5 Ways To Enrich The Clinical Trial Ecosystem

By Efthymia Kostaki

Since the first webinar I joined in the early days of my Ph.D. in business, I kept hearing the same ambition from across the sector: We want to bring new drugs to patients faster. Yet the numbers are hard to ignore: Roughly 80%¹ of trials fail to hit their recruitment targets, and site‑level monthly enrollment has dropped sharply in the last decade, by about 14% in Phase 3 oncology trials and 54% in non‑oncology trials.²

After interviewing several clinical trial stakeholders from across the ecosystem to understand why clinical trials remain so inefficient, my take is this: Clinical trial design as an organizational strategy cannot exist in a vacuum but should strive to involve downstream stakeholders, including sites, investigators, and patients, in upstream processes, as early as possible.

A Stark Reality In Clinical Research

Sites struggle with a power imbalance

Clinical research sites strive to be chosen by a sponsor to conduct a trial, but when they are, it’s not without push and pull. For example, when they are selected, sites may have their own software systems but often need to adopt and train for a new platform. This addition often brings with it numerous logins across different systems — just to run one trial. The remarkable thing is that site staff must embrace these new technologies and processes while simultaneously providing patient care.

In addition to these software challenges, sites struggle to understand sponsors’ complex protocols — what the study goal is, the staff training needed, and the burden of data entry. Often, the sponsors have developed the protocol in another language (even in the same language but a different vernacular), and it needs to be translated for the sites’ local communities.

Budget negotiations also take considerable time, as budgets must be approved by both the sponsor and the site. During this tennis match of approvals, trial execution cannot — or at least, should not — begin until all budgets are signed off. Similarly, payment structures differ across sites, and in some cases, payments to sites are delayed by a year, making it challenging for them to maintain operations and keep the study running smoothly.

A thread through all of this is the issue of communication. A sponsor or its designee may communicate infrequently and/or incompletely, and both communication strategies can hinder enrollment. Interviewees suggested that direct communications to the sites have been reduced since the onset of COVID-19. This communication gap suggests that practical feedback from the sites on logistics, such as how the trial medication is physically managed, packaged, tracked, and stored at the clinic, rarely makes its way to the sponsor. In turn, valuable operational knowledge is not incorporated into clinical trial design. Additionally, sites may receive communications from multiple people within the same sponsor or CRO. When CROs act as middlemen between the site and the sponsor, the sites may want to speak to the sponsor directly because of their relationship continuity, whereas CRO organizations experience high employee turnover.

It’s also crucial to recognize that research nurses, clinical trial coordinators, and site staff feel overburdened when asked to address recruitment problems early. Site staff receive difficult protocols, are pressured to perform, and feel unheard when feedback is not incorporated into the protocol. These may all lead to enrollment performance issues, and in an industry with high staff turnover, may make it harder for the sites to project their objective quality.

Principal investigators Need Support

Some PIs are doctors who do not have their own clinical development department or benefit from being part of a site network. Whether the doctors are general practitioners (GPs) or specialists, they are busy providing clinical care. Even if a PI is part of a larger system, they may not be sufficiently supported by the clinical development and operations teams. In some circumstances, PIs may wait for more than a business day for an answer or not have confidence in the answer received because the person answering the request might be less experienced than they are.

Additionally, while GPs may lack specialized disease-specific experience, this should not put them at a disadvantage for selection. In fact, GPs often care for underserved communities, particularly in rural areas, and see real-world patients who typically do not receive care at specialized medical centers. Involving GPs in clinical research brings testing closer to routine practice generates evidence that better reflects everyday prescribing realities and supports the very doctors who will ultimately be responsible for prescribing these treatments once they reach the market.

Patients still aren’t in the loop

Patients are the end users of the tested drug, but patient preference for visit frequency and location may take a back seat when sponsors design and conduct clinical trials. A clinical trial recruiting adults may include patients in their 20s to their 60s, whose age group requirements are vastly different from one another. For example, younger generations are more familiar with mobile apps that might be used as digital diaries in clinical trials, whereas older generations may prefer a pen-and-paper diary to document their health. Whether a patient lives in a rural or urban area also has implications for protocol design, including sample transportation logistics and patient visit schedules. In practice, the typical trial participant is not the typical patient living with the disease.

Technology adoption remains fragmented

The role of technology in shaping this ecosystem cannot be overlooked. Traditionally, one of the primary ways sponsors prioritized sites was based on their geography, but now some CROs prefer sites that operate within the same health system. That’s because sites, CROs, and sponsors are increasingly adopting systems such as EDC platforms for data integration. However, ethics committees are often hesitant to support this adoption. To convince these committees, the users must explain why the platform is capturing specific data and ensure the data is protected and handled in line with privacy and security requirements.

With the rise of AI, sponsors, sites, and PIs often wonder what information they can share with AI and which operational processes AI may make more efficient. There are already use cases where AI has been successfully employed, such as translating patient information and consent forms. However, GCP guidelines have yet to provide clear direction on the use of AI in clinical research, though regulators have published guidance.³

Strategies To Improve Trial Execution

1. Establish A Medical Affairs Team For Site Communication

Sponsors should safeguard channels of communication for the sites, invest in an experienced medical affairs team, and provide a single point of contact to handle queries. Reducing the volume of site communications helps cut through the noise and allows staff to focus on their core role: recruiting and treating patients. The PI must also have access to timely responses from the medical affairs team, even if they’re in a different location or time zone. What’s more, the medical affairs team must create trust with the PI, who expect answers from someone with appropriate clinical authority.

2. Involve Site Teams Early in Protocol Design

Trial design must involve the PIs, research nurses, and clinical trial coordinators early in the protocol development process. This execution team understands the day-to-day site and patient burden, feasibility of the protocol, and trial alignment with clinical care. When the protocol is cocreated with professionals who understand the patient population in depth, it is more likely to be operationally feasible, attractive to patients, and delivered on time and to the required quality.

Building on this early collaboration, sponsors should then select and partner with sites whose investigators demonstrate a strong understanding of the protocol, are actively involved in trial conduct, see their patients regularly, and closely monitor participation and adherence. Site location is also critical, both in terms of its ability to recruit sufficient patients and to support a diverse patient cohort aligned with the study’s inclusion goals. Sponsors should assess whether potential sites are tracking scientific, therapeutic, and operational trends, as this forward‑looking perspective often indicates a site’s capacity to participate in future trials. In addition, understanding a site’s strategic focus and investment in recruitment capabilities, staffing, resources, and facilities can help sponsors identify high‑performing partners who are more likely to deliver on timelines and quality expectations.

3. Understand That A Site Is More Than Its PI

When recruiting PIs for a trial, sponsors should consider the combined experience of the PI and site staff. Clinical experience, rather than trial experience, might also be sufficient to run a successful trial if study staff know how to do the necessary documentation. This approach is particularly relevant for GPs who are inexperienced in trials and will be the eventual prescribers of the new treatment once approved. If they are involved in the clinical trial, they are able to understand and trust the treatment after seeing the positive impact on their patients, reducing the need for a medical liaison team in routine practice. When PIs are very experienced, they often move between institutions and may no longer be involved in the day‑to‑day conduct of the clinical trial, which then falls largely to the study coordinator.

4. Design Protocols For Patients, With Patients

Protocols must be designed for the patient who will receive the treatment once the drug is approved. Understand that patients are living with the disease but may also have multiple comorbidities. Some of these may fall within the exclusion criteria. However, sponsors should be empathetic to patients’ realities and involve patient groups in protocol development to ensure their needs and preferences are met. In practice, sponsors need to shift their gaze from what they observe clinically to how the patient is actually feeling, using direct patient feedback such as patient-reported outcomes.

5. Embrace Technology

Technology sits underneath all these strategies. Consolidated trial platforms can reduce the number of systems sites must use, structured digital communication can support medical affairs teams in responding quickly and consistently, and patient‑facing tools such as apps, telemedicine, and AI‑assisted translation can make participation more feasible and inclusive. As sponsors adopt these technologies, they must work closely with ethics committees and follow emerging GCP guidance to ensure that data are handled responsibly and transparently.

The Clinical Trial Must Be A Living Ecosystem

Designing a protocol, selecting and managing multiple sites, and engaging with patient communities are all strategic activities where silos frequently emerge, with a measurable impact on trial duration and budget. Important to trials running smoothly, sponsors, sites, and CROs should endeavor to create a harmonized clinical research ecosystem. At sponsor companies, clinical development and operations teams need to build trust and long-term relationships with sites, sometimes via their CROs, by involving them early and communicating with them appropriately. Together, these actors can help break down silos, align incentives, and make clinical development more patient-centered.

About The Author:

Efthymia Kostaki is a Ph.D. candidate in operations management at Cambridge Judge Business School, focusing on streamlining enrollment in clinical trials. Her research uses large‑scale clinical trial datasets to quantify how investigator selection and key protocol and site characteristics affect patient enrollment speed, with direct implications for reducing development timelines and costs. A second strand of her work examines global principal investigator workforce dynamics, highlighting how PI attrition and regional differences in retention create operational risk for sponsors and CROs that rely on repeated trials and complex study portfolios. She teaches on the MBA and executive MBA programs at Cambridge Judge and has authored a case study on a start‑up scaling up in the clinical trial space. Across her work, she focuses on how data‑driven operational choices can make clinical development more efficient, resilient, and patient‑centered.

References:

1. Brøgger-Mikkelsen, M., Ali, Z., Zibert, J. R., Andersen, A. D., & Thomsen, S. F. (2020). Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. Journal of medical Internet research, 22(11), e22179. https://doi.org/10.2196/22179
2. Agrawal G, Keane H, Silverstein A, Kautzky J, Parry B, Sartori V (2024) Accelerating clinical trials to improve biopharma R&D productivity, McKinsey & Company. https://www.mckinsey.com/industries/life-sciences/our-insights/accelerating-clinical-trials-to-improve-biopharma-r-and-d-productivity, Accessed: 28 April 2026.
3. INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (2026) Guideline for good clinical practice E6(R3), ICH. Available at: https://database.ich.org/sites/default/files/ICH%20E6(R3)_Step4_FinalConsolidatedGuideline
   _2026_0616_.pdf, Accessed: 24 August 2026).