Women who participate in clinical trials have better health outcomes

Tagged clinical trials, cancer; Posted 8 years ago by Andreas Obermair

A systematic review has found that women who participated in clinical trials in obstetrics and gynaecology had better health outcomes than women who did not.

Clinical trials are necessary to test the safety and efficacy of new treatments before they are widely implemented.

Patients sometimes ask if they are used as guinea pigs and wonder what’s in it for them to take part in research trials. For doctors, treating patients on a clinical trial means a lot more time and effort than treating a patient as per normal routine.

Research on the effect of participation in trials versus non-participation has not consistently shown evidence of benefit for patients.

In the latest research conducted on this topic, women who participated in randomised clinical trials had 25% higher likelihood of improved health outcomes (OR 0.75; 95% CI 0.64-0.87) compared to women who did not take part in research. The review examined 21 studies which involved 20,160 women, consisting of 11 obstetric and 10 gynaecological clinical trials.

The quality of trials played a role in improved health outcomes. Women who participated in high quality randomized trials had 38% higher chance of improved outcomes (OR 0.62, 95% CI 0.50-0.76). Participation in low-quality randomised trials only saw an improvement of 8% higher odds of improved health outcomes (OR 0.92, 95% CI 0.74-1.16). Studies considered low quality were mainly due to inadequacies in the way participants were randomised (patients get randomly allocated to one treatment group or another) and description of participant withdrawals. Interestingly the benefit gained by women participating in clinical trials was sustained irrespective of whether an experimental intervention proved better than the old standard or not.

This review focused on pregnancy and reproductive health, but a previous retrospective study also found similar results when comparing women with ovarian cancer who took part in clinical trials. In the study of women with ovarian cancer, 53 women participated in clinical trials and 105 women did not. Overall survival was much better in ovarian cancer patients who participated in clinical trials, compared to those who received standard therapies (46 versus 25 months, 95% CI 1.03–2.15 months, P = 0.03).

As many of my readers know, I am not only a gynaecological oncologist but also the Director of Research at The Queensland Centre of Gynaecological Research (QCGC). Currently we run 6 clinical research protocols and we try our very best to enrol as any patients as possible in one or more of our clinical trials. QCGC aims to conduct the highest quality clinical trials that change the treatment of women affected by gynaecological cancer for the better.

For example, the feMMe trial aims to target obese, young or co-morbid patients with early endometrial cancer and to treat these women less invasively through the use of the Mirena IUD which treats the cancer from inside the uterus. If successful the feMMe trial will save more than 100 patients major surgery.  

Another example is the ECHO trial, a randomised clinical trial for ovarian cancer patients to show whether there is an association between physical exercise during chemotherapy and greater adherence to chemotherapy. You can view all current trials at QCGC here.

All our clinical trials are designed to provide a potential win for patients. We always compare the current standard treatment with an experimental treatment that – in the future - might turn out better. Patients also should keep in mind there are many safeguards in place, including stringent ethics guidelines, data and safety monitoring, protocol compliance, to protect the safety and the interests of patients.

From all the above it is almost always a good choice to take part in a research trial if your specialists offers you to take part.

NB: Please consider supporting The Battle, a fundraising event to support gynaecological cancer research.

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