Best Practices to Drive Time and Cost Savings for Contraceptives | Page 7

To ensure that the participants in contraceptive clinical trials are

Figure 6.

What Affects Recruitment?

representative of the end consumers, the FDA has identified areas in
WOMAN HAPPY WITH
CURRENT CONTRACEPTION
LESS LIKELY TO SWITCH

which specific sampling distribution requirements may be required in
the future:
• Socioeconomic status: The FDA has noted considerable variation
across trials and may wish to standardize the distribution to better

WOW

WILLINGNESS TO
ACCEPT RISK
OF PREGNANCY

TO RECRUIT “SWITCHERS,”
CONTRACEPTION NEEDS TO
HAVE A “WOW” FACTOR

MINIMUM NUMBER
OF SEX ACTS
REQUIRED PER MONTH

reflect the characteristics of the anticipated users.
• Body mass index (BMI): There is concern that the exclusion of

PERCEIVED
SIDE EFFECTS

AGE, RELATIONSHIP
STATUS, EMPLOYMENT
STATUS, STAGE OF LIFE
(IN RELATION TO EDUCATION
AND PROFESSION)

FRIENDS,
MEDIA COVERAGE

LACK OF ACCESS
TO AFFORDABLE
CONTRACEPTION

women of higher BMIs, as often occurs in clinical contraceptive
trials, may result in low-dose oral products that have possible
reduced effectiveness in the “real world”.
• Geographic location: In trials where the sponsors aim to enroll
participants from international locations for a product that will
be available in the US, the FDA may require sampling of a specific
proportion of the women from the US owing to improved efficacy
previously observed in foreign-based countries.
As dropout and withdrawal are inevitable, pre-trial planning should
incorporate and document enrollment monitoring for each of the
required characteristics set by the sponsors and regulatory bodies,
in addition to contingency planning for additional enrollment and
improved retention, should they be required.

Recruitment and retention »
The patient profile will guide recruitment and should aim to include a
sample of women that will represent the women who will be using the
product in “real life” and meet regulatory requirements, while balancing

the needs of the study to be completed in a timely manner with
quality data. However, a perfectly constructed profile does not ensure
problem-free recruitment.
A woman who is happy with her current contraception is less likely
switch to another option with unknown efficacy and side effects. To
recruit “switchers”, the new product has to be obviously superior to
her current product; in other words, it needs to have that “wow” factor.
For these women, the perceived side effects of the new product, whether
through previous experience, friends’ experiences, or media coverage
of a similar product, can influence the willingness to participate. Friends
and media could also affect the decision of “fresh starts” to participate.
For example, weight gain, increased acne or facial hair, and an increased
risk of DVT are commonly considered side effects of oral hormonal
contraception and could be strong deterrents for a number of women.

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