When pharmaceutical companies complete a clinical trial, they often organize a 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 five most common ones and ways to overcome them.

Challenge 1: Delays in results meetings impact site staff recall accuracy

Clinical trial results meetings typically take place one to four months after database lock (DBL), depending on company size and agility. Smaller companies can turn around meetings within one to two months post database lock, while larger companies often need three to four months to analyze the data, hold internal meetings, and prepare external communications. Though this timing has improved within recent years, it still presents a significant obstacle. Can site staff remember clearly what they experienced three or four months ago?

The recall issues are particularly pronounced for study sites that recruited patients quickly. Site staff will have had their last patient visit months before database lock, meaning five to seven months may 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 mind may be preoccupied with interesting new trials they're currently involved in. Accurately remembering experiences and differentiating between patients and investigational products is thus an understandable challenge they face.

Challenge 2: Language barriers in global clinical trial

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.‍

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Challenge 3: 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 or coordinators, pharmacists, and other site staff to join. It’s a positive development. Why? Because these professions 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.
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Challenge 4: Assessing and incorporating observational feedback from site staff

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 a principal investigator or 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:

·      Was this an isolated case? Or did other investigators have the same experience?

·      How many patients experienced this?

·      What were the characteristics of those patients?

Without a systematic approach to collecting principal investigators' and study nurses' or coordinators' experiences, these important insights remain anecdotal. However valuable they might be, they cannot be quantified or verified, making it difficult for pharmaceutical companies to incorporate them into future trial planning.

Challenge 5: 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. Shortly after, management decides which new and more extensive clinical trials to initiate. These new trials are often planned and designed 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—even with improved timelines of one to four months post database lock—it is often too late for the company to adjust and incorporate feedback from principal investigators or study nurses or coordinators. The new trials have already been sent for RA and EC approvals and may even have begun.

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

Overcoming these challenges

Principal investigators and study nurses or coordinators have seen and heard from patients how it was to use the IMP. They can elaborate on how the product works in patients compared to other therapies. The key to capturing this feedback effectively is timing:

Interview site staff shortly after their last patient visit, rather than the typical one to four 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 interviews with surveys generates 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.

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.

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