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Understanding the Clinical Trial Process

Tim GarnettToday’s guest post is authored by Timothy J. Garnett, M.D., Lilly’s Senior Vice President and Chief Medical Officer, Medicines Development Unit and Lilly Research Laboratories.

Have you ever thought closely about the contents of your medicine cabinet? The treatments inside may have different purposes, but they have one big thing in common: before reaching you, they underwent years of scientific studies to ensure they were safe for you to take.

These research studies, called clinical trials, are the backbone of medicine development. They provide critical information about a medicine’s safety and effectiveness, and generate in-depth data that can even lead to the creation of other innovative treatments. Every potential treatment undergoes several phases of studies, each with a different goal: for example, to identify the correct dosage or evaluate side effects. If a treatment successfully completes the clinical trial process – which not every medicine does – it undergoes evaluation by a regulatory agency, such as the U.S. Food and Drug Administration, and may receive approval for use by other patients.

The success of clinical trials rests in part on finding the right people to participate in them. Every study has different eligibility requirements, which could include age, gender, treatment history, and stage of disease. Lack of awareness can also present a hurdle to a trial’s progress: patients may not know that there’s a trial available to them. In fact, clinical trials take place all over the country – as of today, more than 14,000 trials in the U.S. are looking for eligible patients. For more information or to learn if there’s a trial for you, visit ClinicalTrials.gov

I started my career as a clinical researcher, where I witnessed first-hand the importance of clinical trials – not just to science, but to patients. Clinical trials give people the opportunity to receive access to a potentially beneficial medicine, one that could give them a better quality of life or more time to spend with their loved ones.

Ultimately, clinical trials make a difference not just to today’s patients, but to those who’ll be diagnosed tomorrow, next month, or even a decade from now. They ensure that a potential new medicine benefits the greatest number of people, from those enrolled in a study to those who receive the resulting treatment. Raising awareness about trials, increasing education about how they work, and encouraging people to participate leads to the treatments that improve – and save – lives.

Take a look at the infographic below to get the full picture on clinical trials.

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