igcs abstract, page-18

Hi ymav4294. I like your informative posts. Seems to be some nervous people around given the sentiment in todays posts lol.

On the process for the trial I dont now specifically what it is for Cvac, but I would expect there would be similarities in trials for any significant drug/medication where FDA approval is being sought. I have some indirect experience in that. My dear father who passed away at the age of 93 was a participant in a trial process.

He was a very active person when aged about 75 he had a sudden heart attack when attending an AFL game. He had a stent placed in a an artery at the time but unfortunately he was unable to consequently walk more than a few metres before experiencing chest pain and shortness of breath and had to stop and administer a nitrolingual spray. This kept recurring and basically had made an invalid of him.

He then got a call from his cardiologist who said that he was conducting a trial of a new heart drug that could prove beneficial to my dad. He explained it was a double blind trial and could not guarantee that dad would not receive a placebo instead of the new drug. Dad agreed to go on it, because having been so active all his life and finding how restricted he had suddenly become he was willing to give it a go. He just prayed that he would not get the placebo.

Anyway I remember him getting all the instructions and explanatory for the trial. I read them and they were detailed and went to great lengths to explain the process and what they would be endeavouring to establish.

His initial examination in hosptital was full on, an all day job with every test imaginable. He wasnt too happy about that lol.

Anyway, he was started on the trial having to take tablets daily that could have been the drug or just a placebo. The name of the drug was "carvedilol" and the trial was called The "Capricorn Trial".

Now he hoped he was taking "carvedilol".

Within a week of starting the trial the chest pains disappeared he started his usual long walks he used to take before his heart attack and it was like a miracle. His nitrolingual spray that he always carried with him was no longer used. We mused that he must be on the real thing because his improvement was just so spectacular. In any event he then had to go to hospital periodically for full day exhaustive assessment as part of the prescribed trial process. The trial was being supervised by dads cardiologist and the hospital medical registrar and a team of staff specialising in various medical areas. Serious business.

Dont want to go too long with this but after some 12months dad was told he had been on the carvedilol not the placebo and had thrived without any adverse incident/reaction and that he could continue taking the drug ongoing for good, outside of the trial. Dad lived a happy and very active life for another 18 years and when he passed away aged 93 he basically was active right up till then and it was a bout of pneumonia that got him. It was in the middle of winter freezing cold. He had a bit of a cold but still insisted going for his two kilometre walk including walking up a long stretch of a 45degree hill. I was there when he got home and he said that he felt that he was going to pass out.

I took him straight to hospital where they did immediate tests, diagnosed pneumonia, administered intravenous antibiotics but he succumbed and went. On reflection I was so grateful of the 18 extra years of happy productive active life the drug gave him, Had he not been on that trial it may have been very different for him.

For the reason of the above I have empathy for those trying to develop a means of improving life quality particularly high mortality illnesses that can impact younger people such as women with ovarian cancer.

So far so good with the trial process for Cvac and I pray that Cvac turns out as effective for women as Carvedilol was for my dad. The interim data hopefully will at least give us some clues.

My apologies for the long post.

cheers