Best Practices to Drive Time and Cost Savings for Contraceptives | Page 14

Conclusion »

Author »

Owing to the wide range of choices, contraception is not just efficacy

Darcy Forman

driven, but involves a high degree of personal preference. These

Senior Director Project Management, Clinipace Worldwide

same preferences influence a woman’s decision to enroll, comply,

Darcy is a clinical research professional with over 16 years of

and complete a contraception clinical trial. Time spent developing a

pharmaceutical experience in project management and clinical

patient profile before trial commencement will save time and costs

operations. As the leader of the women’s health therapeutic division,

later. Further time and cost-savings can be realized by centralizing and

she is responsible for developing therapeutic divisional strategy and

automating processes relating to enrollment, data collection, and risk-

implementing corporate strategy, as well as developing and maintaining

based monitoring. Reducing the participant burden through the use of

therapeutic divisional initiatives. Darcy has global trial experience,

e-diaries may improve both retention and compliance.

including managing trials across the US, EU, Russia, South America,
Australia, and South Africa.

References »
1 Eunice Kennedy Shriver National Institute of Child Health and Human

10 Aziz M, Smith KY. Challenges and successes in linking HIV-infected women to care

Development. Contraception Research and Development. Accessed at www.nichd.

in the United States. Clin Infect Dis 2011; 52:S231–7.

nih.gov/about/org/der/branches/cddb/programs/pages/contraception-research-

11 Food & Drug Administration. Guidance for industry: labeling for combined oral

development.aspx

contraceptives. March 2004.

2 National Health Statistics Reports, Number 60. October 18, 2012. Accessed at http://

12 Food & Drug Administration. General Meeting of the Advisory Committee for

www.cdc.gov/nchs/data/nhsr/nhsr060.pdf

Reproductive Health Drugs. January 23 and 24, 2007.

3 Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy

13 Westhoff CL, Heartwell S, Edwards S, et al. Oral contraceptive discontinuation: do

in the United States, 1994 and 2001. Perspect Sex Reprod Health 2006;38:90–6.

side effects matter? Am J Obstet Gynecol 2007;196:412.e1–7.

4 Stuart JE, Secura GM, Zhao Q, Factors associated with 12-month discontinuation

14 Peipert JF, Zhao Q, Allsworth JE, et al. Continuation and satisfaction of reversible

among contraceptive pill, patch, and ring users. Obstet Gynecol 2013;121:330–6.

contraception. Obstet Gynecol 2011;117:1105–13.

5 Trussell J. Contraceptive failure in the US. Contraception 2011;83:397–404.

15 O’Neil-Callahan M, Peipert JF, Zhao Q, et al. Twenty-four month continuation of

6 Eunice Kennedy Shriver National Institute of Child Health and Human Dev.

reversible contraception. Obstet Gynecol 2013;122:1083–91.

Scientific Vision Workshop on Reproduction: White Paper. January 25-26, 2011.

16 Food & Drug Administration. Guidance for Industry: oversight of clinical

7 Kalmuss D, Koenemann S, Westoff C, et al. Prior pill experiences and current

investigations – a risk-based approach to monitoring. August 2013.

continuation among pill restarters. Perspect Sex Reprod Health 2008;40:138–43.

17 European Medicines Agency. Reflection paper on risk based quality management

8 clinicaltrials.gov, accessed March 5, 2014

in clinical trials. November 13, 2013.

9 Wakasiaka S. Challenges recruiting women into trials. AIDS Vaccine

18 Medicines and Healthcare products Regulatory Agency. Clinical Trial Notification

Handbook 179–181.

Scheme Survey Report. 2012.

clinipace.com

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