Please create a high-level masters level PowerPoint (14 slides) with speaker notes on each slide for the following 2 questions
Please comment on the following questions:
1. How would you go about determining the stakeholders for a study, and what are the most important steps to take to involve stakeholders?
2. What would be some challenges and opportunities to involving communities impacted by clinical research as stakeholders in clinical research?
**Please utilize the following YouTube videos as well as the Attached PDFs, which is requirement of the paper – feel free to utilize other resources if needed but these videos and pdf are part of the requirement**
https://www.youtube.com/watch?v=r6Gpv0oqxEk
https://www.youtube.com/watch?v=RS4djBoGSRA
PowerPoint Presentation Study Protocol and Feasibility Assessment Beth Loots, MPH MSW "Initiating and sponsoring a clinical trial to generate safety and efficacy data for a drug, diagnostic test, device or therapy protocol is an all-consuming team project." Chi, Kelly Rae. "Conducting a Trial." Careers. January 24, 2013. Contents Collaborations and study exploration Stakeholders Protocol components Study purpose and fit Protocol review Feasibility Collaborations and study exploration Generating scientific ideas Clinical trials space Competition to become a site higher Protocols more complex, more procedures More trial sites (to offset low recruitment at sites) More studies decentralized Traditional brick and mortar sites may find it harder to break in https://www.ibisworld.com/united-states/market-research-rep and orts/clinical-trial-support-services-industry/https://www.antidote.me/blog/15-clinical-trial-patient-recruitment-companies and https://acrpnet.org/2020/01/14/leave-no-site-behind-how-sites-sponsors-and-cros-can-speed-clinical-research-together/ Clinical trials space Many companies in clinical trials support market CROs form strategic alliances with biopharma companies, data analytics companies 70% of clinical trials use a CRO – expected to reach $55 billion market in 2025 https://www.ibisworld.com/united-states/market-research-rep and orts/clinical-trial-support-services-industry/https://www.antidote.me/blog/15-clinical-trial-patient-recruitment-companies and https://acrpnet.org/2020/01/14/leave-no-site-behind-how-sites-sponsors-and-cros-can-speed-clinical-research-together/ Clinical trials support industry Preclinical trial preparations Site selection services Recruitment planning Budgeting Study activities Patient engagement, recruitment Pharmacovigilance Patient reimbursement platforms Tracking and recording results Monitoring Data management Biostatistics Preparing data for regulatory submissions and data storage https://www.ibisworld.com/united-states/market-research-reports/clinical-trial-support-services-industry/ Study sites within this landscape Sites may face significant hurdles in meeting new era of drug innovation More than half of new investigators do not do a second trial What do investigators want from sponsors and CROs? Improved communication and collaboration Understanding of resource limitations at the site Streamline the exchange of information – too many places (email, portals, file sharing sites, etc.) Lots of people/lots of redundant steps – simplify Shared focus on improving lives of patients https://acrpnet.org/2020/01/14/leave-no-site-behind-how-sites-sponsors-and-cros-can-speed-clinical-research-together/ Industry and academia – tensions and opportunities Most scientific advances now are coming through sponsored trials, and Ethical and practical questions around: How much influence should sponsors have over design, conduct, and reporting of trials? When is sponsor involvement helpful or heavy-handed? How to avoid conflict of interest if sponsor is overinvolved in clinical trial and yet will profit from drug development? https://www.tctmd.com/news/price-knowledge-industry-sponsored-studies-era-evidence-based-medicine Development of research ideas Often done in collaboration with others in the field May be a pharma collaboration or a standalone application response to RFA May involve local investigators Important to bring parties on board so they get engaged in the project Can be lengthy planning out entire project beforehand for months/years or quick application put together over weeks May be preparing for a collaborative NIH grant funding opportunity, a pharmaceutical company sponsoring clinical trials, or other funding opportunity 9 Team Science Teams can produce better work and take on more ambitious projects than one person alone Promotes learning opportunities for members Team Science Success Factors Trust, common ground, compatible styles Mix of members by skills, disciplines, etc. Clearly defined goals and roles Clear assignments Regular and open discussion Productive communication valuing differences of opinions Effective leader Adequate support resources Schneiderman, B. April 6, 2016. How to do team research. Inside Higher Ed. https://www.insidehighered.com/advice/2016/04/06/advantages-doing-research-teams-essay Stakeholders Stakeholder engagement/management Essential for effective research studies – both ethically and practically Feedback alerts PM to social, environmental, ethical implications of research activities Patients and families are strongly motivated to contribute to planning and implementation Moving more towards engagement with more involvement of stakeholders in decision-making https://www.frontiersin.org/articles/10.3389/fpsyt.2015.00071/full Stakeholder analysis Identify, prioritize, and understand stakeholders Gather qualitative and quantitative data to see who is most impacted/can impact project most "What is a stakeholder analysis?" (4:01). ProductPlan. January 13, 2020. https://www.youtube.com/watch?v=PXCo92Iag3g Identify stakeholders Brainstorm with your team to identify Which groups or people might be affected by your study's activities and/or contribute to them? Anyone potentially impacted by research activities may be a stakeholder Patients have right to be involved in decisions impacting their health care Stakeholders might include Other investigators Sponsors Community organizations Clinical partners Family advisory boards Other stakeholders Patients and families Institutional officials 16 Prioritize stakeholders Who is interested Who has influence To what extent will they be involved – who will contribute time/energy/resources Can use a 'power-interest grid' "What is a stakeholder analysis?" (4:01). ProductPlan. January 13, 2020. https://www.youtube.com/watch?v=PXCo92Iag3g Power interest grid https://www.theprojectmanagementblueprint.com/blog/stakeholder-management/stakeholder-power-interest-grid and https://www2.deloitte.com/mt/en/pages/risk/articles/mt-risk-article-power-and-interest-grids.html Understand stakeholders Figure out how to communicate with each stakeholder What motivates them? How does this study align or compete with their priorities? What can we do to change their negative view of the project? Know that stakeholder concerns can change over the life of the project "What is a stakeholder analysis?" (4:01). ProductPlan. January 13, 2020. https://www.youtube.com/watch?v=PXCo92Iag3g Involving stakeholders "One of your most challenging planning tasks is to meld stakeholders' various expectations into a coherent and manageable set of goals. The project's success will be measured by how well you meet those goals. The more explicitly you state them at the outset, the less disagreement you will face later about whether you have met expectations." HBR Editors. The Four Phases of Project Management. November 3, 2016. Getting stakeholders on your side Stakeholders are the project owners You want them on your side cheering for you, giving you support, resources, etc. Credibility, trust, and results Build and nurture relationships with stakeholders Like you – know you – trust you – invest you https://www.youtube.com/watch?v=RS4djBoGSRA Essential skills and behaviors for stakeholder engagement Communication – identify, plan, and follow methods Interpersonal skills – build trust and resolve conflict Management skills – presentation skills, writing skills, negotiation, organization Maintain documents of discussions and inputs from stakeholders Act on ideas and follow up https://www.frontiersin.org/articles/10.3389/fpsyt.2015.00071/full Stakeholder action items Important to get everyone on the same page so have common goals, each person knows what is expected of them Might look like a stakeholder focus group or other mechanism to gather input and address concerns as they arise in the course of the research study Develop a management/communication plan with details on how, when, where Consider a "stakeholder directory" Protocol components Structure and key elements Designing a protocol Investigators or sponsors should start with what they hope to measure at the end of the study, and work backwards Procedures and study activities should capture data that will be needed for analysis (versus a 'fishing expedition' This will help fine tune the questions asked, measurements made, surveys done Equity and protocols Sponsors can use an equity lens when determining patient populations Sponsors can focus on disease areas that impact diverse populations Providers can be more proactive about involving diverse communities in clinical trials Patients can advocate for clinical trials for themselves and diverse communities Opportunities for remote trials to increase diversity Conduct trials in inclusive and equitable manner "Breaking down barriers to clinical trial diversity - health equity summit" (8:07). Amgen. June 29, 2021. https://www.youtube.com/watch?v=QSI9576c7ag What's in a protocol Background/rationale - why is this study being done Study organization – structure of study, what parties do what, funding Objective/endpoints (or aims) Study design Study population Study treatment plan Safety monitoring Statistical plan Liu, M. & David, K. (2010) A Clinical Trials Manual from the Duke Clinical Research Institute. New Jersey: Wiley Blackwell. pp. 199 -212. Background/rationale Description of disease or disorder Limitation of current treatments Extent of the problem the protocol will address Scientific evidence for the proposed study Study organization Which groups or organizations are involved Roles and responsibilities Funders Study management structure Objectives or endpoints Used to measure/quantify the effect of the study drug/treatment Primary endpoint most important questions to be answered by the trial safe, effective, or both Secondary endpoint additional items of interest Single or composite – single ex. "death"; composite example "all-cause death or stroke" May measure outcomes and/or quality of life, socioeconomic, or other type based on study Liu, M. & David, K. (2010) A Clinical Trials Manual from the Duke Clinical Research Institute. New Jersey: Wiley Blackwell. Study design Intervention or observational Prospective, retrospective, or cross-sectional Screening and enrollment parameters for intervention studies Are control (placebo) groups used Is it blinded Is it randomized Eligibility criteria for observational studies Who is considered in the cohort Treatment period elements and timing Follow up activities LIU M. & DAVIS K. A CLINICAL TRIALS MANUAL FROM THE DUKE CLINICAL RESEARCH INSTITUTE. 2010. NEW JERSEY: WILEY-BLACKWELL. Study population Should be identified using Belmont Report principles of justice Fair subject selection Enroll adults before children; non-vulnerable before vulnerable May require inclusion of women, children, and minorities – to ensure equitable representation Subject population is among potential population of people who will benefit from research How many subjects will enroll over what time period Can they participate in other studies at same time Liu, M. & David, K. (2010) A Clinical Trials Manual from the Duke Clinical Research Institute. New Jersey: Wiley Blackwell. Study treatment plan (schedule of events) Study drug administration Schedule of assessments and procedures Labs Exams Other tests Timepoints/windows LIU M. & DAVIS K. A CLINICAL TRIALS MANUAL FROM THE DUKE CLINICAL RESEARCH INSTITUTE. 2010. NEW JERSEY: WILEY-BLACKWELL. Safety monitoring Plan for how safety issues would be handled How study will handle participants who are withdrawn or lost to follow up LIU M. & DAVIS K. A CLINICAL TRIALS MANUAL FROM THE DUKE CLINICAL RESEARCH INSTITUTE. 2010. NEW JERSEY: WILEY-BLACKWELL. Statistical plan Sample size needed to power the trial Analyses that will be done Study purpose and fit Assess the proposed study in relation to PI and organizational goals Fit with interest and expertise of PI Do the goals and scope fit within the expertise and interests of the potential PI? Must be the case per the regs Sponsor must demonstrate this to move forward Even if PI-initiated, PI expertise is key to obtaining funding Being a PI of any study is a huge time and resource commitment; important to not sign up without a firm commitment, and most importantly, time to do this work Does the study offer improved treatment or information that may help the patient population of the PI? PIs often motivated to advance the field for their patients 37 Barriers to clinician participation Time Doctor-patient relationship Concerns for patients Lack of reward and recognition Disinterest in research question Prescott RJ, Counsell CR, Gillespie WJ, Grant AM, Russell IT, Kiauka S, Colthart IR, Ross S, Shepherd SM, Russell D: Factors that limit the quality, number and progress of randomised controlled tirlas. Health Technol Assess. 1999, 3(20; 1 - 143. Fit with mission Not only should the study fit with the PI's interest, it should fit with the interests and priorities of the PI's department, organization, community. What are the costs of choosing this particular protocol over another one? Many opportunities, choose carefully. Particularly true in academic settings where PIs already have significant clinical responsibilities PI may be proactive in seeking out protocols that fit with organizational priorities Over time PIs often become experts in a certain areas of research, and seek out or respond to more funding opportunities to continue to answer those scientific questions Fit with divisional or organizational priorities Does the study fit within the organizational or division priorities? Connection to mission – should drive study selection What are the goals and objectives of the study, and