There are more active, commercial investigational new drug applications (INDs) circulating through the FDA than ever. Exactly 5,700 at the end of 2008. That's a record high—up 20 percent over the previous year. For now, clinical programs do not appear to have been affected by the larger economy. Numbers of filings are surging, too. A record 795 new INDs were filed with the FDA between the end of 2007 and the end of 2008.

These are the most encouraging findings of Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook, published last month and retailing for $425. Parexel has been putting together the reference tome since 1995; it is distributed by Cambridge Healthtech Institute.

At the Drug Information Association's 45th annual conference last month, a few Parexel executives gathered for a round table discussion and shared highlights from the company's yearly analysis. Their sourcebook breaks down metrics into four handy categories. Below are highlights from each.

Trial Statistics

This year, the largest concentration of clinical trials was under the anti-infective category, which encompasses anti-infective/ophthalmic, antiviral and special pathogens/transplant. Seventeen percent of trials fell into that designation.

The causes of the surge are multiple, said Mark Mathieu, Parexel Consulting's director of publications. The subcategories grew especially strongly: Anti-infective/ophthalmic projects rose by 33 percent, antiviral trials by 30 percent. “Pandemic infections, swine flu, bird flu before it, bioterrorism, which is having an effect,” Mathieu said. “There's also this recognition, several years long, that some of these life-threatening infections have simply developed a resistance to our first-line anti-infectives and we've got to do something.”

Oncology represented almost 15 percent of all clinical trials at the end of last year. Just over nine percent of trials were focused on anesthesia/analgesia/rheumatology. Neurology saw the same heft: just over nine percent of trials were focused on it.

Parexel's sourcebook looks closely at which therapeutic areas are seeing growth and which aren't. Here's what was observed in last year's numbers: Anesthesia/analgesia/rheumatology saw almost 40 percent more trials than the year before.

Oncology in 2008 was up just 11 percent, compared to 2007. It's not actually that oncology trials are on the wane, but rather that there are already so many such studies under way. “It's a large base; it's tougher to make the needle move,” Mathieu says.

Trial Offshoring

To shine a spotlight on which countries trials are being conducted in, Parexel monitors the filings of the FDA's form 1572. In 2008, 23,827 investigators from 89 countries and territories signed new 1572s—a 5.8 percent increase over 2007 and the second-highest number ever.

Eastern European countries saw big spikes, as did those in Asia. South Korea had the largest increase, at 74 percent. Other countries with healthy growth included: Bulgaria (57 percent), Romania (44 percent), Taiwan (21 percent), Russia (20 percent), and Poland (17 percent). India, where lots and lots of trial traffic has gone in the last few years, was up 14 percent.

China Numbers

China was different. The number of new investigators there actually dropped 30 percent (from 92 in '07 to 64 in '08). That may be due to clinical research organizations (CROs) and sponsors discovering China's long trial approval time: six months to a year, says Albert Liou, corporate VP and general manager of Asia/Pacific for Parexel.

Adds Mathieu, “We have seen these countries in their ascendancy have one-year speed bumps, and inevitably they return to their previous trajectories. The allure of China in terms of cost, availability of patients and size of the ultimate market is just too much that companies are simply not going to ignore it.” Russia had a similar speed bump recently after reassessing its own regulatory issues. “And here we are; Russia is in the top four now,” he notes.

Fifty-eight percent of all investigators worldwide are in the U.S., the sourcebook shows. The rest are spread over about 14 countries, with Canada having the biggest percentage: 3.6 percent. Germany is next at 3.2 percent. Then Russia, with 2.4 percent.

Research Starts

New INDs coming into the FDA surged 20 percent from 2007 to 2008—from 662 to 795. Interestingly, gastroenterology was the therapeutic area that saw the biggest annual gain. By the end of 2008, INDs for 208 percent more such trials had come into FDA than the year before. Medical imaging/hematology starts saw a 186 percent increase. And special pathogen/transplant starts had almost 70 percent more IND submissions than in 2007.

In 2007, oncology had the most starts, but in 2008 only saw an 8 percent increase. Still, oncology represented 14 percent of all research starts in 2008, followed by metabolism/endocrine with just over 11 percent, and anesthesia/analgesia/rheumatology with just over 10 percent. “Whatever metric you look at, this clearly is an up and comer,” Mathieu says of anesthesia/analgesia/rheumatology.

New Drug Submissions

NME approvals, says Mathieu, are the purest measure of the industry's new drug productivity. For the sourcebook, Parexel looks at NME submissions, which Mathieu calls a “slightly more upstream measure.” NME submissions in the U.S. had surged a whopping 43 percent from 2007, but in 2008 they fell again. There were 26 NME submissions in 2008, down 13 percent from the 30 submitted in 2007. Last year's number of NME submissions virtually matched the average of per-year submissions from 2000 to 2008: 27.

Says Mathieu, two NME metrics took Parexel by surprise: that 60 percent of Phase I and II drugs today are for unproven targets—biological targets for which no drug has been previously been approved. And that almost 40 percent of Phase III trials now involve these drugs.

“It's fascinating, and yet at the same time, there's a lot of uncertainty,” Mathieu says. “What that tells us is that the most innovator drugs are finding a way to move through the drug development process, and most importantly, past the all-important proof of concept phase. We took that as a very encouraging sign for the future.”

—by Suz Redfearn