What Should You Know Before Entering a Clinical Trial?
July 23, 2001 (Washington) -- In a way, signing up for a clinical trial is a bit like getting married. The ensuing relationship can be sustained by trust and commitment, but if it goes awry there can be bitterness -- or even worse.
"There is no system that can ever assure us that there will be no injuries, no deaths -- no system that can ever assure us that there'll never be genuine confusion ... between researcher and subject," medical ethicist Alta Charo, JD, professor of law and medicine at the University of Wisconsin tells WebMD.
Even though the federal Office of Human Research Protections, or OHRP, has reached an agreement with Baltimore's Johns Hopkins Hospital to resume clinical trials on a limited basis, many are wondering how on June 2, a healthy 24-year-old patient could have died there after taking part in an asthma experiment.
Last week, OHRP put Johns Hopkins on notice that its $301 million in federal research grants were being put on hold until a wide range of safety improvements is put in place. The improvements are largely aimed at increasing research oversight and making sure that patients know exactly what they can expect as test subjects.
The federal safety analysts complained that Johns Hopkins' own safety boards improperly OK'd some experiments and that patient consent forms were often "boilerplate."
For now, as part of the deal reached over the weekend, Johns Hopkins scientists will be limited to experiments that qualify for "expedited review," because their risk is considered minimal. For instance, blood tests in a trial would be OK, but X-rays, because they can be harmful, would be out.
Until safety questions at Hopkins are fully resolved, the institution will have to submit a monthly list of experiments that has been reviewed according to the new criteria. "The case is still open. ... There's not an end day on that for the time being," OHRP spokesman Bill Hall tells WebMD.
Johns Hopkins spokesman Gary Stephenson says some experiments have already resumed. "At the same time we're extremely concerned that the conditions imposed by [OHRP] in order to resume this research will create an enormous new layer of paperwork," he tells WebMD.
There are some 2,000 federally funded experiments at Johns Hopkins affecting as many as 200,000 patients, says Stephenson.
It's not clear just how many Americans are involved in clinical trials, but the number could be one million or more. In the wake of the Hopkins tragedy, and the crackdown on other research institutions for safety violations in recent years, just what should a person ask before enrolling?
Charo, who's also a member of the National Bioethics Advisory Committee, has the following recommendations:
- What exactly are you planning to do to me? Step by step, day by day?
- How many people have you done this to before, and what happened to them?
- What happened in animal studies researching this drug or technique?
- What do you suspect might happen to me based on all the other research that's gone on before?
- What sort of things might make this more dangerous than usual?
- How hard will it be to discontinue the medication?
- What are my alternatives in a nonresearch setting?