Introduction The Ebola virus disease (EVD) outbreak in 2014–2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments. Methods This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection. Results From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those < 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12–17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL. Discussion The PREVAC trial is evaluating—placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children. Trial registration ClinicalTrials.gov NCT02876328. Registered on 23 August 2016.
A qualitative survey was carried out in six countries to gather insights into potential barriers to patient participation in cancer clinical trials (CTs) to help stakeholders develop strategies to improve recruitment and participation. While the research was exploratory in nature, the findings highlight the critical role that doctors play in terms of CTs participation. The research also indicates the need for outreach to raise awareness about CTs both outside and within the clinical research community as well as educating the general public to dispel misconceptions about CTs. The results also indicated that most patients who participated in the research believe all patients should be offered the chance to participate in CTs, wanting all available options presented to them.
A survey was conducted to identify perceptions of cancer and its treatment among the general public, patients, and care givers in six countries. The purpose of the research—the PACE Cancer Perceptions Index (2012)—was to share public perspective on the progress of cancer care and treatment with stakeholders who make decisions about cancer innovation and access to treatments in order to allow patient-centric decisions. The results revealed that although understanding of cancer is increasing, a number of misconceptions persist. Although most respondents recognise that progress has been made in cancer treatment and a majority express satisfaction with this progress, they nevertheless want more investment and faster access to new cancer treatments. In particular, there was clear agreement that more collaboration was needed across countries and between the various stakeholders within countries. In addition, a clear majority of respondents does not think that their country invests sufficient funds in cancer research, and there is concern that progress may be jeopardised by the current difficult economic times.
A35Cancer policymakers, researchers, and advocates have different priorities for cancer treatment research and may define 'value' of new treatments differently. Harmonizing the priorities and values of diverse stakeholders may be neither possible nor desirable. In November 2012, as part of its Patient Access to Cancer care Excellence (PACE) initiative, Lilly Oncology convened a Global Council of opinion leaders in cancer research, care, and policy to identify barriers to innovation in oncology research and develop strategies to improve cancer care. Participants concluded that the cancer policy field lacked tools to visualize these differences and to track progress in cancer treatments based on variable sets of values. Responding to this need, PACE developed the Continuous Innovation Indicators: novel, scientifically rigorous progress trackers designed to increase understanding of continuous innovation in cancer treatments among different stakeholders. The Indicators quantify progress in cancer treatments by: 1) mining the literature to determine the strength of the evidence supporting each treatment; 2) weighting the analysis according to the audience's priorities and values; and 3) calculating Evidence Scores (E-Scores), which are measures of progress based on the strength of the evidence weighted by the assigned value. We introduce a flexible model to illustrate differing values, show how the values from the model can be used to weight the evidence from the scientific literature to obtain E-Scores, and demonstrate how assigning different values influences E-Scores. Differentiated analyses based on values provided by various stakeholders will help the cancer policy field to obtain accurate representations of the complex, stepwise progress against different cancers over time. We envision partnerships and collaborations to support educational efforts, identification and illustration of policy goals, and work in the field of health technology assessments. We will not make this tool available to individuals or organizations for the purpose of deriving treatment recommendations.
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