Readers of this monthly commentary will know that understanding risk is a favourite topic of mine. Most of this risk is linked to research into and the development of new drug entities. About 80% of all drugs fail clinical trials. The majority of these fail because of either toxicity or efficacy issues. The barriers to drug success are high and, as time goes by, become even higher. Closely associated with these problems are the increasing costs of clinical trials.
The recent tragic events in the UK in March 2006, when Phase I healthy volunteers reacted extremely badly to a new anti-inflammatory drug being developed to treat conditions such as leukaemia, rheumatoid arthritis and multiple sclerosis, were exceptionally rare in terms of occurrence. Yet news such as this will have a very negative effect on public perceptions of clinical trials and the safety of volunteers. This could have two potential outcomes: a reduced number of volunteers for clinical trials and greater pressure for increased regulatory control. It would be very unfortunate if the number of volunteers dropped, as this would have a huge impact on drug clinical development and, in itself, could increase the cost of clinical trials. Greater regulatory control should, of course, be welcome to all concerned, but this also increases cost.
The anti-inflammatory drug being trialled was a monoclonal antibody discovered and developed by a small German biotechnology company. Over the years, venture capital-backed biotechs have taken on an increasing amount of the risk when it is at its highest, i.e. in the early stages of development.
"A possible further increase in the cost of clinical trials will make it more difficult for biotechs to take products through to clinical proof-of-concept in Phase II. This could both threaten the ability of the industry to discover and develop new drugs and further undermine the biotech as a successful business model."
A possible further increase in the cost of clinical trials will make it more difficult for such companies to take products through to clinical proof-of-concept in Phase II. This could both threaten the ability of the industry to discover and develop new drugs, and further undermine the biotechnology company as a successful business model.
It is vital for the pharmaceutical industry and regulators to work together to improve the safety of clinical trials, but not at the risk of making them less efficient and less cost effective. A safe and expedient regulatory environment will ensure that the trial design is suitable, allow bad drugs to be spotted sooner and good drugs to get to market faster. In addition, if it is possible to reduce clinical costs, the resulting drugs are more likely to be affordable to patients, while still allowing a necessary financial return for those who invested in the risk of their development.
Fintan Walton
Chief Executive Officer
PharmaVentures Ltd