It could be twoandahalf ordsprog

It could be two-and-a-half to three years before it's ready to market, assuming that we're successful in our clinical trials.

We are excited about offering clinical trials here in Quincy to give patients another option in the treatment of cancer. Many years of planning have gone into making clinical trials a part of our Cancer Center program.

Bonnie Kleissle

Unfortunately, less than five percent of people diagnosed with cancer will be treated through enrollment in a clinical trial. Our organization is very supportive of the Coalition and its efforts to accelerate research. We believe that in recent years patients have received better treatment options in trials, and if we can educate people about clinical trials I am confident that we can increase enrollment in these high-priority colon cancer trials.

We will not make progress without clinical trials. It's wrong and unfair to deny patients access to clinical trials.

Richard Klausner

Anyone who thinks (a) there is adequate supervision of clinical trials or (b) clinical trials at Phase One are not risky ain't paying attention.

We could be in clinical trials this spring to determine safety, ... Two or three years beyond that, we're looking at trials on anti-tumor activity.

The medical community needs to know the results of clinical trials to be able to view the entire picture of how a treatment works, how it compares to other therapies and what choices could serve patients best. It's disturbing to think that important information on clinical trials is being left to gather dust.

Richard Sullivan

Over the years, the whole science of clinical trials in MS has been evolving. We are way ahead of where we were 20 years ago. This is not a field that is standing still.

Nicholas LaRocca

We have done clinical trials over 100 years here at Hopkins. We have had one death in all of these years in a human healthy volunteer,

It makes all the sense in the world to move ahead and take it to the stage where we're ready for clinical trials. This is the next generation.

Keeping in mind that this is only a recommendation, it doesn't mean the FDA will take this product off the market. We have asked [the FDA] for the opportunity to reformulate the product using a non-CFC propellant, which will take us about five years. We need to reformulate it and put it through clinical trials and then submit it to the FDA as a new drug for evaluation.

There's nothing to be afraid of in a clinical trial. I am a walking billboard. I am living proof that clinical trials work.

If the FDA wants this product back on the market, they're much more likely to request post-marketing surveillance. Further clinical trials are unlikely to be required, though they're still a possibility.

Registries for cancer clinical trials exist but they are not compulsory and are far from being complete. There needs to be one comprehensive database so trials can be monitored and a wealth of information can be accessed from a central place.

Richard Sullivan

Pex Tufvesson developed the music program Noisetracker.

Framträdande

If you don't understand exactly what's going on, it's hard to fully evaluate the risks, and it's hard to improve upon it. These are clinical trials, not clinical realities.

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