What the Future of Study Review Processes Should Look Like

Fenja Kruse

Michael Stadler

The goals of study reviews are no different to reviewing any practice or project, put simply, they are used to assess performance, and create reflection to drive future improvements. Most have heard the phrase, “Insanity is doing the same thing over and over and expecting different results,” and this is true for those running studies who want enrollment and study timelines to be shortened, without getting insights from multiple stakeholders, throughout the study’s lifecycle.

In this article, we won’t delve into what’s wrong with current study review processes, instead, we will look at the 360° study review process being piloted by Bayer, which can lead as an example of how to incorporate feedback and insights from multiple stakeholders before, during, and after the study has been completed.

Bayer’s 360° study review framework

At this year’s SCOPE Europe, Silke Strommenger, Head Feasibility, CDO, at Bayer Pharma AG, presented Bayer’s innovative new study review process being used in a neurogenic bladder (NGB) study, of which Clariness provided the patient insights.

While traditionally pharmaceutical and biotech companies only gather limited insights and feedback from a few parties, and on a regional level, Bayer’s international and holistic approach is believed to be the future of study reviews. The reason for this is that Bayer’s new study review process gathers insights from multiple parties, including patients, investigators, and independent bodies, and combines them with data insights. Further, they are gathering these on an international level, which is incredibly important due to reasons explored later.

This chart depicts Bayer’s 360° framework for the neurogenic bladder study.

Source: Clariness

The goal of Bayer’s framework

While discussing this framework with Clariness, Strommenger explained what the study review pilot meant to Bayer, “We hope to set a new industry standard for study reviews, and in doing so, create better trial experiences for patients and sites.”

The benefit of better trial experiences for patients and sites is shorter enrollment and study timelines for sponsors. Insights from both parties, pre-, mid-, and post-study lead to:

• Increased willingness to participate
• Less enrollment barriers
• Reduced site burden
• Higher patient retention
• Improved public opinion of clinical trials

Study stage learnings

Insights are the fuel of study optimization and improving both patient and investigator experiences, and what Bayer’s framework addresses is the need to gather patient insights at each stage of the study. Gathering feedback at each stage, offers different insights, which impact studies differently.

Pre-study insight benefits

Clariness has gathered pre-trial insights from millions of patients and investigators, and even today, our medical and patient insights teams learn new patient motivations, new barriers to participation, unexpected daily implications of various indications, and the differences in patient population preferences by location, indication, and more. In addition to patient preferences changing by current situation, they also change over time, and it’s important to continuously monitor these changes. The perception of clinical trials has changed dramatically in recent years with events such as COVID-19 brining a higher public awareness of clinical trials and their contribution to society.

There are so many influences on a patient’s decision to participate and remain in a study. A few these include:

The patient’s perception of risk vs. reward—Like most big decisions, patients will weigh up the risk of participation vs. the potential reward of a new treatment. This varies hugely between each indication, for example, patients with diabetes typically have access to treatments that can make their condition very manageable, so is study participation worth the reward of a better delivery system, or less frequent injections? Whereas for some indications, a new treatment may be a new, and in some cases unfortunately, a last hope.

The level of support and information a patient receives—The support and information given to patients by their doctors plays a large part in the patient’s decision-making process. They will typically seek advice from their doctor, or look to friends and family for advice, and in many cases, online, searching through forums and experiences reported by other patients who have participated in similar studies. The availability and patient-centricity of study materials and information can be the make or break of enrollment.

Current treatment satisfaction and symptom tolerance—Patients with different conditions, and circumstances also play a part of the decision-making process. Patients in different countries have different healthcare systems, with varying access to different treatments. Patients with access to treatments, of which they are satisfied, are less likely to enroll for a study. Similar to the risk vs. reward calculation, those without access, or are dissatisfied with their treatments, will be more willing to seek new treatments, but with only so much tolerance to the potential symptoms and side effects of the treatment. This tolerance, like many other factors already mentioned, vary by population, condition, and personal situation.

Further, study protocols are targeting more specific patient populations, with increasingly stricter inclusion and exclusion criteria. Here, there is a clear need to research the patient population, for a few reasons:

• Are there enough patients meeting your study criteria in each of your target locations?
• Is your treatment addressing the biggest needs of the patients?
• Are patients willing to participate in your study, and if not, why not?

The answers to these and many more questions are found in pre-trial study insights, and they help sponsors validate the need for their treatment, the patient population exists and is willing to participate, and can identify enrollment and retention barriers before beginning patient recruitment.

Mid-study insight benefits

Often overlooked, or undermentioned, as most consider insights to be either pre-trial for feasibility, or post-trial in the form of exit surveys and feedback, but insights from both patients and investigators throughout the trial has significant benefits, including:

• Checking whether patients are getting the right information
• Ensuring site staff are supporting patients, and building trust with them
• Finding ways to reduce site burden, to improve screening and patient retention

Patients want to speak out about their condition and experiences. In doing so, they hope that their feedback will improve the experience of other patients, and of course, contribute in accelerating the development of new treatments that they could one day use. Patients are referred to as study participants, so why not let them participate in more than just the study, but in providing valuable feedback? Give participants a voice, and the opportunity to speak about their concerns and fears, before they drop out of the study.

Discovering pain points at different stages the patient’s journey, can help identify pain points that can be alleviated while the study is still underway, reducing the cost of learning.

Post-study insight benefits

Gaining insights from patients and investigators allows sponsors to typically do two things—the first is to validate initial pre-trial assumptions, surrounding forecasted willingness to participate, available target population, enrollment rates, which sites would provide the most referrals, and more. The second, and the potentially more important part of post-study insights, is assessing the patient’s complete experience. We typically separate the experience into two parts, on-site experiences, which includes in-person and virtual appointments, and off-site experiences.

• How easy was a patient able to fulfil the study requirements?
• How smooth was the patient’s enrollment and screening journeys?
• Was the patient able to navigate the required paperwork?

Contrary to off-site, we also have on-site experiences, which provide insights into the study, the treatment, and the participating sites. Being able to evaluate the patient’s experience of a site is incredibly useful when making site selections for future studies.

Examples of treatment and study learnings are:

• How easy was it to take the treatment?
• What side effects arose for the patient?
• Would patients enroll in future studies?

Site learnings can include:

• Would patients participate in another study at the same site?
• Were the staff at the patient’s site respectful and empathetic?

Where do we go from here?

Looking to the future, we hope that more leading sponsors such as Bayer continue to share their respective study review frameworks, so as a collective we can create more patient-centric studies, that meet the needs of patients and provide a better experience.

If we as an industry can provide better study experiences, more informative study materials, and more empathetic site staff, the more likely patients are to enroll, recommend, and reenlist for future studies. Put more simply, building more patient-centric studies will improve global study participation.

Fenja Kruse, Patient Insights Manager, Clariness, and Michael Stadler, CEO and Co-Founder of Clariness