Retention to support continued participation
Strategies to support retention of pregnant participants once included in a trial
Once a woman is enrolled in a study, actions need to be taken to foster their continued participation and minimize the potential for withdrawal from the study. Researchers should ensure regular and timely contact with participants to provide progress reports and to share any relevant results. Regular contact also provides an opportunity for researchers to express appreciation and check on the woman’s well-being. Contact visits provide an opportunity to discuss barriers and motivators to continued participation.
Where possible, it may be encouraging to provide personalized information (e.g., updates on pregnancy wellness or child development) to help women feel seen and appreciated and thus improve the likelihood that they will remain in the study.
Strategies to support retention of participants should they become pregnant
Women of childbearing age, participating in investigational therapeutic trials where the developmental toxicity is not known, should, following a review of the potential benefits and possible harms, be offered contraception. Women should be counselled that pregnancies may still occur despite contraception provision and pregnancy testing should also be provided. In the event of a pregnancy, empathetic counselling should be provided, and time should be allocated to discuss with the woman whether she wishes to continue her participation in the study. Her choice should always be respected and supported.
Protocols should:
- allow participants to remain in the study (with or without the investigational product) if the risks to the fetus are justified by the potential benefits to the mother, or if stopping treatment or switching to alternatives may pose greater risks;
- offer re-consent options for continuing treatment, if appropriate, to ensure participants have fully considered the known and unknown risks and benefits;
- include plans for additional data collection (e.g., pharmacokinetics, safety) and follow up postnatally for the woman and any baby; and
- define conditions for study unblinding, which should not occur automatically upon pregnancy, but which may be necessary to inform counselling and decision-making if fetal exposure has already occurred.