, and centers with extensive experience that not only meet recruitment expectations but also ensure data quality; in short, a very efficient environment.

Elevate Your Clinical Trials with EMA's Groundbreaking Initiatives 

19/06/2024

Expanding your clinical trials to include European countries has always been a smart strategy. Now, the European Medicines Agency (EMA) offers two new pathways to streamline the process and elevate the quality of your applications. 

Stats Drops - Descriptive Statistics

12/08/2024

Introducing SMED's STATS DROPS Program!
At SMED, we're thrilled to launch of our new STATS DROPS program, designed to help you master various statistical concepts.
Whether you're curious about understanding a p-value, interpreting a Hazard Ratio, or diving into advanced topics like calculating sample sizes for different types of studies or understanding the impact of censored data, we've got you covered.
Our statisticians Ana Navarro Sellés and Manuel López Romero will be sharing short slide decks explaining all these topics, in an easily understandable way.
We'll be starting from the basics, and today, we're excited to share our first lesson on descriptive statistics with you.

Unlocking Real Value Beyond Speculation

22/8/2024 

While standard reports often rely on published trial results—which, though valuable, may not always reflect future success, particularly in early-phase studies—we delve deeper. Our approach involves evaluating the genuine medical interest, real-world potential, and likely revenue streams of a drug.

Our analysis integrates rigorous risk assessment and financial modelling. We consider various scenarios to gain a comprehensive view of potential profitability, and the risks associated with each project..

Simplifying Manuscript Preparation for Medical Journals

 27/8/20224

Writing and submitting manuscripts to medical journals can be a daunting task. Questions often arise: which journal is the best fit? How should the statistical analysis be conducted? How can I ensure the document is edited accurately? What does the submission process entail?