Re: Clinical Trials Defined

[Guest guest]

Steve Jordan wrote:

> Most clinical trials are designated as phase I, II, III, or

> IV, based on the type of questions that study is seeking to

> answer.

>

> In Phase I clinical trials, researchers test a new drug or

> treatment in a small group of people (20-80) for the first

> time to evaluate its safety, determine a safe dosage range,

> and identify side effects.

>

> In Phase II clinical trials, the study drug or treatment is

> given to a larger group of people (100-300) to see if it is

> effective and to further evaluate its safety.

>

> In Phase III clinical trials, the study drug or treatment is

> given to large groups of people (1,000-3,000) to confirm its

> effectiveness, monitor side effects, compare it to commonly

> used treatments, and collect information that will allow the

> drug or treatment to be used safely.

>

> In Phase IV clinical trials, post marketing studies delineate

> additional information including the drug's risks, benefits,

> and optimal use.

>

> These phases are defined by the Food and Drug Administration

> in the Code of Federal Regulations. I suppose that it's much

> the same in Great Britain and elsewhere.

That is an excellent summary, however I'd like to add a note

that many clinical trials fail to get anywhere near the number

of people to enroll that they hope to get.

I was in a phase II trial conducted at the National Cancer

Institute in Bethesda with a very modest goal of enrolling only

30 patients. They were only actually able to enroll 14

patients. They couldn't get any more. This is in spite of the

fact that they were offering a trial of a refinement of an

already proven technique (HDR brachytherapy + EBRT), given in a

state-of-the-art facility, and it was entirely free. Patients

paid nothing whatever for diagnosis, testing, treatment,

hospital stay, or drugs. Even parking was free. And the trial

was right outside of Washington DC, where lots of uninsured or

underinsured men live.

The last time I inquired, 13 of the 14 men, all " intermediate

risk " patients, appeared to be cancer free. The 14th dropped

out of the trial when his PSA went to 2.4 (not inconsistent with

a bounce, mine bounced up to 1.8) and the NCI folks didn't know

what happened to him.

So in addition to the problems we often cite in delaying new

therapy approval, we can add a lack of support from the cancer

community for clinical trials as another factor in delays.

Alan

[Guest guest]

I have to say that whilst I admire

enormously the courage of people who knowingly participate in the potential

dangers of clinical trials, I would find it very difficult to join one unless I

thought there was no option.

The two issues that would concern me are

the ‘double-blind’ placebo where half the people in the trial do

not get the medication that they hoped to get but get a sugar pill instead.

And the fact that many such trials are testing

in effect the maximum dose that can be given without harm – I’d

hate to find their calculations on that were wrong.

The blind-testing and placebo effect have

always intrigued me. Most medical people will say that you cannot influence the

course of a disease by your attitude: they accept that you can ‘think

yourself ill’ but not that you can ‘think yourself better’. Yet

they go to extremes to ensure that the allocation of placebos is done in such a

way that the person taking part in the trial does not know if they are getting

the placebo or the medication and also that the people administering the

treatment are unaware which of the people get the placebos and which do not, in

case they influence the outcome. How can the outcome be influenced if attitude

does not alter outcome? I don’t get it and never have – anyone clue

me in as to why double blind tests are compulsory??

All the best

Terry Herbert

I have no medical

qualifications but I was diagnosed in ‘96: and have learned a bit since

then.

My sites are at www.yananow.net and www.prostatecancerwatchfulwaiting.co.za

Dr

“Snuffy” Myers : " As a physician, I am painfully aware that most of

the decisions we make with regard to prostate cancer are made with inadequate

data "

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Alan Meyer

Sent: Monday, 24 November 2008

10:28 AM

To: ProstateCancerSupport

Subject: Re:

Clinical Trials Defined

Steve Jordan

<mycroftscj1>

wrote:

> Most clinical trials are designated as phase I, II, III, or

> IV, based on the type of questions that study is seeking to

> answer.

>

> In Phase I clinical trials, researchers test a new drug or

> treatment in a small group of people (20-80) for the first

> time to evaluate its safety, determine a safe dosage range,

> and identify side effects.

>

> In Phase II clinical trials, the study drug or treatment is

> given to a larger group of people (100-300) to see if it is

> effective and to further evaluate its safety.

>

> In Phase III clinical trials, the study drug or treatment is

> given to large groups of people (1,000-3,000) to confirm its

> effectiveness, monitor side effects, compare it to commonly

> used treatments, and collect information that will allow the

> drug or treatment to be used safely.

>

> In Phase IV clinical trials, post marketing studies delineate

> additional information including the drug's risks, benefits,

> and optimal use.

>

> These phases are defined by the Food and Drug Administration

> in the Code of Federal Regulations. I suppose that it's much

> the same in Great

Britain and elsewhere.

That is an excellent summary, however I'd like to add a note

that many clinical trials fail to get anywhere near the number

of people to enroll that they hope to get.

I was in a phase II trial conducted at the National Cancer

Institute in Bethesda

with a very modest goal of enrolling only

30 patients. They were only actually able to enroll 14

patients. They couldn't get any more. This is in spite of the

fact that they were offering a trial of a refinement of an

already proven technique (HDR brachytherapy + EBRT), given in a

state-of-the-art facility, and it was entirely free. Patients

paid nothing whatever for diagnosis, testing, treatment,

hospital stay, or drugs. Even parking was free. And the trial

was right outside of Washington

DC, where lots of uninsured or

underinsured men live.

The last time I inquired, 13 of the 14 men, all " intermediate

risk " patients, appeared to be cancer free. The 14th dropped

out of the trial when his PSA went to 2.4 (not inconsistent with

a bounce, mine bounced up to 1.8) and the NCI folks didn't know

what happened to him.

So in addition to the problems we often cite in delaying new

therapy approval, we can add a lack of support from the cancer

community for clinical trials as another factor in delays.

Alan

[Guest guest]

I have to say that whilst I admire

enormously the courage of people who knowingly participate in the potential

dangers of clinical trials, I would find it very difficult to join one unless I

thought there was no option.

The two issues that would concern me are

the ‘double-blind’ placebo where half the people in the trial do

not get the medication that they hoped to get but get a sugar pill instead.

And the fact that many such trials are testing

in effect the maximum dose that can be given without harm – I’d

hate to find their calculations on that were wrong.

The blind-testing and placebo effect have

always intrigued me. Most medical people will say that you cannot influence the

course of a disease by your attitude: they accept that you can ‘think

yourself ill’ but not that you can ‘think yourself better’. Yet

they go to extremes to ensure that the allocation of placebos is done in such a

way that the person taking part in the trial does not know if they are getting

the placebo or the medication and also that the people administering the

treatment are unaware which of the people get the placebos and which do not, in

case they influence the outcome. How can the outcome be influenced if attitude

does not alter outcome? I don’t get it and never have – anyone clue

me in as to why double blind tests are compulsory??

All the best

Terry Herbert

I have no medical

qualifications but I was diagnosed in ‘96: and have learned a bit since

then.

My sites are at www.yananow.net and www.prostatecancerwatchfulwaiting.co.za

Dr

“Snuffy” Myers : " As a physician, I am painfully aware that most of

the decisions we make with regard to prostate cancer are made with inadequate

data "

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Alan Meyer

Sent: Monday, 24 November 2008

10:28 AM

To: ProstateCancerSupport

Subject: Re:

Clinical Trials Defined

Steve Jordan

<mycroftscj1>

wrote:

> Most clinical trials are designated as phase I, II, III, or

> IV, based on the type of questions that study is seeking to

> answer.

>

> In Phase I clinical trials, researchers test a new drug or

> treatment in a small group of people (20-80) for the first

> time to evaluate its safety, determine a safe dosage range,

> and identify side effects.

>

> In Phase II clinical trials, the study drug or treatment is

> given to a larger group of people (100-300) to see if it is

> effective and to further evaluate its safety.

>

> In Phase III clinical trials, the study drug or treatment is

> given to large groups of people (1,000-3,000) to confirm its

> effectiveness, monitor side effects, compare it to commonly

> used treatments, and collect information that will allow the

> drug or treatment to be used safely.

>

> In Phase IV clinical trials, post marketing studies delineate

> additional information including the drug's risks, benefits,

> and optimal use.

>

> These phases are defined by the Food and Drug Administration

> in the Code of Federal Regulations. I suppose that it's much

> the same in Great

Britain and elsewhere.

That is an excellent summary, however I'd like to add a note

that many clinical trials fail to get anywhere near the number

of people to enroll that they hope to get.

I was in a phase II trial conducted at the National Cancer

Institute in Bethesda

with a very modest goal of enrolling only

30 patients. They were only actually able to enroll 14

patients. They couldn't get any more. This is in spite of the

fact that they were offering a trial of a refinement of an

already proven technique (HDR brachytherapy + EBRT), given in a

state-of-the-art facility, and it was entirely free. Patients

paid nothing whatever for diagnosis, testing, treatment,

hospital stay, or drugs. Even parking was free. And the trial

was right outside of Washington

DC, where lots of uninsured or

underinsured men live.

The last time I inquired, 13 of the 14 men, all " intermediate

risk " patients, appeared to be cancer free. The 14th dropped

out of the trial when his PSA went to 2.4 (not inconsistent with

a bounce, mine bounced up to 1.8) and the NCI folks didn't know

what happened to him.

So in addition to the problems we often cite in delaying new

therapy approval, we can add a lack of support from the cancer

community for clinical trials as another factor in delays.

Alan

[Guest guest]

I have to say that whilst I admire

enormously the courage of people who knowingly participate in the potential

dangers of clinical trials, I would find it very difficult to join one unless I

thought there was no option.

The two issues that would concern me are

the ‘double-blind’ placebo where half the people in the trial do

not get the medication that they hoped to get but get a sugar pill instead.

And the fact that many such trials are testing

in effect the maximum dose that can be given without harm – I’d

hate to find their calculations on that were wrong.

The blind-testing and placebo effect have

always intrigued me. Most medical people will say that you cannot influence the

course of a disease by your attitude: they accept that you can ‘think

yourself ill’ but not that you can ‘think yourself better’. Yet

they go to extremes to ensure that the allocation of placebos is done in such a

way that the person taking part in the trial does not know if they are getting

the placebo or the medication and also that the people administering the

treatment are unaware which of the people get the placebos and which do not, in

case they influence the outcome. How can the outcome be influenced if attitude

does not alter outcome? I don’t get it and never have – anyone clue

me in as to why double blind tests are compulsory??

All the best

Terry Herbert

I have no medical

qualifications but I was diagnosed in ‘96: and have learned a bit since

then.

My sites are at www.yananow.net and www.prostatecancerwatchfulwaiting.co.za

Dr

“Snuffy” Myers : " As a physician, I am painfully aware that most of

the decisions we make with regard to prostate cancer are made with inadequate

data "

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Alan Meyer

Sent: Monday, 24 November 2008

10:28 AM

To: ProstateCancerSupport

Subject: Re:

Clinical Trials Defined

Steve Jordan

<mycroftscj1>

wrote:

> Most clinical trials are designated as phase I, II, III, or

> IV, based on the type of questions that study is seeking to

> answer.

>

> In Phase I clinical trials, researchers test a new drug or

> treatment in a small group of people (20-80) for the first

> time to evaluate its safety, determine a safe dosage range,

> and identify side effects.

>

> In Phase II clinical trials, the study drug or treatment is

> given to a larger group of people (100-300) to see if it is

> effective and to further evaluate its safety.

>

> In Phase III clinical trials, the study drug or treatment is

> given to large groups of people (1,000-3,000) to confirm its

> effectiveness, monitor side effects, compare it to commonly

> used treatments, and collect information that will allow the

> drug or treatment to be used safely.

>

> In Phase IV clinical trials, post marketing studies delineate

> additional information including the drug's risks, benefits,

> and optimal use.

>

> These phases are defined by the Food and Drug Administration

> in the Code of Federal Regulations. I suppose that it's much

> the same in Great

Britain and elsewhere.

That is an excellent summary, however I'd like to add a note

that many clinical trials fail to get anywhere near the number

of people to enroll that they hope to get.

I was in a phase II trial conducted at the National Cancer

Institute in Bethesda

with a very modest goal of enrolling only

30 patients. They were only actually able to enroll 14

patients. They couldn't get any more. This is in spite of the

fact that they were offering a trial of a refinement of an

already proven technique (HDR brachytherapy + EBRT), given in a

state-of-the-art facility, and it was entirely free. Patients

paid nothing whatever for diagnosis, testing, treatment,

hospital stay, or drugs. Even parking was free. And the trial

was right outside of Washington

DC, where lots of uninsured or

underinsured men live.

The last time I inquired, 13 of the 14 men, all " intermediate

risk " patients, appeared to be cancer free. The 14th dropped

out of the trial when his PSA went to 2.4 (not inconsistent with

a bounce, mine bounced up to 1.8) and the NCI folks didn't know

what happened to him.

So in addition to the problems we often cite in delaying new

therapy approval, we can add a lack of support from the cancer

community for clinical trials as another factor in delays.

Alan