Women participating in OB-GYN clinical trials experienced better outcomes in their health than those outside trials, regardless of whether the treatment is found to be effective in the trial, a new review shows. One such trial focused on the control of seizures in pregnant epileptic women.
Clinical research aims to benefit people in the future by leading them to live longer, healthier lives. But it also may provide benefits to those who participate. Results from clinical trials help clinicians better understand how to treat a certain disease, and are necessary to test the effectiveness and safety of new therapies before they are available for general use.
Trial subjects receive care under attentive oversight, above and beyond usual care, which is ensured by ethics guidelines, data and safety monitoring, as well as protocol compliance. However, evidence on the beneficial effect of participation in trials versus non-participation as yet to be consistently shown.
To determine whether participation in clinical trials, compared with non-participation, has a beneficial effect on women’s health, Khalid Khan, PhD, from Queen Mary University of London (QMUL), and his colleagues examined 21 studies that included 20,160 women.
They found that participants had 25% better odds of improved health outcomes, compared with non-participants.
The review focused on pregnancy and reproductive health, and found that the beneficial effect of taking part in a clinical trial was largest when the trial was of high quality, and when the study examined the effect of a specific intervention that was unavailable outside of the trial.
These findings may lead to more clinicians offering participation in clinical trials to their patients and more women volunteering for trials in the area of pregnancy and reproductive health.
“Clinical trials are often perceived as ‘experiments,’ ‘risky’ or ‘dangerous.’ However, our findings challenge these misconceptions, and show not only that they are safe, but that there is a significant benefit associated with participation, with overall 25 percent chance of better health outcomes,” Khan said in a press release.
“Interestingly, we also found that participants still experienced benefits irrespective of whether the treatment in the trial was found to be effective or not,” he added.
While every year more 69 million babies are born worldwide, only a small number of pregnant women participate in clinical studies.
Pregnancy and reproductive health is an area with unique challenges because it deals with controversial topics such as in-vitro fertilization, contraception and abortion. Furthermore, it is an area that lacks research funding, and a field of research with many ethical and legal concerns.
Therefore, research results from general medicine may not always lead to optimum medical care of pregnant women.
“I’m very happy that I took part in a clinical trial and would do it all over again without hesitation. I would tell women who are considering whether to join a clinical trial, that the investment of their time is really quite minimal for the reward,” said Ngawai Moss, a participant in QMUL’s EMPiRE trial, which looked at how to control seizures in pregnant women who live with epilepsy.
“In my case, the trial was pretty straightforward and mainly involved monthly visits to fill in a questionnaire and have a blood test. It was reassuring to be able to see a medical professional on a regular basis, especially as I had a complicated pregnancy. It meant I had access to the team’s medical insight, advice and support on general pregnancy-related issues,” Moss said.
Participation in research studies still can be associated with some risks, so researchers and clinicians must inform their patients of the potential risk and benefit of engaging in research studies. The researchers are hopeful, however, their findings will encourage women to join clinical trials, as this is a population often unrepresented in research.