1. Thou Shall…clearly articulate the project objective. Failure to clarify the aim of the material will result in fragmented writing that is unlikely to achieve any clear purpose or outcome.
2.  Thou Shall…define the audience for the piece, and ensure the language, style and content is tailored accordingly.
3.  Thou Shall…clarify all project stakeholders, define the process and agree on approval timelines for delivery.
4.  Thou Shall...define the ‘story line’ and summarise the key communication messages before fleshing out the content. Carefully consider the title, headings, hook for grabbing audience’s attention and visuals to help bring the piece to life.
5.  Thou Shall….communicate clearly and frequently with all stakeholders.
6.  Thou Shall…flag any potential pitfalls or challenges and offer solutions to overcome any hurdles.
7.  Thou Shall…always maintain a high level of professionalism, integrity and continually build and maintain the trust of stakeholders at all times.
8.  Thou Shall ….always aim to exceed expectations. Thou shall not make promises that cannot be kept, and thou shall not overpromise and under deliver.
9.  Thou Shall… read fervently and keep up to date with medical advances.
10.  Thou Shall….carefully proofread all content and ensure the objective and needs of the intended audience are met before submitting any work for review.

………AND a few more commandments:

 Thou Shall….always remain flexible, transparent, enthusiastic and passionate about the work. If thou makes a mistake, thou shall admit it and fix it as quickly as possible

Thou Shall…aim to continually improve and gain feedback for continuous process improvement.

In 2014, Australian pharmaceutical companies spent more than $2,000,000 on advisory boards over a 6-month period.¹ What was the return on this investment, you may ask?

At one end of the spectrum, advisory boards can be invaluable, providing external opinion, sage advice and input into brand position and strategy. On the other hand, poorly convened meetings can waste time and resources, frustrate and even disenchant members, with little return on investment. Like most activities we undertake, the end result is usually a function of the amount of time invested into planning and pursing the best outcome. Board meetings can be futile unless you have the motivation, time and resources required to make them work!

1.  Set the meeting objective and plan the agenda well in advance

Have a clear meeting purpose and seek stakeholder input on the proposed agenda. Listen and be flexible to change. Board members want to know their time and input is valued. This is important for building interest and soliciting opinion to maximise face-to-face time, so you can focus on what’s most important for driving success. Send out relevant information before the meeting so members can prepare.

2. Ensure you have the right people

You want a mix of knowledge and skills, brand advocates, fence sitters and skeptics, who will collaborate, and generate ideas, not collide. Choose the right chairperson (preferable a well respected external person) to encourage honest feedback, keep the meeting on track, summarise key conclusions and highlight action points from the meeting. Brief the chairperson thoroughly to ensure they’re on the same page.

3. Set expectations

All members should be aware of the board’s mandate, the level of participation required and financial compensation. Honesty, trust and open frank discussion should be encouraged at all times.

4. Be action-oriented

Be clear on what you want to achieve at the end of the meeting. During the meeting, ensure key points are summarised after each session, and make actions, responsibilities and next steps explicit.

5. “Mix it up”

Listen don’t lecture. Avoid lengthy didactic sessions. You’ve engaged board members to hear what they have to say. The company’s role should be to encourage and facilitate discussion. Include a variety of adult learning formats, such as interactive workshops, case studies and activities, which draw out key issues, opinions and ideas.

6. Pay for professional meeting minutes

An experienced medical writer will distill the nib of verbal discussions. Conversation often moves back and forward, in a non-linear or haphazard fashion. Minutes should be informative, but pertinent, collate and crystallise relevant points in a clear, logical order. Good documentation is essential for ongoing reference and to ensure follow up and progression from meeting to meeting. Wherever possible the writer should attend the meeting to glean an accurate and complete perspective of the proceedings.

7. Follow-through

Without action, there is no effect. Ensure responsibility for follow through of all meeting action points and next steps.

8. Review

Continually seek feedback from external and internal attendees regarding the effectiveness of the meeting. If it’s not working, change it. Sometimes you may even need to change board members.

Reference: 1. Medicines Australia. Company Reports Summary. 1 April 2014-30 September 2014, available at: https://medicinesaustralia.com.au/code-of-conduct/education-events-reports/advisory-board-reports/. Accessed 29 May 2015.

Note: Medicines Australia detail a number of professional standards for Australian pharmaceutical advisory boards (see Section 9.9 Code of Conduct Edition 18, available at: https://medicinesaustralia.com.au/code-of-conduct/code-of-conduct-current-edition/

About the author:

Celia Green (B Pharm; MBA) is director of Bioscript Pty Ltd, an Australian medical communications company established in 2003. Celia has over 22 years’ experience in the pharmaceutical industry, including several years as a Medical Liaison Manager, where she assisted with company advisory boards. As a consultant, Celia has attended and written minutes for a large number of diverse pharmaceutical advisory boards.

1. At the project outset determine the objective, the primary audience and budget. The format, structure, style and length of the piece should be agreed with all stakeholders, such as the project lead (primary client contact), all reviewers of the material, the medical writer and graphic designer.
2. Ensure all people involved have the right skill and expertise for the job.
3. Spell out and agree the process for material development, the role of all stakeholders and the process for material review.
4. Set realistic deadlines and stick to them. It is important all stakeholders commit to the agreed time frame.
5. Strike while the iron is hot. Avoid lengthy delays between drafts as efficiencies and motivation wane over time. Important pieces of information may be forgotten and often time is lost “getting back up to speed”.
6. Ensure clear communication throughout the process. Avoid ambiguous comments. Clarify important information as soon as possible, remembering sometimes for particular circumstances it may be more effective to communicate verbally or in-person.
7. Try to offer alternatives, suggestions and specific wording, rather than a comment to change the content. This enables the reviewer to consider the feasibility of the amendment, avoid any miscommunication and expedite the review process.
8. Before submitting the piece for rework or review, all stakeholders should check and double-check their work and comments in line with the agreed project parameters.

An experienced medical communication consultant will:

1. Clarify the project brief including the objective, the intended audience, timeline and budget.
2. Anticipate potential roadblocks and find solutions you may not have considered.
3. Communicate and work with all stakeholders to ensure the content meets the brief and stays on track.
4. Avoid unnecessary drafts, reducing client frustration and time reworking unsatisfactory content.
5. Identify the most cost-effective solutions for you, without compromising quality or cutting corners.
6. Ensure your project meets quality and compliance standards and is delivered on time and on budget.

http://www.hundredsofcustomers.com/wp-content/uploads/2013/10/Theres-always-someone-who-will-do-it-cheaper.jpg

1. Hanging comparators: One of the most common omissions I see is the lack of a comparator. It is insufficient to make a claim about a product, for example “Product X improves symptom severity“ without stating the comparator. Is symptom severity, in this case, better than placebo or another product? Or was symptom severity with Product X improved at a particular time point compared from baseline?
2. Insufficient qualification: All claims must be sufficiently qualified to ensure they are accurate and balanced. For example with the claim, “Product X improves symptom severity”, further information is necessary to support the claim, such as what specific symptom(s) were measured, what dose and duration of treatment were used? How was symptom severity measured? Qualifying statements must be linked to the claim, using a readily identified symbol such as an asterisk, in 3 mm print size (as measured from lower case letter ‘e’ for printed materials) and positioned immediately below or adjacent to the claim.
3. Unqualified animal or in vitro data: This data should not be used as the sole evidence to support a promotional claim. A qualifying statement that animal or in vitro data may not necessarily predict clinical effects must be stated.
4. Graphical omissions: Graphics need to be checked carefully, often several times over, to ensure they are accurate, current and balanced, and not mislead either directly, by implication, or by omission. Sometimes patient numbers, treatment strength, treatment duration, time period over which the endpoint was measured, and statistics (such as p value) are omitted. Ensure x and y axes are adequately labelled, data is accurate and units of measurement are provided. The study design details must be included and there should be sufficient information about the measured endpoint. If the graph is based on another source, it should state “Adapted from…….” with the appropriate reference citation included.
5. Taglines with unqualified superlatives: Taglines must be adequately referenced and qualified. You must not imply a product is unique or has some special merit unless it can be adequately substantiated with evidence of sufficient quality to support the claim.
6. Insufficient detail to stand on its own: Each page must be adequately substantiated, referenced with all the necessary qualifiers. In particular, ensure “Summary” pages pass the “stand alone” test.
7. Unreferenced material: All claims and data must be adequately substantiated and referenced. In particular, check headings carefully, as titles may be phrased as a promotional claim and, therefore, must be adequately referenced.
8. Insufficient evidence to support a claim: Any information used to support a claim must include sufficient detail and be of adequate quality to validate the claim. In particular, comparator claims must be based on unequivocal data. Just because one study reported improved quality of life with Product X compared to a competitor, does not necessarily mean the body of evidence supports superior quality of life. What is the quality of the study? For example, a systematic review of randomised controlled clinical trials is stronger evidence than a retrospective, post-hoc marketing-driven analysis of prescription data. The substantiation of a claim must not rely solely on “data on file”, abstracts or posters.
9. Unregistered products and indications: Caution when reviewing materials sourced from an international affiliate. Particular care must be taken as products and indications approved by the Therapeutic Goods Administration in Australia may vary from overseas regulatory bodies.
10. Inappropriate use of post-hoc analyses and secondary endpoints: The use of post-hoc analyses may be acceptable, according to Section 1.2 of the Code of Conduct, but they must be clearly identified, used in context of the primary end point(s) and appropriately qualified. Carefully examine claims based on secondary endpoints, particularly if the primary endpoints are not met, as they must be consistent with the body of evidence, accurately reflect the conclusion of the study and include a qualifier if the primary endpoint was not met.

Please note this blog is intended only as a brief vignette and is not in any way a comprehensive report of all compliance issues. For further information, please refer to Medicines Australia Code of Conduct and supporting guidelines (see: http://medicinesaustralia.com.au/code-of-conduct/code-of-conduct-current-edition/) together with any other relevant regulations and legislation and internal company guidelines.