Guest Column | March 19, 2024

Why The ‘Illusion' Of Speed In Clinical Trials Unravels As Contracting Demands Scale

By Karl Dorwart, vice president, head of healthcare, life sciences and consumer staples, Factor

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The relentless pursuit of speed in clinical trials is driven not only by the noble quest to expand patient access and deliver novel treatments that save lives but also by more pragmatic time-to-revenue considerations for the drug pipeline. With pressure from investors monitoring trial budgets, regulators demanding review boards, and CROs readying patient enrollment across the world, biotech companies racing to get drugs to market faster often struggle to overcome the many stumbling blocks set by multi-jurisdictional reviews and approvals.

Executing relatively modest volumes of legal agreements can cripple a leanly staffed in-house team, especially as their focus must also be on protecting IP rights and strategic collaborations. As biotechs enter Phase 2 and 3 of clinical research, those small legal teams can be overwhelmed as upward of tens of thousands of trial agreements may be required, resulting in bottlenecks or excessive law firm fees.

Currently, over 80% of trials face delayswith half of those reporting contracting and legal hurdles.

What’s more, delays of four to six months can leak over $100 million over the lifetime of a product, based on numerous academic and research studies over the last decade. The human impact of those delays can be felt in the thousands of patients who urgently rely on getting access to potentially lifesaving treatments or technologies.

In a bid to expedite progress, biotechs find themselves fully reactive to each site and jurisdiction they launch trials in. Expertise and advance knowledge on research institute conventions and multi-jurisdictional regulatory nuances can be lacking.

With late nights and an all-hands-on-deck approach, there’s little choice but to trade off strong contracting procedures and processes to maintain that perceived state of momentum, especially to keep pace with financing and shareholder milestones.

And herein lies the illusion: This furiously paced, “site start-up or bust” mentality inadvertently perpetuates slower and more unpredictable trials, ultimately draining more time and money over the lifetime of the trial.

Mark Zuckerberg coined the phrase: “Move fast, break things.” But behind the scenes at Meta, the call for speed and urgency — while accepting the risk of failure — is underpinned by tech talent as well as sophisticated systems and processes that can keep pace with the fast-moving and innovative work setting.

The same applies to contracting at biotechs: to progress swiftly and bring new treatments to market with speed and safety, a talented legal contracting team, operational acumen, and a robust process are needed to power the administrative labyrinth of sites, global regulatory agencies, review boards, and research partners... and support the myriad of mission-critical work necessary to support the drug pipeline.

Here are some common mistakes that biotechs make (and how to avoid them) in a bid to speed up clinical trial contracting and get drugs to market faster:

Mistake 1: Overlooking the value of contracting operations

In the rush to innovate and bring lifesaving treatments to market, biotechs tend to prioritize R&D excellence over legal contracting expertise (or rely on more expensive resourcing models), sidestepping the establishment of agreement and contract handling engines that form the bedrock of efficient and predictable clinical trials.

However, the cost of less mature clinical trial agreement (CTA) operations can be hard felt in Phase 3 when trials trigger substantial legal complexities — inviting increasingly unpredictable outcomes.

Clinical trial sites often have standard practices and common jurisdictional requirements, and biotechs can quickly find themselves exposed to a range of challenges that can be avoided with an ability to plan for known market norms and regulations across jurisdictions. For example, conducting multinational Phase 3 clinical trials involves navigating diverse legal and regulatory requirements that can derail contracting with investigative sites located across borders. With a mature clinical trial agreements operation, foresight of standard market practices in key jurisdictions leads to faster, more efficient, predictable trials.

In fact, planning ahead and implementing smart process automation to expedite contract negotiation and execution has the potential to reduce time to launch and cycle time in negotiations by 20%-30%, based on improved cycle times recorded by Factor Biotech clients.

Biotechs should seek to build the foundations of a robust contracting framework that mirrors that of more established firms to foster scalable, efficient contracting processes encompassing simple best practices, such as delegation of signatory authority and tiered escalation clauses.

The transition from a small-scale clinical contracting model — where most of the contracting takes place in Legal — to a large-scale model, where Legal is accountable for making available playbooks, templates, and standard negotiation clauses, and teams outside of Legal are empowered to drive contracts to execution, requires making sustainable improvements to contracting processes. A mature contracting operation requires technology to reach out en masse and deliver transparent reporting and clear protocols for escalations and reporting. Only then can you ensure the highest and best use of legal and business resources.

Mistake 2: Failing to integrate contracting expertise into your site start-up strategy

As slim in-house legal teams cross the research site start-up finish line — at times, with morale low (and tension across legal and R&D) and the baseline for escalations even lower — the operational strain can reach a breaking point as the company attempts to scale.

Without market expertise, contracting best practices, and enabling legal technology and with a scarcity of legal talent, a biotech’s fledgling negotiation power and inefficiencies are exposed as trials enter multiple jurisdictions, adding further layers of contracting complexity.

If all (or a high percentage of) contract redlines end up as escalations, in-house legal teams can be diverted away from high-value activities, such as advising on research advancements and IP protection. The result: A critical legal bottleneck is created.

To successfully manage global CTAs, integrating clinical trial contracting expertise must be a strategic imperative.

Aligning legal with the site start-up strategy is essential. This means knowing the market and the regulations and institutions in that market and the company’s institutional positions on issues such as confidentiality and privacy, along with the type of agreements that are required in those markets. This all requires jurisdictional expertise, knowledge of regulatory expectations, and insight into market best practices. That in turn allows you to design a better trial strategy.

Optimizing your trial strategy requires clinical contract specialists working cohesively as a team with multi-jurisdictional expertise. This team need to work collaboratively, ensuring internal and external alignment on priorities and communicating on risk drivers and business specific issues.

Enabling this talent, together with tech-enabled contracts processes forms the linchpin of faster, more predictable clinical trials.

Mistake 3: Being handcuffed by burdensome internal processes

Combatting clinical contracting delays is about more than utilizing the right knowledge, standards, and practices across core markets, jurisdictions, and institutions. Cumbersome internal processes also can be a common source of delay, further increasing costs.

Behind the common complaint “it’s stuck with legal” are often inconsistent contract terms, documents with multiple versions, and other contracts not completely executed. Signature policy, templates, version control, reporting, and audit capabilities can also be lacking, as can acceptable fallback liability and indemnity positions when negotiating.

Effective process automation that empowers legal teams requires thoughtful work up front by biotechs on internal roles, standard documentation, preset negotiating positions, and escalation protocols to streamline the contracting process and enhance trial predictability. 

Agreement on roles and responsibilities and a level of internal readiness are needed to actively automate operational contract processes.

In building streamlined contracting processes, ensure that the roles of ClinOps and Legal are clearly understood and that processes clearly support the end-to-end interactions and accountabilities.

That up-front work can enable incremental gains with each transaction, cumulatively allowing you to run future trials an estimated 20%-30% faster.

Getting your internal house in order means understanding what can be known about your institutions in various jurisdictions, applicable regulators, and partners, etc., which can inform a better trial strategy and a faster path toward adoption or approvals.

Don’t think of each trial as a one-off exercise; instead, build the contracting operations engine to make the right investments in the staffing model, the technology, the tools, and the contracting artifacts (playbooks, clause libraries, etc.) that lead to repeatability and cost-effectiveness as further programs are developed in the pipeline.

This build/operate mentality — versus “just getting it done” — lays the foundation for scaling and replicability, building the valuation of the company in parallel with efficiently supporting the current drug pipeline. One objective does not have to be sub-optimized for the other.

Legal Frameworks Ultimately Enable More Efficient Trials

Embracing mature processes is not about curbing innovation but about ensuring that clinical breakthroughs reach patients efficiently and reliably. This strategic shift involves embedding contracting operational excellence that can keep up with increasing volumes.

A fast cycle time on one site is not enough when time, budget, and negotiation unpredictability prevail. Applying a more programmatic approach embeds predictability into your overall site strategy and improves trial efficiency.

By integrating the essential speed enablers of legal frameworks and operational processes that characterize mature legal teams, biotechs are empowered to not only accelerate trial timelines but also set the stage for sustainable growth and innovation, ensuring that groundbreaking treatments reach those in need with unprecedented speed and efficiency.

About The Author:

Karl Dorwart is the vice president, head of healthcare, life sciences and consumer staples at Factor, an integrated law provider that works alongside legal departments to manage complex transactional legal work. Factor specializes in providing biotech companies with the legal frameworks and operational processes that characterize mature legal teams.