Introduction

Successfully bringing a new treatment to market requires more than just good science. It demands a meticulously orchestrated approach that integrates clinical development, regulatory compliance, and commercial strategies from the outset to ensure your trial captures the high-quality data necessary for regulatory approval and market success.

It's crucial to recognize that clinical development, regulatory strategy, and go-to-market planning are interconnected.

• Clinical development decisions influence regulatory requirements and commercial positioning.
• Regulatory pathways determine clinical evidence needs and market access timelines.
• Commercial considerations inform study design, such as trial population setting and setting, and regulatory approach.

Developing Your Go-to-Market Strategy

Understand Your Market Dynamics

Your go-to-market strategy informs development and regulatory approaches. When designing a clinical trial with the end in mind, it’s crucial to think about commercial goals from the get-go. As you determine priorities for market success, make sure you address the following questions:

• Do you want to seek payer reimbursement for your intervention?
• What are the pricing and reimbursement landscapes in your target market(s)?
• How does your product address unmet needs compared to existing options?
• How can you build evidence for cost-effectiveness alongside clinical efficacy?

Build Market Access Planning into Clinical Development

Ensure your clinical program generates data necessary for market success. This can be achieved through:

1. Incorporation of Health Economic Endpoints: Including quality of life measures, resource utilization data, or other outcomes important to relevant stakeholders.
2. Post-Approval Evidence Generation: Implementing extension trials or real-world evidence studies to support reimbursement negotiations.
3. Inclusion of Companion Diagnostics: Evaluate whether a diagnostic testing strategy could enhance your product's value proposition and market access.

Crafting Your Regulatory Strategy

Understand the Regulatory Landscape

Understanding the regulatory landscape is essential for efficient product development:

• Development Pathways: Evaluate standard approval pathways versus accelerated options.
• Global Strategy: Decide whether to pursue simultaneous or sequential submissions across different markets (FDA, EMA, MHRA, etc.) depending on where you are running your trial.
• Incentives: Explore orphan drug designation, pediatric investigation plans, or other special designations that might offer advantages.

Engage with Regulatory Agencies Early and Often

Proactive engagement with the FDA and other regulatory bodies can save significant time and resources.

• Request Pre-Submission Meetings: Use these opportunities to discuss trial design, endpoints, and statistical analysis plans before finalizing protocols.
• Align on Evidence Requirements: Confirm what data package will be necessary for approval, including any special requirements for your specific indication.
• Develop a Comprehensive Regulatory Timeline: Map out submission milestones, anticipated review periods, and potential advisory committee meetings.

Building Your Clinical Development Strategy

Start With the End in Mind

The foundation of any successful clinical development program is clarity on your end goals. This includes:

• Defining your target product profile (TPP): Outlining your ideal product characteristics including indication, patient population, dosing, efficacy claims, safety profile, and the geographical location(s) where you plan to market your product.
• Identifying critical success factors: What clinical outcomes will make your product commercially viable? What will payers, providers, and patients value most?
• Mapping the competitive landscape: Understanding the current standard of care and competitor products on the market and in development to position your clinical program effectively.

Designing Your Clinical Program

With clear objectives established, design a clinical development plan that will accurately capture the evidence you need that considers the following.

Development Phases

Map out your clinical development journey from early proof-of-concept through pivotal trials depending on your intervention. Drugs and biologics require a structured approach across four phases to obtain clinical validation. Medical devices and digital health solutions, however, can follow a variety of different pathways based on product risk, similar products already on the market, and other factors.

When creating timelines, be sure to account for possible delays in recruitment and other areas of study conduct, as well as time to receive approvals and make changes to trial design and other crucial elements based on regulatory and ethics committee feedback.

Trial Design

Optimizing trial design is key in ensuring your trial captures essential data as quickly as possible. Critical components of trial design include:

• Endpoint Selection: Select appropriate primary and secondary endpoints to prove efficacy and safety that align with regulatory and commercial needs.
• Eligibility Criteria: Determine optimal patient populations and criteria for inclusion/exclusion.
• Randomization: Depending on your endpoints, establish the ratio for how participants will be randomized (active treatment vs. placebo) if applicable.
• Study Duration: Determine how long participants must remain in your trial in order to collect data that accurately reflects how your intervention will perform in the real world. This may include implementing a long-term follow-up period depending on the nature of your treatment.
• Sample Size: Calculate appropriate sample sizes that balance statistical power with feasibility.

For more information on the elements of trial design, please refer to our blog on developing clinical trial objectives, protocols, and synopses.

Trial Setting

Decide which model—virtual, hybrid, or site-based—will be best to collect the data you need. The risk of experiencing an adverse event (AE) should be the driving factor influencing this decision. For low- to moderate-risk investigational products, however, consider adopting a fully virtual or hybrid model to boost recruitment and retention.

With the growing use of wearable devices and blood collection technologies for self use, many endpoints can be captured outside the clinic and shared with research teams in real-time. Quality of life endpoints and other qualitative data can almost always be collected remotely through ePRO.

• Virtual: Participants complete study activities from their homes. This model is ideal for low-risk investigational products where it might be beneficial to see how an intervention is tolerated in participants’ real-world environments. The virtual model is also well-suited for studies that capture a large amount of data pertaining to subjective experiences, or trials where the patient population may face medical and/or logistical barriers traveling to physical sites.
• Site-based: Participants must regularly visit a study site to participate in the trial. This model should be implemented for investigational products that pose a high health risk and trials that require complex procedures or machinery to collect endpoints.
• Hybrid: Participants travel to the site on occasion and can complete some or most study activities at home. This model is appropriate for trials that require some visits to be completed in-person, but not all.

Timelines

When developing timelines, be sure to account for possible delays in recruitment and other areas of study conduct, as well as time to receive approvals and make changes to trial design and other crucial elements based on regulatory and ethics committee feedback

Site Selection

For clinical trials with physical sites, your approach to site selection should consider patient access, investigator expertise, and cost. This involves:

• Researching where your ideal trial population is located in the world.
• Conducting feasibility calls with site investigators and research staff to vet their capabilities for recruiting for and executing your trial.
• Reviewing sites’ overhead fees, compensation for staff and patients, and other costs and determining what is feasible with your budget.

Data Management

Implement data management processes that ascertain quality and compliance. It’s best practice to review trial data on a regular basis to ensure clinical observations and patient-reported outcomes are being recorded adequately.

Bringing Everything Together

Effective cross-functional collaboration—collating insights from clinical, regulatory, commercial, manufacturing, and financial teams—is vital for crafting robust strategies in clinical development, regulatory compliance, and commercialization. Planning in these domains isn’t a one-off task; it requires regular reviews and adjustments as new data emerges.

Conclusion

Developing an integrated clinical, regulatory, and commercial strategy requires significant upfront investment in planning, but this effort will pay dividends throughout the development of your product. By aligning these approaches from the very beginning, you can optimize resource allocation, reduce development timelines, and ultimately increase your chances of bringing a successful product to market.

At Lindus Health, we are passionate about helping innovative companies navigate this complex landscape with our end-to-end approach to clinical trial planning and execution. Contact us to learn how we can support your development program with our expertise in strategic planning, clinical operations, and regulatory affairs.

‍