The industry spent over $200 billion globally in 2021 on developing new therapies for treating cardiovascular diseases. However, it’s estimated that more than half of the investment in clinical development is wasted. Various factors contribute to this, including a lack of efficacy compared to approved competitors, poor trial execution, slow recruitment of the trial, lack of site resources, or insufficient funding. Consequently, the prospects for success when advancing to the clinical stage of therapy development are not very promising.
Contract Research Organizations (CROs) are partners in developing biopharmaceuticals or medical devices that provide services to support the sponsor in conducting clinical trials. A CRO should be selected based on factors beyond cost, including their ability to meet important timelines affecting financial milestones, create value, effectively communicate, resolve problems, and offer favorable contractual terms. Additionally, good CROs understand the purpose and value of the sponsor’s IP, guiding them through protocol development, study planning, site selection, regulatory interactions, and study design adaptations. They prioritize the client’s needs and focus on the feasibility and practicality of the clinical investigation, ensuring that unnecessary assessments and procedures do not interfere with the study’s core outcome evaluations.
Generalist versus specialist: What CRO do you prefer?
CROs mostly fall into two main categories: generalist or niche specialist. Generalist CROs typically offer a broad range of services across various therapeutic areas, while specialist CROs have a focus on a specific therapeutic area or expertise. In cardiovascular medicine, a specialist CRO would have a deep understanding of the unique challenges and complexities of conducting clinical trials in this area and would have a team of experts with deep knowledge and experience in cardiovascular medicine.
Advantages of working with a specialist CRO
There are several advantages to working with a specialist CRO for clinical trials in cardiovascular research. The most significant ones are:
Expertise: A specialist CRO will have a team of experts with deep knowledge and experience in cardiovascular medicine, allowing for better selection of investigational sites and investigators, more efficient trial design and execution, as well as improved data collection and analysis.
Access to patients: Cardiovascular clinical trials require different approaches. A key element is the selection of investigators who not only have access to the patient population but also have a trial team available that can contact study participants efficiently, have a sound understanding of the investigational product, and are, in the best case, convinced by the beneficial nature of the trial from a medical point of view. A specialist CRO will have established relationships with the suitable investigator sites. This includes key opinion leaders and high-performing clinical sites in cardiovascular medicine, allowing for more efficient patient recruitment and retention.
Flexibility: A niche CRO typically shows greater flexibility to sponsor needs due to a smaller customer base and internal standards designed for easy integration with other party providers.
Regulatory knowledge: A specialist CRO will have a thorough understanding of the regulatory landscape in cardiovascular medicine, including any specific requirements or challenges, which can help ensure compliance and avoid delays.
Faster trial completion: With a deep understanding of the disease area and the challenges involved in clinical trials in cardiovascular medicine, a specialist CRO can help streamline the trial process and potentially accelerate trial completion, leveraging faster regulatory submission and approval process and effective patient recruitment.
Improved outcomes: With specialized knowledge and expertise in cardiovascular medicine, a specialist CRO can help ensure that the trial is designed and executed to maximize the potential for positive outcomes. In order to efficiently monitor the main outcome parameters in a clinical trial, experience and knowledge about best practices are important. CRAs and project managers who know how to interpret echocardiographic loops, Holter recordings, 6-minute walking tests, and other key assessments in cardiovascular research studies will contribute to increased quality and integrity of clinical data.
Overall, working with a specialist CRO for cardiovascular trials can lead to better-quality data, faster trial timelines, and more efficient use of resources. It can also provide access to a network of experts and sites that would be difficult to access otherwise. Therefore, if you are conducting a clinical trial in cardiovascular medicine, working with a specialist CRO with a proven track record in this therapeutic area may be beneficial.
Relationship is key
Investing more effort in study planning and design is beneficial in the long run, considering the stringent regulatory standards, complex approval processes, and high failure rates. A specialized CRO should coordinate its internal experts, external consultants, and Key Opinion Leaders (KOLs) for effective project management and integration of valuable inputs. The sponsor and the CRO share responsibility for a successful partnership, and open communication channels, active sponsor involvement, and responsiveness are crucial for fostering a solid and productive relationship.