Many of those working within the medical publishing industry routinely refer to the International Committee of Medical Journal Editors (ICMJE)’s criteria for authorship. However, whether an author’s contribution is sufficiently ‘substantial’ to satisfy the first criterion (substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work) is subjective. The new ISMPP Authorship Algorithm aims to bring a standardised approach to the interpretation and application of ICMJE authorship criteria (focusing on criterion 1), in particular for publications of pharmaceutical industry-sponsored research. Following his presentation at the 2021 Annual Meeting of the International Society for Medical Publication Professionals (ISMPP), The Publication Plan talked to Avishek Pal, Scientific Communications Director, Cell & Gene at Novartis Oncology and lead of the ISMPP Authorship Taskforce Working Group #2, to find out more about the algorithm.

What prompted the ISMPP Author Algorithm Taskforce to develop the new ISMPP Authorship Algorithm?

 “The ICMJE authorship recommendations are a well-accepted industry-wide standard when it comes to authorship decision-making processes. However, over the years, a common point of contention has been the interpretation and application of ‘substantial contribution’.

A common point of contention has been the interpretation and application of ‘substantial contribution’.

Ambiguity around this has often fuelled perceptions of lack of transparency and has raised questions on the validity of the final decisions made. The goal of the ISMPP Author Algorithm Task Force was to address this challenge by developing a standardised quantitative framework to guide and document a consistent authorship decision-making process and to provide clarity in understanding and interpreting ‘substantial intellectual contribution’. I have to thank ISMPP, the Steering Committee and all Working Groups for their interest and support in getting us to the stage at which we are today.”

 At this year’s ISMPP Annual Meeting, you outlined the functionality of the algorithm. Can you tell us a little bit more about what the algorithm offers?

“The ICMJE authorship criterion #1 outlines four aspects that define substantial contributions of a contributor to the work (eg the study or analyses) in order to be considered as an author on the publication:

1. conception or design of the work
2. acquisition of data
3. analysis of data
4. interpretation of data.

The ISMPP Authorship Algorithm focuses on standardising and simplifying decision-making on ICMJE criterion #1. Based on a framework of detailed descriptors for the four themes of ICMJE authorship criterion #1 listed above, the algorithm quantifies/ranks the relative contributions of each contributor/potential author. In addition, it also calls out specific administrative contributions that are considered important and worth acknowledging but not sufficient to qualify an individual for authorship. The underlying premise for these descriptors for inclusions/exclusion is “It’s not who you are but what you do”, ie actual contributions rather than roles and/or responsibilities define eligibility for authorship.”

It’s not who you are but what you do.

 What do you envisage will be the main benefit of the algorithm to medical publications professionals?

“There will be more than one, I would like to believe. Firstly, the descriptor framework will enable better understanding of ‘substantial contributions’. Secondly, the relative quantification approach will allow an objective assessment of all contributions. Thirdly, the recommended documentation-based decision-making approach will enable transparent discussions with internal cross-functional teams as well as external contributors. In fact, our aspiration is that the documentation-based approach will facilitate earlier authorship discussions and set expectations up front, even before the data readout, which can then be revisited throughout a study leading up to the time of publication. And, last but not least, the algorithm will facilitate consistent interpretation of the ICMJE authorship recommendations across industry-led publications thus allowing us to achieve greater consistency in authorship decision-making and gain credibility among our external experts.”

 Can the algorithm be used to help determine author order?

“The primary goal of the ISMPP Authorship Algorithm isn’t about author order, rather, the top priority is to provide a basis to objectively define and assess ‘substantial contributions’ leading to transparent and collaborative authorship decision-making. As the algorithm automatically ranks contributors/potential authors based on relative contributions, there may be the opportunity to identify secondary uses such as author order, however, at this stage of the pilot, we have not explored this. To my knowledge, while some organisations use internal mechanisms to approach this challenge, there is no universally available standardised approach. The ISMPP Authorship Algorithm is possibly the first opportunity to enable implementation of the ICMJE authorship recommendations more effectively and universally in a standardised manner.”

The ISMPP Authorship Algorithm is possibly the first opportunity to enable implementation of the ICMJE authorship recommendations more effectively and universally in a standardised manner.

 How does the algorithm evaluate author contributions and account for the components that make up criterion 1?

 “The ISMPP Authorship Algorithm allows us to quantify/rank the relative contributions of each contributor/potential author through a simple combination of (a) a pre-selected weighting scheme applied to each project and (b) individual contribution scores based on the pre-defined descriptors. The weighting schemes account for the levels of complexity related to the type of studies, study designs, end points, nature of disease, stage of a product’s life cycle and/or therapeutic areas or subsequent associated publication activities, which necessitated more efforts from contributors. In fact, it is recommended that this exercise be undertaken at the level of a division, program, therapy area, or at least a study to avoid bias. On the other hand, the pre-defined descriptors provide specific guidance on how individual contributions should be scored. Together, they form a simple and yet rational basis for the algorithm to automatically rank each contributor/potential author.”

 At the ISMPP Annual Meeting you noted that absolute thresholds for defining ‘substantial contributions’ have not been defined, allowing organisations to adapt the algorithm to their own requirements or policies Could you give a little more detail on the flexibility offered by the algorithm?

“While the overarching goals and principles are possibly the same, we have to recognise the inherent subtle variability across organisations in how they approach authorship decision-making. The ISMPP Authorship Algorithm allows for such flexibility. For instance, an organisation may decide to use the qualitative decision-making framework and not the quantitative component, or, may only utilise the documentation approach. Another aspect of the algorithm which is flexible is how the weighting schemes are pre-defined. Teams could decide to use one universal weighting scheme for all publications or vary them based on program, disease area, study, etc. Finally, the algorithm allows continuous updates as a study progresses, thus ensuring a true representation as contributions continue to evolve over time.”

 What were the key learnings of the pilot test that was run this year?

“A key piece of feedback was around providing more clarity on the weighting scheme – the rationale and how it actually works in the background. A backgrounder on the topic went a long way in changing the initial perception that the algorithm is complex! Other key feedback was on revisiting the descriptors for “Acquisition of data”. Initially, based on lengthy debates, there was just one descriptor that tried to balance the never-ending debate of high enrolment versus quality of data. However, based on further discussions, this has now been teased out separately to allow better relative quantification.”

 How can the algorithm be accessed?

“Post rollout, the ISMPP Authorship Algorithm will be accessible via the ISMPP website.”

 Finally, do you have any future plans for the algorithm, such as further functionality or linking to publications management platforms?

 “As I mentioned at the ISMPP Annual Meeting, this is possibly a small but firm and bold step on a very contentious topic and is in no way conclusive. We will continue to leave a feedback channel open to gather more input as more colleagues start implementing the algorithm. We will then periodically revisit the approach we have taken to explore opportunities to fine-tune the algorithm as required.”

Avishek Pal is Scientific Communications Director, Cell & Gene at Novartis Oncology and lead of the ISMPP Authorship Taskforce Working Group #2. You can contact Avishek on LinkedIn or follow him on Twitter @Avishek_Pal.

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