Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Stopping a cancer trial early: is it for the benefit of patients or industry?

09.04.2008
New research has identified a growing trend for trials of new cancer treatments to be stopped prematurely before the therapies’ risks and benefits have been properly evaluated.

In a study, published online today (Wednesday 9 April) in the cancer journal, Annals of Oncology [1], Italian researchers analysed 25 randomised controlled clinical trials that had been stopped early because they had started to show a benefit to patients and found that the numbers had increased dramatically in recent years. They warn that this could lead to a systematic over-statement of the effects of treatment, and that patients could be harmed by new therapies being rushed prematurely into the clinic.

Out of 14 trials stopped because they started to show benefit to patients and published between 2005-2007, the researchers found that 11 (79%) were used to support an application for marketing authorisation at the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA).

“This suggests a commercial component in stopping trials prematurely. In fact, this strategy (i.e. stopping trials early for benefit) could guarantee quicker access to the market for companies. On the other hand, a quicker clinical drug development may lead to an ‘immature’ benefit/risk balance of new drugs,” Dr Giovanni Apolone, one of the authors, told a news briefing yesterday (Tuesday).

... more about:
»Apolone »Cancer »Oncology »clinic »patients »prematurely »trial

Dr Apolone, head of the Laboratory of Translational and Outcome Research in Oncology, Mario Negri Institute for Pharmacological Research, Milan, Italy, continued: “When we analysed 25 trials over a ten year period between 1997 and 2007, we found a consistent increase in prematurely stopped trials – more than 50% were stopped within the last three years.

“We are aware that trials stopped early because they are showing benefit may result in the identification of promising new treatments for patients. However, findings obtained following this strategy should be considered to be preliminary results that require subsequent confirmation. We believe that only untruncated trials can provide the full level of evidence required to safely translate treatments into clinical practice. Without such evidence, unsafe and ineffective drugs could be marketed and prescribed, and patients’ health could be jeopardised.”

He pointed out that it can take several years for the long-term benefits or adverse side-effects of a treatment to become apparent, but the average study duration was 30 months among the 25 trials they analysed (with a range of between 12 and 64 months).

In their paper the authors write: “If a trial is evaluating the long-term efficacy of a treatment of conditions such as cancer, short-term benefits, no matter how significant statistically, may not justify early stopping. Data on disease recurrence and progression, drug resistance, metastasis, or adverse events, all factors that weight heavily in the benefit/risk balance, could easily be missed.
more/
“An early stop may reduce the likelihood of detecting a difference in overall survival (the only relevant end point in this setting) because of the small sample, the possibility of crossing-over the experimental drugs, and contamination with other treatments.”

The authors said they were particularly concerned that, by the time they were stopped, five studies had enrolled less than 40% of the total number of patients planned for final analysis. “It is obvious that the risk of overestimating treatment effects increases markedly when the sample is small,” they write.

Dr Apolone said: “We believe that, in general and unless harm is being shown, cancer trials should be completed so that the correct number of patients over the correct period of time required for a significant final analysis can be recruited. Our study describes a growing phenomenon of trials stopped prematurely, which is now the subject of debate within the international scientific community.”

Professor David Kerr, the editor in chief of Annals of Oncology, told the news briefing: “We, as scientists, put a great deal of work and effort into designing appropriate clinical trials, and in all but the rarest of cases we should not rush to abandon those designs in the face of early signs of benefit. Moreover, as researchers we make an ethical commitment to patients entering studies to do the research as designed and presented to those patients. Everyone wants new and powerful therapies available quickly in clinic, but we all, patients perhaps most of all, recognise the need for good science and strong ethics.”

Professor Stuart Pocock, Professor of Medical Statistics at the London School of Hygiene and Tropical Medicine (UK), who was not involved in the study, told the news briefing: “Clinical trials need to stop early for superior benefit whenever there’s proof beyond reasonable doubt that the new treatment really is superior.

That would be an ethical obligation. However, too many trials are stopped early claiming efficacy without such strong evidence being available.”

Notes:
[1] Stopping a trial early in oncology: for patients or for industry? F. Trotta, G. Apolone, S. Garattini, G. Tafuri. Annals of Oncology. doi:10.1093/annonc/mdn042.

Emma Mason | alfa
Further information:
http://www.oxford.ac.uk
http://annonc.oxfordjournals.org/

Further reports about: Apolone Cancer Oncology clinic patients prematurely trial

More articles from Life Sciences:

nachricht UNH researchers create a more effective hydrogel for healing wounds
21.11.2018 | University of New Hampshire

nachricht Removing toxic mercury from contaminated water
21.11.2018 | Chalmers University of Technology

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: First diode for magnetic fields

Innsbruck quantum physicists have constructed a diode for magnetic fields and then tested it in the laboratory. The device, developed by the research groups led by the theorist Oriol Romero-Isart and the experimental physicist Gerhard Kirchmair, could open up a number of new applications.

Electric diodes are essential electronic components that conduct electricity in one direction but prevent conduction in the opposite one. They are found at the...

Im Focus: Nonstop Tranport of Cargo in Nanomachines

Max Planck researchers revel the nano-structure of molecular trains and the reason for smooth transport in cellular antennas.

Moving around, sensing the extracellular environment, and signaling to other cells are important for a cell to function properly. Responsible for those tasks...

Im Focus: UNH scientists help provide first-ever views of elusive energy explosion

Researchers at the University of New Hampshire have captured a difficult-to-view singular event involving "magnetic reconnection"--the process by which sparse particles and energy around Earth collide producing a quick but mighty explosion--in the Earth's magnetotail, the magnetic environment that trails behind the planet.

Magnetic reconnection has remained a bit of a mystery to scientists. They know it exists and have documented the effects that the energy explosions can...

Im Focus: A Chip with Blood Vessels

Biochips have been developed at TU Wien (Vienna), on which tissue can be produced and examined. This allows supplying the tissue with different substances in a very controlled way.

Cultivating human cells in the Petri dish is not a big challenge today. Producing artificial tissue, however, permeated by fine blood vessels, is a much more...

Im Focus: A Leap Into Quantum Technology

Faster and secure data communication: This is the goal of a new joint project involving physicists from the University of Würzburg. The German Federal Ministry of Education and Research funds the project with 14.8 million euro.

In our digital world data security and secure communication are becoming more and more important. Quantum communication is a promising approach to achieve...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Optical Coherence Tomography: German-Japanese Research Alliance hosted Medical Imaging Conference

19.11.2018 | Event News

“3rd Conference on Laser Polishing – LaP 2018” Attracts International Experts and Users

09.11.2018 | Event News

On the brain’s ability to find the right direction

06.11.2018 | Event News

 
Latest News

Removing toxic mercury from contaminated water

21.11.2018 | Life Sciences

New China and US studies back use of pulse oximeters for assessing blood pressure

21.11.2018 | Medical Engineering

Exoplanet stepping stones

21.11.2018 | Physics and Astronomy

VideoLinks
Science & Research
Overview of more VideoLinks >>>