Gwen Anderson, RN, Ph.D.
Associate Professor &
Associate Director for Nursing
Research
San Diego State University
&
Adjunc...
The United States conducts the largest percentage
(66 %) with 708 ever funded protocols since 1989.
 UK conducts 11 % (12...
Ethical Concerns Raised by
Gene Therapy Clinical Research
 Cline 1980
University of Los Angeles two patients suffering fr...
Are Nurses Moral Voice Absent or Merely Silent in
Gene Therapy Clinical Research?
Looking into Gene Therapy Clinical PracticesLooking into Gene Therapy Clinical Practices
Institutional
Ethnography Communi...
Pilot Study I
Making the Role of Study Coordinators Visible in
Gene Therapy Clinical Trails
Pilot Study II
Understanding C...
 A web-based survey November 2004
 List of Study Coordinators from OBA, websites,
American Society of Gene Therapy, nati...
Descriptive Analysis
 Types of Clinical Settings
 Characteristics of the Sample of Study
Coordinators
 Years of Clinica...
Certification
22 % hold no certification
25.5 % (14) hold certification in clinical research
18.2 % (10) hold certificatio...
 25.90 % (14) mentoring by the Principal Investigator
 18.2 % (10) self-taught by independent reading
 12.2 % (7) self-...
What are the 5 Top Priority Clinical Skills?
 Protecting Human Subjects and the Research Protocol
 Organizational skills...
 60 % (33) had no formal training about ethics or research integrity
 36.4 % (20) had taken an ethics course in a univer...
Confidence with being prepared to deal with Clinical
Situations Involving Ethics and Research Integrity?
“ It is the weeke...
Understanding Challenges in Gene Therapy Clinical
Trials: Listening to Nurse Study Coordinators
The purpose of this Phenom...
Understanding Challenges in Gene Therapy Clinical
Trials: Listening to Nurse Study Coordinators
A non probability sample o...
Understanding Challenges in Gene Therapy Clinical
Trials: Listening to Nurse Study Coordinators
“ We will get our internal...
Organizational Chart of Components of Gene Therapy Clinical Trials
Industry Sponsor
Pharmaceutical Company
University
Comm...
Are some research partnerships more at risk than others?
The PI, or a study coordinator and the research team write a
rese...
Organizational Chart of Components of Gene Therapy Clinical Trials
Industry Sponsor
Pharmaceutical Company
University
Comm...
Understanding Challenges in Gene Therapy Clinical
Trials: Listening to Nurse Study Coordinators
Ethical Challenges
 “Why ...
Understanding Challenges in Gene Therapy Clinical
Trials: Listening to Nurse Study Coordinators
Research Integrity Issues
...
Understanding Challenges in Gene Therapy Clinical
Trials: Listening to Nurse Study Coordinators
Research Integrity Issues
...
Understanding Challenges in Gene Therapy Clinical
Trials: Listening to Nurse Study Coordinators
“I just think… are we at t...
Nurse’s Moral Voice in Gene Therapy Research Clinical Research
Moral Agents
•Moral sensitivity to self morality
and ethics...
Biomedical Ethical Principles
Informed
Consent
IRB, FDA,
RAC
Regulations
Narrative Ethics: Descriptive Ethics
Expressive C...
ARE THERE BEST AND WORST PRACTICES IN GENE
THERAPY RESEARCH?
 Would we recognize them if we saw them?
 Do they look any ...
Gwen Anderson, RN, Ph.D.
Associate Professor &
Associate Director for Nursing
Research
San Diego State University
&
Adjunc...
ethics.ucsd.edu
ethics.ucsd.edu
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ethics.ucsd.edu

  1. 1. Gwen Anderson, RN, Ph.D. Associate Professor & Associate Director for Nursing Research San Diego State University & Adjunct Assistant Professor University of California, San Francisco ganderso@mail.sdsu.edu (619) 473-0185 BEST AND WORST PRACTICES IN GENE THERAPY RESEARCH
  2. 2. The United States conducts the largest percentage (66 %) with 708 ever funded protocols since 1989.  UK conducts 11 % (123)  Germany 6.6 % (71)  Switzerland 3.6 % (39)  France 21.7 % (18)  Australia 1.4 % (15)  Canada 1.1 % (12) This website currently lists 65 active ongoing trials in the US. ( http://www.wiley.co.uk/genetherapy/clinical/ July 2005) Gene Therapy Clinical Trials Worldwide
  3. 3. Ethical Concerns Raised by Gene Therapy Clinical Research  Cline 1980 University of Los Angeles two patients suffering from B Thalessemia treated in Israel and Italy:  Wilson 1999 Jesse Gelsinger treated for ornithine transcarbamylase (OTC) deficiency  Fishcher 2002 10 children in France treated for X-SCID
  4. 4. Are Nurses Moral Voice Absent or Merely Silent in Gene Therapy Clinical Research?
  5. 5. Looking into Gene Therapy Clinical PracticesLooking into Gene Therapy Clinical Practices Institutional Ethnography Communication Patterns & Clinical Decision Making within the Cultural Complex of Gene Therapy Clinical Research Pilot Study I Pilot Study II Types of Cultural Milieus Types of Practices that promote or compromise Research Integrity Policy Recommendations Redress IRB Protocol s & Policies Redress Institutional & Research Ethics Policy Design Educational Programs for Study Personnel Survey: Characteristics of Study Coordinates Main Study OutcomesInterviewing Nurse Study Coordinators: Clinical Challenges
  6. 6. Pilot Study I Making the Role of Study Coordinators Visible in Gene Therapy Clinical Trails Pilot Study II Understanding Challenges in Gene Therapy Clinical Trails: Listening to Nurse Study Coordinators
  7. 7.  A web-based survey November 2004  List of Study Coordinators from OBA, websites, American Society of Gene Therapy, national associations for hereditary diseases, biotechnology companies  Convenience national sample of 136  55 coordinators responded  40 % response rate Making the Role of Study Coordinators Visible in Gene Therapy Clinical Trails
  8. 8. Descriptive Analysis  Types of Clinical Settings  Characteristics of the Sample of Study Coordinators  Years of Clinical Research Experience and Type of Specialty  Role Title and Characteristics  Orientation and Training to be a Study Coordinator Role in Gene Therapy  Interest in Continuing Education  Confidence with being prepared to deal with Clinical Situations Involving Ethics and Research Integrity Making the Role of Study Coordinators Visible in Gene Therapy Clinical Trails
  9. 9. Certification 22 % hold no certification 25.5 % (14) hold certification in clinical research 18.2 % (10) hold certification in a nursing specialties: pediatric nurse practitioner, adult nurse practitioner, oncology, CNS Nurse Study Coordinators 35/55 were nurses = 71% 31% master’s degree 34 % BSN prepared 35 % diploma in nursing Experience as a Clinical trials Coordinator 12.7 % (7) had less than 2 years 70.9 % (39) had 2 to 14 years 16.4 % had 15 to 25 years of experience. Making the Role of Study Coordinators Visible in Gene Therapy Clinical Trails
  10. 10.  25.90 % (14) mentoring by the Principal Investigator  18.2 % (10) self-taught by independent reading  12.2 % (7) self-seeking of mentorship from other study coordinators  12.2 % (7) on the job training by other research staff Making the Role of Study Coordinators Visible in Gene Therapy Clinical Trails What is the primary way study coordinators are oriented to their role?
  11. 11. What are the 5 Top Priority Clinical Skills?  Protecting Human Subjects and the Research Protocol  Organizational skills  Communication skills  Recruitment  Ability to identify ethical issues Making the Role of Study Coordinators Visible in Gene Therapy Clinical Trails
  12. 12.  60 % (33) had no formal training about ethics or research integrity  36.4 % (20) had taken an ethics course in a university based clinical research certificate program  9.1% (5) had taken a university graduate course that had some research ethics  54 % (30) had attended an ethics or research integrity oriented conference  32.7 % (18) had taken a university-based or NIH-based online course on research integrity Making the Role of Study Coordinators Visible in Gene Therapy Clinical Trails
  13. 13. Confidence with being prepared to deal with Clinical Situations Involving Ethics and Research Integrity? “ It is the weekend and you are the on-call research team leader for a group of PIs involving more than one gene therapy research protocol. A staff nurse is requesting that you come to the unit to respond to questions asked by the patient and family member about the science behind a brand new research protocol.” They are prepared, but are they Qualified? Do they have the knowledge they need? Making the Role of Study Coordinators Visible in Gene Therapy Clinical Trails
  14. 14. Understanding Challenges in Gene Therapy Clinical Trials: Listening to Nurse Study Coordinators The purpose of this Phenomenology study is to understand the lived experience of the nurse in the role of study coordinator including:  recruiting patients into a study  coordinating a calendar of events unique to each patient and each protocol, and  negotiating relationships and responsibilities with a wide variety of health care providers to do necessary tests and collect research data  ethical issues
  15. 15. Understanding Challenges in Gene Therapy Clinical Trials: Listening to Nurse Study Coordinators A non probability sample of 10 nurses from diverse settings and geographic locations in the US were randomly selected from a list of study coordinators obtained from the Office of Biotechnology at NIH after obtaining informed consent from the IRB at San Diego State University Data Collection  Private Voice Recorded interviews (90-120 minutes)  Transcribed verbatim and cleaned of identifiers
  16. 16. Understanding Challenges in Gene Therapy Clinical Trials: Listening to Nurse Study Coordinators “ We will get our internal paperwork started to go before our IRB and our IBC. Once that is in the process, then we have to identify which unit in the hospital that would be involved, so that we can do the IBC-required documentation of training for that unit. We also get our infectious disease folks involved with this, so that they always know what’s going on, in case there is any issue, they work with us, and they feel pretty comfortable with everything. We have an investigational pharmacy here that prepares all of our test articles, so that’s kind of… I’m trying to think of who else would be involved. The IRB and IBC both have templates of things, but, typically, the sponsor company will send us their protocol and their investigator’s brochure, and using our template I am able to usually pull out from the protocol and investor’s brochure what’s necessary to go into that. And then, along with that, they usually send me a draft consent document, and then I have to adapt it to fit what our IRB requires. And, you know, we submit simultaneously to the IRB and the IBC…” Getting a protocol approved and ready to roll
  17. 17. Organizational Chart of Components of Gene Therapy Clinical Trials Industry Sponsor Pharmaceutical Company University Community Hospital/ Physician Clinic Clinical Research Department Study Coordinator CRC Study Monitor FDA Infection Control Investigational Pharmacy GCRC IRB IBC Attending Physicians OBA RAC Physicians Fellows Investigational Pharmacy University Medical Hospital Principal Investigator
  18. 18. Are some research partnerships more at risk than others? The PI, or a study coordinator and the research team write a research protocol that is funded by a national funding agency such as NIH in collaboration with a university/ medical center Industry Sponsor approaches an acute care medical center and sponsors a clinical trial at a per patient fee used to buy supplies, salaries, operating costs, education Industry Sponsor provides the Clinical Research Organization service of data entry and data monitoring; they may or may not offer Regulatory Affairs Services The NIH initiates a major grant to fund special disease organization research networks and these grants are distributed to PIs. NIH and perhaps Specialty National Disease Organization Funding These are NIH funded centers of excellence which fund an interconnected program of research in the same institution. The grant is held by a Medical Center a Director and there are 3 more PIs that conduct studies.
  19. 19. Organizational Chart of Components of Gene Therapy Clinical Trials Industry Sponsor Pharmaceutical Company University Community Hospital/ Physician Clinic Clinical Research Department Nurse Study Coordinator CRC Study Monitor FDA Infection Control Investigational Pharmacy GCRC IRB IBC Attending Physicians OBA RAC Physicians Fellows Investigational Pharmacy University Medical Hospital Principal Investigator Nature of the Relationship between the Study Coordinator and the PI Scope of Practice Issues  Outside influence by the type of Research Partnership
  20. 20. Understanding Challenges in Gene Therapy Clinical Trials: Listening to Nurse Study Coordinators Ethical Challenges  “Why put very sick patients who are already vulnerable through the rigors of a protocol if the likelihood of helping the patient is minimal?”  “I’m always looking out for the patients best interest; I’m looking for other studies for them to try”  So I think it’s different in gene therapy, if you find out it doesn’t work or it’s not working long-term, it’s almost a personal thing now, because now it’s like, ‘Oh, this sucks! These people don’t feel better. I really thought, you know, we had something to offer.’  So I think they might get unblinded soon, and I’m going to have a hard time with the unblinding, I think, just as hard as the patients might have. They may do better than me, because now we’ve all just… you know, you’ve been involved with these patients’ care for now two, three years. You know, you’re hoping for the best for them.
  21. 21. Understanding Challenges in Gene Therapy Clinical Trials: Listening to Nurse Study Coordinators Research Integrity Issues  “Everyday is chaotic, stressful, wearing many hats; I’m always trying t stuff 5 pounds of working into a 2 pound bucket, so you learn to cut corners”  “It is a big mistake if you enroll a patient into a study if they don’t meet all the criteria; if you have to tell your boss and the industry sponsor, maybe you just might not draw it to their attention”  “ I disagree that this department has used non RNs as coordinators…I don’t think a non RN should have the key to a drug cabinet and be handing out to patients…Where in their schooling were they taught how to do education, how to know reactions, to know drugs effects…They are just handing them [patients] a box …I don’t know where you can do that at a hospital besides research, where you just hand a patient a box of meds and say see you later. I think that’s scary”
  22. 22. Understanding Challenges in Gene Therapy Clinical Trials: Listening to Nurse Study Coordinators Research Integrity Issues  “If there is something on the line, I will tell [the PI] my opinion of it… You’re putting me in a bad position here. If I know for sure it’s not right, then I will send the [PI] a copy of the protocol with that page highlighted, so [s/he] can have it refreshed. The [PI] is use to being right and not being that that [s/he] is wrong and doesn’t always want to accept how I interpreted it [the protocol]. I follow it all the way through. I see what the company has to say about it so we get into some pretty heated discussions, you know, who should be enrolled and who shouldn’t and why. So that at times, you know, we almost fight, you know saying, ‘no not doing it that way. [PI] says, ‘you’re suppose to do what I say. Well no, not at that far right… Most of the time [PI] lets is die at that point.”
  23. 23. Understanding Challenges in Gene Therapy Clinical Trials: Listening to Nurse Study Coordinators “I just think… are we at the point… are you doing what’s best for the patient? If I have a coordinator who has been pushed and pushed and pushed to meet her numbers, and hasn’t been, and now this month she is just so sick of being yelled at or, you know, pointed out, and she’s going to meet those numbers no matter what. How do I know she’s giving appropriate informed consent? How do I know she’s not leaving something out? How do I know she’s not leaving something out, in her talk, in her approach to the patient, inadvertently influencing that patient? You have just put in… you know, everything has some type of… every incentive has a type of behavior that is going to promote good or bad, you know, and usually both. You know, and so by putting this type of incentive there, which is, I think you could get, you know, people are going to try to get to it.”
  24. 24. Nurse’s Moral Voice in Gene Therapy Research Clinical Research Moral Agents •Moral sensitivity to self morality and ethics •Desire for promoting patient advocacy & Research Integrity •Knowing the difference between right Negative Outcomes •Compromised data •Mistrust •Nurse & pt Drop out of Study •Compromised PI/Nurse / Pt. Relationships •Making mistakes •Patient safety is back stage not able to have moral voice hushed or ignored •Betrayal of values and beliefs Positive Outcomes •Trust •Faith •Feeling Well •Increasing the Placebo Effect •Pt. Committed to study & long term follow up •Patient safety integrated front stage & holistic •Emotional exhaustion Clinical Decision Making •Experiencing ethical dilemmas •Potential for violations of research integrity •Conflicts b/t nurses and physicians scope of practice & degree of involvement • Potential for patient harm vs. benefit • Meeting patient quota vs. reluctant consent • Intra-personal struggle over values • Moral & ethical certainty •Sponsor driving the protocol •Organizational structure Regulators (IRB, GCRC Background Social-Cultural Context of Clinical Environment •Social cultural morality Organizational structure • Nature of Relationships Communication Moral Courage Feeling comfortable speaking your moral voice Advocate patient holism & Protect research integrity Moral Distress Lack of clinical knowledge, moral courage, self confidence Conflict & distress within setting Internalized Distress Self Deprecation Loss of self esteem Burnout, Guilt Externalized Distress Bitching & Complaining Unloading to others Moral Residue Emotional Strain and Stress Initial Distress Frustration, Anger, Anxiety Stress & Chaos
  25. 25. Biomedical Ethical Principles Informed Consent IRB, FDA, RAC Regulations Narrative Ethics: Descriptive Ethics Expressive Communicative Social Construction of Moral Conversations in Communities Clinical Decision Making about Ethics and Research Integrity is Multi-layered and Complex
  26. 26. ARE THERE BEST AND WORST PRACTICES IN GENE THERAPY RESEARCH?  Would we recognize them if we saw them?  Do they look any different in Gene Therapy Research as compared to any other type of clinical research?  Would it help if IRBs, hospital administrators, or industry sponsors involved in each research partnership did something different?  Do hospital environments create the kind of cultural milieu for all team members to exercise their moral voice?
  27. 27. Gwen Anderson, RN, Ph.D. Associate Professor & Associate Director for Nursing Research San Diego State University & Adjunct Assistant Professor University of California, San Francisco ganderso@mail.sdsu.edu (619) 473-0185 BEST AND WORST PRACTICES IN GENE THERAPY RESEARCH

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