Clinical Trials in Palliative Care: Challenges and Opportunities

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1 Clinical Trials in Palliative Care: Challenges and Opportunities Russell K. Portenoy, MD Chairman and Gerald J. and Dorothy R. Friedman Chair in Pain Medicine and Palliative Care Department of Pain Medicine and Palliative Care Beth Israel Medical Center Chief Medical Officer Continuum Hospice Care Professor of Neurology and Anesthesiology Albert Einstein College of Medicine

2 Clinical Trials in Palliative Care: Challenges and Opportunities Evidence-based medicine: The role of RCTs in palliative care Expanding the evidence: : Planning and conducting RCTs of symptom control drugs

3 Clinical Trials in Palliative Care: Challenges and Opportunities Definition of evidence-based medicine (EBM) Evidence-based medicine is the conscientious, explicit, and judicious use of the best current evidence in making decisions about the care of individual patients Sackett et al., BMJ 1996; 312:71

4 as we know, there are known knowns, there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns the ones we don t know we don t know. Donald Rumsfeld

5 Clinical Trials in Palliative Care: Challenges and Opportunities Palliative care should embrace the tenets of EBM Practice guidelines should be based on systematic review of evidence Clinicians should be able to critically interpret what they read about new therapeutic advances New studies should be designed with consideration of their ability to contribute to evidence

6 Understanding the Nature and the Use of Evidence Key outcomes in EBM Quality of evidence Quality of evidence from existing studies about a specific question or intervention Strength of recommendation Recommendation for practice change based on analysis of benefits, burdens and costs

7 Grading Evidence and Recommendation Quality of evidence Example: high, moderate, low and very low Strength of recommendation Example: strong and weak Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group (Atkins( D, et al, BMJ ;328:1490)

8 Study Design and the Level of Evidence Observational Studies

9 What Is a High Quality Randomized Controlled Study? Methodology determines quality Adequate randomization Computer-based or random numbers table Not adequate: alternating treatments or other assignments Adequate allocation concealment Centralized allocation or blinded codes or other methods Similarity of baseline groups Should be demonstrated in the analysis

10 What Is a High Quality Randomized Controlled Study? Methodology determines quality Blinding of patients and care providers through the use of identical placebo or other controls, or sham therapies Blinding of outcome assessors and data analysts Similarity of concurrent therapies across treatment groups Low drop-out out rates Analysis includes intent-to to-treat treat approach

11 RCT Quality: The CONSORT Consensus Consolidated Standards of Reporting Trials (CONSORT) Consensus-driven instructions and reporting templates Includes checklist of 22 items that may guide study design and objective reporting statement.org Moher D, Schulz KF, Altman DG. Lancet 2001; 357:

12 Clinical Trials in Palliative Care: Challenges and Opportunities Where do we stand? What are the challenges in planning and conducting RCTs of symptom control drugs

13 Evidence in Palliative Care: Where Do We Stand? Very limited work: 1% of 8,688 NIH grants in 2008 study symptom control But some improvement: Palliative care-related related publications increased from 0.08% 0.38% of the literature Clinical trials reports increased from 0.96% 7.22% of the palliative care literature Rate of growth in palliative care trials was 1.4X greater than the corresponding general literature Tieman J, Sladek R, Currow D, J Clin Oncol,, 2008;26:

14 Challenges in Planning and Conducting RCTs More high quality evidence is needed in palliative care Large (adequately powered), well designed RCTs are highly desirable in the search for evidence Key considerations Is enough known to consider a RCT? How to define the question? What is a feasible methodology? Is there adequate funding?

15 Is Enough Known to Plan a RCT? To plan a high quality RCT of a symptom- control therapy The questions (specific aims) must be clarified The epidemiology and natural history of the symptom must be known The related biomedical and psychosocial aspects of the illness must be appreciated The treatment must be understood sufficiently to plan the study dose, titration, duration of treatment, sample size, timing of assessments, safety monitoring

16 Is Enough Known to Plan a RCT? Before planning a high quality RCT Qualitative studies may be needed to define the variables of interest Observational studies may be needed to understand the epidemiology of the symptom and its relevant covariates clarify likely effect size, non-therapeutic effects and risks, time-action relationships, relevant covariates, and feasible procedures Small uncontrolled or controlled drug trials may be needed to understand range of beneficial effects and risks, pharmacokinetics and time-action relationships

17 Defining the Question in Planning a RCT Efficacy vs. effectiveness Efficacy: Does it work (better than placebo)? Effectiveness: Does it work with a favorable therapeutic index in the target population? Reflects clinical practice Comparative effectiveness studies are likely to change practice most quickly

18 Defining the Question in Planning a RCT Pragmatic vs. explanatory Pragmatic: Primary aim is clinically relevant Explanatory: Primary aim is about mechanism or physiology Studies can do both, but one aim usually predominates

19 What is a Feasible Methodology? Ethical considerations Practical considerations

20 What is a Feasible Methodology: Ethical Considerations Legitimate concern about informed consent Coercion or confusion in vulnerable populations Some reassuring data Systematic review of 11 studies assessing cancer patients attitudes toward research (Todd et al, J Pain Sympt Manage, Manage, in press) 10 suggest that altruism, hope and rational perception of self-benefit lead to consent Study of patients participating in NIH phase I cancer trials (Seidenfeld J et al, Arch Intern Med ;168:16-20) 20) Most had good performance status and characteristics not suggestive of vulnerability

21 What is a Feasible Methodology: Ethical Considerations To minimize ethical concerns Assessment of decisional capacity Full disclosure Unimpeded drop-out out Periodic review by a Data Safety Monitoring Board Generally required in US federally-funded, funded, phase III trials

22 What is a Feasible Methodology: Practical Considerations Anticipate problems with recruitment, retention and instrument completion Worst case planning within the limits of funding

23 What is a Feasible Methodology: Practical Considerations Study procedures should Limit patient burden Not rely on professional caregivers Be based on pilot work as needed With limited burden, high completion rates are possible Example: 95% completion of daily pain and analgesic use diary by 244 patients with advanced pancreas cancer followed till death (Eckhardt etl J Pain Symptom Manage 2009;37: ) 143)

24 Multicenter Drug Trials in Palliative Care Goals: Increase recruitment, reduce study time, possibly increase generalizability of data ( UK SUPAC initiative, EAPC Research Network) Concerns Introduces variation: more difficult to pick up a signal Increases costs and complexity of quality control and data management Burden of specific requirements, e.g. multiple IRBs, translation of instruments, overall project management

25 Multicenter Drug Trials in Palliative Care Addressing concerns Central IRB can provide uniform and timely review Centralized project management, data management, and statistical support can improve efficiency and reduce variation Single independent Data Safety and Monitoring Board can reduce risk

26 Multicenter RCTs in Palliative Care: Adequate Funding? Most funding for multicenter drug trials is from industry Concern about bias Many questions do not interest industry Lack of government funding for research networks remains a serious problem in establishing an evidence base for palliative care

27 Clinical Trials in Palliative Care: Challenges and Opportunities Conclusions Multicenter RCTs of symptom control drugs can change practice by providing high quality evidence of effectiveness Methods are established but continue to evolve Badly needed Non-industry research funding mechanisms Growth of the research community Commitment to best practice research by the academic and clinical communities

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