How and Why to Include Patients in the Design of Clinical Trials

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How and Why to Include Patients in the Design of Clinical Trials

We recently talked with Rosamund Round, Vice President, Patient Innovation Center and Decentralized Trials at Parexel, about how to include patients in the design of clinical trials for the benefit of all stakeholders. The following is an edited version of our conversation.

How can sponsors go about including patients in clinical trial design?

RR: It begins with the protocol. Traditionally, protocols were designed more with the science in mind than the practical implications for patients, but this has certainly changed in recent years. At Parexel, we are taking our commitment to patients even further with our patient advocacy team and a dedicated Patient Advocacy Council across five regions. We need to engage patient communities and include their insights and feedback into the drug development process early on. This feedback can help us make participation in a clinical trial as easy as possible.

How can we know what patients need or want?

RR: One of the things we like to do at Parexel is digital ethnography studies. When we first start thinking about a trial, we put a diary–video or written–in the hands of a patient and invite them to share  a day in their life, a complete record of what they did and how they felt: “I woke up this morning and every part of my body was aching. It was really difficult to get out of bed . . .” This allows us to get a sense of what everyday disease experiences are like for the patient. And these diaries can be shared with multiple stakeholders on the trial team. As a result, you’re thinking of a real patient, their needs and everyday challenges as you put together your plan for the trial.

Are there other inputs that you consider?

RR: Our Patient Insights Service offers numerous ways to seek patient and caregiver feedback very early on in the protocol design process. It covers everything from how a patient goes about getting diagnosed to their regular treatment, but then we also ask specific questions like, “How many visits could you fit into your life?” We augment this with input from a Nurse Advisory Council to help us understand more about tests and procedures that patients may not have experienced and therefore be unable to comment on. As well as qualitative feedback, this also includes a visit duration calculator. We're always surprised by these results. The first time we ever did it we found that one visit was going to take 17 hours. That is a lot to ask of anybody. Having these insights allows us to dive into protocol and patient support adjustments to make life easier.

In such a case, how do you go about deciding what tests or procedures to remove?

RR: The key is to balance the scientific integrity of the study with asking for only the most critical information needed from patients. We look at what could potentially be simplified, consolidated, or captured in a less burdensome way. And, for those more challenging studies, considering what we can do to make patient and caregiver’s lives easier for non-medical aspects such as travel, accommodation, childcare support etc.  

What other efforts go into making considerations for patients?

RR: Think through all aspects of the study from a patient perspective, from how they learn about the trial, what information is presented to them and the suitability of the format, how they are supported during participation, all the way to how we provide them with information at the end of the trial and thank them for their efforts. It is all about treating patients how you would like to be treated – with compassion, respect and kindness. Some of this information comes from trial participants, our colleagues who may be patients or caregivers themselves,  via our Patient Insights service or through our global Patient Advisory Councils. There’s continuous listening, learning, iterating, and improving. We believe making patient’s lives easier whilst also improving the speed of a trial and quality of the data is a business imperative.