Clinical Research News Roundup — September 18, 2014

Industry Clinical Data Transparency On The Rise

Citeline released a report last week that suggests clinical data transparency (aka responsible data sharing) is “in a much healthier state” than in the past. In previous studies, 23 to 57 percent of completed clinical trials did not reveal results of the study. However, in its recent analysis of 7,500 phase 2 and 3 industry sponsored trials that occurred between 2008 and 2012, Citeline found 78 percent of these trials had distributed interim or final results. This percentage increased to 81 percent when only looking at the more costly, high-profile phase 3 trials.

Tropical-Disease R&D Becoming Industry Priority?

As drug makers set their sights on researching and developing treatments for the recent R&D outbreak, it seems as though the market is becoming more invested in tropical diseases that have long been overlooked. As the Wall Street Journal highlighted in a recent article, between 2008 and 2012, R&D on diseases including Ebola, malaria, dengue, tuberculosis, and parasitic worms has rising by almost 20 percent. While this is still a small percentage compared to cancer and heart disease, spending in these areas accounts for roughly $500 million a year. According to one health care analyst, drug company’s peaked interest in tropical disease treatment development stems from both social responsibility and “strategic investment in the customers of tomorrow, given that the tropics are home to over 40 percent of the world’s population.”

ARCO Survey Reveals Strength Of CRO Industry

A recent survey put forth by the Association of Clinical Research Organizations, or ARCO, reveals that members of ARCO have more than doubled in size over the past 10 years and represent roughly 100,000 researchers earning a payroll of nearly $6 billion. Similarly, just as employment rates have increased, so have company revenues by 10.8 percent CAGR, hitting $14.2 billion. This amount represents roughly two-thirds of contract biopharmaceutical development spending and suggests that demand from pharma, biotechs, and medical device companies for CROs is hitting new highs. The survey also revealed that top indications and research areas being explored by CROs include breast cancer, Alzheimer’s Disease, hepatitis, diabetes, asthma, hypertension, and vaccines.

FDA Looks To Beat 2013 Drug Approval Record

According to the Wall Street Journal blog, the FDA has approved 27 new novel medicines so far in 2014. This figure, which also includes biologics, is the same number of the total novel drugs approved in 2013. The blog speculates that the FDA could tie with its approval rate in 2012, during which the FDA approved 39 novel new medications. According to the agency’s 2013 report, the FDA also met 100 percent of its application reviewing goals and 74 percent of medicines were approved in the U.S. before they were approved in other countries.

NSCLC, Breast Cancer Pipeline Gaining Market Prominence

Two research reports from GBI Research were released recently emphasizing the strength and value of two different therapeutic areas. According to GBI research, the global Non-Small Cell Lung Cancer (NSCLC) treatment market is set to grow at a Compound Annual Growth Rate (CAGR) of 6.6 percent, taking the market value from $5.1 billion in 2013 to $7.9 billion by 2020.

In another recent report, GBI Research found that the breast cancer pipeline is the largest and most innovative pipeline in the pharmaceutical industry today. There are currently 826 products in active development across all stages of the pharma industry. Of these, there are 245 first-in-class programs acting on 175 first-in-class molecular targets. Signal transducer proteins are currently the most widely studied first-in-class targets. Many of these first-in-class treatments are expected to make it to the market sometime in the next 10 years.

NICE To Seek Out Clinical Data If Unsupplied By Drug Makers

The Wall Street Journal blog reported last week that the National Institute for Health and Care Excellence (NICE) plans to ask European regulators for clinical data should drug companies not release data. This is just one of many current initiatives in the pharma industry that are ongoing in order to increase transparency. At this point however, it is unclear whether NICE would be able to attain the data it is hoping to receive. The EMA is still expected to release a policy on data trial disclosure within the next month, the blog says, however the date of this policy’s release is still unknown.