Eyes On Trials

Background: A Visionary Scientist's Mission: In the early 2000s, breast cancer was a relentless adversary, affecting millions of women worldwide. Dr. Laura Esserman, a distinguished oncologist, emerged as a beacon of hope in the battle against this formidable disease. Driven by her unwavering commitment to improving outcomes for breast cancer patients, she embarked on a mission to transform breast cancer care. Dr. Esserman's unique background as both a clinician and researcher provided her with invaluable insights. She saw the urgent need to revolutionize the traditional clinical trial model, which often moved at a snail's pace. Her vision and dedication paved the way for a groundbreaking study that would leave an indelible mark on the clinical trial industry. The I-SPY 2 Trial: An Innovation in Design : The I-SPY 2 Trial was no ordinary clinical trial; it was a groundbreaking endeavor characterized by its innovative and adaptive design. Here's why it became a game-cha

  Clinical research in India has witnessed substantial growth in recent years, with Site Management Organizations (SMOs) playing a pivotal role in conducting trials efficiently. However, challenges arise when dealing with unorganized SMOs, which lack regulatory oversight and financial transparency. This case study explores the issues stemming from such SMOs and offers a comprehensive strategy to mitigate risks and ensure successful clinical trials in India. Understanding the Unorganized SMO Landscape :  Insights into the Growth of Unorganized SMOs in India and the Reasons Behind Their Frequent Closure: The landscape of Site Management Organizations (SMOs) in India has witnessed exponential growth in recent years, with multiple SMOs often operating within a single research site. This proliferation can be attributed to several factors, primarily the absence of robust regulatory oversight and accountability mechanisms specific to SMOs in the clinical research ecosystem.  Lack of Regulator