Please create a high-level masters level PowerPoint (14 slides) with speaker notes on each slide for the following 2 questions
1. Who do you think bears responsibility for the conduct of clinical research?
2. What steps if any would you take as a Clinical Research Manager should you observe or suspect misconduct on the part of a principal investigator? What would be the potential ramifications of those actions or inactions?
**Please utilize the following YouTube videos as well as the Attached PDF, which is requirement of the paper – feel free to utilize other resources if needed but these videos and pdf are part of the requirement**
(Project management and leadership for Clinical Research)
https://www.youtube.com/watch?v=rZB7E8cZSKM&t=3s
(Project management factors)
https://www.youtube.com/watch?v=M5aADEEkLIk&t=1s
(Clinical trial challenges & success factors)
https://www.youtube.com/watch?v=u7G9lHWRqvs
PowerPoint Presentation Project Management and Leadership for Clinical Research Beth Loots, MPH MSW Contents Clinical Research Organization (CRO) Principal Investigator variables Project Management factors Clinical Research Team Clinical trial challenges and success factors Key leadership behaviors Clinical Research Organization (CRO) And Site Management Organizations (SMoS) CROs – and CRAs Companies that run parts or all of clinical trials under contract to pharma companies (Sponsors) Pharmaceutical companies focus on developing molecules and drugs CROs specialize in running clinical trials and monitoring study sites Clinical Research Associates CRAs are individuals with experience running and monitoring clinical trials CRAs provide guidance and oversight to the site to ensure high quality data and safety reporting CRA should maintain a respectful, collaborative, positive attitude with study sites Emotional intelligence and respect for site staff are key https://www.youtube.com/watch?v=UZeWR9ed2qk Principal Investigator variables OVERSIGHT AND TIME PI responsibilities Ensure the study is done per protocol and signed investigator statement Protect the rights, safety, and welfare of study participants Control the study drug Medically qualified and trained to conduct the trial Maintain list of people to whom duties have been delegated Allow monitoring of study Responsible for medical care of study participants Norris, D. (2019). Clinical Research Coordinator Handbook. 5th Edition. New Jersey: Deborah Norris. and https://www.youtube.com/watch?v=U-kwHG36Y_k Trial success is related to PI factors Clinician interest in evidence based practice Participation in an academic group Comfort explaining the study Interested patients Hire staff focused on study recruitment Farrell B, Kenyon S, on behalf of the UK Trial Managers' Network: A Guide to Efficient Trial Management. https://cdn.ymaws.com/www.tmn.ac.uk/resource/resmgr/tmn_guide/uktmng2.web.pdf PI pitfalls Inadequate oversight Ensuring participants understand study risks Compliance with GCP Only enrolling eligible participants Adequately reporting adverse events (AEs) Following the protocol (may need to change clinical care offered) Training staff TIME Liu M. & Davis K. A clinical trials manual from the duke clinical research institute. 2010. New Jersey: Wiley-Blackwell. Effective PIs Stay engaged and informed on trial progress Extensive knowledge of the clinical field being studied Good communication skills with staff and patients Familiarity with GCP and regulatory requirements Collaborative open communication with CRCs, PMs High integrity Give praise to team and collaborators Liu M. & Davis K. A clinical trials manual from the duke clinical research institute. 2010. New Jersey: Wiley-Blackwell. Conflict of Interest (COI) management PI may have COI if receive funding from pharma companies Speaking, travel funds, grants, stocks, professional opportunities, etc. Key is to disclose on a regular basis May have a committee review to manage the COI Sometimes another investigator will consent instead of PI May need systems to objectively enroll participants in trials Delegation of Authority PIs can and do regularly delegate study tasks to others Activities delegated must be appropriate to role Need to disclose on DOA log PI still retains responsibility Some things cannot be delegated like signing the 1572 Project Management factors LEADERSHIP AND COMMUNICATION CRM/PM Delegated to manage day to day operations at site Supervise team members PM swimming pool Usually you join an existing team with studies and projects at different midstream points Projects may be a mix of clinical trials, registries, observational, or other Often underfunded and understaffed, may have staffing issues May or may not have good PI oversight of studies The institutional environment may not be ideal – under-resourced, other priorities, process issues, communication problems, community reputation, etc. Your primary objectives within this controlled chaos are successful planning, startup, implementation, maintenance, and closeout of clinical research studies PM key skills and behaviors PM top skills 70% communication and 30% research knowledge and technical skills Very important to know how to manage and motivate people and teams PM is usually the hub for team direction, prioritization, facilitating and following up The best laid plans...usually don't work, and you have to be ready to readjust Windstorm...righting a ship...putting out fires...choose your metaphor Goal is to establish systems and processes for more proactive and effective work There are methods and skills you can use to do this PMs and trial success Some estimates that 50% of planned trials fail to reach 80% of planned sample size (as an indicator of relative success) In a comprehensive study of clinical trials, those with a dedicated project manager were much more likely to successfully recruit participants Successful trials had a trial manager who developed a work plan or work scope and a timeline Project management reduced waste and improved trial implementation Leadership, negotiation, and communication skills result in improved project deliverables, patient recruitment, and regulatory compliance. Farrell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, 78 (2010). htttps://doi.org/10.1186/1745-6215-11-78; Goodarzynejad H. & Babamahmoodi A. Project management of randomized clinical trials: A narrative review. Iran Red Crescent Med. J. 2015 Aug: 17(8): e11602 Clinical research team ROLES and responsibilities Many studies have a group of experts from multiple sites who oversee the trial(s) or study Contribute to protocol design Review participant enrollment Discuss participant progress and any safety issues Scientific discussion of the study drug, vector, etc. being used or studied Discuss and direct study activities May meet approximately monthly Important for PM and key CRCs to attend along with PI Sponsor, Coordinating Center, NIH or other funders may attend Steering Committee Co-Investigators PI may delegate some responsibilities to other physicians at local level May serve as backup to the PI May be involved in certain aspects such as study manuscripts, recruitment, or study procedures Shares responsibility with the PI for the study Clinical Research Coordinator (CRC) Backbone of clinical research Usually does most of the work of the studies Important to stay within scope – non-clinical, don't do what PI should do Medical background or clinical trials experience helpful Often learn things on the job Time intensive processes for documentation, screening and enrollment, study activities Good CRCs are able to communicate about their work while working somewhat independently Great attention to detail and organization are a must Clinical Research Nurse Another option for coordinating study activities Advantage is can take on clinical work that otherwise might need to pay outside entity for Medical monitoring, medication management, study visits, patient education More costly than CRC Clinical Research Assistant Entry level position at the study site Cheaper than CRC Assists the CRCs/CRNs/PM Data Manager Nice to have if needed and can afford Specializes in coordination, data entry, queries etc. of data May assist with pulling records for recruitment Statistical analysis for study manuscripts Management of patient files and source documents Regulatory Coordinator Often this tasks is done by the CRC but nice to have if can afford Focuses on IRB and other regulatory requirements and upkeep Clinical Research Associate (CRA) Unlike the other roles, this person is sited at the CRO or study Sponsor Liaises with the site PI and site study staff Involved in various activities such as: Site selection and initiation Routing monitoring Source data verification Reviewing critical documents Developing consent forms Investigator site files Site training Clinical trial challenges and success factors Opportunities for continuous improvement Common challenges Failure to show efficacy Failure to show safety Out of control costs Eligibility criteria too strict or loose Recruitment and enrollment problems Failure to show efficacy or safety May be due to flawed study design such as underpowered trial Lack of enough enrollment/drop out can lead to not enough power Not catching safety issues early on (patients don't report or study team misses) Fogel, D. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018 Sep; 11: 156-164. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/ Burgeoning cost problems Study interventions may be expensive to run – unforeseen or incorrectly budgeted Large number of screen failures can eat up budget Financial issues may impact ability to enroll participants Fogel, D. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018 Sep; 11: 156-164. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/ Eligibility criteria problems If too strict, they may exclude study population that is sicker or want more clinically stable This could result in discrepancy between study population and the population that would benefit from the drug Too narrow and could be hard to find participants Fogel, D. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018 Sep; 11: 156-164. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/ Recruitment problems A chronic issue in clinical trials – study sites enroll fewer than projected Takes a lot more resources to effectively recruit than predicted, and need creative ways to do it Inconclusive evidence that increasing payment to participants increases enrollment Patients may be concerned that study is not offering them good treatment May be costly or time consuming for patients ICF written too complexly so patients don't understand Fogel, D. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018 Sep; 11: 156-164. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/ Factors to improve recruitment Healthcare providers support for study can lead to patient buy-in Consider incentivizing staff for enrollment Spend funds on recruitment and have a plan/system Quick turnaround from IRB approval to first enrollment Dedicated study coordinator History of high enrollment at the site Investigator enthusiasm Reimburse study participants for time and travel Make scheduling and completing the visit easy and efficient for the participant (can do remote?) Close and accessible geographic location to eligible participants Fogel, D. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018 Sep; 11: 156-164. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/ What factors are related to success? Quality and engagement of PI, PM, and study team Effective organizational infrastructure Project planning including mapping out timelines, resources, deliverables Access to study population ... Successful trials have... Interesting and meaningful research question Easy to understand protocol and straightforward data collection Low demand on participants Carefully planned recruitment strategies Farrell B, Kenyon S, on behalf of the UK Trial Managers' Network: A Guide to Efficient Trial Management. https://cdn.ymaws.com/www.tmn.ac.uk/resource/resmgr/tmn_guide/uktmng2.web.pdf Key leadership behaviors Communication, Collaboration, organization, and accountability Thought exercise How do you approach any new thing? What is your learning style? How do you lead? What should PM leadership of a research study look like? Clinical research leadership starting points Often you have to explicitly discuss the study, its priorities, timelines, etc., especially when different groups involved in the work have different priorities. Your goal is to develop a project team on same page/same priorities. Team building, scope, and planning start early. Do you understand who you are working with, what challenges they face in their day to day, and how this work fits in with everything else? Take the time to understand strengths and challenges. Does your organization value, promote, and support clinical research? This can be a key factor in success. Communication Leadership must model this, and expect it of everyone We can’t work as a team without it Importance of SDI or other system