Ethics of Clinical Trials...

Most of us who have been working in clinical development can see a radical shift in focus of research (and business focus) to what we call the emeging markets. More and more of the research we see in patient and healthy volunteer groups are now moving to countries outside Europe..to a lesser extent outside US too..

Why?

• Aging populations in developed countries
• Cost of doing research high
• Barriers due to regulations, increased timelines
• inability to find a treatment naive population
• patients refusing to participate in trials
• ..
• ..

However, under the circumstances, how ethical is it to expose a patient group to a risks of a new treatment when they are not the focus of a commercial launch of a new product, which will be launched in the more affluent markets first. The answer is tough as we know that research focus in emerging markets fuels economy, gives patient benifits, focusses on the health care infrastructure, makes sure regulators clean up their act, is the first step towards awareness of disease and rights, ..

As long as stakeholders dont walk away with the benifits and leave behind a trail of uninformed or misinformed patients... and play a significant role in improving health care and building local infrastructure and ensure that the rights and safety of patient populations are protected... why not?

Back office functions on the other hand are moving and have moved.. to the IT savvy countries. India is preferred to China because English is a definate advantage. Data management, pharmacovigilance and safety monitoring, even sales analysis are the focus of BPOs..

Early days yet.. but very promising avenues opening up!