Considering
Harms and Benefits:
A patient perspective
29 January 2014, EFGCP Annual Conference
Jan Geissler, CML Advocates...
Willingness of patients to take risk for
potential benefits differs

Survival probability

CML IV

2013, 10 years survival...
Quality of life (%)

Cure

Un
tre
ate

Effective
palliation,
increased
survival
d

Effective
palliation,
same
survival

Ov...
It is not just about clinical efficacy:
Different patients want different things
Being part of decision-making?
Ownership ...
There is no „magic bullet“
for most patients yet




“Success stories” available only to
small numbers of cancers,
rare ...
What patients need to know
about BENEFITS in clinical trials


Knowing that trials exist at all



Benefits of participa...
Quality measures of study sites are
improving overall quality of care & outcome


Example quality assurance programme QII...
What patients want to know
about RISKS in clinical trials








Uncertainty/risk of therapy,
prior results of stu...
Barriers to trial participation are well
documented 1






1

Uncertainty: Proven vs. experimental
Lack of informati...
Five suggestions
to improve
patients’
understanding
of harms/benefits
1. Make „informed consent“
and patient info more accessible

§
2. Involve patient
organisations as navigators









Average consultation: 8-12 minutes
Medical language barrier
...
3. Educate the public on “basics of
research” to improve understanding of risk
and benefit in research
?
4. Increase transparency of research
(results, harms and benefits) to patients
Research only helps if it reaches out to pa...
5. Seek input from patient organisations in
regulatory risk/benefit assessment
Example EMA:
Considering refusal, withdraw...
No research
No research
about us
about us
without us!
without us!
Jan Geissler
Jan Geissler
jan@patientsacademy.eu
jan@pat...
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Harms and Benefits in Health Research - A patients' view (Jan Geissler)

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Presentation of Jan Geissler at EFGCP Annual Conference on 29 January 2014 about "Harms and Benefits in Health Research: The patients' perspective".

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Harms and Benefits in Health Research - A patients' view (Jan Geissler)

  1. 1. Considering Harms and Benefits: A patient perspective 29 January 2014, EFGCP Annual Conference Jan Geissler, CML Advocates Network / EUPATI
  2. 2. Willingness of patients to take risk for potential benefits differs Survival probability CML IV 2013, 10 years survival 83% Mortality of co-morbidities > CML CML IIIA 2000, 10 years survival 50% CML III CML I/II CML I/II CML I Year after diagnosis German CML Study Group (2013) 1990s
  3. 3. Quality of life (%) Cure Un tre ate Effective palliation, increased survival d Effective palliation, same survival Overtreatment decreased survival Overtreatment, same survival Overall survival Start of therapy Lifetime gained 3 Senn. H. J.. Z. Allg. Med. 55. (1979) 284-295.
  4. 4. It is not just about clinical efficacy: Different patients want different things Being part of decision-making? Ownership vs “fix it for me”?  A quick fix vs. long durable remissions?  Maximum disease control?  Fewer side-effects / better QoL?   Oral outpatient treatment or hospital based care? Ability to work? Have a social life?  Impact on family / family planning?   Financial impact (travel, patient/carer’s ability to work)
  5. 5. There is no „magic bullet“ for most patients yet   “Success stories” available only to small numbers of cancers, rare diseases, patients at “best age” Research is crucial to address unmet needs RareCare (Gatta et al, 2012)
  6. 6. What patients need to know about BENEFITS in clinical trials  Knowing that trials exist at all  Benefits of participation in trials • Personal benefit: Access to innovative treatment, “hope” or “last resort”, hope for response, closer monitoring, better quality of life • Altruistic reasons: Contributing to progress beyond their own case
  7. 7. Quality measures of study sites are improving overall quality of care & outcome  Example quality assurance programme QIII 2001 German Working Group Gynecological Oncology Ovarian Cancer (AGO OVAR)  Standard therapy FIGO I-IIA Site without clinical trials (n=68) Study center (n=56 patients) 52% 48% 25% Standard therapy Suboptimal therapy 75% Jalid Sehouli (Charité), on: QS-Programm der AGO Organkommission OVAR, Zentralbl Gynakol 2005; A. du Bois DOI 10.1055/s-2005-836289
  8. 8. What patients want to know about RISKS in clinical trials        Uncertainty/risk of therapy, prior results of studies Impact on quality of life, unpleasant diagnostics Risks about fertility Pediatric trials: administration Influence on family life (intensity of care) and financial impact (travel) Influence on ability to work (both patient & carers) Protection from unauthorized and unwarranted use of data and tissue: stigma and discrimination
  9. 9. Barriers to trial participation are well documented 1      1 Uncertainty: Proven vs. experimental Lack of information and understanding (no real „informed consent “) Therapy preferences, fear of randomization Impact of quality of life, inappropriate burden of diagnostics Time of recruitment conflicts with patients‘ life (e.g. family planning, children, work, mobility) Fayter, D. et al. (2006): Systematic Review of barriers, modifiers and benefits involved in participation in cancer clinical trials.
  10. 10. Five suggestions to improve patients’ understanding of harms/benefits
  11. 11. 1. Make „informed consent“ and patient info more accessible §
  12. 12. 2. Involve patient organisations as navigators       Average consultation: 8-12 minutes Medical language barrier Different perceptions on what matters to patients Poor Adherence Patient organisations: experts on patient information, quality of life, anxiety, expectation management, “navigation” to clinical excellence, compliance Help understanding benefits and risks
  13. 13. 3. Educate the public on “basics of research” to improve understanding of risk and benefit in research ?
  14. 14. 4. Increase transparency of research (results, harms and benefits) to patients Research only helps if it reaches out to patients!  „Had I only known about this study / had I understood“ (Most patients are not even informed about the existence of studies, or there is no time for consultation. Patient organisations often act as navigators.)  „What was the result of ‚my‘ study?“ (90% of study participants want to know results of the study1, 93% never receive study results from doctors or sponsors2, 98% of study doctors would like to share results3)  Only what is being published is also being picked up (32% of industry studies, 18% of academic studies have not been published 5 years after conclusion of trial, BMJ @ 585 studies with >500 participants 4) 1. Shalowitz, D. and Miller, F. 2008. PLoS Medicine. 5: 714-720. 2. Sood, A. et al. 2009. Mayo Clinic Proceedings. 84(3): 243-247. 3. Dixon-Woods, M. et al. 2006. BMJ. 332: 206-210. 4. Jones, C et al, BMJ 2013;347:f6104
  15. 15. 5. Seek input from patient organisations in regulatory risk/benefit assessment Example EMA: Considering refusal, withdrawal, suspension, revocation of a medicine in an area where there remains unmet medical need Advice on package leaflet, risk management plan Acceptability of comparators and endpoints Ethical issues Drug shortages
  16. 16. No research No research about us about us without us! without us! Jan Geissler Jan Geissler jan@patientsacademy.eu jan@patientsacademy.eu Twitter @jangeissler Twitter @jangeissler

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