Tina Aswani Omprakash is an award-winning blogger, speaker and patient opinion leader who advocates for chronic illnesses and disabilities, including Crohn’s disease. Her personal journey with Crohn’s has not been easy to say the least. She was diagnosed with Inflammatory Bowel Disease (IBD) when she was 22 years old and underwent over 20 surgeries in seven years along with hundreds of procedures and imaging studies. At one point, she had tried many of the common Crohn’s treatments on the market and was not getting a response while her condition kept worsening. That’s when her doctor asked her to consider a medication that was still being tested in clinical trials. Aswani Omprakash said yes.
About eight months into this new treatment, her condition started to improve. Further, as a clinical trial participant, she was able to appreciate the meticulous care and monitoring she received. Unlike Aswani Omprakash, however, not all IBD patients are forthcoming when it comes to participating in clinical trials. There are genuine concerns about the safety of a new treatment and the fear of enduring potential side effects. But the truth is that about one-third of IBD patients don’t respond to initial treatments and more than half lose responsiveness to treatments over time. That’s why there is an urgent need for developing and approving new treatments to improve patients’ quality of life, which makes clinical trials indispensable.
Before reaching the market, regulatory authorities such as the European Medicines Agency, the Food and Drugs Administration and other national bodies need to approve any new drug or treatment for its use. So, after researchers demonstrated that a new drug has treatment potential in the lab and in animals, these authorities grant them permission to study its effects on people. This is when a clinical trial starts: a long journey of different phases, each one designed to answer a separate research question – Is the drug safe to use? Is the drug effective? Does the drug work better than currently available treatments?
If researchers see positive results in all clinical trial phases, they submit an application to the regulatory authorities, who review the clinical trial data and decide if the drug will be approved. When this happens, the last trial phase starts where researchers monitor patients for several years to evaluate the long-term effects of the drug.
In addition, there are many different types of clinical trials that answer different questions about the disease beyond new treatments. Some of them aim to find better ways to prevent or lower the risk of getting IBD or relapsing. Others look for better ways to diagnose this condition. Certain clinical trials pursue a better understanding of how genes can protect people against IBD or increase their risk of getting the disease, while others research new ways to improve comfort and quality life of patients already diagnosed with IBD.
For clinical trials to be successful and useful, their needs are to active participation and engagement with patients. It is no secret that involving patients in the entire research process may lead to more relevant results and new knowledge that benefit not only clinical trial participants but also future patients. For this to happen, the onus is on the scientific and medical communities to motivate patients to participate in research by giving them an active role in setting research priorities, facilitating their access to clinical trials, providing them with adequate information about the study and their results and assessing their experience through the clinical trial.
Building trust in new treatments and encouraging participation in clinical trials go hand-in-hand and require simultaneous engagement from the scientific, medical and patient communities. To this end, the New Deal Project is organizing a live online debate featuring Aswani Omprakash along with medical expert Prof. Fernando Gomollón, who is an IBD specialist at the Clinical Hospital of Zaragoza, and Prof. Alan Boyd, the project’s resident regulatory expert and director/founder of Boyd Consultants. The aim of this event is to start the conversation on building trust in a new therapy by understanding the role of clinical trials and regulatory processes. Attendance is free and requires registering your email at https://bit.ly/3kqKYAs where you can also leave any questions and comments that you´d like to be discussed during the event. The debate is scheduled for 25th November at 16:00 (Madrid/GMT +1) – register now and don’t miss the chance of getting your questions answered!