Building the capabilities to launch a competitive trial

Picture this: The protocol for a new clinical trial is almost complete. On your desk is a document that explains how potential site investigators and subjects view the protocol, including what they find valuable, potential pain points, and key areas where they will need support. Site investigators have been grouped based on their expertise, past enrollment success, and attitudes toward clinical research. Involved relationship managers know what investigators value most within trials, what’s top-of-mind for trial coordinators and what patients like or dislike. Medical science liaisons (MSLs) are notified when certain materials are expected to arrive, when meetings will take place, and what to say when issues and objections inevitably arise. When the time comes to conduct the trial, site investigators feel supported by the sponsor and clinical research organization (CRO). They’ve attained the necessary materials to support potential referrals and can discuss the trial with confidence. If any issues arise, the trial operations team can easily identify course corrections by conducting research and refining the strategy.

This sort of efficiency unfortunately remains a pipe dream, since clinical trial delays continually plague pharmaceutical companies. However, if given the proper guidance, pharma companies can improve their strategic trial launch capabilities to avoid delays in getting needed therapies to patients and the associated financial losses.

Commercial teams’ post-approval marketing efforts lean on vast resources and tactical plans to ensure that their products are differentiated in the market. So, what if our clinical teams applied similarly rigorous strategic thinking toward running a clinical trial?

As the number of registered clinical trials more than tripled between the start and the end of the last decade, competition for eligible patients has become intense in many areas, including immuno-oncology, autoimmune, and severe asthma, often resulting in investigators and their patients choosing between more than one clinical trial and perhaps several approved treatments. Even when only one clinical trial is active at a site for an indication area, competition for the attention and resources of said sites exists, and even for investigators who may be juggling multiple studies across various therapy areas.

Despite these struggles, sponsors have taken steps in the right direction to stand out in the crowd by including patients in the trial design process, as well as considering competing studies and their participating sites. But in what can feel like a mad rush to get a trial started is a tendency to rely on what has been done before.

Achieving clinical trial success in a crowded market requires strategic organizational changes:

• Protocol design: While protocols have historically been designed with key opinion leaders’ (KOLs) input, sponsors should also consider collecting insights from primary research and a range of sites and investigators. This allows for easier site understanding and operationalization, which may decrease screen failure rates and accelerate enrollment across trials. 
• Site and investigator selection: Although sites and investigators are often selected based on experience, potential, existing relationships, and CRO recommendations, these criteria should also include how the protocol will be perceived relative to other options. This enables the selection of sites and investigators who understand and value the intellectual property and protocols. Additionally, site and investigator selection should be considered a part of the broader clinical development plan that works to enable the success of the portfolio strategy.
• Site engagement strategy: Sites are engaged for monitoring and operational needs, but could be more strategically engaged using tailored activities to groups of sites with similar behaviors. This allows for a greater return on time invested in site engagement, investigator’s needs addressed quickly, and stronger site relationships.
• Communication strategy: Communication within clinical trials has historically been a one-size-fits-all style—something that must change. Instead, communication should be pre-planned with an engagement strategy tailored to different segments, all while keeping the broader portfolio strategy in mind. This communication style allows for greater site and subject satisfaction, confidence, willingness to recruit, and partnership building.

Expedited enrollment of subjects into a clinical trial is fundamental to getting approved therapies to patients as quickly as possible. The best way to support this process is to understand the needs and perspectives of potential and current trial sites and subjects.

By implementing a dedicated market research capability that supports the clinical operations, you can collect insights that form the foundation of your overall strategy. 

Market research should be conducted systematically during trial design, testing a “target trial protocol” and a “target product profile” to gauge perceptions on the expected process. This research is essential when assessing the needs of sites and trial subjects in a systematic way; one new insight can have a significant impact on trial enrollment.

This function likely requires an additional team member—backed by the clinical development, clinical operations, and legal teams—to support the primary market research and insights collection. Hiring this person also may introduce a deliberate internal process change that allows time and space for research.

The best way to engage with stakeholders is by empathizing with their situation and discussing the value of a trial to assist with their decision-making. That’s the nucleus of marketing: Not promotion, but empathetically and effectively communicating with decision-makers. A marketing strategy represents the choices we make when creating messages to do so.

We believe that site engagement is built by segmenting site stakeholders based on behaviors and attitudes. Once divided, we adjust engagement accordingly:

Site engagement also involves developing and using messages for stakeholders based on what they value most​:

Site segmentation and trial value message development would be conducted after we have insights from sites and before feasibility outreach starts. This allows us to maximize sign-up to join the trial and categorize sites as they activate. While sponsors and CROs historically have used similar communication strategies to analyze site characteristics, this “segmentation” tactic often isn’t linked to engagement strategies, with value messages being implied rather than explicitly stated.

This strategic trial marketing process may require adding a new team member with strategy or marketing-style skillsets or up-skilling a clinical operations lead. Additionally, teams may want to conduct trial value communication training for the site-facing teams.

Once insights have been generated and the marketing strategy has been created, it’s time to consider the most effective way to engage with sites. This requires a deliberate site-engagement strategy that contains a suite of clinical operations capabilities, including:

• Capturing and translating key research insights into implications for the trial.
• Planning the experience of a site—from first contact to activation to trial completion—while noting interactions with the sponsor and CRO along the way.
• Choosing how to contact and pull resources through stakeholders—also known as a channel strategy—by way of new technologies.
• Creating a detailed communication plan for direct face-to-face contact and indirect contact.
• Capturing enrollment forecasts and thresholds that may trigger the need for further data collection to course correct the strategy.
• Strengthening communication channels to capture research and field insights.

While strategic brand planning and key account management have been shown to improve physician engagement for approved drugs, it’s rare to see the same rigorous strategies and approaches used with the same people when conducting clinical trials. Though uncommon in the industry, we could expect to see improved levels of site motivation by putting the site at the center of trial planning, and designing an experience that makes working on the study as positive and frictionless as possible.

The site-engagement strategy should be managed by the new team member, who would mastermind the strategic marketing capabilities and focus on designing the site experience and structure, roles, and processes to realize this experience.

Having spoken with leaders in the industry about the concept of upskilling capabilities around site engagement, we appreciate that there’s an appetite to address these core problems. These potential changes and approaches indeed fit within the current processes of trial design and operationalization.

Of course, there are still plenty of key questions to address, ranging from prioritizing time and effort across trials and the team’s responsibilities, to attaining proper resources and funding. While we agree with the need to take a sensible approach to integrating new capabilities, we also advocate for a pragmatic and piloted approach. This approach allows us to assess specific needs, demonstrate impact, and mitigate negative consequences or perceptions that may arise. Capability development is a journey, not a destination.

Fundamentally, change is essential to keep sites engaged with clinical trials. As sponsors, the best way to elicit that change is by developing capabilities that enable a better understanding of sites’ and investigators’ needs and how best to communicate with them.