Contraceptive Research, Introduction, and Use Lessons From Norplant, Summary (1998) / Chapter Skim
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3. Lessons Learned
3. Lessons Learned
Pages 8-14
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From page 8... ...
Second, contraception is also closely linked to social, cultural, and personal norms and values that, varying, by setting, require considerable sensitivity. Third, the likelihood in the foreseeable future of a single contraceptive that will be perfect for all potential users across their lifetimes, totally effective yet totally free of side effects, is small.
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From page 9... ...
Areas for Strengthening or Expansion 1. Clinical Research Data reported at the workshop pointed to two areas where more fundamental research is needed to strengthen the position of implantable contraceptives in the array of contraceptive options: research on vaginal response to hormones, including cyclic hormonal effects, and on the use of progestins in contraceptives on the incidence of sexually transmitted disease, importantly including HIV; and · research on the causes of hormonal side effects that, in addition to their implications for the users of hormonal methods, also affect the ability of providers to manage and treat those events clinically.
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From page 10... ...
"Introduction" was thoughtfully utilized by the Population Council as a bridge from research and development and from the successful completion of clinical trials, to Norplant's entry into national family planning programs. The key mechanism was introductory trials in a limited set of facilities that then became centers for extension of training after national product registration; their purpose was to identify management and technical issues affecting method delivery and to develop and refine guidelines, standards, counseling materials, and training programs for clinical management.
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From page 11... ...
The questions the workshop participants flagged as of greatest concern were: · how mechanisms for informed decision-making are to be developed and by whom; · the distinctions and connections among the kinds of information needed in the experimental stages of product development, compared to what is needed in the introductory phases and in routine clinic settings; the purposes and practical implications of labeling, informed consent documents, and clinical guidelines for informational and decision-making purposes; what is essential as opposed to discretionary information; and · the impact of all the above on participation in contraceptive research and development. If and when new long-acting, provider-dependent contraceptive products are developed and introduced, each of these concerns would ideally be part of a systematic strategy for informed decision-making, to then be tested and refined in the product's clinical trial and preintroductory phases.
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From page 12... ...
Accordingly, the subcommittee concluded from the workshop discussions that collaboration with professional medical societies and major managed care organizations on strategies for training and assuring provider competence would be a critical preparatory step in introducing the next new provider-dependent contraceptive technology, most immediately the LNG two-rod implant.
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From page 13... ...
The most immediate example is the fact that the improved two-rod, three-year implant that is significantly easier to insert and remove is not being introduced in the United States by its European manufacturers, apparently owing to litigation concerns related to Norplant, so that it may not become available as a contraceptive option for American women. A related concern is the current controversy around silicone products and its potential effects on the supply of biomaterial not only for implant contraceptives but for other medical devices, some of which—for example, cerebrospinal fluid shunt systems and pacemaker leads are essential to life.
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From page 14... ...
A pivotal challenge will be determining how those initiatives are to be pursued and by whom. The workshop participants and the subcommittee agreed that contraceptive research and development have fallen behind in the great advances propelling the rest of medicine, including all other areas of women's health, and that, without attention to these areas of major impediment, contraceptives will continue to compete poorly when industries contemplate alternative new directions for their investment portfolios.
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