The Real Cost of Complexity: What Every Drug Developer Needs to Know

Increased complexity in clinical trial protocols has significantly contributed to rising costs. Learn what’s driving both and how to respond successfully.

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD™ clinical research business of Thermo Fisher Scientific.

Cost and complexity go hand-in-hand

The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Pressure and requirements to engage diverse patient populations in trials have become more challenging and expensive, requiring tailored strategies that can stretch both resources and budgets.

Simultaneously, data shows accelerated timelines press sponsors to deliver therapeutics faster, often with limited resources, while continuously adapting to shifting regulatory standards across regions. Addressing these underlying factors is essential; only by tackling the complexities of recruitment, timelines and regulatory compliance can sponsors achieve cost-effective and efficient trials, paving the way for long-term success in today’s demanding market.

Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

• Internal costs: The complexity of protocol designs — a necessity for innovative therapies — often requires more diverse patient populations, more extensive data collection and sophisticated trial methodologies, all of which demand higher financial outlays.
• External costs: Factors like inflation and heightened regulatory demands add further strain, increasing operational expenses and creating new hurdles to compliance. Recruitment costs are also surging as trials aim to engage diverse patient populations and address geographical barriers.

As a result, the financial demands of clinical trials continue to escalate, with sponsors facing complex costs that require both strategic planning and innovative solutions.

Increased complexity in clinical trial protocols has become a major contributor to rising costs, especially as trials for innovative therapies require more intricate designs and expanded resources.

Nearly 39% of sponsors cite these costs as primarily driven by complex protocols. This complexity is fueled by challenges in recruiting diverse patient populations, meeting regulatory standards, the need to capture more data, the development of innovative therapies and managing longer trial timelines.

To manage these costs, sponsors need to address the root contributors to trial complexity. Enhancing patient recruitment strategies, carefully assessing timeline efficiencies and proactively ensuring regulatory compliance are critical steps for mitigating costs while preserving trial integrity and supporting the development of groundbreaking therapies.

Patient recruitment: A persistent hurdle

Recruiting the right patients and finding suitable sites for clinical trials has become an increasingly difficult task for sponsors. With a growing number of companies competing for similar patient demographics, the pressure to recruit efficiently has intensified. Trials demand access to qualified patients willing and able to participate, but barriers such as geographic limitations, awareness gaps and site accessibility create roadblocks.

For larger companies, competition with other ongoing trials is a major challenge, while smaller and mid-sized sponsors often face issues with identifying and reaching suitable patients. This struggle is further complicated for small sponsors conducting trials in rare disease areas where limited patient pools are available, and for all sponsors facing diversity requirements that mandate reaching underrepresented populations. These challenges underscore the need for efficient and innovative recruitment strategies to maintain trial momentum and success.

Strategies and goals

To meet patient recruitment challenges head-on, sponsors are deploying a range of strategies to expand patient access and improve enrollment.

Building relationships with patient advocacy groups has been an effective approach to reach targeted communities and support patient engagement throughout the trial process. Many sponsors are also expanding the number of sites per trial and conducting research in additional countries to broaden their recruitment reach.

With the resources to leverage advanced data and technology, larger sponsors are using patient-centric platforms and applications to identify and engage target patients more effectively.

Ultimately, these strategies aim to remove barriers that prevent patient participation and to increase overall enrollment rates, supporting a more diverse and comprehensive data collection process.

How a CRO can help

A trusted contract research organization (CRO) can be instrumental in overcoming recruitment obstacles by offering targeted recruitment strategies, digital solutions and patient-centric services.

• Targeted recruitment strategies: Experienced CROs provide deep expertise in patient-focused recruitment, using advanced technology to connect with diverse and hard-to-find populations. Leveraging their reach, global CROs can engage with potential patients across trial phases, helping sponsors reach enrollment goals faster and more effectively.
• Digital and decentralized solutions: A strong CRO will implement digital tools and decentralized clinical trial (DCT) elements to expand reach, reduce site burden and remove patient participation barriers.
• Patient-centric services: CROs with flexible recruitment models tailored to global, regional and local communities can ensure a diverse patient population while addressing specific recruitment and retention challenges.

A successful CRO should bring to the table robust patient advocacy networks, offer digital and community-based recruitment models and use real-time data to monitor and adjust recruitment strategies for faster enrollment.

The impact of lengthening timelines

Ballooning timelines in clinical trials have a profound impact on drug development, driving up operational costs and delaying market access for promising new treatments. Extended recruitment phases, often compounded by challenges in reaching suitable patients, add months to trial timelines, while slow regulatory approvals create further setbacks. With trials facing a median delay of 12.2 months, sponsors risk millions in potential revenue, highlighting the importance of keeping trials on schedule.

This impact is particularly significant given the narrow odds of success; only about 10% of drugs that enter Phase I trials ultimately make it to market. Each delay not only increases costs but also jeopardizes a treatment’s viability, underscoring the urgency for efficient timelines and streamlined processes.

Roadblocks

Today’s drug development environment is burdened by these increasing delays, with 45% of sponsors reporting longer timelines compared to two years ago. Key roadblocks, ranging from a surge in trial volume to rising costs, make it harder to keep clinical trials on track.

• Clinical trial volume: Since 2020, registered studies have surged by 50%, leading to fierce competition for resources, patients and trial sites. This surge stretches resources thin and increases the time required to secure suitable trial locations and recruit participants, both of which are essential to moving trials forward.
• Rising trial costs: Development costs have jumped by double digits, further straining budgets. Increased financial demands, combined with extended timelines, add up quickly, increasing the financial risk of each trial.
• Unpredictability: The majority of Phase I, II and III studies encounter at least one substantial amendment, often requiring enrollment suspensions, participant reconsent, and internal and regulatory approval. These adjustments are necessary for patient safety and data integrity, but they also increase the burden on timelines.
• External pressure: Small to mid-sized sponsors are under heightened pressure to meet aggressive timelines while also capturing more data and insights. As trial complexity increases, these sponsors face the challenge of balancing resource limitations with the need for robust, insightful data.

Strategies and goals

Sponsors are increasingly turning to artificial intelligence (AI) to enhance various aspects of the drug development process. Currently, AI is predominantly leveraged for technical tasks such as analyzing large datasets, but also for operational efficiencies like transcribing meetings or phone calls, allowing teams to save valuable time and streamline workflows. This cautious yet strategic adoption reflects a growing confidence in AI’s potential, as both large and small to mid-sized biopharma sponsors recognize its transformative capabilities.

In fact, 50% of respondents from each group cite AI as a top transformational trend within their organizations. While AI’s broader applications extend far beyond these initial use cases, sponsors are finding immediate value in its ability to accelerate processes, thereby setting the stage for more comprehensive integration of AI technologies in the future.

However, even with these advancements, timelines remain a significant challenge. Lacking internal expertise or capacity often slows progress, making outsourcing a strategic necessity. Functional service provider (FSP) models are instrumental in addressing these gaps. By leveraging AI-driven efficiencies, improving patient recruitment and expediting regulatory submissions, CROs provide the resources and expertise needed to navigate complex trials. And as talent shortages and the scarcity of specialized vendors persist, FSP models play a critical role in ensuring progress and maintaining momentum.

How a CRO can help

Here are key ways a CRO can help drive efficiency for drug developers:

• Accelerating timelines: By implementing predictive analytics, optimizing patient recruitment strategies and expediting regulatory submissions, CROs streamline trial processes, allowing sponsors to reduce the overall time required to bring new therapies to market.
• Data-driven decision making: With real-time data, CROs enable faster decision-making, which means less time spent waiting for critical information. This minimizes delays in site activation, recruitment and regulatory approvals, allowing sponsors to address challenges swiftly and keep trials on track.
• Innovative trial designs: A proactive CRO focuses on using predictive analytics to optimize trial timelines, ensuring that sponsors spend less time waiting and more time advancing their go-to-market strategies with confidence.
• FSP partnerships: Through an FSP model, CROs offer sponsors access to specialized expertise and scalable resources tailored to their needs. Whether addressing talent shortages or operational bottlenecks, FSP partnerships provide the flexibility and support needed to maintain momentum, overcome challenges and deliver results efficiently.

Through unbridled support across these areas, CROs empower sponsors to navigate development with greater speed and agility — paving the way for further innovations in bringing therapies to market.

The burden of increasingly complex regulatory environments

Regulatory complexity is a growing challenge, particularly for global trials that need to meet diverse requirements across different regions. Each region presents its own set of unique and complex regulations that must be met, creating a daunting landscape for companies striving to bring their therapies to market. The burden doesn’t end with initial approval; lifecycle maintenance becomes critical as companies engage in ongoing activities to keep their products compliant. This includes authorization renewals, managing changes in manufacturing processes and ensuring that safety and quality standards are consistently upheld.

The challenges are numerous and multifaceted:

• Continuous oversight: Products can remain on the market for decades, requiring ongoing regulatory vigilance and compliance.
• Fluctuating workloads: In-house regulatory affairs (RA) teams often encounter varying levels of activity, leading to strained resources and inefficiencies.
• Complex product portfolios: Managing products across multiple countries necessitates deep, long-term regulatory knowledge to avoid mismanagement.
• Risk of non-compliance: Mismanagement can lead to non-compliance, which may result in market withdrawal and significant financial consequences. Additionally, as innovative therapies enter the pipeline, compliance with shifting and region-specific regulatory requirements becomes a top concern for drug developers.

Effectively addressing these challenges demands a thorough understanding of the regulatory landscape, along with strategic planning and resource allocation for long-term success in a competitive market.

Strategies and goals

Demand for regulatory consulting has surged in 2024 as drug developers face a growing need for specialized support. While many sponsors are effective in maintaining compliance, limited in-house resources and expertise are prompting increased outsourcing to regulatory experts. Regulatory compliance is essential for keeping clinical trial timelines on track; missing requirements or processes can lead to costly delays.

Although adhering to complex regulations may initially complicate trials, it serves as a critical safeguard against future roadblocks. Balancing compliance with the operational demands of trials is key to avoiding escalated expenses and ensuring smoother study progress.

How a CRO can help

Outsourcing to an FSP partner offers numerous advantages for sponsors navigating the complexities of regulatory compliance. Here are some key benefits of collaborating with a CRO:

• Reduced internal RA burden: Partnering with an FSP partner alleviates the strain on internal RA teams, enabling sponsors to focus on strategic initiatives rather than compliance tasks.
• Cost-effective solutions: FSP partners deliver regulatory solutions that maintain product supply and compliance, minimizing disruptions and financial losses.
• Enhanced management of global submissions: A CRO provides better oversight of global regulatory submissions, effectively managing complexities across markets.
• Dedicated regulatory team: FSP partners offer dedicated RA teams with expertise in global regulations, ensuring sponsors remain compliant and well-informed.
• Specialized technology utilization: Leading CROs leverage advanced technologies for efficient regulatory intelligence sharing across 100+ countries, enhancing submission accuracy and speed.
• Continuous regulatory support: A follow-the-sun operational model ensures seamless project progress and continuous regulatory support.

Additionally, CROs offer comprehensive regulatory support. Top-tier CROs provide a full range of regulatory support, from submission strategy to post-approval maintenance, helping sponsors navigate complex landscapes, including:

Early success

• Provide strategy development, module and content development, SME review, application publishing and maintenance submission
• Support a variety of submissions
• Assist with regulatory authority meetings

Submission success

• Develop submission strategy
• Provide project planning, tracking and management
• Prepare and manage source documents
• Assemble, publish and validate submissions

Life cycle success

• Act as an extension of a company’s regulatory team, providing scalable resources to meet peaks in activity
• Offer leadership to contribute to strategic plans that support market expansion
• Utilize tools and processes to effectively manage regulatory information and provide metrics for assessing KPIs
• Identify new automations to reduce risk and eliminate errors
• Establish aligned governance with clear roles and responsibilities for long-term success

When selecting a CRO, sponsors should prioritize partners with a proven track record in global regulatory submissions; those who utilize advanced regulatory information management systems (RIMS) to streamline compliance and those who are adept at navigating complex regulatory environments — particularly for innovative therapies. By doing so, sponsors can enhance their chances of success in today’s competitive pharmaceutical market.

The right partner brings valuable expertise and advanced, data-driven solutions and patient-centric designs that reduce the burdens of both cost and complexity.

Easing the burden of the cost-complexity conundrum with the right partner

Rising costs and increasing complexity will continue to challenge drug developers, but these challenges are interconnected and can be addressed through strategic focus.

As a true partner for your success, we empower drug developers to be fully equipped to navigate complex regulatory landscapes, optimize patient recruitment and accelerate timelines — all of which are essential in driving market success.

By partnering with our teams, you’re positioned to overcome today’s obstacles and bring innovative therapies to patients more swiftly and successfully than ever before.