With our population rapidly ageing and improvements in care in other conditions—enabling people to live longer—cardiovascular disease remains the leading cause of death worldwide. Therefore, there is an ongoing need for evaluation of novel treatment strategies. In this commentary, Vijay Kunadian and Kathryn Procter review how clinical trials not only benefit patients with cardiovascular disease overall but also benefit those participating in the research.
When designing a clinical research trial, it is imperative that the aim of the research is to address an unmet clinical need. Such trials help us to develop better strategies for improving care and outcomes. However, trials need to be adequately powered to answer the question that is being raised—underpowered studies may be hypothesis generating but are unlikely to lead to changes in clinical practice by themselves. For example, an increasing number of patients aged 80 or older (including centenarians) are presenting with non-ST-segment elevation (NSTEMI), but only two randomised trials (to date) with a total sample size of 770 have explored the management of NSTEMI in this age group and they have produced conflicting results; therefore, the data are insufficient to change practice or to influence physician guidelines. At present, how NSTEMI patients aged 80 or older are managed varies depending on the institution where they are being managed. This emphasises need for a much larger well powered trial.
Given this need, the BHF SENIOR-RITA trial (The British Heart Foundation older patients with non-ST Segment elevation myocardial infarction randomised Interventional treatment trial) has been designed to determine whether the beneficial effects of revascularisation, seen in younger populations, will be seen in frail older (≥75 years) NSTEMI patients with comorbidities (NCT03052036). The study aims to enrol 2,300 patients.
In addition to addressing an important clinical question and informing the medical community of the best way of managing patients, a trial such as the BHF SENIOR-RITA has the potential to benefit the patients participating in the study. Patients, before being enrolled in a study, are told of the potential risks and benefits of participating but they are rarely told of the “hidden” benefits of participating. Theses hidden benefits can vary from study to study and from site to site; they are also very subjective and individual to each patient depending greatly on the level of participation. They include but are not limited to:
- Having direct access to an experienced clinical research team with special expertise in the area of study. Clinical research study participants are given a telephone number for the research team on the “patient information sheet” and also on alert cards. This allows them to contact the research team with any concerns they are experiencing with the study or, more importantly for the patients, with any queries they have health wise in general. The benefits of this direct telephone access are vast. A lot of the patients are post myocardial infarction and are understandably anxious post discharge from the index event. Thus having this additional contact to the clinical research team which they would not get as part of standard care is invaluable to some patients
- Extra clinic visits, tests, investigations and procedures (sometimes very expensive supported through research grant budget) that would not be part of their standard care follow up
- The feeling that they “are doing something worthwhile” and “giving something back”. Many of our patients feedback to us that they feel proud to take part in our studies and are more than happy to help us out as we have helped them
- Being part of a trial that might change practice or shape the future. The majority of the studies may not have any direct health benefit for the patients participating in them but, during the recruitment process, we explain that although their participation may not help them, it will hopefully help the future generation/patients as the studies help to ensure which treatments are best to provide optimum care to our patients
- Research has also shown that patients participating in a trial whether on active medication or placebo do better than their counterparts because of the “placebo affect”.
Once the study has been conducted and all data have been collected, it is important to share the knowledge with the wider audience of the patient and scientific community to disseminate the findings. This is often carried out through presentation in large scientific congresses and publication in major journals. The key to having them published in high-impact journal will consists of the novelty of the study, its findings and the impact that the study has on patient outcomes.
Vijay Kunadian is a consultant interventional cardiologist and Kathryn Procter is a research nurse (cardiology) at Newcastle upon Tyne Hospitals NHS Foundations Trust and Newcastle University, Newcastle upon Tyne, United Kingdom
I thought it was interesting how you explained that those patients in clinical trials have direct access to the clinical research team. My friend is thinking about joining a clinical trial, and I’ve been curious about the whole process. It seems like she’ll have lots of information at her disposal to help during the whole process.