Benefits of Partnerships in Clinical Trials and Why They’ve Become the Norm in Clinical Research

The rise of partnerships in clinical trials and the era of specialized service providers

The organizational and operational structures of clinical trials have evolved significantly over the past decades. Trials were traditionally conducted by pharmaceutical firms in-house, with dedicated personnel in charge of conducting clinical research studies to gain insights into the safety and efficacy of the new drugs that were being developed. Over time, clinical trials have become increasingly intricate, in line with numerous underlying trends:

• Transition toward multicenter studies to reach wider populations and capture demographic and genetic variability in study results
• Rise of globalized trials, which make regulatory affairs considerably more complex to navigate
• Growing adoption of technological tools and solutions required dedicated training and adjustment to new workflows, but also opened doors to new methods of conducting clinical trials
• More collaborations between industry, academic, and healthcare stakeholders
• Increasing prioritization of patient needs and preferences, as in patient-centric clinical trials
• Development of new and more complex clinical research methodologies, such as adaptive clinical trials, master protocol designs, remote and decentralized clinical trials

As the possibilities in clinical research study designs widened and the complexity of operations expanded accordingly, service providers specializing in specific aspects of clinical research began to flourish. Clinical trials began to require specialist expertise in the various pillars of the intricate, multidisciplinary endeavors – something which represented an increasingly unrealistic situation for the in-house teams of (especially smaller) pharma and biotech companies wanting to focus their efforts and resources on drug and device development. These changes ultimately ushered in a new era dominated by strategic partnerships in clinical trials, characterized by increased prevalence of outsourcing agreements and contracting of services and technologies from dedicated clinical service providers.

Clinical research organizations (CROs) in particular have secured a role as major players in the clinical research landscape, offering resources, infrastructure, and specialized expertise to trial sponsors for conducting clinical trials, in whole or in part. CROs generally offer a selection of individual services including study design, site identification and selection, patient recruitment, data management and analysis, regulatory affairs compliance, and monitoring – or comprehensive services spanning all of the above.

In parallel, an expanding cohort of technology and eClinical service providers started to offer innovative software tools and solutions such as clinical trial management systems (CTMS), electronic data capture (EDC) systems, wearable devices, remote monitoring platforms, advanced analytics tools, and more. Currently, there is a shift taking place toward comprehensive solutions encompassing all of these functionalities and services into single-provider, single-sign-on platforms, further streamlining trial operations by optimizing interoperability, data sharing, and ease of use. These tools enable important advances such as real-time adverse event monitoring, remote data collection, automated data validation and discrepancy flagging across sites and data sources, and enhanced transparency, in turn supporting patient safety, regulatory compliance, and scientific integrity. Most CROs use one or more of these eClinical solutions, meaning that a sponsor is almost guaranteed to find a partner who can provide exactly the right combination of tools and services required to support each unique trial, whether that’s a comprehensive trial solution or individual services.

Further still, increasing global collaborations opened up opportunities to expand the reach of clinical trials across vastly diverse populations worldwide. Through partnerships between researchers, pharmaceutical companies, academic institutions, and healthcare organizations in different countries – along with the growing feasibility of remote trials – it became more possible than ever before to enroll increasingly diverse populations in clinical research studies, and thus capture variations in genetic backgrounds, environmental exposures, and treatment responses. Diversity in clinical research is essential for securing equal access to healthcare opportunities, as well as for ensuring that approved treatments are effective and safe in patients of different ethnicities and varied genetic makeups.

Who are the key stakeholders in a clinical trial?

In light of the situation described above, clinical trials now typically involve a multitude of stakeholders working collaboratively towards a common goal:

- Sponsors/Funders: Provides financial support (research funding) for the clinical trial

- Investigators/Clinicians: Responsible for conducting the study at participating sites. A principal investigator could be a physician, or a clinical researcher or academic researcher as long as there is a medical doctor appointed under them if the investigator is not a medical doctor

- Medical centers, clinics, research hospitals: As trial sites, provide the physical infrastructure and equipment necessary for conducting the trial, as well as drawing upon patient databases

- Patients/Participants: Volunteer to participate in the trial, representing units of study, but also increasingly seen as stakeholders and collaborators in the design of patient-centric trials

- Patient advocacy organizations (PAOs): Patient groups advocating for representation of their members’ needs in research, also representing an important authority for patient insights and a platform for diffusion of study openings, results, and recruitment of patients

- Institutional Review Boards (IRBs)/ Independent Ethics Committees (IECs): Review and approve trial design, protocols, and study materials to ensure participant safety and ethical conduct

- Contract research organizations (CROs): Act as research partners, providing services ranging from trial design to data analysis, or comprehensive conducting of trials.

- Regulatory agencies: Set forth and enforce compliance with international, national, and local regulations and guidelines governing clinical research

- Local laboratories, pharmacies, mobile health units: Increasingly involved as local facilitators of study drug distribution, laboratory tests, medical procedures, and other study-related interactions, particularly in decentralized and remote clinical trials

Maximizing efficiency through collaboration: Streamlining complex trials for success

The shift to increased collaboration and digital connectivity in clinical trial operations is being driven by a key factor – efficiency. Clinical trials are becoming more costly as they become more complex, which underlies the need for streamlining operational efficiency in order to accelerate trial timelines and keep costs from getting out of hand. In many cases, the best way to maximize efficiency is to delegate specific trial operations to dedicated teams with extensive experience and expertise. For smaller pharmaceutical and biotech firms, this might imply outsourcing the entire clinical trial to a CRO, whereas other trial sponsors might contract a partner just to design a recruitment advertising campaign, if they feel their in-house team is underpowered in that aspect of patient recruitment. The possibilities for collaborations and partnerships in clinical research are nearly endless, but the underlying goal tends to be the same – optimizing operational and economic efficiency.

Partnership-driven approaches allow sponsors to leverage the distinct expertise and resources (including facilities, personnel, and networks of partners and patients) of experienced research partners. Pooling resources via partnerships helps optimize resource utilization and avoid redundancy, while simultaneously supporting adherence to quality standards. When agreements are developed and implemented clearly and honestly, such collaborative efforts promote efficiency throughout all stages of a clinical trial, in addition to increasing knowledge-sharing, which has the potential to create synergies leading to further advancements across the clinical research industry.

See the section “5 Key benefits of partnerships in clinical trials” below for a closer look at the benefits that strategic partnerships in clinical research bring to the table.

Types of partnerships in clinical trials

Public-Private partnerships in clinical trials

Public institutions involved in clinical research include public universities and academic research centers, public hospitals, and government bodies. Collaborations between public and private entities are common in clinical research, particularly in funding and partnership agreements. For example, a privately owned pharmaceutical corporation might receive a government grant to sponsor a study that has important implications in relation to a prevalent condition with a significant public health burden, or that same firm could contract an academic research center of a publicly funded university to conduct a study in one of their areas of expertise.

Academic-Industry partnerships in clinical research

Joint ventures between academic and industry partners facilitate the translation of scientific discoveries into clinical practice, based on innovative research approaches grounded in the combination of academia's theoretical rigor and industry's practical insights. Although not a partnership per se, investigator-initiated trials (IIT) are a type of trial where an investigator – often a clinical practitioner or an academic researcher in healthcare – sponsors a trial, assuming the responsibilities of both the investigator and the sponsor (which is otherwise generally an industry stakeholder). These trials are unique in that they are often designed to test a hypothesis that arises during real-world clinical practice, such as studying new indications for an approved drug or comparing the efficacy of two existing treatment options (in contrast to sponsor-initiated trials which tend to seek approval for new drugs/investigational products designed by the sponsor organization).

Inter-institutional collaborations for large-scale trials

Large-scale trials often require collaboration among multiple research institutions to gather statistically significant data. This is the case of most modern multicenter trials, wherein resources, expertise, and patient populations are pooled across sites or networks of sites. Inter-institutional collaborations increase trial feasibility by providing access to wider and more diverse patient populations and distributing study tasks across different sites, and further enhance accessibility for patients from different regions and thus ensure greater generalizability in the study results.

CRO-sponsor partnerships

Contract research organizations (CROs) work closely with trial sponsors to provide specialized services encompassing study design, site selection, patient recruitment and enrollment, data management, monitoring, and regulatory compliance support, amongst others. Working with a CRO has become a common way for sponsors to enhance operational efficiency while ensuring adherence to Good Clinical Practice (GCP) and regulatory standards by contracting services to experienced teams with well-established research practices and facilities.

Partnerships with patient advocacy organizations (PAOs) and patients as stakeholders

Increasingly, patients are being considered not only as participants in clinical research studies, but also as partners and stakeholders. Engaging patients or patient advocacy organizations (PAOs) as partners is a way for sponsors to consider and incorporate patient insights and perspectives into the design of the trial. This practice aligns with the concept of patient centricity, wherein studies are designed and executed in a way that aims to meet the real needs of patients and minimize the burden they experience (i.e., optimize their comfort and lived experience) during participation. Involving patients as key contributors can also help improve overall clinical outcomes by fostering mutual respect, engagement, and their autonomy as decision-makers in their healthcare journeys, which may improve their willingness to participate as well as treatment and protocol adherence.

What is the difference between a sponsor and a funder in a clinical trial?

While these terms are sometimes used interchangeably, sponsor typically refers to the entity responsible for initiating a study, overseeing trial design and protocol development, and importantly, ensuring compliance with regulations and GCP guidelines throughout the trial’s conduct (whether activities are outsourced or not). The research funder, on the other hand, refers explicitly to an entity who provides financial support for conducting a trial, which could be different from the sponsor. For example, a university medical center could sponsor a trial with financial support (funding) through a government grant.

What is the relationship between a CRO and a sponsor?

CROs collaborate with trial sponsors to provide clinical trial (and/or drug development) services. While the CRO may conduct certain trial operations – or even all of them – the sponsor holds ultimate responsibility for the study's conduct, including securing funding, ensuring regulatory approvals are obtained and that ethical responsibilities are fulfilled, and answering to any issues of non-compliance.

5 Key benefits of partnerships in clinical trials: How partnerships drive successful trials

Depending on the nature of the specific partnership agreements, collaborative efforts can foster increased access to diverse participant populations, improved patient recruitment rates, enhanced design of patient-centric protocols better matched to real patient needs, real-time data and safety monitoring, more-accurate and higher-quality data, and streamlined regulatory approvals and compliance, amongst numerous other potential advantages. We go into more detail on 5 major advantages of partnerships in clinical trials below:

1. Addressing funding challenges in clinical trials

One major benefit of clinical partnerships is the ability to address funding challenges that often arise in research endeavors. Individual clinical trials can cost up to $50 million USD (although there is no real limit), and collaborative efforts can help research partners secure the necessary financial resources, minimizing the burden on individual organizations or institutions. By pooling funds and sharing costs, joint clinical research efforts can overcome financial barriers that may otherwise hinder the study from ever being realized.

2. Innovation, knowledge transfer, scientific exchange and research capabilities

Partnerships foster clinical trials innovation by bringing together diverse and unique perspectives, expertise, and resources from various stakeholders, supporting enhanced transfer of knowledge and scientific information along with expanded research capabilities. Collaborations facilitate a multidisciplinary approach to research that can accelerate the development of novel ideas, improved study designs, and eventually improved treatment options for patients.

Academic institutions offer a particularly strong contribution in terms of deep theoretical knowledge in areas such as the mechanisms of disease and treatment modalities, along with strong capacities in data analysis and publishing research findings. Industry partners tend to bring valuable and unique insights into other aspects such as drug development processes, market needs, and regulatory requirements. Patients can be involved as stakeholders to make sure that research questions and modalities are aligned with gaps in treatment options and real patient needs and preferences. The combination of these perspectives opens the doors to enhanced design and implementation of patient-centric studies, powered by interdisciplinary insights and research capabilities, and supporting streamlined development of novel treatments and therapies for improved patient outcomes in real-world settings.

3. Optimizing patient recruitment and retention

Patient recruitment and retention are critical factors for success in clinical trials, but they also represent one of the major bottlenecks in study timelines. An estimated 85% of trials run into delays in recruiting patients, leading to significant monetary losses that can amount to as much as $8 million USD per day of unexpected delay.

Clinical research partnerships and collaborations can improve participant recruitment in numerous ways:

• Sponsors can leverage modern, high-quality online patient databases such as www.withpower.com to advertise their study and connect with high-intent participants, thanks to built-in prescreening features
• Facilitating access to the study for patients by activating multiple sites across different regions and countries
• Engaging PAOs and patients as partners provides insights into patient needs such that studies can be made more attractive to potential participants, and also works as a bridge to connect directly to patients
• Sponsors can leverage the patient databases and networks of CROs and research sites, as well as those of their respective networks
• Trial recruitment specialists can be contracted to design clinical trial recruitment and outreach campaigns, further leveraging their own networks of patients and partners
• Advertising and marketing firms can be contracted as partners to design effective social media clinical trial recruitment campaigns to reach the massive, diverse user bases on these platforms which are increasingly important as recruitment platforms

4. Enabling multicentric trials to improve reach and reliability of study findings

Clinical research collaborations involving multiple research sites enables the conduct of multicenter trials, which facilitates the recruitment of participants from diverse geographic locations and ethnic backgrounds. The inclusion of a more representative study population increases the generalizability of research findings and ensures that approved treatments are safe for people with diverse genetic makeups.

Other trial models designed to increase accessibility and inclusion of diverse populations include remote and decentralized trials. Although these don’t necessarily require collaborations, the complexity of remote consenting, data collection, monitoring, and other operations in decentralized trials essentially necessitates the use of software solutions, which are often contracted from a service provider. Further, the decentralized nature of such trials makes them particularly suitable for collaborations, since various partners with unique skill sets and strengths can work together on the same trial from different locations.

5. Strengthened research credibility and diversity

Collaborations between stakeholders from different backgrounds can strengthen the credibility of research findings by demonstrating the integration of interdisciplinary/cross-sector expertise and insights. By the same logic, the diversity of research questions being studied can be expanded through the combination of perspectives from different sectors, such as routine healthcare practice and academic research. Clinical research partnerships also help bridge the gap that exists between clinical research and clinical practice by connecting real-world experience from uncontrolled scenarios with the results of research studies conducted under controlled conditions.

Navigating challenges in building effective partnerships in clinical trials

Establishing and maintaining successful partnerships in clinical trials can be a demanding process due to logistical factors, negotiations and the time required to reach agreements, and upholding clear communication and effective handling of relationship dynamics. Below are 5 factors to keep in mind when building strategic partnerships in clinical trials:

1. Establishing clear partnership agreements and contracts

Clear clinical trial agreements are vital for establishing a mutual understanding regarding the roles and responsibilities expected of each party, along with outlining details of data usage and sharing, decision-making processes, intellectual property rights, and financial agreements. Contracts should be drafted carefully and reviewed closely by both parties before signing. Ensuring that all aspects of the collaboration are clearly defined will facilitate a smooth working relationship and prevent potentially costly or troubling disagreements.

2. Developing a common vision and aligned objectives

Ideally, all partners involved in a trial will share a common vision for the clinical trial's success and will be aligned according to a series of common objectives. Clearly setting forth not only the operational details of the agreement but also the underlying values can help ensure that all partners are working with a unified focus on achieving the outcomes that are considered to be most meaningful for the research study or the sponsoring organization. It can also support an atmosphere of teamwork, which can assist with communication and dispute resolution.

3. Ensuring responsible data management practices

In the world of increased online connectivity, it’s important that data management protocols be set in place to ensure secure and responsible handling of sensitive personal health information. It is the sponsor’s responsibility to ensure adherence to regulatory requirements and data privacy regulations such as HIPAA, even if third parties are involved in the research study. Any data breaches or issues of non-compliance will fall on the sponsor, so it is also their responsibility to establish codes of practice with all partners who will handle the clinical data. For more on regulatory compliance and data protection, see the next section.

4. Navigating cultural and operational differences between entities

As clinical research efforts become increasingly globalized, partnerships often involve organizations or institutions from different cultural backgrounds, with varying priorities, and with dissimilar operational procedures. It is crucial to understand these differences and find common ground through effective communication. Having a local team member in any region in which you commonly operate may be a vital asset for navigating language and cultural nuances, particularly for cultures that are significantly different from that of the sponsoring organization. Even between institutions in the same region, operating procedures and the software systems used in workflows could be significantly different, which requires special attention in order to ensure smooth operational efficiency. Interoperability between different software providers and a lack of standardized data formats in health records have presented challenges in collaborative research efforts, but both of these issues are current areas of focus that will hopefully be improved in the coming years.

5. Communication: Maintaining transparency and trust between partners

Transparency and communication are vital for successful partnerships in clinical research. Effective communication channels should be established to encourage open dialogue and promote regular interaction and feedback between collaborators. This might include regular check-ins and updates on project progress, sharing of challenges encountered, and open discussions that encourage individuals to raise attention to any aspects of the trial operations that are encountering roadblocks or could be improved. Transparency lays a solid foundation for trust in long-term collaborations, which strongly encourages honest communication. Both clear communication and transparency are important for avoiding misunderstandings and identifying problems efficiently while also building harmonious and satisfactory working relationships. Using project collaboration tools or dedicated platforms accessible to everyone involved is an excellent way to stay connected and allow different stakeholders to quickly flag and address any issues that should emerge.

Regulatory considerations for robust partnership agreements

Regulatory compliance is a critical aspect that must be carefully woven into partnership agreements. Regulatory and legal considerations deserve special attention, as each additional partner involved in a clinical trial represents another party that may have access to private health data and which must act in compliance with all applicable regulations and guidelines. Further, due to the potentially significant sums of money involved in contracts and the high stakes (risking patient safety, study termination, and fines), it is essential that agreements between partners be clear and legally valid.

The main concepts at play here include compliance with FDA regulations and GCP guidelines, safeguarding of patient data privacy and confidentiality, and clarifying intellectual property and data ownership rights. Legal advice may be required in some instances, particularly when operating across jurisdictions with distinct regulatory standards and when signing contracts with new partners.

All providers and partners involved in a clinical trial must adhere to the same regulations that apply to the sponsor, and ensuring appropriate conduct is ultimately the responsibility of the sponsor. The principal regulatory agencies responsible for approving trials and overseeing compliance with ethical and quality standards in clinical research are the FDA in the US, the MHRA in the UK, HC in Canada, the TGA in Australia, and the EMA in the EU. For other selected countries, see this resource. It is crucial to have a clear understanding of applicable regulations and ensure that all parties involved are compliant throughout the duration of the trial, which will likely form part of the monitoring strategy enacted by the sponsor.

Respecting the basic rights of patients as research participants, implementing adequate informed consent procedures, and ensuring compliance with data privacy regulations such as HIPAA or the GDPR are not only ethical imperatives, but also legal requirements. Building robust data handling and protection protocols and confidentiality agreements into clinical trial partnership agreements is essential for maintaining compliance with privacy laws and ethical standards.

Conclusion

The clinical research industry is transforming quickly, with the trend toward patient-centric trials and data-driven science being supported by significant technological advances and increased adoption of clinical technologies, a deepening understanding and growing consideration of actual patient needs and preferences, novel research study designs like fully remote studies and master protocols, and increasing strategic partnerships in clinical trials focused on optimizing operational efficiency and expanding the horizon of what’s possible in clinical research. International collaborations are supporting the inclusion of underserved populations in research, enabling the collection of patient data across geographies and demographics to gain more comprehensive insights into population-level health trends and outcomes, while breakthroughs in personalized medicine are improving resolution at the individual (genome) level. The future of clinical research looks promising, and it is expected that clinical trial partners will continue to work together to streamline the development of new treatments and improve health outcomes for patients around the world.