Clinical Trial Outsourcing – Beyond patient pool and cost saving
February 15, 2009
Sometime ago, Pfizer felt compelled to apply brakes on phase III clinical trials of torcetrapib, a drug that was being investigated for its purported benefits in raising “good” cholesterol in blood vessels, when it turned out to be increasing the risk of heart attacks instead!
By the time this discovery was made by a Data Safety Monitoring Board, the drug maker had already recruited some 15,000 patients in 100 hospitals in three continents. It cost the cost Pfizer nearly $1 billion in jettisoning that trial and the time lost? Nearly three years of wasted efforts!
Nonetheless, the incident also underscored a bigger danger — lack of ethical controls, especially in emerging markets where such norms are still weak. It also drove home the need for institutional review boards to comply with international standards, no matter where the trials are being conducted. “There is also a need for more GCP-trained investigators, improvement of informed consent process and ensuring quality data at the investigator site level,” recommends Lisa Marie Castro in Global News.
As of July 9, 2008, a dedicated website established by the Indian government listed 721 ongoing trials in India. Many large multinational companies including Pfizer, Novartis, Eli Lilly, AstraZeneca, Wyeth, and Merck meanwhile have been active in India for the past several years. More recently, Bristol Myers Squibb, Boehringer Ingelheim, and Eisai have established their individual CRO bases in India.
The CRO market is projected to more than double between 2007 and 2012, according to RNCO there are still serious challenges to be overcome in unethical trials, delays in trial approval, inappropriate protection of clinical data, and lack of Good Clinical Practice (GCP) certified sites and investigators, according to the RNCO report.
At present, the market for overseas R&D outsourcing is believed to be close to $12 billion. At the current annual growth rate of nearly 15%, the market for overseas R&D outsourcing in 2014 could be as much as $33 billion. Of this, McKinsey estimates that the Indian CR (clinical research) market will grow to USD 1.5 billion in value by 2010. Already, the number of clinical trials conducted by non-Indian pharmaceutical companies in India has surged from 40 in 2002 to 200 in 2005, a 500% increase in just three years. The CRO market in India overall is believed to be expanding at more than a 22% CAGR.
As per an FDA and Proximare Analysis, while clinical trial cost is US$ 300-350mn in US, the cost in India is US$ 25mn for new molecule. The country also commands the second highest number of qualified doctors in the world. In fact, a recent Tufts CSDD analysis of the FDA’s Bioresearch Monitoring Information System (BMIS) database reveals a staggering 433% increase of registered clinical investigators in India. Patient enrollment phase III studies are up to six times faster than in the western countries. Presently market is at US$ 100mn and expected to grow to US$ 1bn in the next 4-5 years.
From the Indian perspective, however these numbers can be good so long as the need to cut time and cost does not impinge on the need to protect patients’ rights. “These are very challenging times for the research-based pharmaceutical and biopharmaceutical industry. While profits have remained relatively high for many of the top-tier companies, stock prices have tumbled precipitously,” warns Kenneth Kaitin Director and Professor of Medicine at Tufts Center for the Study. In such a scenario, the temptation to cut corners is always high. Two years ago, a BBC documentary Drug Trials—The Dark Side, highlighted some of these dangers implicit in the CRO industry.
Companies are attracted by the opportunity for rapid enrollment of subjects, which is a major bottleneck in the drug development process in the West, and the resultant promise of obtaining regulatory approval and reaching the marketplace more rapidly. Faster access to the market means that companies can start generating revenues on the product earlier and can extend the period of effective patent life,” writes Kaitin in his article.
Thankfully there does appear to be some awakening in this regard. In New Era of R&D Laws in India, Munish Mehta writes “In July 2007, India joined the United States, UK, Australia, and New Zealand to create an online registry similar to the FDA’s clinicaltrials.gov to allow for registration of trials being conducted in India. This registry allows data to be integrated with the World Health Organization’s online database of clinical trials to ensure research meets global standards. This increased transparency is expected to ensure the ethical conduct of and public trust in clinical trials.”
In addition, recent changes at DCGI allow for expedited regulatory approval for multicenter and multicountry trials, so long as the trial is also being conducted in one or more of the following countries: the United States, UK, Switzerland, Australia, Canada, Germany, South Africa, and Japan. These are referred to as Category A trial applications. Current metrics for Category A trials are a response in two to four weeks and for Category B trials in eight to 12 weeks.
All this and more are indeed to increase transparency in this sector.
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[...] talking about outsourcing, it is impossible not to mention India. This country has become in a short time global leader in IT services and software development, [...]
The outsourcing of medical trials gained prominence approximately a decade back; since then, many questions have been raised about it. There are at present some 400 clinical trials happening in India, where the industry is likely to be worth $1 billion to $1.5 billion by 2010. For western drug companies, it’s a benefit: India’s vast pool of capable, English-speaking doctors and lower labor costs make clinical trials up to 50% to 60% cheaper here.