| Six men were taken into intensive care when they suffered devastating effects after taking a drug in a medical trial at private medical research centre at Northwick Park Hospital, Harrow.
The Dundee company, Drug Development Solutions Limited, formerly DDS Medicines Research Limited, the Contract Research Organisation based at Ninewells, carries out a range of clinical trials on new and developing drugs using volunteers recruited locally.
DDS says while it has been involved in “first in man” studies, it says it is not involved in any way with Parexel the CRO conducting the London trial, or with the drug involved.
“Most importantly, our sympathy is with the unfortunate volunteers involved in the Parexel drug trials and their families,” commented Dr Brian Sanderson, chief executive & medical director of DDS.
“Although we know no more than what has appeared thus far in the media, I would stress the horror reaction which these volunteers have tragically experienced is an unprecedented and unique event in drug development history.”
Dr Sanderson told the Tele DDS has been carrying out phase 1 clinical trials for the last 23 years and had never experienced anything like this — or even heard about it within the industry.
He said thousands of healthy volunteers have been involved in over 650 trials in Dundee during this time, with no similar serious adverse medical reaction.
“All our studies undergo rigorous review by regulatory authorities, independent ethics committees and scientific and medical review within our unit before they are conducted,” says Dr Sanderson, a former general practitioner, who has been involved in medical research for the past 12 years.
“We intend to continue being part of the process to develop new medicines. Without this, there would be no new medicines to help fight disease.
“Paramount in this process is the safety of our study participants, which is always our main concern.
“Within our hospital-based unit, we ensure extensive and comprehensive medical safety monitoring during each and every one of our studies.”
An independent ethics committee and the UK regulatory authority review all DDS studies before they can proceed.
Dr Sanderson also indicated that the UK as a whole has some of the most stringent regulations in the world regarding clinical testing. |
