Laboratory Products
Experts claim that clinical trials are being held back by red tape
Feb 18 2013
Clinical trials are being held back by government regulations, according to leading experts.
Many researchers are arguing that the guidelines put in place by the European Union, in order to protect patients, are causing major delays in the research of treatments.
An example of this is where a trial must be signed off and agreed to by a series of managers at every location where the trial is taking place. This could include dozens of clinics across Europe if a drug was being tested on a widespread scale.
Furthermore, all the additional paperwork is causing costs to rise and therefore many drugs do not even get past the screening process.
Speaking to The Telegraph, Judith Bliss, deputy head of clinical studies at the Institute of Cancer Research, said: “Because the level of paperwork you have to have now ahead of trials is so much more detailed, the resources you need have really increased. There are less trials being funded because individual trials cost more, and there are very good research questions out there but the trials can not be funded."
Due to such regulations, there are many trials that are falling under a ‘high risk’ category. One such drug is the diabetes treatment Metformin which is being tested on cancer patients.
There has to be obvious caution when it comes to trials but many leading figures in the industry are suggesting that the trial process needs to be re-organised. Peter Johnson, chief clinician of Cancer Research UK, added: "Research has been heavily burdened by regulation, most of which does not contribute to the safety of participants or the quality of information you get from the trial.”
How far government regulation will affect work in the clinical laboratory remains to be seen.
Digital Edition
Lab Asia 31.2 April 2024
April 2024
In This Edition Chromatography Articles - Approaches to troubleshooting an SPE method for the analysis of oligonucleotides (pt i) - High-precision liquid flow processes demand full fluidic c...
View all digital editions
Events
May 21 2024 Lagos, Nigeria
May 22 2024 Basel, Switzerland
Scientific Laboratory Show & Conference 2024
May 22 2024 Nottingham, UK
May 23 2024 Beijing, China
May 28 2024 Tel Aviv, Israel