Research in Human Health and Illness

Research – does that word bring up images of Dr. Jekyll and Mr. Hyde or Frankenstein? Do you imagine uncaring scientists who keep trying random potions as they jump unheeding from one experiment to the next?

 

Nothing could be further from the truth! The days of cellar experiments by solo scientists are long gone (if they ever existed). Now we have research conducted by teams of scientists, carefully controlled and, in the case of drug or medical device research, subject to ongoing review through various “stages”. Please don’t think that I am naïve or an apologist for Pharma. There are abuses and researchers who only wink at negative results in their drive to publish. However, given the vast number of research proposals that enter the pipeline in a given year, abuses are very few indeed. Any proposal that suggests the need for human participation must go before committees for approval. These “human subject committees” have the final say on whether any research may even be begun, whether that research is a student’s dissertation or a pharmaceutical mega-buck project.

 

The final step for drug and medical device research is the Clinical Trial. There are four phases to a clinical trial. The research project may be stopped during any of the phases. All volunteers and must be completely advised, in their own language, of the purpose of the research, the risks and benefits of participation and must also be informed that they can withdraw at any time without penalty.

 

Phase I of a clinical trial involves a small group of volunteers and the first test of the drug or device on humans. This is the first test for possible side effects in humans and also an attempt to determine a safe dosage range.

Phase II is basically the same but involves a larger group of participants.

Phase III involves even more participants. The drug or device is compared to existing treatments, its effectiveness confirmed (or not) and side effects are monitored.

Phase IV occurs once the drug or device is on the market.

 

Many, many potential treatments never get to the clinical trial. Others are withdrawn during the trial. Some do not have to complete Phase IV because their safety and efficacy have been determined.

 

Once again – are there abuses? Do some drugs and treatments that shouldn’t be approved, get approved? Yes. But until a technological model of human responses can be developed, medical treatments can move forward only with research on human participants. We must all stay vigilant to research abuse and eliminate it whenever possible. But eliminating all research on human participants is not a desirable option.

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Mary Lou Bernardo, PhD, MSN

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