India is viewed by clinical development executives as the most attractive of the BRIC (Brazil, Russia, India and China) emerging markets for access to patients, one of the key drivers for offshoring of clinical trials from the mainstream territories of North America or the European Union.
On patient retention, China scores higher than India in a new study by Cutting Edge Information, which sought the views of clinical executives on 13 criteria influencing the choice of location for clinical trials in emerging markets.
On neither of these counts, though, did the scores achieved by either India or China versus other BRIC markets approach the massive advantages these two countries enjoy in terms of available patient populations.
Specifically, notes one of five new Cutting Edge studies in the Emerging Markets Clinical Development series, India and China have total populations of 1,156.9 million and 1,338.6 million respectively, compared with populations of 198.7 million and 140 million in Brazil and Russia.
On the patient access rating, clinical executives ranked India at an average of 9.0 out of 10 (where 10 is “ideal”) and China at 8.3, compared with 7.9 for Russia and 7.2 for Brazil. On patient retention, China scored 8.4 out of 10, India 8.3, Russia 7.9 and Brazil 6.6.
Moreover, the BRIC study comments, in nearly every category analysed by Cutting Edge Information in its emerging markets series – these range from patient access and retention to the regulatory environment, intellectual property provisions, data, site and investigator standards, technology infrastructure, supply chain management, and costs – Brazil, Russia, China and India score lower than “less-discussed regions”.
All the same, the study asserts, “as companies develop their global clinical strategy and compare the emerging markets, they should know that BRIC offers unmatched advantages”.
These include not just volume of potential patients but the vast size of the BRIC countries, which results in “higher percentages of patients without adequate access to quality care who are willing to participate in clinical trials in exchange for this care”.
Also cited is the markets’ strong global presence. Brazil, Russia, India and China “not only represent the future of the life sciences industry, but they also lead developing countries in nearly every other industry”, the study comments. “The resources and knowledge poured into these countries will manifest in swift growth in all areas.”
And while multinational companies are relatively new to the BRIC region, all four of these countries “internally enjoy strong life sciences industries backed by highly educated and talented leaders”, the study notes. “Many of these leaders have trained in the world’s best universities and are more than ready to lead the clinical development industry within emerging markets.”
Another factor to consider is study saturation. While pharmaceutical companies run tens of thousands of clinical studies in developed countries, none of the BRIC markets currently has more than 2,000 trials ongoing, Cutting Edge Information points out.
Hand in hand
According to the executives interviewed for the BRIC study, patient access and retention “often go hand in hand” in these countries. Cutting Edge Information identifies three key factors affecting recruitment and retention in the BRIC region:
• Strong patient-physician relationships. The heritage of Communism in Russia and China “encourages citizens’ obedience to government personnel”, the study says. With most of these populations using government-run healthcare institutions, there is solid adherence to physician directions.
A similar effect is seen in Brazil and India, with physicians accorded a high level of respect in deference to religious tradition rather than politics. “Companies running trials in these countries find that if they can get the investigators focused on the trial, they will not need to worry about patient recruitment or retention,” the study comments.
• Low availability of leading medicines. Many companies do not even attempt to market some of their brands in the BRIC countries – especially India and China – due to concerns over intellectual property violations and government price controls.
As such, the study points out, patients in these countries “will simply not be able to take the newest medications for their indications. Trials offer not only investigational medications, but often also test for expanded access or long-term safety of medications taken in developed countries. This gives patients in BRIC countries the same level of treatment provided elsewhere”.
• Limited access even to older therapies. With the exception of Brazil, currently most patients in the BRIC countries pay for most of their medical treatment out of pocket, the study notes. Many patients may therefore shun treatment simply because they cannot afford it. “If investigators can get these patients into clinical trials, the patients may finally receive care they can afford,” Cutting Edge Information says.