Clinical Research Quality Concerns


Pharmaceutical research quality concerns have increased significantly over the past few years. FDA and sponsor actions in response to quality issues at selected providers, such as Cetero (which is no longer in operation) and in certain countries, such as India, is greatly influencing where studies are conducted. A few years ago, many sponsors were directing increasing study volumes to lower cost regions with the view that migrating their drug testing to places such as India would be cost effective.

Projections suggested that over time more work would be conducted outside the United States. However, with the repeated regulatory issues uncovered by the FDA in India over the past year or so, including instances of data integrity and even falsification by some pharmaceutical companies and service providers resulting in the FDA invalidating the studies and refusing to accept data from certain providers, this trend has reversed course 180 degrees and studies are coming back to the US. As a result of apparently endemic industry quality problems in India, the NIH terminated all clinical development activities in the Country, including pulling more than 30 trials. In addition, several US companies, including Quintiles, the largest global CRO, and Pfizer and Novartis, two of the largest multinational global pharmaceutical companies, closed their clinical development facilities in India. In fact, the situation with drug testing in India became so problematic that the Indian Government put a moratorium on its own industry conducting any studies in the country until further notice.

Quality is Everything in Clinical Research

Often lip service is given to activities that are not directly revenue generators, such as quality control. In the end, however, in the clinical research arena, as the saying goes, you are only as good as your data. The recent history of Cetero and the state of the clinical research industry in India are stark reminders of this.