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   A Memorial University of Newfoundland Publication

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March 31, 2005
 Insight

 

Participating in medical research
Physician beware


Are you flattered when SuperDrugCo asks us to recruit patients and take part in the latest drug trial? Most of us are. But there are a few things you should know about trials first.

Before a company can sell a new drug (which has not usually been developed by SuperDrugCo, but most likely developed or discovered in a university or government-sponsored laboratory), the drug has to be proven to be reasonably safe and effective. The clinical trials that provide this evidence are divided into phases.

Phase I entails giving the drug to a small number of normal volunteers (convicts, university students, or people of that ilk). This helps to establish safe dosage levels and helps scientists study the metabolism and the side effects of the drug. These trials are usually done by the agency that developed the drug.

Phase II, done when the drug looks promising, involves giving the agent to a relatively small number of people – as few as a hundred – who have the disease or medical condition that is the therapeutic target of the drug. In this phase the drug is given at different doses and its effects and side effects are compared with a similar group of patients not taking the drug. Once again, scientists and physicians usually do these trials.

Phase III happens if all has gone well so far. These are usually what we think of when we hear about large randomized trials. Hundreds or thousands of patients are involved, and there is always a comparison or control group of patients, usually taking the current best agent for treatment. These are the trials that produce the best evidence for the efficacy of a drug. At this stage, most of the work (in Phase I, II and III trials) has been done, not by SuperDrugCo, but by academic doctors at medical schools and teaching hospitals. (Although the cost of such trials, like the HOPE study, is so great, that partnerships between university and industry are now common). After a successful Phase III trial, a drug is licensed for clinical use and can be marketed.

Most of the trials that ordinary doctors are asked to take part in are Phase IV trials, also called “post-marketing trials.” Every year hundreds of Phase IV trials take place in Canada. These are trials of drugs that are already on the market. These trials are not usually done by respected and objective academics, in search of scientific truth. They are done by SuperDrugCo. Although such trials are publicized by SuperDrugCo as efficacy studies, or further studies on the side effects of the drug, many thoughtful people think they are just a way to find new uses for old drugs to expand the market share (often when the patent for the original use has expired, as when an anti-depressant suddenly becomes indicated for a newly created disease like “situational anxiety disorder”). Such studies are also viewed as a way in which SuperDrugCo can pay doctors to put patients on the company’s already approved drug.

Is this for an illness I never heard about at medical school? Examples such as GERD for indigestion, estrogen lack for normal menopause, situational anxiety for shyness, erectile dysfunction for normal aging come to mind.

So, when you’re asked to take part in a trial of a pharmaceutical agent, ask yourself a few questions:

Is this a Phase III or a Phase IV trial? (Hint: see who’s running the trial);

If it is a Phase IV trial, why does it need to be done? (Hint: If a decent Phase III trial was done, as is likely if the drug is on the market, why do another one? Do we really need another ACE-inhibitor, another SSRI, or another proton-pump inhibitor?);

Is the control group taking another agent, or a placebo? (Hint: most ethical trials will compare the new agent against the current best treatment, to test whether it really is an advance. If a placebo is used, the trial will only show that the drug is better than nothing.);

Why am I being paid to take part in the trial? (Hint: impoverished academics running trials funded by peer-reviewed granting agencies don’t have the moolah, whereas a large proportion of SuperDrugCo’s much touted “research” budget is spent on Phase IV trials.);

Who is really running this trial? (Hint: look for evidence of reputable academic backing, and ask whose property the results of the trial will be once it’s completed.);

Is this for an illness I never heard about at medical school? (Hint: when did normal physiology become an illness? Examples such as GERD for indigestion, estrogen lack for normal menopause, situational anxiety for shyness and erectile dysfunction for normal aging come to mind.)

If you can satisfy yourself on all these questions, you probably should help with the trial, if you have the time. If not, politely explain to the person from SuperDrugCo that you are a member of the second-oldest profession, not the oldest of all.

Are you flattered when SuperDrugCo asks us to recruit patients and take part in the latest drug trial? Most of us are. But there are a few things you should know about trials first.

Before a company can sell a new drug (which has not usually been developed by SuperDrugCo, but most likely developed or discovered in a university or government-sponsored laboratory), the drug has to be proven to be reasonably safe and effective. The clinical trials that provide this evidence are divided into phases.

Phase I entails giving the drug to a small number of normal volunteers (convicts, university students, or people of that ilk). This helps to establish safe dosage levels and helps scientists study the metabolism and the side effects of the drug. These trials are usually done by the agency that developed the drug.

Phase II, done when the drug looks promising, involves giving the agent to a relatively small number of people – as few as a hundred – who have the disease or medical condition that is the therapeutic target of the drug. In this phase the drug is given at different doses and its effects and side effects are compared with a similar group of patients not taking the drug. Once again, scientists and physicians usually do these trials.

Phase III happens if all has gone well so far. These are usually what we think of when we hear about large randomized trials. Hundreds or thousands of patients are involved, and there is always a comparison or control group of patients, usually taking the current best agent for treatment. These are the trials that produce the best evidence for the efficacy of a drug. At this stage, most of the work (in Phase I, II and III trials) has been done, not by SuperDrugCo, but by academic doctors at medical schools and teaching hospitals. (Although the cost of such trials, like the HOPE study, is so great, that partnerships between university and industry are now common). After a successful Phase III trial, a drug is licensed for clinical use and can be marketed.

Most of the trials that ordinary doctors are asked to take part in are Phase IV trials, also called “post-marketing trials.” Every year hundreds of Phase IV trials take place in Canada. These are trials of drugs that are already on the market. These trials are not usually done by respected and objective academics, in search of scientific truth. They are done by SuperDrugCo. Although such trials are publicized by SuperDrugCo as efficacy studies, or further studies on the side effects of the drug, many thoughtful people think they are just a way to find new uses for old drugs to expand the market share (often when the patent for the original use has expired, as when an anti-depressant suddenly becomes indicated for a newly created disease like “situational anxiety disorder”). Such studies are also viewed as a way in which SuperDrugCo can pay doctors to put patients on the company’s already approved drug.

So, when you’re asked to take part in a trial of a pharmaceutical agent, ask yourself a few questions:

Is this a Phase III or a Phase IV trial? (Hint: see who’s running the trial);

If it is a Phase IV trial, why does it need to be done? (Hint: If a decent Phase III trial was done, as is likely if the drug is on the market, why do another one? Do we really need another ACE-inhibitor, another SSRI, or another proton-pump inhibitor?);

Is the control group taking another agent, or a placebo? (Hint: most ethical trials will compare the new agent against the current best treatment, to test whether it really is an advance. If a placebo is used, the trial will only show that the drug is better than nothing.);

Why am I being paid to take part in the trial? (Hint: impoverished academics running trials funded by peer-reviewed granting agencies don’t have the moolah, whereas a large proportion of SuperDrugCo’s much touted “research” budget is spent on Phase IV trials.);

Who is really running this trial? (Hint: look for evidence of reputable academic backing, and ask whose property the results of the trial will be once it’s completed.);

Is this for an illness I never heard about at medical school? (Hint: when did normal physiology become an illness? Examples such as GERD for indigestion, estrogen lack for normal menopause, situational anxiety for shyness and erectile dysfunction for normal aging come to mind.)

If you can satisfy yourself on all these questions, you probably should help with the trial, if you have the time. If not, politely explain to the person from SuperDrugCo that you are a member of the second-oldest profession, not the oldest of all.