Professional Research Subjects: Issues to Consider

Luca Volpi

The way our system of drug and medical device testing is set up requires the participation of human subjects. And early phase testing often calls for healthy participants, for at least two reasons. First, side effects are usually more easily observed and measured in healthy individuals because they are not masked or affected by other health problems. Second, healthy individuals are more likely to be able to tolerate obnoxious side effects.

While it may seem to be more efficient and effective to enroll in more than one clinical trial at the same time, it is almost never a good idea. Clinical trial protocols usually prohibit it because it confounds the science. It is nearly impossible to be certain which of two or more drugs are causing a particular reaction. Maybe they both are, but it is unclear how much each drug is contributing to the reaction.

More important than the science, however, is the safety issue for research participants. Many side effects or reactions would not occur at all, or are magnified, by a combination of drugs. We pay attention to this when we ask the pharmacist or doctor about taking more than one medication at the same time. But it's even more a concern for drugs that have not been extensively tested!

When the need or desire for income outweighs the volunteer's ability to fully appreciate the risk and dangers of participating, then clearly that individual is unable to give truly informed consent. Often, this causes the potential subject to lie about something, such as whether they drink alcohol, smoke, have headaches, or have a history of a particular medical condition in their family, in order to meet the criteria for enrollment in the protocol. For obvious reasons, this is dangerous for the individual. And it's another factor that negatively affects the science. Potential participants should be truthful when being interviewed for enrollment. And clinical researchers should develop protocols so that inaccurate responses by potential participants are detected.

Finally, participants should consult their personal physicians about volunteering for clinical trials - both before they enter the trial and for the entire duration of their participation. Being up front with your doctor will help her advise you in your decision to volunteer.

In summary, with adequate medical oversight, participating as a clinical research subject may be a viable way of earning money on an occasional basis. As a career, I'd say it's not only risky, but it promotes bad science.

~Joe

Related Topics:

• WebMD Video: Behind the Scenes of a Clinical Trial
• 12 Answers to Common Questions About Clinical Trials

Technorati Tags: clinical trials, health-and-wellness

Professional Research Subjects: Paid Guinea Pigs?

The concept of earning something of a living by volunteering for clinical trials is not new. Clinical trials often pay volunteers to participate. Payment usually reflects to some degree the time required by the participant, as well as the discomfort and risk s/he will experience. A clinical trial requiring a 24-hour presence in a hospital setting to undergo safety monitoring for a drug which may have unpleasant side effects, for example, may pay several hundred dollars or more a day and may last a week or more.

This may be an appealing employment option for some, including the unemployed, those who are "between jobs," students, and others. Usually, the volunteers are healthy individuals, as required by the research protocols. Healthy, that is, until they subject themselves to potentially risky effects of the drug being tested. And that's the real challenge - balancing the desire of the subjects to enroll (for the money) and the desire of the researchers to enroll subjects against the risk (largely unknown both in nature and degree) to the subjects of enrolling in early phase testing.

That said, potential research participants and the clinical researchers who would enroll them should keep a few key issues in mind. Next time, I'll introduce those issues, which should also be of interest to health care providers of individuals considering volunteering for clinical trials.

~Joe

Related Topics:

• WebMD Video: Behind the Scenes of a Clinical Trial
• WebMD Clinical Trials Center

Technorati Tags: clinical trials, health-and-wellness

Unapproved Drugs for the Terminally Ill?

Marcelo Alves

If federal regulations change - and they are being reviewed by the FDA and the courts this spring - drugs that have not yet been approved for use will be made available to patients.

As the regulations currently stand, a physician can prescribe a drug that shows potential even though it has not received FDA approval if certain conditions are met.

• The patient's condition must be "serious" or "immediately life-threatening."
• Comparable approved and experimental treatment options must not be readily available to the patient for some reason.
• The drug must have some potential to save the patient's life as shown in preliminary, ongoing clinical trials.
• And (and this is the center of the current debate) the FDA must approve the use of the drug in the patient. This is done on a case-by-case basis - for what is known as "compassionate use" or "investigational new drug treatment" use.

It is the requirement for FDA approval that is being questioned.

Patient advocacy groups argue that the terminally ill should hold special status when it comes to experimental compounds that have not been fully tested in clinical trials. For those for whom all existing medications have failed, the opportunity for hope provided by drugs having the potential to prolong life should not be denied.

The pharmaceutical industry and the FDA raise several objections to this argument. First, the FDA approval process relies on sophisticated and relatively long-term science to assure that drugs that reach the market are both safe and effective. Second, the Big Pharma foresees numerous lawsuits against the manufacturers of compounds that prove to be unsafe, perhaps even dangerous. Finally, there are fears that patients will take this "easy route," making fewer individuals available for clinical trials.

Should the safeguards that are now in place to protect the market from drugs with significant life-threatening side effects be jettisoned for the terminally ill who may feel they have no choice but to gamble on a cure or improvement because their dire prognoses warrant the risk?

Perhaps this is not the real question. Perhaps the real question is exactly what value is the FDA's approval contributing to the existing decision-making process? If it is not adding significantly to the effort, then what is the harm in eliminating it?

Even if the FDA approval does not reflect a thorough case-by-case review of risks and benefits, the very fact that the requirements for approval are checked and documented, may be enough to keep the process honest and give terminal patients some legitimate hope.

-Joe

Related Topics:

• Experimental Treatments? Unapproved But Not Always Unavailable
• 12 Answers to Common Questions About Clinical Trials

Technorati Tags: clinical trials, FDA, drug approval, terminal illness