Edit my grammar please

[bmo]

Clinical Trials and My Role

When a pharmaceutical company wants to market a new drug, it must first get an approval from the FDA, the Food and Drug Administration. What does the FDA have to base on to approve or disapprove claims that certain new drug is effective in treating certain disease or symptom, it is the clinical trial data.

In a simple trial example, a drug company has two "drugs" to compare: a treatment drug and a placebo. First, a trial group gets the patients (called human subjects) together; divide them into two groups - treatment and placebo. The patients take the medications for certain length of time, and later data are collected and analyzed. If the results show the treatment group is better than the placebo group, the new drug is effective. The drug company submits its results to the FDA for approval to market and label the drug as an effective agent to treat certain disease or symptom.

Sometimes drug companies ask an outside agency (called contract research organization (CRO) or clinical trials coordinating center) to conduct trials for them. Our office, a U.S. government agency, coordinates clinical trials conducted in the Veterans Hospitals in the U.S. However, our goals are in research, not in making money or marketing a new drug. The basic principal is, if a drug or device is cheaper, more effective, and producing less side effects, the VA will use it.

We work with doctors and nurses (called principal investigator and research nurse) to design forms, collect and analyze data, and publish findings. Our research area includes many fields; sometimes it is a cancer trial of chemotherapy vs. surgery or radiation; other times it is a psychological study. We have about 7 or 8 projects going on at this moment.

Our office has fiscal and regulatory management persons, bio-statisticians, computer programmers, data entry persons, computer hardware and software experts, and other data management persons. We don't have doctors or nurses in our office; we work very closely with them in the field.

In our office, a typical trial project includes 500 patients in 15 sites but some have more. We finished one that had 90 sites, including one in Canada. My role is to provide technical support on a software that we use to capture data from forms sent to us by many hospitals in our studies.

In addition, I am currently helping a doctor with data from an old study that was completed more than 10 years ago. This is a retrospective study. In research, when you collect data and analyze them right away, it is called prospective study; but when you look at data collected years ago, it is called retrospective study. This doctor, a hypertension clinic director in another state, wants to prove certain drug taken by patients in that study to thin the blood (called anti-coagulant) to prevent stroke raised blood pressures.

Thanks.

BMO

[RonBee]

Originally Posted by bmo

Clinical Trials and My Role

When a pharmaceutical company wants to market a new drug, it must first get an approval from the FDA, the Food and Drug Administration. What does the FDA have to base on to approve or disapprove claims that certain new drug is effective in treating certain disease or symptom, it is the clinical trial data.

Try:

• When a pharmaceutical company wants to market a new drug, it must first get approval from the FDA, the Food and Drug Administration. The FDA uses the clinical trial data to prove or disprove claims that a certain new drug is effective in treating certain diseases or symptoms.

What do you think?

:)

[bmo]

It is much better. Could you explain the difference between approve and prove a claim?

Thanks.

BMO

[RonBee]

Originally Posted by bmo

It is much better. Could you explain the difference between approve and prove a claim?

Thanks.

BMO

Claims can be proven or disproven. However, it is the drug itself that is approved. To prove a claim is to establish its validity. When the FDA approves a drug it declares that it is safe and effective.

Does that help?

:)

(I'll try to get to the rest of the essay later.)

:)

[RonBee]

Originally Posted by bmo

In a simple trial example, a drug company has two "drugs" to compare: a treatment drug and a placebo. First, a trial group gets the patients (called human subjects) together; divide them into two groups - treatment and placebo. The patients take the medications for certain length of time, and later data are collected and analyzed. If the results show the treatment group is better than the placebo group, the new drug is effective. The drug company submits its results to the FDA for approval to market and label the drug as an effective agent to treat certain disease or symptom.

Try:

• In a simple trial example, a drug company has two "drugs" to compare: a treatment drug and a placebo. First, a trial group gets the patients (called human subjects) together. Then they divide them into two groups--the treatment group and the placebo group. The patients take the medications for a certain length of time, and later data are collected and analyzed. If the results show that the treatment group has done better than the placebo group, the new drug has been demonstrated to be effective. The drug company submits its results to the FDA for approval to market and label the drug as an effective agent to treat certain diseases or symptoms.

What do you think?

:)

[MikeNewYork]

Originally Posted by bmo

It is much better. Could you explain the difference between approve and prove a claim?

Thanks.

BMO

I'll add to what Ron said. The FDA approves drugs for sale in the marketplace. For that to happen, the company must prove several things to the FDA: efficacy, lack of toxicity, etc. When the company wants to release a drug, it makes some claims about what the drug will do. The FDA must also approve those claims, to make sure that the company is telling the whole truth. The FDA may also get involved with non-pharmaceutical products, if the manufacturer wants to make a claim on a package. For example, if a cereal company wants to state that its cereal will lower your cholesterol, the FDA would have to approve that claim.

[RonBee]

Originally Posted by bmo

Sometimes drug companies ask an outside agency (called contract research organization (CRO) or clinical trials coordinating center) to conduct trials for them. Our office, a U.S. government agency, coordinates clinical trials conducted in the Veterans Hospitals in the U.S. However, our goals are in research, not in making money or marketing a new drug. The basic principal is, if a drug or device is cheaper, more effective, and producing less side effects, the VA will use it.

Say conducted at Veterans Hospitals. (People say, for example, "I work at Barnes Hospital." Say the basic principle.

Originally Posted by bmo

We work with doctors and nurses (called principal investigator and research nurse) to design forms, collect and analyze data, and publish findings. Our research area includes many fields; sometimes it is a cancer trial of chemotherapy vs. surgery or radiation; other times it is a psychological study. We have about 7 or 8 projects going on at this moment.

The only thing I would change there is to say "seven or eight" and delete "about".

Originally Posted by bmo

Our office has fiscal and regulatory management persons, bio-statisticians, computer programmers, data entry persons, computer hardware and software experts, and other data management persons. We don't have doctors or nurses in our office; we work very closely with them in the field.

Say:

• Our office has fiscal and regulatory management people, bio-statisticians, computer programmers, data entry people, computer hardware and software experts, and other data management people. We don't have doctors or nurses in our office, but we work very closely with them in the field.

Originally Posted by bmo

In our office, a typical trial project includes 500 patients in 15 sites but some have more. We finished one that had 90 sites, including one in Canada. My role is to provide technical support on a software that we use to capture data from forms sent to us by many hospitals in our studies.

Say:

• In our office, a typical trial project includes 500 patients at 15 sites. We finished one that had 90 sites, including one in Canada. My role is to provide technical support on software that we use to capture data from forms sent to us by the hospitals in our studies.

Originally Posted by bmo

In addition, I am currently helping a doctor with data from an old study that was completed more than 10 years ago. This is a retrospective study. In research, when you collect data and analyze them right away, it is called prospective study; but when you look at data collected years ago, it is called retrospective study. This doctor, a hypertension clinic director in another state, wants to prove certain drug taken by patients in that study to thin the blood (called anti-coagulant) to prevent stroke raised blood pressures.

Say:

• In addition, I am currently helping a doctor with data from an old study that was completed more than 10 years ago. This is a retrospective study. In research, when you collect data and analyze it right away, it is called prospective study; but when you look at data collected years ago, it is called retrospective study. This doctor, a hypertension clinic director in another state, wants to evaluate a certain drug taken by patients in that study to thin the blood (called anti-coagulant) to prevent stroke and high blood pressure.

What do you think? Do you have any questions?

:)

[bmo]

Hi,

Thanks to Mike and RonBee. Sorry to get back just now. I am in Taiwan (from California) and will stay till Sunday. I have been busy since I came back here.

I will look over the corrections in details later on. Briefly, the last sentence:

The original study was to see if the drug prevented or reduced stroke, it did not include any blood pressure study. Because of new suspicions in the past 15 years since the original study was completed that the experimental drug raised BPs, we are looking back on the old data.

Mike is correct to say about other role of the FDA, the Food and Drug Administration, plays. I did not think of non-pharmaceutical claims.

Thank you all. I will get back on this.

BMO

[MikeNewYork]

Originally Posted by bmo

Hi,

Thanks to Mike and RonBee. Sorry to get back just now. I am in Taiwan (from California) and will stay till Sunday. I have been busy since I came back here.

I will look over the corrections in details later on. Briefly, the last sentence:

The original study was to see if the drug prevented or reduced stroke, it did not include any blood pressure study. Because of new suspicions in the past 15 years since the original study was completed that the experimental drug raised BPs, we are looking back on the old data.

Mike is correct to say about other role of the FDA, the Food and Drug Administration, plays. I did not think of non-pharmaceutical claims.

Thank you all. I will get back on this.

BMO

We'll be here. :wink:

[RonBee]

Originally Posted by bmo

Hi,

Thanks to Mike and RonBee. Sorry to get back just now. I am in Taiwan (from California) and will stay till Sunday. I have been busy since I came back here.

I will look over the corrections in details later on. Briefly, the last sentence:

The original study was to see if the drug prevented or reduced stroke, it did not include any blood pressure study. Because of new suspicions in the past 15 years since the original study was completed that the experimental drug raised BPs, we are looking back on the old data.

Mike is correct to say about other role of the FDA, the Food and Drug Administration, plays. I did not think of non-pharmaceutical claims.

Thank you all. I will get back on this.

BMO

Rather than "looking back on" say you are "taking another look at" the old data.

:)