Research study
This presentation is the property of its rightful owner.
Sponsored Links
1 / 27

Research Study: PowerPoint PPT Presentation


  • 38 Views
  • Uploaded on
  • Presentation posted in: General

Research Study:. The Participation of Pregnant Women in Clinical Research: Implications for Practice within the U.S. Pharmaceutical Industry University of North Carolina Gillings School of Global Public Health Kristine Shields MSN, DrPH 2012. Millenium Development Goal #5:

Download Presentation

Research Study:

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Research study

Research Study:

The Participation of Pregnant Women in Clinical Research: Implications for Practice within the U.S. Pharmaceutical Industry

University of North Carolina

Gillings School of Global Public Health

Kristine Shields MSN, DrPH

2012


Problem

Millenium Development Goal #5:

Reduce Maternal Mortality

1.7 Million Pregnant Women

2 die every day

600,000 have complications

> 1 million are prescribed drugs

Problem

See References slide


Problem1

Problem

80%

Bioterrorism

Abortion

Thalidomide

Death

See References slide


Policy window opens

Policy Window Opens

FDA Draft Guidance:

Pregnant Women in Clinical Trials: Scientific and Ethical Considerations


Policy window theory of change

Policy Window Theory of Change

Kingdon: Agendas, Alternatives, and Public Policies


Kingdon recommends

Indicators of the existence and magnitude of issue

Promotion of constituent feedback

Kingdon recommends:

Special studies of the issue

  • Quantitative methodology

  • Qualitative methodology

Kingdon: Agendas, Alternatives, and Public Policies


Quantitative study

Quantitative Study

  • ClinicalTrials.gov

  • U.S. industry-sponsored Phase IV studies

  • Exclusion criteria


Quantitative study results

555

Studies

5

452

98

Enrollment limited to pregnant women

Potentially include

Appropriately excluded*

301 Excluded

149

Unknown

2

Not Excluded

Confirmed criteria = 368 studies

Total excluding = 347 (94%)

Total not excluding = 21 (6%)

84

No Response

65

Responded

19

Not Excluded

46

Excluded

* Pregnant women were excluded because the drug was in FDA Category D or X, or the age or topic (menopause, contraception, lactation) prohibited pregnancy.

Quantitative Study Results


Qualitative study

Key Informant interviews:

Pharma companies

Big Pharma……………5

Biotech…………….......3

Industry attorneys………..3

IRBs……………………….3

PhRMA association……...1

FDA………………………..1

(N = 16)

Qualitative Study


Qualitative study results

Qualitative Study Results


Plan for change problem

Problem

Awareness of the issue as a problem

Politics

Influence within company, within industry, within country

Plan for Change: Problem

Policies

Propose potential solutions for consideration and debate


Plan for change in problem stream

Solution:

Communicate the extent of pregnant women’s exclusion from clinical research and why this is a problem

Increase awareness of the 'issue as a problem' among individuals in industry, IRBs, and industry associations

Intervention:

Publication on quantitative results in peer-reviewed scientific literature

White Paper distribution to industry associations (PhRMA and BIO), to key informants, and to colleagues in the industry

Plan for Change in Problem Stream


Plan for change policies

Problem

Awareness of the issue as a problem

Politics

Influence within company, within industry, within country

Plan for Change: Policies

Policies

Propose potential solutions for consideration and debate


Plan for change in policy stream

Solution:

Provision of potential solutions for industry consideration in guidance responses & internal policies

Industry perspective included in discussion of the issue

Provision of potential solutions for Merck's draft response

Intervention:

White Paper to FDA, PhRMA, BIO, and pharmaceutical and biotech companies (via key informants)

Present study findings at FDA hearing, if applicable

Participate in drafting response to FDA’s call for comment

Plan for Change in Policy Stream


Plan for change politics

Problem

Awareness of the issue as a problem

Politics

Influence within company, within industry, within country

Plan for Change: Politics

Policies

Propose potential solutions for consideration and debate


Plan for change in political stream

Solution:

Personal influence on internal deliberations on issue

Issue remains in public and professional consciousness;

Continued advocacy for increased evidence-based treatment for pregnant women

Intervention:

Continue involvement in issue

Continue involvement in other industry and non-industry organizations

Additional publications and presentations provide information for advocates to influence legislators, legislation

Plan for Change in Political Stream


Impact of deliverables

Impact of Deliverables


The purpose of this study was to

The purpose of this study was to:

  • Quantify the problem and

  • Isolate and barriers to and opportunities for change

  • In order to influence policy

  • That will improve maternal health


Questions

Questions?


References

REFERENCES

  • [i]Daniel I et al. Magnitude of maternal morbidity during labor and delivery: United States, 1993-1997. American Journal of Public Health 2003; 93(4):631-4.

  • [ii] Heron M et al. Deaths: Final data for 2006, National Vital Statistics Reports 2009; 57(14):116, available at http://www.cdc.gov/nchs/data/nvsr/nvsr57/nvsr57_14.pdf.

  • [iii] Andrade SE et al. Prescription drug use in pregnancy. American Journal of Obstetrics and Gynecology 2004; 191:398-407.

  • [iv] Glover DD et al., Prescription, over-the-counter, and herbal medicine use in a rural obstetric population. American Journal of Obstetrics & Gynecology 2003; 188:1039-1041.

  • [v] Lo WY & Friedman JM. Teratogenicity of recently introduced medication in human pregnancy. Obstetrics & Gynecology 2002; 100:465-473.


Back up slides

Back-up Slides


Has this been done before

Has this been done before?

  • Precedent:

    • Pediatric Exclusivity Provision, FDAMA (1997)

    • Best Pharmaceuticals for Children Act (2002)

    • Pediatric Research Equity Act (2003)

  • Results:

    • increase in pediatric drug testing

    • changes in labeling regarding dosing and pk, safety, lack of efficacy, etc.


How will study results promote a plan for change

How will study results promote a Plan for Change?

Leadership is a “process of influencing others to understand and agree about what needs to be done and how to do it, and the process of facilitating individual and collective efforts to accomplish shared objectives.”

Gary Yukl, 2006


Ethics

Ethics

  • Arguments for and against inclusion

    • Beneficence/Non-maleficence

    • Justice

    • Autonomy/Respect

    • Ethic of Care

    • Stakeholder theory


Public health advocacy

Public Health Advocacy

  • Every public health decision is a political decision.

  • Public health historically fails to close the sale with policy-makers and politicians.

  • Public health officials tend to be scientists at heart with an innate aversion to politics.

  • We must leverage status as public health leaders to get the political system working for public health - and not against it.

Risa Lavizzo-Mourey, President and CEO, RWJF 2008


Limitations qualitative

Limitations: Qualitative

  • Limited to U.S. Phase IV clinical trials – not generalizable ex-US.

  • Phase IV is proxy for Phase II and III trials because I cannot evaluate if it would be appropriate for pregnant women to be included in Phase II or III studies from the data source or in the public domain.

  • Some of the inclusion and exclusion criteria listed may not mention pregnancy or pregnancy potential. Cannot assume that if pregnancy is not mentioned as an exclusion criterion then pregnant women can be included as study subjects. In order to validate the initial findings, any protocols that do not mention pregnancy or pregnancy prevention per se will be contacted.

  • However, this still may not address de facto exclusion, i.e. the "inadvertent" failure to recruit pregnant women.


Limitations qualitative1

Limitations: Qualitative

  • Participants interviewed may or may not represent the perspectives of other companies and organizations or a consensus on the subject.

  • In telephone interviews physical proximity, visual clues such as body language and facial expressions are lost.

  • Convenience sample based on my contacts in the industry and related organizations. Most, but not all, participants will be known to have worked on pregnancy-related issues which will improve their ability to discuss the issue in depth but this may introduce bias as they may not represent the thinking of the industry at large.

  • In the interview data analysis, findings could be subject to other interpretations that may differ from my interpretation. Using evidence from inside and outside industry will add to the validity of the findings by using triangulation –to see if similar themes are identified.

  • As someone with background in women's health, I bring knowledge but also certain biases to this study. I acknowledge that I agree with proponents who seek a more rational and inclusive policy toward pregnant women in research studies. And I acknowledge that, while I will strive to maintain objectivity in the data collection and analysis, my biases may influence my findings.


  • Login