Conducting cardiology clinical trials requires a knowledgeable partner with a proven track record in trial design, patient recruitment, and final marketing approval. Because of this, specialized cardiology CROs will provide the best chance of completion for any trials involving the prevention and treatment of:
- Chronic coronary disease
- Peripheral vascular disease
- Heart failure
- Cardiac arrhythmias
- Heart malformations
- Other illnesses known to exacerbate heart conditions
- Long-term cardiovascular outcomes trials
What Sets the Best Cardiology CROs Apart?
Interventional trials for cardiovascular indications often involve pharmaceutical approaches, medical devices, and non-medical approaches. Cardiology is more likely to deal with patients hospitalized in acute care units or who have comorbidities than other specialties.
As a result, a CRO’s ability to design a dynamic yet thorough trial falls largely on its team. It should include:
- A multidisciplinary team of medical consultants that cover (at the very least) cardiology, respiratory diseases, and endocrinology;
- Sites that employ cardiothoracic surgeons with product-specific training;
- Partnerships with academic research organizations;
- Medical science liaisons with connections in the field.
How to Choose the Right Cardiology CRO?
The partnership between CRO and Sponsor can follow different dynamics and still deliver a successful clinical trial.
In addition to a knowledgeable team, other qualities that point out at the “right” cardiology CRO include:
- Therapeutic Expertise within Cardiology
- A similar philosophy when dealing with patient safety and regulatory compliance
- Willingness to adapt to the Sponsor’s existing work methods
- Direct experience in the specific type of trial performed
- A strong presence and network in the country or region where the trial will be performed
Often, entrusting a large project like a clinical trial to a completely new vendor may leave too many unknowns. When possible, try to work on a smaller project first (such as a feasibility study or a consultancy).
Conducting Cardiology Trials: What Makes Them Different?
The complexities behind planning and executing cardiology clinical trials often come from two main factors. First, these trials must handle a unique patient population. Second, the subspecialty often deals with a high prevalence of confounding factors.
Patient recruitment for Cardiology trials
Figures from the last ten years show that approximately 10% of all clinical trial participants in the United States are enrolled in cardiology trials.
The prevalence of cardiovascular conditions is rising across most of the world. At first glance, any trials involving cardiovascular diseases should benefit from a more extensive and more spread patient pool. However, this is often compensated by the following challenges:
- Patients in cardiology trials tend to require acute care, often at very short notice
- There is an ongoing selection bias in cardiology trials, which often include fewer female participants
- This patient population is also generally older and less likely to be treatment-naïve
- For pharmacological outcome trials, treatment adherence can be low or difficult to achieve
- Outcome trials for drugs and devices alike tend to require surrogate endpoints.
Overall, patient participation in cardiology clinical trials has been steadily dropping in industrialized nations.
Dealing with confounding factors
An additional problem ailing long-term clinical trials is to adequately discern the impact of lifestyle choices on the overall outcome. Factors like exercise, stress levels, and nutrition are highly personal, hard to classify, and almost impossible to monitor thoroughly. Because of this, most studies rely on self-reported data.
Trends in Cardiology Trials: What the Best Cardiology CROs are Doing
The challenges listed above may raise the overall cost of your upcoming trial. Partnering with a flexible and innovative CRO can help you design a study that minimizes these factors.
Some of the main concepts used here include:
A precision medicine approach for randomization
By testing for specific biomarkers, precision medicine allows a better understanding of each patient’s specific pathophenotype. Taking these individual differences into account can help spot statistically significant results with smaller patient populations.
Registry-based randomized clinical trials
Registry-based clinical trials offer a less resource-intensive alternative to traditional RCTs. This is done by using data from existing observational health registries. This can help access a larger pool of patients and facilitate follow-ups at a fraction of the cost.
Current Cardiology Clinical Trials at a Glance
As of September 2021, there are currently 275 ongoing, temporarily halted, or recently restarted clinical trials with a cardiology indication registered on EudraCT (the European Union’s Clinical Trials register).
Meanwhile, in the United States, there are currently 957 active studies with a cardiology indication. There are an additional 2,664 studies that are actively recruiting or enrolling by invitation.
The most common trial topics deal with heart failure and electrophysiology. Their average expected length is 414 days.
Major CROs with Experience in Cardiology
At TrialTop, we currently have many international CROs declaring a specialization in Cardiology. Some of the biggest Cardiology CROs include:
- Syneos Health
- Labcorp Drug Development