To bring new therapies to the market, biotech and biopharma companies engage contract research organizations (CROs) for their expertise in running clinical trials, streamlining processes, and increasing the speed at which new interventions are made commercially available. When a sponsor is looking to run a cardiology clinical trial, the selection of a Cardiology CRO depends on the experience, areas of expertise, geographical reach, and, importantly, the ability of the CRO to meet the sponsor’s clinical objectives. In this article, we explore the evolving needs of cardiology clinical trials and how a small CRO might be the right fit for yours.
Cardiology Clinical Trial Landscape
The COVID-19 pandemic affected clinical research worldwide, with cardiovascular (CVD) trial activity reduced by 95% in 2020. Two years later, CVD was identified as a rapidly growing therapeutic area in clinical trials. The pandemic also demonstrated that important clinical trials could be performed quickly and efficiently in busy clinical settings. Harrington et al. (2022) describe contemporary CVD clinical trials as increasingly complex, large, and with exponentially increasing costs. Cardiology clinical trials have evolved to replace traditional processes and to address prevailing trial efficiencies. For example, pragmatic trials are streamlined trials aligned with routine clinical care and more closely represent “real world” settings. These trials provide a more realistic understanding of population-level effectiveness and costs of therapies and highlight barriers to implementation.
Reinventing Cardiology Clinical Trials
In December 2022, leading cardiology societies issued a joint opinion to reinvent randomized clinical trials (RCTs) fit for the 21st century. The European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the World Heart Federation maintain that cardiology has historically led the way in transforming clinical practice through ground-breaking clinical trials. Still, over the past 25 years, the increase in regulations and bureaucracy has impacted the running of trials swiftly and cost-effectively. In the joint opinion published on December 16, 2022, Bowman et al. (2022) outlined measures for streamlining trial processes by reinventing simple trials with global impact. Trials conducted during the pandemic were highly streamlined and designed to be easy to run in busy hospitals while complying with Good Clinical Practice (GCP) principles. The authors highlight the role of forward-looking innovation in trial methods, including the appropriate use of routine healthcare data, digital tech, and direct-to-patient designs, such as utilizing high-quality electronic health records (EHRs) for recruitment and follow-up.
Trends in the Pragmatic Nature of CVD Clinical Trials
Pragmatic trials were first described more than 50 years ago. A recent review was conducted to ascertain the need for increased pragmatism in CVD RCTs. The authors assert that contemporary trial designs increase internal validity but provide limited information about the effectiveness of therapies in routine clinical practice. In turn, this compromises the generalizability of trial results. Further, such trials are resource- and time-intensive. According to Sepehrvand (2019), pragmatism in CVD trials has increased moderately over the last two decades.
Small CROs Meeting the Evolving Needs of CVD Clinical Trials
Below, we explain a few methods of how a small CRO can meet the needs of your cardiology clinical trials and may be a better option over larger CROs.
1. People
Sponsors prefer to work with a CRO team that has expertise at all levels and who pay attention to detail. Unanticipated changes in ClinOps professionals, project managers, and clinical research associates (CRA) result in extended timelines, unforeseen disruption, and dissatisfaction at research sites. Smaller CROs tend to have a much lower turnover than large ones, providing more stability and continuity that sponsors need.
2. Trial Design
Pragmatic trials test interventions in routine clinical settings with patients broadly representative of the condition under study. Pragmatic trials also reduce trial costs and complexity by streamlining clinical trial conduct, e.g., minimizing protocolized clinical evaluations, trial-specific visits, and testing beyond standard care. This reduces the research burden on participants, investigators, and providers, positively impacts patient recruitment, allows flexibility in delivery and adherence, and enjoys potential benefits from applying tech for follow-up.
Sponsors planning to introduce changes and increase the pragmatism of their cardiology clinical trial may value a high-touch CRO relationship. Small CROs can offer close contact, good oversight, and a more personal experience. In a partner-like model, small CROs are responsive and mindful of their sponsor’s needs and can provide undivided attention.
3. Limited Organization and Follow-up of Pragmatic Trials
Pragmatic RCTs are designed to collect data during routine rather than trial-specific visits. Patients can be engaged virtually or over the telephone for any additional follow-up required. To reduce the need for specialist teams to collect data, EHRs, patient registries, and administrative databases are used. In choosing a CRO, sponsors express the need for transparency, flexibility, and problem-solving skills. Smaller CROs offer more customization flexibility and can jointly develop out-of-the-box solutions and approaches for projects.
4. Leveraging Tech for Pragmatism
EHRs can be analyzed to identify potential participants who meet trial eligibility criteria. If an in-person visit is required, patients can be contacted via email, phone call, or EHR portal for a screening visit. Alternatively, an eConsent can be requested virtually. Small CROs are well-placed to adopt the latest tech, identify opportunities for application, and provide insights on how to improve your cardiology clinical trial’s performance.
5. Therapeutic Experience, Outcomes, and Analysis
Pragmatic trials evaluate the quality of life through online questionnaires and wearable devices, which provide data on the functional status of patients. Smartphone applications, biosensors, and wearable tech continuously track a participant’s cardiovascular health and lifestyle. Sponsors (or Cardiology CROs) must then establish the processes and infrastructure to record this data.
Sponsors are more inclined to select CROs with experience in a relevant therapeutic area, such as cardiology, and who understand the challenges on the path to regulatory approval. Small CROs focus their resources and energies on developing in-depth expertise and current knowledge that contribute to the successful completion of trials.
Vial Cardiology CRO
In conclusion, a small CRO like Vial is an excellent fit for biotech sponsors looking to run a cardiology clinical trial. Vial is supported by an intuitive technology platform that incorporates modern EDC, ePRO, and eSource, and an experienced team of ClinOps experts and scientific advisors. With the increasing trend towards pragmatic trials in cardiology clinical trials, Vial’s focus on streamlining trial conduct, minimizing protocolized clinical evaluations and testing beyond standard care, and applying tech for follow-up, is perfectly aligned with evolving industry needs.
Additionally, a small CRO offers a more personal experience, with close contact and good oversight, and a partner-like model, providing undivided attention to the sponsor’s needs. Ultimately, Vial’s unique approach to clinical trial management and its commitment to delivering successful results make them a great option for sponsors of all sizes.
For more information on the tech-enabled Vial Cardiology CRO, visit us here or contact a team member today!
