a benchmark of medical publications compliance among ... · of marketing and msls in the...

A benchmark of medical publications compliance among pharmaceutical companiesGreg Thompson1; Melissa Piper2; Angela Cairns2; Jim Mercante3 KnowledgePoint360 Group, 1Secaucus, NJ, USA; 2Macclesfield, Cheshire, UK; 3TGaS Advisors, East Norriton, PA, USA

Backgroundl Regulatory authorities, the pharmaceutical industry, and

professional societies continue to refine guidelines for interactions between the pharmaceutical industry and healthcare professionals, including activities relating to scientific publications and promotional medical communications. Employees of pharmaceutical companies and medical communications agencies must understand and consistently comply with these laws, regulations, and guidelines — and companies need to devise training and evaluation programs to ensure compliance mastery.

Methodsl In September 2011, we conducted a mini-benchmark of medical

publications professionals to assess the processes used to manage adherence to scientific publication compliance guidelines. We invited 184 medical publications professionals to participate, and received 25 responses representing 21 pharmaceutical companies. The benchmark was web-enabled using QuestionPro technology. Data are reported for all respondents and by company. For company responses, comparisons are made between large- (>2,000 sales reps; multi-billion in annual US revenue) and mid-sized (500 to 2,000 sales reps; high hundreds of millions to low billions in annual US revenues) organisations and between companies that are and are not operating under a US Corporate Integrity Agreement (CIA). However, no distinction is made between those whose CIA includes or does not include a publications component.

60%40%

Publications/Medical Affairs/Medical Strategy department

Corporate compliancedepartment

In your organisation, which group is entrusted with assuring that any changes in external compliance guidelines are evaluated and

incorporated into your organisation’s compliance guidelines?

A marketing representative is a memberof the publication team

Have no role in the publication planning process

Provide suggestions for which publicationsshould be developed

Are included in reviews of primaryresearch articles

Are included in reviews of all manuscripts,including review articles

Provide input on author names

44%

28%

24%

12%

12%

16%

Provide suggestions for whichpublications should be

developed

A marketing representativeis a member of the publication team

Are included in reviews of allmanuscripts, including

review articles

Companies with a CIA (n=5) Non-CIA companies (n=16)

56%

20%

38%

0%

19%

0%

MSLs use company sponsored publications in externaldiscussion with healthcare professionals 19

MSLs send reprint requests into a central groupfor appropriate response 6

MSLs bring ideas for manuscripts to the publicationsteam based on their interactions with healthcare professionals 9

MSLs interact with authors on behalf of the publications team 10

MSLs suggest potential authors for publications based on interests raised by healthcare professionals with whom they interact 9

MSLs are part of the publication team and review all manuscripts 2

MSLs have no role in publications 3

MSLs bring supported study pubs to the publications team for review 1

N=25

Responses ranked based on the combined number of responses to “Most consistently challenging”

AND “Challenging”

Consistent applications of our internal SOPs across all teams

Appropriate and timely author interactions and documentation

Appropriate level and timing of internal review of publication drafts

Timely dissemination of clinical trial data

Identification of qualified authors throughout the process

Coordination of statistical analyses of clinical trial data

Documentation of the publication development process

Financial disclosures

Acknowledgement statements; verbiage and use

Providing author access to data

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Most consistently challenging Moderately challenging Not challenging

N=25

Written guidlines accessiblein a central location

Informal team meetings with discussion

Formal training sessions

Documents distributed to individualsvia line managers

88%

68%

60%

44%

N=25

How are compliance guidelines communicated to all publications teams in your organisation (eg, across regions or therapy areas)?

(Check all that apply)

Formal trainingsessions

Written guidelinesaccessible in a central

location

Informal teammeetings with

discussion

Documentsdistributed toindividuals vialine managers

80%

44%

Companies operating under a CIA (n=5) Non-CIA companies (n=16)

100%

75%80%

56% 60%

38%

How are compliance guidelines communicated to all publications teams in your organisation (ie, across regions or therapy areas)?

(Companies operating under a CIA vs non-CIA companies)

32%

48%20%

Not yet, but are consideringimplementing such a process

YesNo

Do you formally test employees’ understanding and application of your internal compliance guidelines?

Yes, always Yes, in some casesNo, there is noformal policy


19%

20%

6%20%

75%

60%

Do you employ publication steering committees for your publication plans? (Companies operating under a CIA vs non-CIA companies)

What role does marketing play in your publication processes? (Check all that apply)

What role does marketing play in your publication processes? (Check all that apply)

Describe the role of your MSLs (eg, medical science liaisons or medical science managers) with the publications team.

(Check all that apply)

What are the more challenging areas of publications compliance within your publications team? Please rank in order of priority.

YesNo

25%

0%


40%

31%

60%

44%

Not yet, but are consideringimplementing such a process

Do you formally test employees’ understanding and application of your internal compliance guidelines? (Companies operating under a

CIA vs non-CIA companies)

16%68%

16%

No, there is no formal policy

Yes, in some cases

Yes, always

Do you employ publication steering committees for your publication plans?

Rely on publication managersto monitor (self-regulation)

Do not have a formal monitoring orauditing process in place

Groups monitor adherence themselvesbased on SOP/Directive

Monitor through a publication tracking tool

Checklist in place for all publication projects

Formal process of internal audit

Oversight function by a different group(I.e. compliance department)

Requirements are includedin employee objectives

32%

28%

28%

4%

8%

0%

0%

0%

How do different decentralised groups in your organisation (located either in different locations or in different therapy areas) ensure adherence to centrally defined internal publications policies?

ResultsCategory: Maintaining Internal Publication Guidelines

l The majority of respondents (60%; mainly mid-size companies) report that the Publication, Medical Affairs or Medical Strategy departments are responsible for reviewing and updating internal publication guidelines, while 40% (mainly large-size companies) report that this is the responsibility of the corporate compliance department.

l Of companies operating under a CIA, 20% state that marketing representatives are members of the publication team versus 56% without a CIA. Of those companies under a CIA, none report marketing involvement in reviews of manuscripts.

Category: Challenging Areas for Publication Teams

l The most challenging areas of publication compliance identified by respondents are: consistent application of internal SOPs across teams, appropriate and timely author interactions and documentation, appropriate level and timing for internal review of publication drafts, timely dissemination of clinical trial data, and identification of qualified authors.

Category: Ensuring Employee Understanding of Guidelines

l Respondents report using a combination of methods to ensure compliance guidelines are communicated to all publications teams across the organisation. Centralised written guidelines are most frequently utilised, followed by informal team meetings. Formal compliance training is used by 60% of respondent companies. Most of those who selected all four answer options are from large organisations.

Abstract

Legal/regulatory/corporatecompliance department

Self-regulation bypublications

planning team

Combination of self-regulation by publication team and

compliance/legal/regulatory

56% 36%

8%

In your organisation, which group is responsible for monitoring and enforcing adherence to

compliance guidelines?

l Use of formal training is higher (80%) in companies under a CIA than in non-CIA companies (44%).

Category: Use of Publication Steering Committees

l Published in November 2009, GPP2 recommends consideration of publication steering committees for external input into publication development. Most respondents (68%) indicate that publication steering committees are being used at least some of the time, with only 16% of respondents reporting use for all publication plans.

l A comparable percentage of companies under a CIA do not have a formal policy compared to those not under a CIA.

l While 38% of companies reply that Medical Science Liaisons/Medical Science Managers (MSLs) are primarily users of the publication team’s services (eg, use publications in external discussions and send requests for reprints), 48% of companies report that MSLs play an active role in the publications team (eg, interact with authors, suggest ideas or topics for publication development, discuss authorship, or review manuscripts). Further, 14% of companies report that MSLs have no role within the publications team.

Category: Document and Records Retention

l All but two respondents report having a company policy requiring documentation and record retention. Of those with a policy in place, 48% state that it is a corporate policy while 44% have a specific publications team policy. Those who responded that there was no policy or SOP regarding documentation and record retention were from mid-size companies. Of those organisations with a documentation and records retention policy, 48% of respondents indicated that a time period for retention is specified. All CIA companies reported that file retention was for a specified time period.

Objective: We sought to understand differences in how pharmaceutical companies are managing publication compliance.

Methods: We conducted a mini-benchmark of publication planning professionals to assess the processes used to manage adherence related to scientific publication compliance guidelines. We invited 184 publication planning professionals to participate, and received 25 responses representing 21 pharmaceutical companies. The benchmark was web-enabled using QuestionPro technology.

Results: For 60%, responsibility for updating and maintenance of internal publication policies and procedures falls either to the Publications, Medical Affairs, or Medical Strategy department. 28% responded that the publications planning team is responsible for self-monitoring of compliance, and 32% have no formal monitoring or auditing system in place to assess adherence to publications policies. 52% reported not testing their employees’ knowledge of compliance guidelines, though 62% of those reported they are considering testing. 92% reported that they have a publications-related document retention policy; 48% directed by corporate compliance and 44% directed by publication-specific guidelines. We also evaluated the role of marketing and MSLs in the publication process, utilisation of publication steering committees, and challenging aspects of publication practice.

Conclusion: The evolving focus on scientific publications sponsored by pharmaceutical companies has led to increased attention to internal compliance programs. This benchmark provides a current snapshot of how different companies manage publication compliance. However, the pace of change and the areas of focus vary between organisations.

Category: Monitoring Adherence to Internal Publication Guidelines

l Almost a third (32%) of respondents report no formal process in place to ensure adherence to publications policies for decentralised teams, and only one reports having a formal internal auditing process. While 28% use a publication tracking tool to monitor compliance, 28% report that the publication team has a self-regulation system in place (ie, publication managers or group SOP). No respondents report using checklists for publication projects or inclusion of policy adherence within employee objectives.

l Responsibility for monitoring and enforcing adherence to compliance guidelines is assigned to different groups; however, the majority of respondents (56%) rely on self-regulation by the publications planning teams. The Legal, Regulatory, or Corporate Compliance department is responsible for monitoring and enforcing adherence according to 36% of respondents.

l About half of respondents (52%) report that they currently do not conduct formal testing of employees’ knowledge of compliance guidelines; although 32% state that their organisation is considering such testing.

Conclusions

l The evolving focus on scientific publications sponsored by pharmaceutical companies has led to increased attention to internal compliance programs. This benchmark provides a current snapshot of how different companies manage publication compliance. However, the pace of change and the areas of focus vary between organisations, and according to whether or not they are subject to a CIA.

l Of those companies under a CIA, 60% report using formal testing and 40% report considering such a program. Of those not under a CIA, 44% use formal testing and 31% are considering such a program.

Category: Role of Marketing and Medical Liaisons

l While 28% of respondents indicate that the marketing department has no role in the publications process, 44% report that a marketing representative is a member of the publication team. Roles that marketing plays related to publications include: providing suggestions for publications (24%) and providing input on authorship (12%). Only 16% report that marketing is included in reviews of manuscripts (note: one respondent indicated review of both primary and review manuscripts).

N=25

N=25

N=25

N=25

8%

20%

36%

48%Retain all files (drafts and communications)

for a specified time period

More than three years

Time period is not specifically defined

Less than three years

For those answering Yes to the previous question, how long does your organisation’s documentation policy require that these records

be kept? (Check all that apply)

N=22

48%44%

8%

NoYes, this is a

specific publicationteam policy

Yes, this falls underour corporate

documentationpolicy

Do you have a policy or SOP regarding documentation and record retention related to your publication plan or specific publications?

N=25

N=25

N=25