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Clinical trials involving investigational products almost always require female participants to take birth control methods through condom use and/or another contraceptive method. However, many trials now require long-term family planning methods such as IUDs and Implants to be part of the eligibility criteria. This can often be a challenge in resource poor settings where expertise and facilities for the insertion and removal of these methods are often lacking, and participant knowledge and exposure to long-term methods is limited. Does anyone have any experience in promoting long-term family planning methods for clinical trial recruitment and if so what advice can you give to guide others?
Hello Sam, are you referring to commercially funded trials? We have a couple of WHO funded trials and they specifically told us to exclude women of child bearing age because of the exact issues that you raised!
I have no experience with this kind of specific requirements. When I was in the private sector (quite a long time ago!), the requirement was generally stg like "to ensure that the woman is willing to take adequate contraceptive measures". However, the assessment of the appropriateness of such measures was left to the study physician, and the discussion on the better methods was left to the patient-physician dialogue.
In my personal view, this criterion touches very sensitive points, related to personal history and choices, culture, resources, and there is the risk of imposing external standards from another context. So I would be personally in favour of leaving the decision on the most adequate methods to the patient-physician dialogue (so that all the personal and contexts aspects can be considered, on a woman-by-woman basis).
Hello Sam,I have to agree with Dr Ravinetto. I am worried about asking women to make a choice based upon a research need rather than her and her family planning requirements. This is an ethic and potentially legally sensitive matter. I have not come across such a requirement in my own studies from the sponsors we work with, but I have heard of other people experiencing this request - also with HIV studies. It is worrisome and should be openly discussed. It would be helpful to hear of other specific experiences and how this is justified.
Thanks for all the comments. There have been some very interesting points raised. The trials I am referring to are actually non-commercial trials and while the protocols may not specify the exact nature of contraceptive method, site physicians are often in favour of long term family planning methods, if they are freely available at the site health centre. I agree that it would raise ethical issues to insist on long term methods after proposing the trial to potential participants since they may be encouraged to opt for a method they would otherwise not have wanted. However, only approaching and recruiting participants who had already opted for long term methods would not have the issue of undue incentives, since the patient had already decided on the best method for them prior to knowledge of the trial.
It’s a very interesting point that certain trials will exclude women of child bearing age to avoid the issue of family planning. Understandably, the rate of accidental pregnancy may be unacceptably high for certain trials when short term methods such as condoms/oral contraceptives are used. However, if the use of long term methods were made more available and patients only approached after they had made a decision based solely on the method that was best for them, then potentially those trials excluding women of child bearing age could be made more inclusive. A major point of research ethics is that participants should not be excluded without sound justification. Given this, excluding women of child bearing age from trials without considering offering long-term family planning methods to those who have previously shown interest in them, may raise some ethical issues in itself. It would also go a long way to increasing the social value of the research.
In my experience, as patients become aware of services offering long term methods they are very popular. Perhaps a key issue then is the general lack of long term family planning methods available in resource poor settings. If they were to become more available and promoted on a basis that was separate from the trial, then potentially a much larger part of the population could be opened up to recruitment and not excluded due to lack of services –beneficial for both trials and the research population alike.