Incorporating JCAHO Pain Standards into Clinical Trials:

Transcription

1 Incorporating JCAHO Pain Standards into Clinical Trials: Nursing Opportunities, Industry Benefits Consultant Los Altos, CA American Society of Pain Management Nurses, Myrtle Beach, SC March 18, 2004

2 Overview Background Drug Development Process Players and roles JCAHO Pain Standards Evaluation/Identification of Key Standards Study Highlights Implementation of Standards in CT Outcomes

3 Background

4 RNs: The Critical Element in Successful Clinical Trials Familiar RN Role Patient advocate Expanded Role JCAHO Pain Standards expert Clinical Trial Design Contributor Real world patient care expert

5 SOURCE: FDA [

6 Clinical Trial Phases Phase I: Healthy, normal subjects GOAL: Establish safety in healthy humans before going onto later phases in patients Very small Ns (20 or so) Lots of testing to measure pharmacokinetics (PK)

7 Clinical Trial Phases, cont d. Phase II: Patients In most cases, first exposure to patients with medical indication drug is intended to treat GOAL: Identify dosing and treatment characteristics to use in design of Phase III trials Small N (up to several hundred)

8 Clinical Trial Phases, cont d. Phase III: Patients GOAL: Establish safety and efficacy N = Several hundred to several thousand Placebo controlled and/or active controlled At least 2 required by FDA Multi-center/multi-country to get as wide experience as possible

9 The Players FDA Pharmaceutical Company Advisory Board DESIGN RN (Study RN, CRC) CRO Patient MD/PI (Principal Investigator) IMPLEMENTATION = Lines of communication

10 The Roles FDA Oversight, Approval of Clinical Plan CRO CRA, Monitor Pharmaceutical Company/CRO Regulatory, Clin Dev, Data Mgmnt, Drug Safety, Project Mgmt Advisory Board MDs, some RNs content experts RN ADVOCACY real world expertise patient care expert JCAHO pain stds. expert Patient Family, SO, Caregiver MD/PI (Principal Investigator) Also PCP

11 Where Do RNs Contribute? FDA Oversight, Approval of Clinical Plan CRO RN CRA, RN Monitor Study RN ADVOCACY real world expertise patient care expert JCAHO pain stds. expert Pharmaceutical Company/CRO Regulatory, RN Clin Dev, Data Mgmnt, RN Drug Safety, RN Project Mgmt Patient Family, SO, Caregiver Advisory Board MDs, some RNs content experts MD/PI (Principal Investigator) Also PCP

12 My Experience New Drug Application Submitted for Needlefree E-TRANS Fentanyl HCl Patientcontrolled System for Acute Pain Management ( Post-op pain model (PCA) My role

13 JCAHO Pain Management Standards

14 JCAHO Pain Management Standards Institutional shift in context of how pain is assessed, treated, reassessed Emphasis on staff and patient education Patient as an active participant in treatment Charting and documentation standards

15 Identification of Key Standards Review of JCAHO Pain Standards to identify areas of greatest potential impact: Patients have the right to appropriate assessment and management of pain Initial assessment and reassessment of pain Providers knowledgeable in pain assessment and management

16 Key Standard Patient Education : Patients were educated about pain and about managing pain as part of treatment Understanding pain Risks associated with untreated pain (harmful effects) Importance of pain management Pain assessment process Methods for pain management Pre-emptive analgesia Barriers/Misconceptions to effective pain management

17 Key Standard Site Staff Training: Sought to provide consistency of patient education during screening phase Investigator sites required to perform the education prior to consent/day of surgery Investigator sites given video how-to of patient pain management education

18 Development of Video Script developed out of role-play interview with patient regarding pain Patient pain history: individual experience Importance of post-op pain management and impact on recovery Introduction to NRS used to rate pain Pain assessment Anchored in patient experience Comfort function scale questions Establishment of post-op pain goal

19 Study Highlights

20 Study Highlights Required assessment of pain after cough/deep breathing - not stationary on gurney in PACU Required NRS <5 for enrollment consistent with research Instructed patients on pre-emptive analgesia

21 Outcome

22 What Difference Did It Make? Outcome: Very robust data regarding patient pain experience Ability to evaluate patient s time at or below pain goal Increased patient understanding of how/when to use pain management Removed subjective investigator assessment of patient comfort Potentially lasting benefits to patients and site staff

23 Nursing Opportunities & Industry Benefits Nurses: Use our advocacy role and experience to enhance patient outcomes in clinical trials Expand practice to new arena Collegial relationship and respect for our unique contributions Industry: Harvest wealth of knowledge about practical patient care issues More real life clinical trial scenarios Catch potential showstopper issues early

24 Selected Nursing Roles in Pharmaceutical Industry Advisory Board Member Clinical Development Clinical Research Associate (CRA) Clinical Research Coordinator (CRC) Clinical Study RN Clinical Study Unit Manager Drug Safety Associate (DSA) Medical Information (Science) Liaison

25 More Information FDA: drug development GCP and human subjects research guidelines Association of Clinical Research Professionals: courses, networking, resources for clinical research professionals Drug Information Association: courses, conferences, networking for drug industry professionals Healthcare Businesswomen s Association: professional women in healthcare, pharmaceutical industry, research