Best Practices to Drive Time and Cost Savings for Contraceptives | Page 9

However, even the provision of free contraception does not

Compliance »

guarantee 100% retention. Just as perceived side effects can

Compliance to the study protocol ensures quality data and remains

affect enrollment, experienced side effects can affect retention.

the primary issue for trials. Non-compliance with either the drug/

Previous studies have reported that side effects contributed to

product or the documentation of use, endpoints, side effects, and

discontinuation of oral contraceptives in 60% of young women

sexual activity limits the ability to evaluate the success or failure of

after 6 months. Tolerance to side effects can vary depending on

the product. Participants who are habitually non-compliant may have

previous experiences with birth control, expectations on study

to be withdrawn from the study, affecting the study duration as new

entry, and personal preference.

participants are recruited to ensure an adequate number of quality

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data points. Trials that continue with poor quality or missing data
Greater retention has been reported with the long-acting reversible

run the risk of being re-run after their initial completion.

contraceptive options (77–86%) than with the patch (40–42%), pill
(43–55%), or vaginal ring (41–51%) at 12 and 24 months when

Satisfaction with the product itself will determine its continued use,

provided at no cost,4,14,15 demonstrating that the product itself will

particularly as there are a number of other options available that

play a large role in the retention of study participants. It is also

may be better suited to the person. Therefore, compliance with the

important to keep participants engaged through the process for

product will depend, in part, on each person’s perception of ease of

improved retention.

use and side effects associated with the investigational product.
Further, compliance is affected by similar participant characteristics

The types of people who
may be more committed and
conscientious are also those
that may not be willing to take
a chance on a contraceptive of
unknown efficacy and therefore
not likely to participate.

as those that affect recruitment and retention. Age, employment
status, socioeconomic status, family status, external commitments,
marital status, relationship status, and frequency of sex can all
influence how diligent a person is with product use and recording.
The types of people who may be more committed and conscientious
are also those that may not be willing to take a chance on a
contraceptive of unknown efficacy and therefore not likely to
participate. This may result in a sample of women who do not
possess the characteristics associated with better compliance.

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