Seven challenges in capturing actionable feedback from clinical trial results meetings—and how to overcome them

When pharmaceutical companies complete a clinical trial, they often organize a clinical trial results meeting with participating site staff, including principal investigators (PIs) and study nurses or coordinators. These meetings, which are typically led by company representatives who present the trial results, have increasingly been held virtually in recent years, allowing for reduced costs and expanded access.

Whether conducted virtually or in person, obtaining structured feedback from clinical trial results meetings presents several challenges. Here are the seven most common ones and ways to overcome them.

Challenge 1: Clinical trial results meetings are often a one-way communication

When pharma companies organize clinical trial results meetings for the clinical sites that have participated in the clinical trial, the pharma companies focus very much on presenting the results from the trial. That focus makes sense. But if the pharma companies do not take the time to properly discuss the results with the principal investigators, they can miss out on a valuable source of input for drug development: the clinical site staff, who have first-hand experience treating patients with the pharma company's new molecule.

Not taking the appropriate time to listen to the principal investigators' and study nurses' observations and experiences is one important challenge.

Challenge 2: Clinical sites' recall challenges

Clinical trial results meetings with the clinical sites typically take place up to five months after the Key Result Meeting (KRM), depending on company size and agility. Smaller companies may turn around meetings within a shorter period, while larger companies often need three to five months to analyze the data, hold internal meetings, and prepare external communications with the investigators. Though this timing has improved within recent years, it still presents a significant obstacle. If asked, can site staff remember clearly what they experienced up to five months ago? Can you?

The recall challenges are even more pronounced for the study sites that recruited patients quickly. These site staff will likely have had their last patient visit months before database lock, meaning several months may easily have passed since they actively participated in the trial.

Furthermore, memory retrieval might also be challenged by the fact that many (principal) investigators and study nurses or coordinators are often involved in multiple trials at once. Consequently, when they attend a clinical trial results meeting, their minds may be preoccupied with new interesting trials they're currently involved in. Accurately remembering their observations and experiences, and differentiating between patients and investigational products, is thus an understandable challenge they face.

Challenge 3: Language barriers in global clinical trials

Although it's a prerequisite that the principal investigators and study nurses or coordinators can read and speak English to participate in global clinical trials, this requirement is not always met in practice. Often, investigators and study nurses or coordinators from countries where English is not widely spoken can be reluctant to speak up if they are required to communicate in English. Therefore, it is often the (principal) investigators and study nurses or coordinators with higher levels of fluency that lead the conversation during results meetings.

Some companies now address this by holding regional or country-specific virtual meetings, allowing dialogue in local languages when necessary. However, the challenge remains throughout meeting discussions, particularly when feedback is sought from global trials.

Challenge 4: The influence of unspoken power structures

Before clinical trial results meetings were held virtually, it was less common for multiple delegates from a site to participate, with attendance typically limited to principal investigators and sub-investigators. However, the shift to virtual meetings has made it more widespread for study nurses and other site staff to join. It's a positive development. Why? Because these professions, in particular the study nurses, often have more frequent and much closer interactions with trial patients, managing many of the tasks related to visits and observing how patients progress during the trial.

However, it is important to mention that the tacit clinical hierarchy persists in virtual settings. Even though study nurses or coordinators have valuable patient-derived insights to offer, it is often the principal investigators who take the microphone and speak up during results meetings. The power dynamics that exist within clinical teams don't disappear simply because a meeting is held virtually.

Challenge 5: Unstructured feedback from site staff is hard to adopt

Another hurdle for principal investigators and study nurses or coordinators at results meetings is sharing experiences that go beyond the measurements included in the trial. This is particularly challenging if their observations relate to something not formally measured, or if the feedback is not entirely positive. Feeling exposed in front of colleagues and pharmaceutical company representatives may prevent them from speaking freely about their experiences.

Even if an investigator or a study nurse or coordinator does share what they experienced, it can be difficult for the company to utilize this information. The company faces critical questions:

• Were the investigator's patients on active drug or placebo?
• Was this an isolated case the investigator spoke about? Or did other investigators have the same observation with their patients?
• What were the characteristics of the investigators' patients? Which of the patients was the investigator referring to?

Without a systematic approach to collecting the investigators' and study nurses' observations, these important insights remain anecdotal, making it difficult for pharmaceutical companies to incorporate them into future trial planning.

Challenge 6: Missing perspectives from daily practice

Clinical trials may be artificial by design, particularly in the early phases, which may impact the interpretation of the clinical trial results. Additionally, there are clinical sites that focus mainly on participating in clinical trials. Nonetheless, important perspectives and insights may be left out if feedback is not gathered in a structured way from the site staff who are used to treating similar patients in their daily practice: how was it to treat the participants with the novel investigational drug? How did this compare to treating similar patients with standard of care in their daily practice?

Would the investigational drug in its current form work for them in their daily practice? Would they envision any barriers to adopting it? What would they see as a relevant comparator in their country?

These important perspectives from the first-hand users of the investigational drug can help inform drug development, ensuring that the following trials are appropriately designed and relevant.

The gathering of these insights from (a subset of) investigators and study nurses can be planned in the protocol, to be captured when the first clinical sites each complete their last patient visit. Today, however, the insights are at best gathered at the clinical trial results meetings, many months after the clinical trial is over, which is often too anecdotal and too late for pharma companies to incorporate into their following trials.

Challenge 7: Factoring in a company's internal decision-making process

The internal processes within pharmaceutical companies may also limit the ability to incorporate feedback from a clinical trial results meeting. When a clinical trial is completed, the results are first presented to the company's upper-level management team in a so-called Key Result Meeting (KRM). Shortly after, management often decides which new and more extensive clinical trials to initiate. These new trials are often planned and designed in a new trial protocol while the original trial is ongoing.

Thus, when upper management decides to initiate new trials, the new trial protocols are often more or less ready, making it easy to submit them for Ethics Committee (EC) and regulatory approval (RA). The primary motivation for this process is to minimize the time from investigational medicinal product (IMP) patent filing to market launch.

The consequent effect is that when a company gets feedback from a clinical trial results meeting, it is often too late for the company to adjust and incorporate feedback from the principal investigators or study nurses. The new trial protocol(s) may already have been sent for RA and EC approvals.

Naturally, it is possible to amend or re-submit a protocol, and pharma companies do make amendments when necessary. However, this may add both time and costs to a development timeline.

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Overcoming the seven challenges

Principal investigators and study nurses are important first users of a pharma company's new molecule. They can elaborate on their observations and often are able to compare them to what they see in their daily practice when treating patients with standard-of-care therapies. The key to capturing this feedback effectively lies in the timing and format.

Solution: Interview a subset of site staff shortly after their individual last patient visit, as a part of the trial protocol, rather than waiting the typical three to five months after trial completion. This approach can:

• Capture feedback while experiences are fresh in mind and before details are forgotten.
• Inform clinical trial protocols and strategies before key decisions are made.

Additionally, combining site interviews with trial data from these sites can enrich the understanding of the feedback, providing even more structured, quantifiable data for future trial programs and comparative insights on the IMP versus existing therapies. Lastly, conducting individual interviews rather than group meetings addresses language barriers and power structures, allowing all site staff to speak freely without hierarchy constraints.

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In conclusion, some questions to consider

How do you capture your investigators' and site staff's experiences and observations of your investigational drug? When do you currently collect the feedback? Is this feedback gathered in a manner and in time to influence your next trial design?

By asking these questions, you are more likely to capture critical insights about your investigational drug that ultimately help optimize drug development and improve clinical trials.