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ADVOCATE REQUESTS FOLLOWING CS TRIAL CLOSED

By Tiffany Simmons,2014-12-13 08:42
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ADVOCATE REQUESTS FOLLOWING CS TRIAL CLOSED

    Possible Advocacy Responses to the

     Closure of the Cellulose Sulfate Microbicide Trial

    A document to jumpstart discussion

    Around the world advocates committed to social justice, HIV prevention and care, and women’s sexual and reproductive health are grappling with the implications of the recent

    decision to halt two clinical trials testing cellulose sulfate (CS), a candidate microbicide. Many of us have been vocal advocates for more research into new HIV prevention strategies, so this setback is disappointing news.

    The Global Campaign for Microbicides (GCM) and the African Microbicides Advocacy Group (AMAG) are working together to catalyze discussion about what our roles can and should be as advocates in response to this development.

    To jumpstart this discussion, we have compiled this list of possible advocacy responses to the different challenges posed by the trial closure. We encourage you to discuss these options in your various networks and send us your comments and questions at: info@global-campaign.org.

    In addition, AMAG will be hosting a moderated discussion of these points on their list-serve beginning early April 2007.

To join this discussion:

    - if you are an AMAG eforum member, do nothing and be prepared to contribute

    - if you would like to join the group, send an email to amag_join@dgroups.org with

    your contact information. AMAG is a closed forum for African researchers and

    advocates interested in microbicides.

    ******

Support for the women in the CS trials

    Advocates were instrumental in pushing the field to adopt -- as a normative obligation of phase 3 trial sponsors -- the development of explicit, advance agreements capable of assuring that comprehensive care would be provided to all women who seroconvert during microbicide trials.

Possible advocacy responses:

    ; We can work with the trial teams to look for creative ways to hear/amplify the

    voices from the women in the CS trials, while still respecting their confidentiality

    What was their experience? How do they feel?

    ; Advocates and local partners can seek to monitor whether trial participants

    actually get the care they were promised

    ; We can track how the funding set aside by CONRAD for their care is managed.

    ; We can advocate that participants who were given CS receive compensation

    and/or payment for their medical care if further data analysis confirms that the

    product appreciably increased their risk of infection.

    ; We can encourage all trial sites to actively assist women to access the care they

    need via accompaniment programs, help with enrolment, transportation

    assistance as needed, etc.

    ; We can call on the trial sites to develop formal “exit plans” to help women

    transition into other services and ensure that their physical and emotional health

    needs are adequately provided for.

Keeping communities updated

    Possible advocacy responses:

    ; We can urge trial teams to document the steps they are now taking to inform

    communities and groups about why and how the CS trials are being closed. We

    can request access to this information and work with our partners to make sure

    those reports are widely available.

    ; We can encourage trial sponsors to interview both the study participants and trial

    community members about the closure of the trial to assess their understanding

    of the reasons for closure, their concerns about it, etc. (It is our understanding

    that CONRAD and FHI have already developed protocols for such studies and

    have submitted them for accelerated ethical review).

Access to analysed trial results

    Given the volume of data and the complexity of the task, we have been informed that the process of entering, collating, cleaning and fully analysing the results may take as much as 6 months.

Possible advocacy responses:

    ; We can advocate for the speediest possible analysis of these data and the

    deployment of extra resources to this task.

    ; We can insist that a plan for sharing this information with the scientific community,

    trial participants and communities and advocates be designed and circulated as

    soon as possible.

    ; We can encourage accelerated peer review of the findings and joint sharing of

    authorship with in-country investigators.

    ; We can advocate for country-level and regional forums to help share the results

    and seek input from country-level policymakers, advocates and scientists in

    interpreting the implications of these findings for the wider microbicide field.

    ; We can create spaces for discussion between advocates and researchers to

    better understand the results and their implications for the larger field.

    ; We can compile a repository of information/materials related to CS: pre-clinical

    and clinical data, press statements, media reports, trial site reports

    Answering outstanding questions

    Possible advocacy responses:

    ; We can continue to collect and field questions related to the trials closure and

    ensure that advocates have access to researchers to ask questions directly.

    ; Advocates can call on scientists to convene a high level consultation on

    evaluating the safety of candidate microbicides in light of the CS findings.

    ; We can collectively work to expand our understanding of the scientific challenges

    of assessing safety in products for which “proof of concept” has not yet been

    established. This will enable us to advocate more effectively for improved safety

    assessment.

    ; We can push researchers to analyse whether the prevention package offered to

    women in the trial (condoms, risk reduction counselling and STI treatment)

    actually helped reduce participants’ overall risk, as compared to community

    women not enrolled in the trial.

    Trial closure lessons learned

    Possible advocacy responses:

    ; We can encourage that the Data Safety Monitoring Committees of on-going

    microbicide trials take an “expedited look” to see whether similar safety concerns

    may be emerging.

    ; We can push for all future microbicide trials to adopt explicit guidance for Data

    Monitoring Committees about boundaries for stopping trials early, either due to

    safety concerns, unexpected benefit, or futility (if the trial, for whatever reason,

    cannot answer the question originally posed).

    ; We can insist that trials have concrete plans on how to manage different types of

    trial closures what information should be provided and when to trial participants,

    staff, other stakeholders, advocates. These plans should especially address the

    special challenges of managing unexpected findings from DMC reviews.

    ; We can encourage advocates to analyse the events from their perspective,

    identify what it means to their advocacy efforts on the ground; and plan ahead so

    that advocates at all levels are better prepared to deal with trial closures.

    ; We can work with media groups so they have better and continuous access to

    accurate information about clinical trials and are able to provide accurate

    coverage as the research proceeds.

Maintaining momentum for prevention research

Possible advocacy responses:

    ; We can emphasize the vital importance of additional prevention tools and the

    need for continued research despite setbacks.

    ; We can work to get accurate information into the hands of stakeholders and to

    counter misinformation and sensationalism in the media.

    ; We can advocate with donors for greater investments in developing research

    literacy among civil society actors and in inculcating “community literacy” among

    researchers.

    ; We can advocate with donors and partners to allocate resources for capacity-

    building and advocacy efforts for community/civil-society groups at the national

    and grassroots levels.

    In the coming weeks, GCM will be establishing its own advocacy priorities in consultation with the GCM steering committee.

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