Roche to shed light on clinical trials
Swiss pharmaceutical company Roche is to publish data about current and completed clinical drug trials.
The move comes after a number of drugs firms signed an international agreement aimed at improving transparency in the industry.
Roche, Switzerland’s number two drugmaker, said it would set up an online registry of clinical trial protocols.
The company also plans to create a database for key results from completed trials by the end of March.
“It is important that we protect the safety and the rights of patients, and secure the quality and integrity of the data and related conclusions,” said Ed Holdener, head of Global Pharma Development at Roche.
The Basel-based company said on Friday that it was committed to making information more widely available to doctors and patients.
“The database will ensure fair and balanced reporting of all Roche-sponsored clinical trials that might affect the practice of medicine,” a company statement said.
The registry will be managed by an independent body and the data should be accessible to the public sometime during the first quarter of 2005.
On Thursday Roche’s main Swiss rival, Novartis, announced plans to take similar steps.
Last September the British company, GlaxoSmithKline, launched its own register of results from clinical trials.
Voluntary accord
Earlier this month the international pharmaceutical industry approved a voluntary agreement to publish a detailed registry of trial research and results.
The industry said the accord was a major step towards achieving greater transparency.
However, critics say the database is an attempt to pre-empt tougher legislation on the information companies have to disclose about drug trials.
They also point out that the register is voluntary and will only include details of mid- to late-stage trials.
“There are already many registers available and one of the problems with that is that you need to harmonise them and link them together,” said Cameron Abbasi of the British Medical Journal.
Vioxx case
The issue of drug safety hit the headlines last year over the controversial arthritis painkiller, Vioxx.
The United States company, Merck, withdrew Vioxx in September after it was revealed that the drug doubled the risk of heart attacks and strokes in patients who had used it for 18 months or more.
A study showed that the dangers posed by Vioxx were apparent almost four years before it was pulled from the market.
In November the US Food and Drug Administration listed five drugs, including Roche’s acne treatment Accutane, that might not be safe.
The five companies targeted by the regulatory authorities – AstraZeneca, GlaxoSmithKline, Abbott Laboratories, Pfizer and Roche – immediately defended the safety of their products.
swissinfo with agencies
September 2004 – Merck pulls its arthritis drug Vioxx from the market.
September 2004 – GlaxoSmithKline launches registry of results of clinical trials of marketed medicines.
January 2005 – The international pharmaceutical industry strikes voluntary agreement to publish data about clinical drug trials by July 1.
January 2005 – Roche and Novartis announce plans to improve drug-trial transparency.
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