How to Build Clinical Trial Partnerships in Europe
Research methodologies are becoming more diverse, sometimes with the perks of lowering costs and increasing research speed. In many cases, individual entities cannot address these complexities by themselves, be it due to a lack of expertise, a lack of physical infrastructure, or a lack of resources. Partnerships in clinical trials enable stakeholders to address multifaceted challenges that may hinder progress and the timely delivery of innovative products to patients. These collaborations can help you overcome limitations related to access to funding, diverse patient populations, and expertise. Here’s some intel on how to build clinical trial partnerships in Europe.
Models of Partnerships in European Clinical Trials
Partnership models for clinical trials can be broadly categorized into academic-industry collaborations, public-private initiatives, and patient advocacy group involvement. Let’s take a look at each of these.
Academic-Industry Collaborations
Academic-industry collaborations involve a spectrum of models, from industry sponsors engaging academic groups to conduct trials to joint research projects where expertise and resources are shared, and the integration of academic experts into industry-led research endeavors. Initiatives such as the Clinical Academic Cancer Research Forum (CAREFOR) exemplify efforts to enhance these collaborations within specific therapeutic areas.
The “Fit for Filing” model represents an evolving trend where academic-led trials are designed to generate data that meets regulatory standards for drug licensing, presumably increasing the direct impact of academic research on clinical practice. Platforms like the Innovative Health Initiative (IHI) function as frameworks that facilitate these collaborations by bringing together academic researchers and pharmaceutical companies to work on pre-competitive research projects across various disease areas. The increasing focus on academic research generating “fit for filing” data may imply a growing recognition within the academic community of the importance of aligning research with regulatory requirements. This shift can potentially accelerate the process of making new treatments available to patients by ensuring that the data collected in academic trials is directly usable for licensing applications.
Academic institutions will generally possess relevant clinical expertise and direct access to diverse patient populations, while the pharmaceutical industry can provide funding, knowledge in drug development, and a good understanding of regulatory pathways. Academia’s strength arguably lies in early-stage discovery and a deep understanding of disease mechanisms, whereas industry may excel to a higher extent in the later stages of drug development, including large-scale manufacturing and commercialization. The table below further illustrates the different types of collaborative arrangements and their characteristics.
| Collaboration Type | Description | Advantages | Challenges | Examples |
| Industry-Sponsored Research | Pharmaceutical companies fund and manage clinical trials conducted by academic institutions or research networks. | Access to established research infrastructure, large patient cohorts, and specialized clinical expertise for the industry. Provides funding, resources, and potential for publication for academic partners. | Potential conflicts of interest regarding intellectual property and publication rights. Industry may have significant influence over trial design and data analysis. | Many Phase II-IV trials are conducted under this model. Specific examples are often detailed in publications related to particular drug development programs. |
| Joint Research Projects | Collaborative projects where academic and industry partners jointly design, conduct, and analyze clinical trials, sharing resources, expertise, and intellectual property rights. | Combines scientific knowledge of academia with drug development expertise and resources of industry. Facilitates mutual learning and fosters innovation. | Requires careful negotiation of roles, responsibilities, and intellectual property sharing. Potential for diverging priorities and timelines. | The Cancer Grand Challenges program by Cancer Research UK and the National Cancer Institute in the US funds international, multidisciplinary teams to tackle major challenges in cancer research. These often involve academic-industry collaborations. |
| Integration of Academic Experts into Industry Research | Academic researchers are embedded within industry teams or serve on advisory boards, providing scientific input and guidance throughout the drug development process. | Industry benefits from cutting-edge scientific knowledge and clinical insights. Academics gain exposure to the practical aspects of drug development and regulatory processes. | Potential for conflicts of interest and concerns about academic freedom. Requires clear agreements regarding confidentiality and intellectual property. | Pharmaceutical companies often have scientific advisory boards comprising leading academic experts in relevant fields. Details of these collaborations are typically not publicly disclosed in full. |
| Public-Private Partnerships (PPPs) | Initiatives supported by public funding that bring together academic institutions, industry partners, and sometimes patient organizations to address specific healthcare challenges or accelerate the development of new therapies. | Leverage the strengths of multiple sectors, pool resources, and facilitate knowledge sharing. Can address research areas that may not be commercially viable for individual companies. | Complex governance structures and decision-making processes. May face challenges in aligning the diverse interests of stakeholders. | IHI is a good example, as it funds large-scale collaborative research projects across various disease areas. Individual projects within these initiatives involve academic institutions, pharmaceutical companies, SMEs, and patient organizations. |
| “Fit for Filing” Academic Trials | Academic-led trials are specifically designed and conducted to generate data that meets the standards required by regulatory authorities for drug approval. | Increases the likelihood of academic research directly leading to new treatments for patients. May enhance the impact and visibility of academic research. | Requires significant investment in regulatory expertise and adherence to stringent quality standards. May necessitate changes in academic research practices. | Several academic medical centers and research consortia are now focusing on conducting “fit for filing” trials, often in areas where there is a high unmet medical need and a clear regulatory pathway. Specific examples may emerge from publications detailing successful academic-led drug development programs that have resulted in regulatory submissions. |
These varied models underscore the multifaceted nature of academic-industry collaborations in European clinical trials, highlighting the importance of understanding their characteristics, advantages, and challenges for effective engagement and successful outcomes.
Public-Private Partnerships
Public-private partnerships (PPPs) are also useful in European clinical trials, especially when it comes to addressing health challenges that require substantial investment and coordinated efforts. Initiatives such as the European and Developing Countries Clinical Trials Partnership (EDCTP) focus on infectious diseases, while the EIT Health platform fosters innovation in healthy living and active aging.
These partnerships offer a mechanism to pool resources, share risks, and leverage the diverse expertise of stakeholders to accelerate the development of new treatments and improve healthcare outcomes. They play quite an important role in addressing public health priorities and promoting innovation in areas where market incentives alone may be insufficient.
Patient Advocacy Groups
Patient advocacy groups (PAGs) are the way to bring the perspective of patients to the research process. More specifically, PAGs can contribute to trial design, recruitment strategies, and the dissemination of findings, making it more likely that research is relevant to patient needs and preferences.
By representing the patient voice, PAGs are meant to make it so that clinical trials are not only scientifically sound but also meaningful and beneficial to those who stand to gain from the research. Their insights into the patient experience, unmet needs, and preferences can inform all stages of the clinical trial process, from the initial design to the interpretation and dissemination of results.
Steps to Achieve Significant Partnerships
Now that you know a few things about clinical trials partnerships types, you are arguably more ready than ever to achieve a strong partnership. Your objective may be achieved by completing the following steps:
Step 1: Set Your Objectives and Scope: Clearly define the objectives of the partnership and the specific scope of collaboration. This involves outlining the research questions to be addressed, the anticipated outcomes, and the roles and responsibilities of each partner. A well-defined scope ensures that all parties have a shared understanding of the goals and can align their efforts accordingly.
Step 2: Identification of Complementary Expertise and Resources: Great partnerships are often built on the principle of synergy, where the combined expertise and resources of the partners create value greater than the sum of their individual contributions. You will want to identify potential partners whose skills, knowledge, and resources complement those of your own organization. For instance, an academic institution with strong expertise in basic research might partner with a pharmaceutical company that has extensive experience in drug development and commercialization. Similarly, collaborations might involve bringing together research institutions with access to specific patient populations or technologies that are essential for the trial.
Step 3: Building Effective Communication Channels: As you might suspect, open communication can come in handy. Establishing clear and consistent communication channels can allow information to flow freely between partners, allowing for the timely resolution of issues and the effective coordination of activities. Regular meetings, shared platforms for data and document management, and clearly defined points of contact can facilitate seamless interaction and collaboration.
Step 3: Establish Clear Governance Structures and Agreements: A well-defined governance structure is the way to go for managing multiple stakeholders with potentially different interests. Your well-thought structure should clearly outline the decision-making processes, the roles and responsibilities of each partner, and the mechanisms for resolving conflicts. Formal agreements, such as memorandum of understanding (MOUs) or collaboration agreements, can be put in place to codify these aspects and to address critical issues such as intellectual property rights, data ownership, and publication policies.
Step 4: Understand the Regulatory Landscapes or Work with Others that Do: Each partner must have a clear understanding of the applicable regulations, guidelines, and ethical principles governing clinical research in the relevant European countries. This includes regulations related to data privacy (such as GDPR), clinical trial conduct (such as the Clinical Trials Regulation (EU) No 536/2014), and ethical review processes. Partnerships should ensure that they have the necessary expertise and resources to comply with these requirements and to uphold the highest ethical standards in their research. Collaborative efforts may involve joint training on regulatory and ethical matters, the establishment of joint ethics committees, or the involvement of regulatory experts to provide guidance throughout the trial process.
Why Should You Care about Partnerships in Clinical Trials
OK, time to discuss benefits. You may already know most of them, but here are some things you may not know:
You May Get Enhanced Access to Funding and Resources: Collaborations often bring together partners with complementary financial resources and infrastructure, enabling access to a broader pool of funding opportunities and the sharing of costly resources such as equipment, facilities, and specialized personnel.
You May Get Access to Expanded Patient Recruitment and Diversity: Partnerships can facilitate access to more diverse and larger patient populations, which should mean generalizability and robustness of clinical trial results. Collaborations involving multiple sites across different regions or countries can significantly improve recruitment rates and the representation of various demographic and genetic backgrounds.
You May Enjoy a Larger Pooling of Expertise and Knowledge: By bringing together researchers, clinicians, and other experts from different fields and organizations, partnerships foster the exchange of knowledge, skills, and best practices. This interdisciplinary collaboration can lead to innovative approaches to trial design, data analysis, and the interpretation of results, thus improving the quality and relevance of the research.
You Share Risks: Clinical trials, particularly those involving novel therapies or complex methodologies, often carry significant financial and operational risks. Partnerships allow these risks to be shared among multiple stakeholders, reducing the burden on any single organization. This can make it feasible to undertake ambitious research treks that might otherwise be considered too risky or resource-intensive.
You May Enjoy an Accelerated Pace of Research and Development: Collaboration can streamline the clinical trial process by leveraging the efficiencies and expertise of different partners. For example, industry partners can bring their experience in project management and regulatory navigation, while academic partners can contribute their deep scientific knowledge and access to patient networks, leading to a faster pace of research and development.
You May Get Increased Translational Impact: Partnerships that bridge the gap between academia and industry can enhance the translation of basic research findings into practical clinical applications. By involving industry partners early in the research process, academic discoveries can be more effectively developed into new therapies and diagnostics that benefit patients.
You May Become More Credible and Visible: Involvement in well-structured and collaborative clinical trials can enhance the credibility and visibility of all participating organizations. Partnerships, especially those involving reputable academic institutions or well-known industry players, can lend greater weight to the research findings and facilitate their dissemination and adoption within the scientific and medical communities.
Key Organizations and Initiatives that Might Help You Get the Right Partnerships
Several key organizations and initiatives in Europe actively promote and support partnerships in clinical trials, including:
The European Union (EU) Framework Programmes for Research and Innovation: These programs, such as Horizon Europe, provide significant funding for collaborative research projects, including clinical trials. They often encourage and facilitate partnerships between academic institutions, industry, SMEs, and other stakeholders across Europe and beyond.
IHI: As the successor to the Innovative Medicines Initiative (IMI), IHI is a major public-private partnership that aims to accelerate the development and access to innovative health solutions by fostering collaboration between the life sciences industry and academic researchers.
National Institutes for Health Research (NIHR) in the UK: While specific to the UK, the NIHR plays a significant role in supporting clinical research infrastructure and facilitating partnerships between academia, the NHS, and industry. Its initiatives and networks often involve collaborations with European partners.
European Infrastructure for Translational Medicine (EATRIS): EATRIS provides access to research infrastructure and expertise to support the translation of biomedical discoveries into patient benefits.
European Union Funding & Tenders Portal: This portal provides comprehensive information on funding opportunities for research and innovation under Horizon Europe and other EU programs. It allows users to search for calls for proposals that encourage or require collaborative projects.
European and Developing Countries Clinical Trials Partnership (EDCTP): This website offers information on funding opportunities for clinical trials and research capacity building in sub-Saharan Africa, often involving collaborations between European and African institutions.
Regulatory Frameworks You May Want to Know About
The EU is heavily regulated, which comes with both pros and cons. Key regulations include:
The Clinical Trials Regulation (EU) No 536/2014: This regulation harmonizes the rules for conducting clinical trials across the EU, impacting how multinational partnerships are structured and managed.
The General Data Protection Regulation (GDPR): GDPR sets strict rules for the processing of personal data, including health-related data collected in clinical trials. Partnerships must ensure compliance with GDPR requirements regarding data privacy, security, and the rights of trial participants.
National Regulations and Guidelines: In addition to EU-wide regulations, individual European countries may have their own national regulations and guidelines that need to be considered when forming partnerships and conducting clinical trials within their borders.
Potential Challenges to Developing the Right Partnerships and Mitigation Strategies
Despite the numerous benefits, partnerships in clinical trials can also face challenges. For instance, the ownership, management, and commercialization of intellectual property developed during a collaborative clinical trial can be tricky. You will want to have clear agreements in place at the outset of the partnership that address these aspects, outlining who owns the IP, how it will be protected, and the terms for its potential commercialization. These agreements should be carefully negotiated and legally sound to avoid disputes later in the collaboration.
Also challenging can be navigating the administrative and bureaucratic processes of different organizations and regulatory bodies across multiple countries. Streamlining these processes through clear protocols, designated points of contact, and a thorough understanding of the regulatory requirements in each jurisdiction is important. Engaging project management expertise can also help to keep the partnership on track and ensure that administrative tasks are handled efficiently.
Bottom line: Partnerships are like Internet Dating—Swipe Right Wisely
Building clinical trial partnerships in Europe is not that different from online dating. You’ve got to clearly define your expectations, find someone whose strengths complement your weaknesses, and communicate openly to avoid awkward misunderstandings down the road. Sure, public-private partnerships and academic-industry collaborations might not have catchy dating app bios, but their potential is often more exciting.
Like any relationship, you might face disagreements over who owns the intellectual property or struggle with navigating complex regulatory landscapes. But hey, sharing risks, pooling resources, and combining expertise can lead to breakthroughs faster than solo ventures ever could.
Remember, a great partnership doesn’t just enhance credibility and visibility; it also gives you something worth bragging about at your next professional ‘speed dating’ event, aka, networking conference. So, swipe right carefully, communicate clearly, and set your boundaries upfront —because the right partnership could be the start of a beautiful (and highly productive) relationship.
Last but not least, if you need help with getting those partnerships, feel free to contact us. At On Treks, we provide all sorts of services that can help you advance on your trek.
