This paper explores outsourcing of clinical trials to developing countries focusing on current trend and providing brief overview of the clinical trials. The paper covers major reasons for outsourcing of trials to developing countries especially focusing on India with ethical and scientific concerns raised in conduct of clinical trials at foreign sites, throwing a light on growing career opportunities in developing countries and steps for ethical conduct.
Clinical Trial Outsourcing:
Global Drug and Medical Device makers based in developed countries are now focusing on developing countries to carry out their clinical trials. These players (pharmaceutical and device makers) have embraced outsourcing as a core component of their business models especially in realm of clinical trials. “Outsourcing may be defined as shifting or delegating a company’s day to day operations or business process to an external service provider.”
For instance, 20 largest United States (“U.S.”) based companies are now conducting one third of their clinical trials outside the U.S. According to a report from the inspector general of Department of Health and Human Services (“DHHS”) the number of clinical trials conducted at foreign sites has increased to 6,485 in 2008 from 271 trials in 1990. This trend suggests that the outsourcing of clinical trials has become one of important aspects of business fostering development of safe and effective drugs and devices that are interest of through out the world but at same time raising many ethical and scientific concerns.
According to U.S. government publications, clinical trials that are registered with U.S health authorities are being conducted in middle and low income countries of Asia like India, China, Russia, Thailand, Malaysia, Philippines and African countries .
A clinical trial is a form of research study/ experiment that involves some intervention with human subjects that answers specific questions about new therapies or new ways of using known treatments. Clinical Trials are used to determine whether new drugs or treatments are both safe and effective.
A clinical trial that is regulated by the U.S. Food and Drug Administration (FDA) involves drug, biologic or medical device and fall into four phases each having different goals and designed to answer specific questions.
The four different phases involved in clinical trials are:
Phase I: These studies are designed to test the safety of treatment. In detail, these studies are conducted to determine metabolic and pharmacologic actions of interventions, the safety in human subjects and also to determine some evidence on efficacy. Phase I studies are conducted commonly in healthy volunteers; however, there are some exceptions where studies are performed on actual patient population (e.g., cancer therapies). This phase studies involve 20-100 subjects.
Phase II: These studies are conducted...