[Industry Voice #12] NANOLEK: Lifesaving…
ICH E9(R1) Addendum on Estimands and…
Cardiology is an important area of study that stands to be improved by more robust research strategies. The World Health Organization reports that cardiovascular diseases are the leading causeof death worldwide. In 2018, there were over 1.1 million new cases of hypertension in Russia alone, as well as over 330,000 new cases of other heart diseases.
Study Sponsors, cardiology CROs, and medical experts should seek out more patient-centric approaches to strengthen clinical development — especially in the wake of COVID-19, which has posed added dangers for those with cardiovascular conditions. The points that follow address both current and long-term considerations for strengthening cardiology research and managing clinical trials.
1. Special measures are critical for clinical study management during the COVID-19 pandemic.
The COVID-19 pandemic has adversely affected all aspects of clinical research, but particularly patient participants. Patients with heart failure are at a much higher risk of developing life-threatening symptoms if they contract SARS-CoV-2. Efficient cardiology research has never been more critical, but there are many factors that dictate how it can proceed. The European Association of Cardiology has several recommendations on maximizing safety and patient care during the pandemic, including the following:
○ Patients who do not require urgent care should avoid hospitals and clinics
○ COVID-19 trials should be prioritized over other cardiology research
○ Ongoing cardiology trials should continue as long as there is no added risk
Put simply, safety must come first, but should be balanced with a sense of urgency. Comorbidity factors put COVID-19 patients with cardiovascular conditions at significantly higher risk. Contract research organizations should work to determine ways to carry out critical research while minimizing risk.
2. Correcting gender imbalances better serves both the Sponsor and the cardiology CRO — and creates better patient outcomes.
Historically, cardiovascular conditions have most often been associated with men. This has meant that broadly speaking, cardiology research has not benefited women the same way it has benefited men. Because women are not as likely to be considered as participants, the pool for recruitment is often limited (which poses a challenge for CROs in cardiology trials). Seeking out more female participants ultimately makes managing clinical trials easier and less time-consuming. The perception that men suffer more from cardiovascular conditions across the board is untrue. According to the American Heart Association, more women have died from ischemic heart disease (IHD) than men since 1984. Additionally, low representation in the patient pool can skew trial outcomes and create gender bias in administering therapies. Women with coronary artery disease (CAD), for example, are less likely to receive treatment than men with the same condition. Proportional gender inclusion leads to more robust and efficient research. It also offers more accurate insights into biological differences that affect drug development, improving outcomes for women who will rely on the therapies brought to market.
3. Clinical development professionals should seek out ways to encourage trial participation among the elderly.
Cardiovascular disease is the most common cause of death for elderly individuals. Because the elderly are disproportionately affected by cardiovascular conditions, it is important to ensure they are well-represented in trials. Cardiology CROs with strong patient recruitment expertise are best equipped to meet this need.
While it may be more difficult to recruit elderly patients, researchers should work to understand the factors that affect participation so that elderly populations are included and their interests are addressed in clinical research. It is especially important that participants in Phase II and III trials accurately reflect the populations that will use the drug when brought to market. Some experts recommend that age limits be raised or eliminated to ensure that participant pools in cardiology trials are representative of heart disease patients in general.
With 45 clinical trials in cardiovascular diseases initiated in 2019, Russia has become an attractive location for clinical research. A large, diverse population is ideal for offshoring clinical trials to ensure that quality research is conducted in the most efficient manner possible. Learn more about Russia as a clinical trial location in an article by Irina Petrova, MD, Director of Clinical Operations at OCT Clinical.
OCT Clinical has been managing clinical trials for over 15 years. We have helped conduct over 300 studies, including over two dozen rescue studies, in the CEE and CIS regions. Among our core strengths are the abilities to meet enrollment targets, streamline project management, and properly manage data to optimize research quality. In the midst of the demanding circumstances created by the COVID-19 pandemic, our CRO services provide much-needed efficiency to reduce the burden of drug development timelines on study sponsors worldwide.
Contact us to learn more or request a proposal.