Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

2020 ◽  
Author(s):  
Brian Perry ◽  
Carrie Dombeck ◽  
Jaye Bea Smalley ◽  
Bennett Levitan ◽  
David Leventhal ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Product Development ◽  
Patient Group ◽  
Medical Product ◽  
Structured Interviews ◽  
Web Based ◽  
Research Activities ◽  
Development Lifecycle ◽  
Patient Groups ◽  
Group Engagement

Patient group engagement is increasingly used to inform the design, conduct, and dissemination of clinical trials and other medical research activities. However, the priorities of industry sponsors and patient groups differ, and there is currently no framework to help these groups identify mutually beneficial engagement activities. Methods: We conducted 28 qualitative, semi-structured interviews with representatives from research sponsor organizations (n=14) and patient groups (n=14) to determine: 1) how representatives define benefits and investments of patient group engagement in medical product development and, 2) to refine a list of 31 predefined patient group engagement activities. Results: Patient group and sponsor representatives described similar benefits: engagement activities can enhance the quality and efficiency of clinical trials by improving patient recruitment and retention, reduce costs, and help trials meet expectations of regulators and payers. All representatives indicated that investments include both dedicated staff time and expertise, and financial resources. Factors to consider when evaluating benefits and investments were also identified as were suggestions for clarifying the list of engagement activities. Discussion: Using these findings, we refined the 31 engagement activities to 24 unique activities across the medical product development lifecycle. We also developed a web-based prioritization tool (https://prioritizationtool.ctti-clinicaltrials.org/) to help clinical research sponsors and patient groups identify high priority engagement activities. Use of this tools can help sponsors and patient groups identify the engagement activities that they believe will provide the most benefit for the least investment and may lead to more meaningful and mutually beneficial partnerships in medical product development.

scholarly journals Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

2020 ◽  
Author(s):  
Brian Perry ◽  
Carrie Dombeck ◽  
Jaye Bea Smalley ◽  
Bennett Levitan ◽  
David Leventhal ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Product Development ◽  
Patient Group ◽  
Medical Product ◽  
Structured Interviews ◽  
Web Based ◽  
Research Activities ◽  
Development Lifecycle ◽  
Patient Groups ◽  
Group Engagement

Abstract Introduction Patient group engagement is increasingly used to inform the design, conduct, and dissemination of clinical trials and other medical research activities. However, the priorities of industry sponsors and patient groups differ, and there is currently no framework to help these groups identify mutually beneficial engagement activities. Methods We conducted 28 qualitative, semi-structured interviews with representatives from research sponsor organizations (n = 14) and patient groups (n = 14) to determine: (1) how representatives define benefits and investments of patient group engagement in medical product development, and (2) to refine a list of 31 predefined patient group engagement activities. Results Patient group and sponsor representatives described similar benefits: engagement activities can enhance the quality and efficiency of clinical trials by improving patient recruitment and retention, reduce costs, and help trials meet expectations of regulators and payers. All representatives indicated that investments include both dedicated staff time and expertise, and financial resources. Factors to consider when evaluating benefits and investments were also identified as were suggestions for clarifying the list of engagement activities. Discussion Using these findings, we refined the 31 engagement activities to 24 unique activities across the medical product development lifecycle. We also developed a web-based prioritization tool (https://prioritizationtool.ctti-clinicaltrials.org/) to help clinical research sponsors and patient groups identify high-priority engagement activities. Use of this tool can help sponsors and patient groups identify the engagement activities that they believe will provide the most benefit for the least investment and may lead to more meaningful and mutually beneficial partnerships in medical product development.

Evaluation of adolescents and young adults (AYA) attitudes towards participation in cancer clinical trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10047-10047 ◽  
Author(s):  
Abha A. Gupta ◽  
Jennifer A.H Bell ◽  
Kate Wang ◽  
Victoria Forcina ◽  
Seline Tam ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Logistic Regression ◽  
Peer Group ◽  
Randomized Study ◽  
Structured Interviews ◽  
Patient Centered ◽  
Logistic Regression Models ◽  
Age Related ◽  
Ordered Logistic Regression ◽  
Patient Groups

10047 Background: Participation in clinical trials (CT) for AYA ( < 39 years) remain the lowest of any patient group with cancer. Little is known about the personal barriers to AYA accrual. The aim of this study was to explore AYA attitudes that influence CT participation. Methods: A mixed methods approach included 1) qualitative: interpretive descriptive methodology guided individual semi-structured interviews with 21 AYA for factors influencing CT enrollment and 2) quantitative: AYA and non-AYA (≥40) matched for histology completed Cancer Treatment subscale of Attitudes toward Cancer Trials Scales (ACTS-CT) (Schuber, 2008) and 9 supplementary questions formed from interview analysis. Differences between AYA and non-AYA cohorts were analyzed using the Mann-Whitney U test and ordered logistic regression models were constructed for prediction of the effect of baseline demographics. Results: The major themes influencing CT participation were: (1) family/peer group opinion (2) CT impact on daily/future life (e.g. school; starting a family) and (3) illness severity/psychological readiness for CT information. Surveys were distributed to 61 AYA (median age: 29 years (17-39)); 74 non-AYA (55 (40-88)). Compared with non-AYA, AYA perceived CT to be unsafe/more difficult (Personal Barrier/Safety domain; p = 0.01). AYA were also more concerned with CT interference in their long term goals (p = 0.04). Logistic regression identified participants who had previously been offered a CT (p = 0.01) or who spoke English as their first language (80% of cohort)(p = 0.01) reported less barriers to CT. There were no differences based on age in other domains (Personal Benefits; Personal/Social Value; Trust in CT). In all participants, differences were seen in the Personal Benefits domain if respondents had children (p = 0.05) or were currently working (p = 0.04). Conclusions: Age-related differences in attitudes towards CT suggest that tailored approaches to CT accrual of different patient groups may be warranted. Patient-centered delivery of information regarding CT, particularly for those in whom English is a second language and who are trial-naïve, may improve accrual and warrants further prospective, randomized study.

Defining E-Novation in Action

2011 ◽  
pp. 58-74
Author(s):  
Ehsan Ehsani
Keyword(s):  
Product Development ◽  
Virtual Worlds ◽  
Participant Observation ◽  
Point Of View ◽  
Product Development Process ◽  
Successful Implementation ◽  
Structured Interviews ◽  
Organizational Models ◽  
Efficient Manner ◽  
Web Based

Managing product development in an efficient manner is considered a crucial element for a company’s survival in today’s world. Current markets usually consist of highly fragmented segments of customers looking for customized and differentiated products at lower costs. Intense competition has also pressured companies to launch the products faster to the market in order to reap the planned benefits. Usage of collaborative Web-enabled models for innovation and product development, what we refer to as E-Novation, has become more popular as a result of responding to the aforementioned challenges. From technological point of view, the E-Novation models are particularly enabled through collaborative Web solutions, Web 2.0 tools, and Web-based virtual worlds. This chapter deals with the application of such collaborative Internet-based technologies in the product development and discusses their use in various stages of product development process; from idea management to prototyping. Based on existing literature in the area, the analysis of four cases (Dell, InnoCentive, Ponoko, and Implenia), participant observation and experience with such applications and semi-structured interviews with both managers of such projects and the projects’ stakeholders, this chapter demonstrates that new organizational models and skills are required to manage interdependencies internally and externally in collaboration through E-Novation. It also provides some insights about the future trends and opportunities in this era and guidelines for successful implementation of these technologies in reality.

scholarly journals Developing a model of a patient-group pathway to accessing cancer clinical trials in Canada

2018 ◽  
Vol 25 (6) ◽  
Author(s):  
G. Batist ◽  
S. Michaud ◽  
D. P. Richards ◽  
F. Servidio-Italiano ◽  
B. D. Stein
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Patient Group ◽  
Working Group ◽  
Grey Literature ◽  
Central Element ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Scientific Advisory ◽  
Patient Groups

Background Colorectal Cancer Canada, in partnership with a Scientific Advisory Committee, is developing a Canadian Patient Group Pathway to Accessing Cancer Clinical Trials (“Pathway”). A central element of the Pathway is presented here—namely, a set of recommendations and tools aimed at each stakeholder group.Methods A summary of the peer-reviewed and grey literature informed discussions at a meeting, held in June 2017, in which a cross-section of stakeholders reached consensus on the potential roles of patient groups in the cancer clinical trials process, barriers to accessing cancer clinical trials, best practice models for patient-group integration, and a process for developing the Pathway. Canadian recommendations and tools were subsequently developed by a small working group and reviewed by the Scientific Advisory Committee.Results The major output of the consensus conference was agreement that the Clinical Trials Transformation Initiative (ctti) model, successfully applied in the United States, could be adapted to create a Canadian Pathway. Two main differences between the Canadian and American cancer clinical research environments were highlighted: the effects of global decision-making and systems of regulatory and funding approvals. The working group modified the ctti model to incorporate those aspects and to reflect Canadian stakeholder organizations and how they currently interact with patient groups.Conclusions Developing and implementing a Canadian Pathway that incorporates the concepts of multistakeholder collaboration and the inclusion of patient groups as equal partners is expected to generate significant benefits for all stakeholders. The next steps to bring forward a proposed Pathway will involve engaging the broader cancer research community. Clinical trial sponsors will be encouraged to adopt a Charter recognizing the importance of including patient groups, and to support the training of patient groups through an independent body to ensure quality research partners. Integration of patient groups into the process of developing “real world” evidence will be advanced by a further consensus meeting being organized by Colorectal Cancer Canada for 6–7 November 2018.

scholarly journals Patient and Patient Group Engagement in Cancer Clinical Trials: A Stakeholder Charter

2021 ◽  
Vol 28 (2) ◽  
pp. 1447-1458
Author(s):  
Stéphanie Michaud ◽  
Judy Needham ◽  
Stephen Sundquist ◽  
Dominique Johnson ◽  
Sabrina Hanna ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Group ◽  
Real World ◽  
Cancer Clinical Trials ◽  
Real World Data ◽  
Cancer Trial ◽  
Adoption And Implementation ◽  
Real World Evidence ◽  
High Standards ◽  
Group Engagement

Background—to guide the implementation of patient centricity and engagement in cancer clinical trials (CTs) and to operationalize the Canadianized version of the Clinical Trials Transformation Initiative (C-CTTI) model, the development of a charter was identified by cancer CT stakeholders. Methods—the Canadian Cancer Trial Stakeholder Charter (the Charter) was initiated by Colorectal Cancer Canada (CCC) and developed via the—1—formation of an inclusive working group (WG) that drafted the document using recommendations collected during the development of the C-CTTI model; 2—socialization of the draft Charter to solicit feedback from cancer CT stakeholders, including those who attended the 2019 CCC Conference; and 3—incorporation of stakeholders’ feedback and finalization of the Charter by the WG. Results—the Charter was built around five guiding principles—1—patient centricity; 2—commitment to education and training; 3—collaboration as equal and independent partners in research; 4—transparency and accountability; and 5—high standards in data collection integrity and honesty. These principles led to the Charter’s five tenets, which stipulate stakeholder commitments, aiming to make CTs accessible to all patients, improve the design and implementation of CTs to benefit patients, expand recruitment and retention of patients in CTs, and further advance cancer research and treatment. Conclusions—the Charter is intended to integrate the patient voice into the Canadian cancer CT continuum. The next phases of the C-CTTI model include the adoption and implementation of the Charter, the establishment of a patient group training program, and the development of real-world evidence/real-world data methodologies.

scholarly journals Patient engagement in clinical trials: The Clinical Trials Transformation Initiative’s leadership from theory to practical implementation

2018 ◽  
Vol 15 (1_suppl) ◽  
pp. 19-22 ◽  
Author(s):  
Bray Patrick-Lake
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Group ◽  
Patient Engagement ◽  
Crucial Role ◽  
Project Work ◽  
Practical Implementation ◽  
The Past ◽  
Patient Groups ◽  
Group Involvement

Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative’s role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

scholarly journals Development of an international template to support patient submissions in Health Technology Assessments

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Nigel Cook ◽  
Heidi Livingstone ◽  
Jennifer Dickson ◽  
Louise Taylor ◽  
Kate Morgan ◽  
...  
Keyword(s):  
Patient Group ◽  
Health Technology ◽  
Plain Language ◽  
Group Discussions ◽  
Web Based ◽  
Semistructured Interviews ◽  
Patient Groups ◽  
Group Interviews ◽  
Additional Support ◽  
Deliberative Processes

Abstract Objectives To develop an international template to support patient submissions in Health Technology Assessments (HTAs). This was to be based on the experience and feedback from the implementation and use of the Scottish Medicines Consortium's (SMC) Summary Information for Patient Groups (SIP). Methods To gather feedback on the SMC experience, web-based surveys were conducted with pharmaceutical companies and patient groups familiar with the SMC SIP. Semistructured interviews with representatives from HTA bodies were undertaken, along with patient group discussions with those less familiar with the SIP, to explore issues around the approach. These qualitative data informed the development of an international SIP template. Results Survey data indicated that 82 percent (18 of 22 respondents) of pharmaceutical company representatives felt that the SIP was worthwhile; 88 percent (15/17) of patient group respondents found the SIP helpful. Both groups highlighted the need for additional support and guidance around plain language summaries. Further suggestions included provision of a glossary of terms and cost-effectiveness information. Patient group interviews supported the survey findings and led to the development of a new template. HTA bodies raised potential challenges around buy-in, timing, and bias connected to the SIP approach. Conclusions The international SIP template is another approach to support deliberative processes in HTA. Although challenges remain around writing summaries for lay audiences, along with feasibility considerations for HTA bodies, the SIP approach should support more meaningful patient involvement in HTAs.

A design contribution to the entrepreneurial experience

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Juan David ROLDAN ACEVEDO ◽  
Ida TELALBASIC
Keyword(s):  
Product Development ◽  
Qualitative Analysis ◽  
Design Research ◽  
Recent Literature ◽  
Early Stage ◽  
Entrepreneurial Activity ◽  
Value Proposition ◽  
Structured Interviews ◽  
User Centric ◽  
Constant Growth

In recent history, different design approaches have been entering fields like management and strategy to improve product development and service delivery. Specifically, entrepreneurship has adopted a user-centric mindset in methodologies like the business canvas model and the value proposition canvas which increases the awareness of the users’ needs when developing solutions. What happens when a service design approach is used to understand the entrepreneurs’ experience through the creation of their startups? Recent literature suggests that entrepreneurial activity and success is conditioned by their local entrepreneurship ecosystem. This study investigates the Entrepreneurship Ecosystem of Medellín, Colombia - an ecosystem in constant growth but that lacks qualitative analysis. The sample consists of 12 entrepreneurs in early-stage phase. The data was gathered with two design research methods: Cultural Probes and Semi-structured interviews. The analysis of the information collected facilitated the development of 4 insights about the entrepreneurs and an experience map to visualise and interpret their journey to create a startup. The results of this study reflected the implications of the ecosystem, the explanation of the users’ perceptions and awareness and propose a set of ideas to the local government to improve the experience of undertaking a startup in Medellín.

scholarly journals Birds of a Feather Flock Together: Disadvantageous Decision Making in Augmented Restless Legs Syndrome Patients with and without Impulse Control Disorders

2021 ◽  
Vol 11 (3) ◽  
pp. 383
Author(s):  
Beatrice Heim ◽  
Philipp Ellmerer ◽  
Ambra Stefani ◽  
Anna Heidbreder ◽  
Elisabeth Brandauer ◽  
...  
Keyword(s):  
Decision Making ◽  
Restless Legs Syndrome ◽  
Impulse Control ◽  
Compulsive Sexual Behavior ◽  
Structured Interviews ◽  
Restless Legs ◽  
Information Sampling ◽  
Patient Groups ◽  
Post Hoc ◽  
Beads Task

Background: Augmentation (AUG) in patients with restless legs syndrome (RLS) can be associated with impulse control disorder (ICD) symptoms, such as compulsive sexual behavior, gambling disorder or compulsive shopping. In this study, we wanted to assess whether RLS patients with AUG differ in decision making from those patients who have augmentation and in addition ICD symptoms (AUG + ICD) in a post hoc analysis of a patient cohort assessed in a previous study. Methods: In total, 40 RLS patients with augmentation (19 AUG + ICD, 21 AUG without ICDs) were included. RLS diagnosis, severity, and diagnosis of augmentation were made by sleep disorder specialists. ICD symptoms were assessed using semi-structured interviews. All patients performed the beads task, which is an information sampling task where participants must decide from which of the two cups colored beads were drawn. Results were compared to 21 healthy controls (HC). Results: There was no difference in information sampling or irrational decision making between AUG and AUG + ICD patients (p = 0.67 and p = 1.00, respectively). Both patient groups drew less beads and made more irrational decisions than HC (all p-values < 0.03, respectively). Conclusions: Our results suggest that augmentation itself is associated with poorer decision making even in the absence of ICD symptoms. Further studies are necessary to explore whether rapid and hasty decision making are a harbinger of augmentation in RLS.

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