Mapping the Landscape of Patient-centric Activities Within Clinical Research

Lamberti, Mary Jo; Awatin, Josephine

doi:10.1016/j.clinthera.2017.09.010

Cited by 33 publications

(31 citation statements)

References 9 publications

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“…For this reason, we developed our own conceptual model in an effort to explain participants’ ethical oversight expectations through their past data-sharing behavior, their previous participation in research, their perceived importance of having transparent guidelines on Web-based data-sharing platforms and perceived knowledge of them, their attitudes toward data sharing and self-experimentation, and their future data-sharing intention (see Multimedia Appendix 1). To build measures for our variables of interest, we relied on the literature on the ethical principles of standard research [49,57-59], on what characterizes PLR [12,16,19,37,60-62], and on barriers to and facilitators of data sharing in varous contexts (eg, biobanking) [30-32]. Below we have described how survey questions were created on the basis of the literature across all variables.…”

Section: Methodsmentioning

confidence: 99%

User Perspectives of a Web-Based Data-Sharing Platform (Open Humans) on Ethical Oversight in Participant-Led Research: Protocol for a Quantitative Study

et al. 2018

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BackgroundAdvances in medicine rely to a great extent on people’s willingness to share their data with researchers. With increasingly widespread use of digital technologies, several Web-based communities have emerged aiming to enable their users to share large amounts of data, some of which can possibly be employed for research purposes by scientists, or to conduct participant-led research (PLR). Scholarship has recently addressed the necessity of interrogating how existing ethical standards can and should be applied and adapted in view of the specificities of such Web-based activities. So far, no study has explored participants’ beliefs about and attitudes toward ethical oversight when it comes to platforms that involve medical data sharing.ObjectiveThis paper presents the protocol for a survey study aimed at understanding users’ beliefs about Web-based data-sharing platforms regarding how research ethics principles should be applied in such a setting. Furthermore, the study aims at quantitatively assessing the relationship between participants’ perspectives on ethical oversight and other variables such as previous participation in research, beliefs about data sharing, and attitudes toward self-experimentation.MethodsWe are conducting a Web-based survey with users of a popular Web-based data-sharing platform, Open Humans. The survey has been sent to approximately 4640 users registered for the Open Humans newsletter. To fill out the survey, participants need to have an account on Open Humans. We expect a 5%-10% response rate (between 200 and 400 completed surveys out of approximately 4000 survey invitations sent). Independent variables include past data-sharing behavior and intention, beliefs about data sharing, past participation in research, attitudes toward self-experimentation, perceived knowledge of the platform’s guidelines and terms, perceived importance of having transparent guidelines, and governance-related beliefs. The main dependent variable is participants’ expectations regarding who should ensure that ethical requirements are met within research projects conducted on open data-sharing platforms, based on Emanuel et al’s ethical framework. We will use chi-square tests to assess the relationship between participants’ expectations regarding ethical oversight and their past behavior, future intentions, beliefs, attitudes, and knowledge.ResultsData collection started on June 13, 2018. A reminder to fill out the survey was sent to participants in mid-July. We expect to gain insights on users’ perspectives on the ethical oversight of Web-based data-sharing platforms and on the associated experiences, beliefs, and sociodemographic characteristics.ConclusionsWhen digital tools allow people to engage in PLR including medical data, understanding how people interpret and envision the ethical oversight of their data-sharing practices is crucial. This will be the first study to explore users’ perspectives on ethical oversight of Web-based data-sharing platforms. The results will help inform the development of a fr...

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Section: Methodsmentioning

confidence: 99%

User Perspectives of a Web-Based Data-Sharing Platform (Open Humans) on Ethical Oversight in Participant-Led Research: Protocol for a Quantitative Study

et al. 2018

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“…These therapies include promising new modalities, such as bispecific (e.g. blocking both TNF-a and IL-17 16 ) (180,181), and even trispecific antibodies (182), as well as vaccines (183). A compilation of these new and emerging treatment options for psoriasis can be found in Table 2.…”

Section: Risk Factors and Triggersmentioning

confidence: 99%

“…288) GSE57225 2014 PSO-AD/ACD PSO(23), AD(10), ECZ(13), NL(16) SurePrint G3 8x60K(289) GSE63741 2016 PSO, AD, other AD-LS, PSO-LS, ACD, LP, NN (30 each) PIQOR 2.0 (290) GSE80047 2016 PSO, PPP(P) PPP (3), PPPP (6), PSO (10), NN (31) HG-U133_Plus_PM (291) GSE79704 2017 PSO, GPP, NN GPP-LS (32), PSO-LS (12), NN (20) HG 2.1 ST (292) GSE73894 2017 PSO, NN DNA methylation, LS (135), NL (41), NN (62) Infinium 450k (293) GSE115797 2018 PSO DNA methylation, LS (24), NL (24) Infinium 450k (185) ACD, allergic contact eczema; Dx, diagnosis; d, day; epi, epidermis; ECZ, eczema (non-atopic); GPP, generalized pustular psoriasis; LCM, laser-capture microdissection; LP, lichen planus; PPP, palmoplantar pustulosis; PPPP (palmoplantar pustular psoriasis); PSO-AD, patients co-affected by both PSO and AD; w, week.…”

mentioning

confidence: 99%

Personalized medicine—concepts, technologies, and applications in inflammatory skin diseases

Litman

2019

APMIS

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“…Detailed descriptions of the 23 PCIs identified through this process have been published. 11 The working group developed a web-based survey to gather metrics on the various stages of adoption of these PCIs (implementing, planning, piloting, or not considering). Built in Qualtrics, a survey software, included 26 questions and asked respondents to evaluate the status of the 23 PCIs within clinical research at their organizations as implemented, in the planning or piloting stages, or not being considered.…”

Section: Assessing Adoption Rates Of Pcismentioning

confidence: 99%

“…Figure 1 shows the distribution of activity for specific types of PCIs, which are defined in previous publications from this study. 11,13 The most implemented initiatives (blue bars) were patient organization landscape analysis tools ( Looking at the top piloted and planned initiatives, end of study surveys (9 of 22) and use of patient wearables (8 of 22) were the PCIs most often piloted, and e-consent (11 of 22) was among the top planned initiatives. Other top planned initiatives included adaptive trial designs and adaptive licensing (10 of 22) and establishing patient communities during and after clinical trials (10 of 22).…”

Section: Assessing Adoption Rates Of Pcismentioning

confidence: 99%

Assessing Biopharmaceutical Company Experience with Patient-centric Initiatives

Michaels¹,

Lamberti

Peña

et al. 2019

Clinical Therapeutics

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Purpose: A growing number of biopharmaceutical companies have been implementing patient-centric initiatives (PCIs). The Drug Information Association (DIA) and the Tufts Center for the Study of Drug Development (CSDD) collaborated on a study to gather data on the usage and impact of these PCIs to characterize company experience and impact. Methods: DIA and Tufts CSDD collaborated with 17 organizations to define PCIs used in clinical research and development and to quantify their use, and to define metrics in use to document impact and return on engagement (ROE) for these PCIs. The study used a mixed methods approach that consisted of an online survey, in-depth interviews, and literature review. Findings: Twenty-two unique companies responded to an on-line survey on the use of 23 PCIs identified by the study working group. PCIs most frequently implemented included patient organization landscape analysis, support of patient advocacy groups, use of patient advisory boards, and use of home nursing networks. Seven additional PCIs were found through a literature search and included in the group of PCIs for which impact measures were assessed. A total of 121 cases of use of the 30 PCIs and associated impact measures and impact data were gathered through literature review, in-depth interviews with the study companies, and in-depth interviews with organizations identified in the literature as having experience with patient engagement in clinical research as well as with patients who had participated in clinical trials. Analysis of the 121 case studies resulted in a list of 666 measures of impact (metrics) in use for 13 of the PCIs. Assessment of overall ROE for these PCIs found that PCIs such as support of patient advocacy groups and use of patient advisory boards indicated the greatest ROE, whereas costlier, more complex PCIs such as digital medicine and gaming indicated relatively low ROE. Implications: Activity around PCIs among the companies studied was widespread, with initiatives more frequently planned and piloted than implemented at the time of this study. Measures of impact have been identified and can be used to assess ROE, providing insights to facilitate the adoption of PCIs of highest impact for patients and biopharmaceutical research organizations.

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Mapping the Landscape of Patient-centric Activities Within Clinical Research

Cited by 33 publications

References 9 publications

User Perspectives of a Web-Based Data-Sharing Platform (Open Humans) on Ethical Oversight in Participant-Led Research: Protocol for a Quantitative Study

User Perspectives of a Web-Based Data-Sharing Platform (Open Humans) on Ethical Oversight in Participant-Led Research: Protocol for a Quantitative Study

Personalized medicine—concepts, technologies, and applications in inflammatory skin diseases

Assessing Biopharmaceutical Company Experience with Patient-centric Initiatives

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