Professional Research Subjects: Issues to Consider
Luca Volpi
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
Labels: clinical trials
3 Comments:
Joe-
You have an interesting insite to research. But I wonder, where your information comes from? Having been involved in clinical research for over 15 years, the myth of being in 2 trials that pay sizable amounts, would be almost impossible to do. Reason being- these high paying studies require an inpatient setting. Not easy to be in 2 places at once.As for the medical history being withheld- most good research sites recruit subjects from their own data base or practice- therefore, the incident of hidden history is not achieved. If a subject from outside the practice participated, the site should obtain a letter or written document from the individuals care provider to verify disease or medications before the subject can enroll into the study.
So once again, misinformation is being passed on to the population that reads your column.
The final word- Clinical Trials are voluntary-and subjects must be consented prior to any study related procedure being performed.
Bonnie
I would challege you to come up with an actual example of a clinical trial within the past two years that would pay a helthy volunteer an inapprioriate amount of money. This is a highly regulated area. Furthermore, no institutional IRB would allow it
Conducting clinical trials is extremely regulated at many levels and ultimately regulated by FDA. I agree with Bonnie, misinformation can deter a patient who can benefit from a clinical trial. Even clinical trials outside US are being regulated and have a very stringent Ministry of Health and (EC)ethics committee approval process before the clinical study is presented to the patient.
Clinical trial enables the new techology to meet the clinical need.
Raj Nihalani, MD, RAC(US)
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