Difficulties in Multinational Clinical Trial Supply

Pharma IQ
Posted: 11/23/2011

Clinical trials are a vital part of the research and development of new drugs and, as one of the final stages in the process, the speed at which they are undertaken and the prevention of unnecessary delays could get drugs to market quicker, potentially saving lives.

However, many in the industry are calling for the process to be shortened as some drugs can take up to two decades or longer in development, and, with many diseases like malaria, TB and dengue fever, reducing this progression by even a few years could literally mean the difference between life and death for millions.

Regulatory restrictions to supply

Writing for the Atlantic, Amanda Glassman, the director of Global Health Policy at the Center for Global Development, said that currently clinical trials are a mess, a "tangled process", which urgently needs overhauling so that pharmaceutical companies can capitalise on promising new medicines, vaccines, and diagnostic techniques and the global population can benefit from their use. She explained that there are currently 90 drugs or processes in the pipeline for malaria and 59 for TB, with just a fraction of those getting through to the final stages of clinical development.

"The many other drug and vaccine candidates for neglected diseases waiting in the pipeline for late stages of clinical development must face lengthy, inefficient review processes or non-existent regulatory capacity in the poorest, least developed countries before these technologies can reach the millions in need," Ms Glassman explained, adding that many trials, particularly those spanning many different countries, face delays of a year and upwards while approval is sought from authorities in those nations involved. This can then be subject to even more postponement if approvals need to be sought in sequence rather than concurrently.

The bottlenecks in regulations dramatically extend the length of the clinical trial process and can count for as much as half of the end cost of conducting the research, however, she suggested that introducing a regional approach to regulation would provide a more sustainable platform for supply and oversight, dramatically reducing costs.

"Clinical trials produce goods that span entire regions and, as such, they need a system of regulations to match. Reducing inhibitory costs and bureaucratic hold-ups would benefit the estimated one billion people that suffer from neglected diseases - be it malaria, TB, or other lesser known diseases - every year," Ms Glassman insisted.

Distribution costs

However, it is not just regulations that can drive up the cost of drug development and, eventually, distribution, some practitioners are calling for even more testing prior to approval, to ensure that drugs are actually cost effective to use – particularly with rare drugs and in countries with no public health care system.

Speaking to AZ Central, Michelle Ruha, a Banner Good Samaritan Medical Center Poison and Drug Information Center physician, who took part in the US clinical trials for a scorpion sting anti-venom which is particularly rare, said that more research needs to be done during clinical trials to ensure the new drugs on the market are actually affordable. Her comments were prompted by the revelation that a single vial of the anti-venom costs over $7,900 (£4,967), sometimes up to $15,120, however John C Lincoln hospital has only recouped $10,047 of the $68,040 it has spent on the treatments as patients cannot afford it.

"You don't want to look at a parent who has a very sick child in the emergency department and say we can give you one treatment and it will cost you this, or we can give you another treatment and it will cost you that," Ruha said. "It's not just the cost that's important. If you use the anti-venom, children will be able to go home in most cases."

Given the increasing costs of drug development and research, both in regulation and in delivery costs, it is little wonder that many pharmaceutical firms are looking at their supply chains to see if they can recover any costs.

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Pharma IQ
Posted: 11/23/2011

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