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Patient Engagement in the Evolving World of Clinical Trials

by Imogen Cheese
Patient Engagement in Clinical Trials

I was delighted to speak at the 2022 KPM Morgan Operational Excellence in Clinical Trials (OECT) Summit in Berlin. My topic was one I am passionate about – patient engagement. I was happy to see others speak about this important subject, too.

Industry Voices on Patient-Centricity

There was a fascinating talk titled “Reimagining Feasibility in Clinical Drug Development” by Zina Sarif of AstraZeneca. She said that oncology trial design, particularly in our industry, is repeating the way it has always done things, and as a result, trials are coming up short. In everything from trial design to site selection, the same challenges emerge, almost without exception, which leads to delays. The time required to bring an oncology study through the process can be accelerated, but our industry needs to get better at talking – to the physicians, the sites, and the patients. Innovation begins with the very framework of trials.

Clinical training consultant Jo Burmester talked about the impact on monitoring patients. She explained how trials have been forced to evolve as a result of the Covid pandemic and stressed that this process of adapting can be successful if patient needs are the priority.
In his talk about decentralized trials, Rasmus Hogreffe of Medable said it is important for our industry to follow through on putting the patient first. “We need to not just talk about how we are patient-centric, but we need to act patient-centric,” he said. Rasmus pointed out that patients are often willing to take part in clinical trials, but our industry must get better at informing them.
I agree with him. The following initiatives will help:

  • Recruitment efforts must expand to reach more patients who may qualify. Examples to aid expansion include:
        • Revisit the materials created to introduce the trial to patients and ensure they are visually appealing and in lay terms.
        • Work with advocacy groups to share details about clinical trials directly with patient groups.
  • Recruitment strategies require a more patient-centric fine-tuning. We cannot expect that patients always know about clinical trials or where they are taking place. To improve patient knowledge and awareness of trials, consider satellite sites away from large trial centers and targeted digital marketing.
  • Hospitals must be supported and encouraged to more frequently include clinical trials in treatment conversations.
  • Patients must be better informed and engaged while they are participating in trials. This includes confirming that they understand what they are told and the materials they are given to read.
Patient-centric clinical trials

Hospitals must be supported and encouraged to more frequently include clinical trials in treatment conversations.

Feedback is an Important Tool

Roger Legtenburg of AdMedicum spoke about feedback. He said that patients must get feedback after a study and that it is critical to success and learning. He added that feedback should go two ways. Patients should be told about the outcomes of the study, and they should be asked about their experiences taking part. An evaluation form filled out after study participation can go a long way in helping sponsors learn and improve subsequent studies.
Gaining this insight from patients can have a hugely beneficial long-term impact. By better understanding the burden of patients and the elements of the trial they find challenging, sponsors can then make adjustments at the protocol stage for future studies. This will automatically improve the recruitment process for subsequent studies, making it quicker and more cost-effective. Taking the patient burden into account will likely lead to a reduction in attrition rates.

Data Can Be Lacking

Other subjects came up with great passion and discussion. Data was one – critical issues include:

  • Data interpretation
  • Comparing global data when the capture sources differ
  • Cross-industry systems sharing data
  • (And most important of all), data ownership

A mountain of data is obtained in every study, and there could be added value in sharing key data with the patients. This is especially true in oncology settings where the information could be used after a clinical trial for decisions regarding the patient’s next treatment options.
Perhaps a lesson to take home from the dialog at this event is this: talking to patients and gaining feedback will lead to a better understanding of what really matters to them. What patients have to say is valuable and unique – their concerns aren’t always obvious, black and white, or clear cut.

Patient Voices

During my talk, I presented interviews with four clinical trial participants from around the world. It was a virtual focus group. The participants spoke frankly about their experiences and gave us input on where our industry can improve.
Stay tuned for that! I will go into detail with what the patients told us and what we learned in my next blog post.
The OECT conference is always a pleasure to attend. The speakers are clearly focused on patient engagement. I’d like to hear about your patient engagement challenges as we adapt to our post-Covid era. Please scroll down and leave your thoughts in the comment box.

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