Question: Do people who participate in clinical trials/research have better health outcomes (mortality/reduced symptoms/reduced recovery time) than people who do not?

Answer:

One well-conducted systematic review suggested that when participants are invited to participate in a randomised controlled trial, in addition to being informed about the risks and harms of specific clinical interventions, they can also be told that participating in a trial is likely to result in similar outcomes as if they receive similar treatment outside the trial. Similarly, other authors stated that patients being considered for entry into trials can be reassured that they will not be disadvantaged by entering a trial.

In contrast, some authors stated that more patients should be encouraged to enroll in clinical trials due to an apparent improvement in some outcomes. However, authors also noted that disclosure of this information to potential clinical trial participants may represent an ethical conflict and should be carefully considered in light of existing ethical guidelines.

Research implications were not often reported in the included studies. Authors reported that randomised comparisons with adequate sample sizes are needed to provide reliable evidence of potential differences in outcomes between patients who participate in randomised trials compared with those who do not participate. Some authors suggested that their studies required further validation at other institutions, preferably on a multi-institutional basis, because the situation may be different at other institutions.

To view the full summary, click the Download Document link to the right.

To view the Cochrane review which is included in this summary, click Related Documents, below.