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In the Heart of Russia

Lyubov Semenova at Pharm-Olam evaluates cardiology research in the Russian Federation and gives a forecast of things to come

In 2009 cardiology represented the fourth largest area of clinical research in Russia (10 per cent of all studies), following closely behind oncology (14 per cent), CNS (11 per cent), and infectious disease (11 per cent) (1). The pattern of clinical research in cardiology for the last three years has not varied considerably; however, there is a trend to change the ratio of cardiologic nosologies within the group. Taking into account the high prevalence of cardiologic diseases, as well as the increasing death rate due to these diseases worldwide, it is clear that there is a growing to need advance treatment through clinical trials. For example, the reported number of patients with hypertension in Russia in 2008 and 2009 was 11,341,294 and 11,439,994 respectively (9,800 and 9,875 per 100,000 adult population respectively). Russia’s largest cities, Moscow and St Petersburg, contributed the highest number of hypertension patients to this total with 865,507 and 559,934 reported patients (9,610 and 14,273 for 100,000 adult population respectively (2).

CURRENT CARDIOVASCULAR RESEARCH

According to data provided by the Federal Service on Surveillance in Healthcare and Social Development Roszdravnadzor (Russian Regulatory Authority), 581 clinical trials were approved in Russia in 2009. However, the number of cardiology clinical trials conducted does not match the needs in this area; according to WHO data, cardiovascular diseases result in the death of 15 million people every year.

In Europe, cardiovascular disease (CVD) is the main cause of death before the age of 65, accounting for over 803,000 deaths each year, and of this figure 31 per cent are male and 29 per cent are female. This means that one in eight men and one in 20 women die from CVD before the age of 65 (3). Furthermore, cardiologic diseases contribute an increasing percentage to total mortality and are currently the leading causes of death (see Figure 1) (4).

As for the nosology of studies in Russia, the pattern changed slightly in 2009. The majority of the studies conducted were focused on arterial hypertension (both essential and secondary hypertensions), however the 2009 figures show the number of hypertension trials were fewer than in both 2007 and 2008. A similar pattern was seen for studies treating rhythm disorders and hypercholesterolaemia (see Figure 3).

In comparison, a small upward trend has been observed over the last three years in clinical trials for treating pulmonary hypertension, stable angina and chronic heart failure. The figures for clinical trials for acute coronary syndrome have not changed considerably.

A paper by Shlyakhto and Konradi illustrated that clinical trials in cardiology for the last five years in Russia could be demonstrated in the following way (5):

  1. Urgent cardiologic state:
    – Acute coronary syndrome – 80 per cent
    – Acute rhythm disturbance, hypertensive crisis and syncope state – 20 per cent
  2. Stable cardiologic state:
    – Arterial hypertension – more than 50 per cent
    – Chronic heart failure and stable angina – about 35 per cent
    – Stable rhythm disturbance – 15 per cent

PLANNING FOR STABLE & URGENT STUDIES

Stable cardiologic conditions are generally easier to organise than studies of urgent cases. First of all, stable patients have enough time to read the informed consent form, ask questions and advise relatives if they wish. Most stable patients are recruited from site level and centralised databases, as well as via new admissions and referrals. Many studies can enrol all required patients in one or two large cities as they can support more high enrolling sites. This results in cost savings across the study, including investigator meetings (if local), site evaluation and initiation, monitoring visits and delivery of supplies. Urgent conditions typically involve hospitalised patients, although many charges related to hospitalisation are reimbursed by the State, allowing for significant cost savings compared to other nations.

Traditionally the most strategic cities are Moscow, St Petersburg and Novosibirsk; they contain the most approved sites for clinical trials as well as having the highest metro populations (about 411 out of 946 sites in 2009). However, smaller cities are often ideal for outpatients and observational studies as there are rarely any competing studies.

A completely different approach to patient recruitment is used for urgent cases such as acute coronary syndrome. Recruitment of eligible patients is dependent on choosing a hospital with emergency services and ambulance support. In addition, many more investigators and coinvestigators should be involved in the study compared to stable trials, as each of the doctors on duty should have an opportunity to receive inform consent and have an access to the study drug. For studies that do not require high tech equipment it is often beneficial to involve smaller Russian cities which occasionally lack equipment and laboratory supplies but can enrol higher numbers of patients from local databases. These sites often view these trials as an opportunity to bring resources and advanced testing to their patients through clinical research. For example, in most clinical hospitals Troponin I and T tests are rarely used for myocardial infarction diagnosis, which is required in most clinical trials. As a result investigators are willing to participate in complicated studies which provide opportunities to diagnose and treat patients according to the latest available methods.

LEGAL CHANGES

The legal environment for clinical trials in Russia is expected to change in light of a new law which came into effect on 1 September 2010. The qualification requirements and experience level of the principal investigators are expected to be significantly raised in the view of the new law, including requirements that principal investigators must be certified in the medical field related to the same nosology. For example, a principal investigator for cardiologic trial should be a cardiologist and not a general practitioner (although uncommon) which was previously acceptable. Another requirement is that they should have previous experience in clinical trials prior to assuming the role as principal investigator; such as a co-investigator or similar role. These changes are expected to improve existing high standards of clinical trials in Russia as well as setting the bar higher for global standards.

CONCLUSION

The global burden of cardiology diseases continues to drive new research from sponsors attempting to bring more advanced treatment to market. Internationally Russia is ranked 11th in terms of pharmaceutical sales, presenting additional incentives for sponsors to conduct studies there to support post-marketing activities (6). With Russia’s high burden of disease, a growing number of cardiology sites, a proven track record of FDA inspections/approvals, and the ability to exceed global standards for principal investigators through new legislation, the country currently offers sponsors of cardiology research opportunities across all indications and will likely remain a leader in global cardiology research.

References

  1. Roszdravnadzor (Russia Regulatory Authority), http://www.roszdravnadzor.ru/
  2. Morbidity of population in Russia for 2009 year, Roszdravnadzor, department of healthcare development
  3. www.heartstats.org/datapage.asp?id=756index.html
  4. www.who.int/mediacentre/factsheets/fs317/en/index.html
  5. Shlyakhto E and Konradi A, Features of clinical trials in cardiology, www.roszdravnadzor.ru/search
  6. IMS Health MIDAS, Market Prognosis October 2009

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Lyubov Semenova is a Senior Clinical Research Associate for Pharm-Olam International in Russia. Before joining Pharm-Olam, Lyubov obtained her residency in Cardiology from the Baculev Scientific Centre of Cardiovascular Surgery. She has authored several papers in the field of cardiology and surgery for Russian and international journals. 
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