Points to consider: Does the degree of discrepancy in the data require an intervention? If yes: o o o o

Transcription

1 ISMPP Cde f Ethics cases Preamble The current ethics cases were reviewed fr relevance and areas fr imprvement were identified. In additin, the cases were aligned with the new Cde f Ethics (Nvember 1, 2016). Mst f the case scenaris were determined t be mstly n target, but the pints t cnsider sectin was depersnalized and revised t be mre applicable t a wider audience in sme cases. 1

2 ISMPP Cde f Ethics cases Case Study 1: Issue: What are yur respnsibilities if yu learn abut data discrepancies between manuscripts and ther surce dcuments, such as reprts? Relevant ISMPP Cde f Ethics Sectins: Ethical Principles I. 1, 2, 3. Scenari: Yu are assigned t an established team and are asked t cmplete an nging prject. Discrepancies are evident between the data in the study reprts r ther surce dcuments and the resulting manuscript(s). Pints t cnsider: Des the degree f discrepancy in the data require an interventin? What type f interventin is apprpriate? Have apprpriate team members been invlved in making this evaluatin? D these discrepancies affect the final cnclusins r clinical interpretatin f the study? D these data represent a cmpletely different dataset cmpared with the ne that shuld be published accrding t the publicatin plan? Hw can yu meet minimum acceptable ethical standards and maintain relatinships? If changes wuld be beneficial but nt abslutely required: Is the team pen t making the suggested changes? Hw can this situatin be used t encurage better practices in future? If n: Are these differences cnsistent with legitimate differences f medical pinin? Can discrepancies be explained as minr differences likely t ccur when separate table packages are run fr publicatins and reprts? Shuld these differences and the reasns behind them be dcumented? Can clleagues in clinical develpment r medical writing prvide additinal infrmatin regarding the data? Des this manuscript pssibly represent a deviatin frm a publicatin plan mandated by a CIA? If n: Can the plan be updated under usual prcesses? Is sme ther interventin necessary? Shuld these differences and the reasns behind them be dcumented? D cmpany prcedures require that publicatins table packages be prepared as addenda t the study reprt? Are there legal r intellectual prperty ramificatins? 2

3 ISMPP Cde f Ethics cases Case Study 2: Issue: What are yur respnsibilities fr accurately cnveying qualificatins and cmpetencies? Relevant ISMPP Cde f Ethics Sectins: Ethical Principles I. 3, 4, 5. Scenari: A medical cmmunicatins agency has been invited t take n a publicatins prgram in a therapeutic area in which they have n expertise. Hwever, this is a fantastic pprtunity fr the agency t expand its business. Further, it has been implied that there wuld be a significant amunt f additinal wrk in the near future shuld things g well. Pints t cnsider: Shuld the medical cmmunicatins agency advise the ptential client f their lack f experience in this therapeutic area? If n: Will it jepardize this new business pprtunity? Will it jepardize existing business and/r future pprtunities with this client? Will this tarnish the agency s name and reputatin if it is discvered that their expertise has been misrepresented? Will it ptentially cmprmise existing wrk with this client? Will it jepardize future pprtunities with this client and/r ther cmpanies? Wuld ethical standards be vilated by nt revealing r being transparent abut the agency s lack f qualificatins? Shuld the agency refer this ptential client t anther medical cmmunicatins agency that is knwn t have expertise in this therapeutic area? Or: Will the ptential client respnd well and cmmend the agency fr being truthful, and fr assisting their immediate needs by recmmending a cmpetitr? Will this enhance the agency s reputatin and increase their chances f future wrk, r will this jepardize existing and future pprtunities with this lng-standing client? Shuld the agency cnsult with an external expert in the therapeutic area befre making any decisins regarding what infrmatin t prvide t this ptential client? What are the respnsibilities f the pharmaceutical cmpany, r thse individuals respnsible, when chsing an agency fr new business as it relates t therapeutic area expertise? What are the ptential risks assumed by a pharmaceutical cmpany, and/r individuals within the cmpany wh are respnsible fr selecting the agency, when hiring an agency withut experience in the therapeutic area f interest? Hw might the lack f experience in a given therapeutic area affect the agency s ability t effectively wrk with authrs wh have expertise in this area? Culd the agency s lack f experience cmprmise existing relatinships with experts/authrs in the area? 3

4 ISMPP Cde f Ethics cases Case Study 3: Issue: What are yur respnsibilities when yu discver a pssible premature submissin? Relevant ISMPP Cde f Ethics Sectins: Ethical Principles I. 1, 2, 3. Scenari: An academic authr frwards the acceptance and manuscript versin fr a rapid nline publicatin by a prminent medical jurnal. Yu believe that the manuscript in questin is still under internal medical and legal review by the Spnsr, and the legal reviewer determined that intellectual prperty issues had t be reslved prir t jurnal submissin. The cntent f the accepted manuscript, and the authr list, differ substantially frm that f the versin under medical and legal review. Pints t cnsider: Is this the same manuscript/dataset/study (as ppsed t a clsely related ne)? If n: Did the academic authr prematurely submit secndary r explratry data? Are the data frm an ld versin f a study reprt r preliminary data package rather than the final data? Is this manuscript n the publicatin plan? Shuld it be n the plan? Des it require medical accuracy review r full develpment review? Can it be added withut creating anther ethical questin? D the authrs n the current list meet apprpriate authrship criteria? Is the authr list cmplete? Are the listed cauthrs aware f the submissin and versin submitted? If n: Can review and necessary updates be made in the timeframe permitted? What are the intellectual prperty and liability issues in this situatin? Can the existing manuscript be reviewed? If a crprate integrity agreement is in place, is this submissin in vilatin f the accepted publicatin plan? Were internal plicies and status clearly cmmunicated? By whm? Was an authrship cntract issued? What steps can be taken t prevent this situatin in future? What steps shuld be taken (if any) t infrm the jurnal f patent-related issues (if they still exist) which may delay publicatin? 4

5 ISMPP Cde f Ethics cases Case Study 4: Issue: Hw d cultural differences affect authrship? Relevant ISMPP Cde f Ethics Sectins: Ethical Principles I.1; II.A.1; II.B. 4 & 5; II.C. 3 & 4. Scenari: Yu have been wrking with investigatr authrs n a manuscript t reprt the results f a cmpany-spnsred multinatinal clinical trial n an investigatinal drug. The manuscript is clse t cmpletin and will sn be ready t submit t the chsen jurnal. Upn review, yu ntice that there is a new authr listed in this draft. After checking, yu discver that this authr is nt an investigatr and lists his affiliatin as the same institutin as the lead authr, ne that is lcated in a cuntry in the emerging markets. After cnsulting with the publicatin team, yu apprach the lead authr abut the inclusin f this new authr and are infrmed that he was critical t the successful executin f the study. Pints t cnsider: ICMJE criteria fr authrship Were all authrs made aware f ICMJE criteria fr authrship? D they understand the criteria and implicatins theref? Des the target jurnal adhere t ICMJE requirements? Des ICMJE criteria reflect Western values? If s, is it fair t impse these values n all cultures? Have the cauthrs been infrmed abut the additin f the new authr and are they in agreement t include the new authr? Are there different cultural practices in ther cuntries regarding authrship requirements fr medical publicatins? Are yu aware f the accepted practices in the cuntry where the new and lead authrs live? Might this new authr be a guest r hnrary authr, eg, is he the lead authr s mentr, r is he the head f department in which the clinical research was dne? Hw d yu accmmdate differences in cultural values? What are the cnsequences f nt accmmdating the newly added authr? Hw will it affect yur relatinships with the lead authr, ther authrs, spnsr, publicatin team and ther stakehlders? Hw culd this situatin have been prevented? Hw might yu wrk with spnsrs and authrs in future t avid this happening again? Hw might yu, in cnjunctin with the clinical trial spnsr and the investigatrs, determine authrship requirements fr future publicatins activities? Hw and when shuld these authrship requirements and respnsibilities be cmmunicated t ptential authrs f future publicatins? 5

6 ISMPP Cde f Ethics cases Case Study 5: Issue: Shuld medical writers ever qualify fr authrship? Relevant ISMPP Cde f Ethics Sectins: Ethical Principles I.1-5; II.A. 1, 7, 9, 10, 15, 16; II.B.5. Scenari: A prfessinal medical writer paid by a pharmaceutical cmpany is wrking with external authrs t develp a review article. The medical writer perfrms the research required t identify requisite materials fr the review article. During submissin, the medical writer is required t prvide details f his/her cntributins t the wrk. Shrtly thereafter, the jurnal sends ntificatin that the submissin cannt be prcessed because, accrding t their specificatins, the medical writer qualifies as an authr but has nt been listed as ne. Unless this is crrected within a specified time, the manuscript will be cnsidered t have been withdrawn. Pints t cnsider: Is the jurnal crrect is the medical writer an authr? Des the medical writer meet the ICMJE criteria? If yes, why was the medical writer nt listed as an authr? If n, why des the jurnal see it therwise? Are the ICMJE criteria sufficient fr authrship? Are any pinins stated in the manuscript thse f the medical writer? Yes/N; why? Is the medical writer qualified t defend their pinins stated in the manuscript? Yes/N; why? Are there ther criteria that need t be cnsidered fr authrship? GPP3 guidelines and recmmendatins regarding medical writers Exceptin if a medical writer cntributes substantially t a review article If the medical writer is t be included as an authr, what are the ramificatins? Hw will this actin affect relatinships with the currently listed authrs? D all current authrs agree with the jurnal s requirement? If the medical writer is nt t be included as an authr, what are the ramificatins? Hw will the decisin be explained t the jurnal? What is the recurse if the jurnal des nt accept the explanatin? What can be dne t avid this cnundrum? What actins can be taken t practively ensure that there is n cnflict? Des the medical writer s cmpany have a plicy? D ther stakehlders have a plicy? 6

7 ISMPP Cde f Ethics cases Case Study 6: Issue: Shuld all data, regardless f quality, be published? Relevant ISMPP Cde f Ethics Sectins: Ethical Principles I.3; IIA.1, 2, 3, 6, 7. Scenari: An early review f the data frm a Phase 3 study cnducted utside f the United States indicates statistically significant adverse events and failure t meet primary endpints fr a drug that is already marketed in the United States. The lcal investigatrs cite issues with the integrity f the drug and suggest nly psting the final findings n the relevant trials database in accrdance with the cmpany's plicies and in cmpliance with the law. They further suggest repeating the study with prduct whse integrity is nt in questin. There is disagreement amng the investigatrs regarding bth the validity and medical imprtance f the adverse event data, as well as the urgency with which they need t be disseminated. What shuld be dne in this case with regard t psting and publishing these data? Pints t cnsider: Shuld ptential issues with the drug prduct integrity used in this study factr in the decisin t pst and/r publish these data? Shuld this issue be investigated and mentined in any ptential psting r publicatin? Des publishing these data help practicing clinicians and patients r d they just muddy the waters? In deciding abut publicatin and urgency, hw much weight shuld be given t the fact that these ptentially negative/neutral data are nt final? What shuld be dne abut publishing data frm trials that d nt meet desired endpints? Hw wuld yu respnd t thse wh claim that nly psting data rather than submitting it fr publicatin in a jurnal undermines the integrity and value f the bdy f medical literature that is available t practitiners? The legal requirements fr psting differ based by cuntry and apprval status. T which legal requirements wuld yu adhere? What is yur justificatin fr yur chice? Hw wuld yu address questins frm ther jurisdictins? 7

8 ISMPP Cde f Ethics cases Case Study 7: Issue: What shuld be dne abut clinical data when the spnsr has changed its business fcus? Relevant ISMPP Cde f Ethics Sectins: Ethical Principles I.3; IIA. 1, 2, 3, 6, 8. Scenari: As part f a rerganizatin, a pharmaceutical cmpany has decided t limit the number f therapeutic areas f fcus fr its research. Cnsequently, a prgram fr a drug in develpment has been terminated immediately and all resurces (persnnel and funds) have been reassigned t ther areas and prducts. Yu are aware that there are still sme unpublished data frm trials already cmpleted, including the primary data frm ne study and secndary data frm anther. Pints t cnsider: What are yur ethical bligatins? Is there a necessity/ethical bligatin t publish all f the unpublished data, including secndary endpints? If the data are nt published, hw will it affect yur relatinship with the investigatrs/authrs t stp any nging publicatins? What actins can yu take practively t ensure legal and ethical bligatins are met Hw wuld yu avid this situatin in the future? 8