Your Feedback on Study Result Summaries

Deborah CollyarVice Chair, Publications Committee

Alliance Fall 2016 Meeting

Have you heard of AllianceStudy Result Summaries (SRS)?

1. Brief background

2. Example (CALGB 40603)

3. Publications and Health Outcomes Committees want your feedback!

l Fun with electronic “clickers”l Paper, if we must

Under “trials” header

Background: how these startedl 2005+ CALGB CARE: research on returning results

l Ann Partridge et al (references for all at end of presentation)

l 2008/2009 research (Shalowitz/Miller, Sood)l 90% trial participants want results of their clinical triall 89% don’t understand trials until a result summary (Getz)

l 2014: EMA (FDA in Europe) created a regulationl All trial sponsors publish a public summary

l 2015: MRCT Center Return of Results Working Groupl Guidance Document and Toolkit

l 2015: Transcelerate, PHRMA, and EFPIA recs l Guidance Document and Toolkit

l 2016:l HHS regulations & NIH policy on results in clinicaltrials.govl NCI CTEP supports study result summariesl Health Literacy Media (HLM) Plain Language Research Summaries

Current picturel Alliance leads in NCTN

l Over 40 summariessince 2009l trials > study result summaries

l Never promotedl Used? Useful?

l Publications & HealthOutcomes Committeeswant your feedback!l Also plan survey with

Alliance trial participants

New approach –health literate

Now, it’s YOUR turn: 9 questions

1. Please choose your role in the clinical trial system:A. PhysicianB. Research NurseC. Clinical Research

Professional/Clinical Research Associate

D. Alliance Staff/StatisticianE. Patient AdvocateF. Other

Physic

ian

Resea

rch Nurse

Clinica

l Res

earch

Pro...

Alliance

Staff/S

tatist

ician

Patien

t Advo

cate

Other

0% 0% 0%0%0%0%

2. Are study result summaries (SRS) useful to patients?

A. Yes, absolutelyB. Yes, possiblyC. Not likelyD. Definitely not

Yes, a

bsolutel

y

Yes, p

ossibly

Not lik

ely

Definite

ly not

0% 0%0%0%

3. Are study result summaries (SRS) useful to you & your staff?A. Yes, absolutelyB. Yes, possiblyC. Not likelyD. Definitely not

Yes, a

bsolutel

y

Yes, p

ossibly

Not lik

ely

Definite

ly not

0% 0%0%0%

4. Would you use study result summaries (SRS) when a publication was released?

A. Yes, absolutelyB. Yes, possiblyC. Not likelyD. Definitely not

Yes, a

bsolutel

y

Yes, p

ossibly

Not lik

ely

Definite

ly not

0% 0%0%0%

5. Would you use study result summaries (SRS) for routine/local media coverage?

A. Yes, absolutelyB. Yes, possiblyC. Not likelyD. Definitely not

Yes, ab

solutel

y

Yes, poss

ibly

Not lik

ely

Definite

ly not

0% 0%0%0%

6. How clear is the study result summaries (SRS) information (new format)?

A. Clear to publicB. Clear to patientsC. Clear to medical

staff onlyD. Unclear to everyone

Clear to

public

Clear to

patien

ts

Clear to

med

ical s

taff...

Unclea

r to ev

eryone

0% 0%0%0%

7. What would be the best way to distribute study result summaries (SRS) to you (select one)?

A. EmailB. Alliance websiteC. Alliance newsletterD. All of the aboveE. None of the above

Email

Alliance

web

site

Alliance

newsle

tter

All of th

e abo

ve

None o

f the a

bove

0% 0% 0%0%0%

8. Who in your office would share study result summaries (SRS) with patients?

A. PhysicianB. Research NurseC. Clinical Research

Professional/Clinical Research Associate

D. Not surePhy

sician

Resea

rch Nurse

Clinica

l Res

earch

Pro...

Not su

re

0% 0%0%0%

9. When and how will study result summaries (SRS) be shared with patients?

A. Next office visitB. Phone callC. EmailD. Specific appointmentE. Not sure

Next o

ffice v

isit

Phone c

allEmail

Specif

ic ap

pointmen

t

Not su

re

0% 0% 0%0%0%

Thank you for showingpatients you care!

l 7 committees (Fall 2016)l Analyze resultsl Trial participant surveyl Look for funding (SWOG interested too)l More input?

l deborah@tumortime.com

Referencesl Partridge AH et al

l https://www.ncbi.nlm.nih.gov/pubmed/15100341https://www.ncbi.nlm.nih.gov/pubmed/15766998https://www.ncbi.nlm.nih.gov/pubmed/18543100https://www.ncbi.nlm.nih.gov/pubmed/19164202

l Shalowitz & Miller. 2008 PLoS Medicine. 5(5):714-720

l Sood et al. 2009. Mayo Clinic Proceedings. 84(3): 243-247

l Getz et al. 2012. Expert Rev. Clin. Pharmacol. 5(2): 149-156

l EMA regulationsl http://www.pmlive.com/pharma_news/the_new_eu_clinical_trial_lay_summaries_95007

4 http://ec.europa.eu/health/human-use/clinical-trials/regulation/index_en.htm

l MRCT Centerl http://mrctcenter.org/projects/return-of-results-to-participants/

References, con’t.l Industry

l http://www.transceleratebiopharmainc.com/wp-content/uploads/2015/04/TransCelerate-Non-Promotional-Language-Guidelines-v10.pdfhttp://www.phrma.org/sites/default/files/pdf/042009_clinical_trial_principles_final.pdfhttp://www.efpia.eu/uploads/EFPIA_Reflection_Paper_-_Guiding_Principles_on_The_Content_of_the_Layperson_Summary_Sep_2015_FINAL_clean.pdf

l HHS & NIHl https://www.nih.gov/news-events/summary-hhs-nih-initiatives-enhance-availability-

clinical-trial-information

l Health Literacy Media (HLM)l http://www.healthliteracymissouri.org/services/health-literacy-in-action/