Often, patients who live with Inflammatory Bowel Disease (IBD) do not respond to conventional drugs and are offered to participate in clinical trials for new treatments. When this happens, patients tend to have doubts and may feel scared because they do not have enough information about the process. This was the case for Tina Aswani Omprakash, IBD patient, patient thought leader, and award-winning author of the blog ´Own your Crohn’s´, when she was offered to participate in a clinical trial.

Aswani Omprakash talked about her experience from having participated in two clinical trials during the online debate ´IBD & Tea´, streamed live on our Twitter account on the 25th of November. She was accompanied by IBD medical expert Prof. Fernando Gomollón from the Clinical Hospital of Zaragoza, Spain and Prof. Alan Boyd, our project’s resident regulatory expert and director/founder of Boyd Consultants. The event, moderated by Kira Keini, from the science communication company and our communication partner, Scienseed, has been watched more than 700 times so far.

Participants talked about clinical trials and how they are perceived by patients. “I had doubts, at first. I think we all do. But I think it was because I lacked education around clinical trials”, said Aswani Omprakash. According to her, patients, in general, do not know how clinical trials work and therefore, are unsure as to how they will be treated or what to expect from this process. Prof. Gomollón agreed: “In most cases, patients are not well informed about what clinical trials consist of, and it is a very difficult concept to transmit to them”.

That is why Aswani Omprakash encourages patients who have participated in clinical trials to talk about this process – “I think it’s very important for patients to share their experiences around this because this kind of information is limited”.

She elaborated on her positive experience from participation in clinical trials for IBD and the “robust care” she received during the entire process. “From a personal point of view, I don’t think I ever felt safer because I was so closely monitored all the time,” she said.

Prof. Gomollón underlined the safety of clinical trials from the clinical perspective – “The standards of care and safety in clinical trials are very high. It is a very controlled environment”.  He added, “there is an external committee working exclusively on safety and they have all the power to interrupt the trial if anything goes wrong”.

Another big concern for patients, according to Aswani Omprakash, is the lack of clarity regarding their rights when participating in a clinical trial. “I’ve heard this a lot. They wonder, am I locked into this? Is this some kind of binding contract? And it generally isn’t. You are allowed to back out of it if it does not suit your purposes or if it’s not something you can commit to at that time,” she stated.

Prof. Boyd pointed out that all this relevant information is given to the patient through a consent form at the beginning of the process. “The consent form also explains how the process is going to be and what side effects and adverse effects have been seen in the previous work”. However, Prof. Gomollón stated that these consent forms tend to be written in technical language and they are “very difficult to understand for patients and need help from physicians”. All three participants advocated for including patients in the clinical trial design, including the drafting of these consent forms

“I would like to see a little bit more flexibility in some of these clinical trials to make them more feasible and attractive for patients to join as well”, Aswani Omprakash insisted.

She summarised the debate by encouraging fellow patients to consider participating in clinical trials and initiate conversations around them with their doctors. She added, “It is important to recognise that in clinical trials we are making our own future and we are making the future for a lot of patients that will be diagnosed with IBD or are moving on new treatments.”