Clinical trial protocols become overly complex because teams copy and paste from previous studies, accumulating unnecessary data points and criteria. Merck advocates for "protocol lean design," which starts from the core research question and rigorously challenges every data collection point to reduce site and patient burden.

The medical community is slow to adopt advanced preventative tools like genomic sequencing. Change will not come from the top down. Instead, educated and savvy patients demanding these tests from their doctors will be the primary drivers of the necessary revolution in personalized healthcare.

When trying to influence external partners, start with those most eager to collaborate. This 'coalition of the willing' builds momentum, helps set standards, and creates social pressure for larger, slower-moving players to join the initiative.

To avoid stakeholders undermining research results later ('you only talked to 38 people'), proactively collaborate with them before the study to define the minimum standard of rigor they will accept. This alignment shifts the conversation from a post-mortem critique to a pre-launch agreement, disarming future objections.

While the FDA is often blamed for high trial costs, a major culprit is the consolidated Clinical Research Organization (CRO) market. These entrenched players lack incentives to adopt modern, cost-saving technologies, creating a structural bottleneck that prevents regulatory modernization from translating into cheaper and faster trials.

When integrating acquired biotechs, Merck prioritizes retaining key talent and preserving ongoing science. The strategy involves immediate face-to-face engagement to reduce anxiety, followed by a pragmatic assessment of which processes must be standardized versus which can remain to avoid disrupting critical trials, a practice they call avoiding 'mercification'.

For smaller biotechs, the key to a successful CRO relationship is treating them as a genuine partner. This requires moving beyond a transactional, fear-based dynamic to one of open communication and mutual respect. Biotechs should actively solicit CRO feedback, as they possess valuable cross-industry insights and can identify sponsor-side behaviors that need to change.

Modernizing trials is less about new tools and more about adopting a risk-proportional mindset, as outlined in ICH E6(R3) guidelines. This involves focusing rigorous oversight on critical data and processes while applying lighter, more automated checks elsewhere, breaking the industry's habit of treating all data with the same level of manual scrutiny.

Merck uses a functional service provider (FSP) model, integrating CRO staff directly into their teams. They follow Merck processes and use Merck systems, creating a seamless experience for trial sites and avoiding the transactional conflicts and change orders common in fully outsourced models, which allows for greater agility.