For the increasingly-stretched Medical Information department, standard response documents (SRDs) are a double-edged sword. On one hand, they increase inquiry-handling efficiency, and ensure a level of consistency and control over the information provided to customers. On the other hand, however, the time and effort required to write, review, edit, approve, maintain, distribute and update these documents while retaining an auditable record of your search strategy is a great burden on resources. And that’s before you introduce multiple languages into the equation! What started as the set of succinct SRDs you prepared at product launch based upon the handful of key studies, can quickly become a sprawling headache once the product is on the market, had several labeling updates and been the subject of hundreds of clinical publications.
It is therefore important to give serious consideration to any plan, either in-house or outsourced, to undertake a SRD writing project. In this three-part blog series, we will cover pre-project considerations, approaches to structure/content, discuss several case studies we have encountered, and review the SRD solutions that were put into place.
In this first installment, we will discuss the pre-project considerations.
Should you pro-actively generate SRDs at all?
There are a number of factors to consider in this decision: Does the product receive (or if pre-launch, is it expected to receive) a high volume of inquiries? Does the product receive frequently asked questions (FAQs) for which it would be more efficient to have pre-prepared responses? Are response times to the inquiries subject to exacting Key Performance Indicators (KPIs) or a key company focus? Are you required to demonstrate particular control over the responses used, such as in an outsourced model?
If the answer to any of these questions is “yes”, then an SRD project is likely to be of value to you. If not, and a broad range of inquiries are received in low volumes, a better use of resource may be to generate responses on an “as needed” basis.
Defining the scope of the responses
Having decided to go ahead, it’s key to plan the SRDs to be generated in order to maximize their value. It is equally important to determine what not to write and waste resources on – if an SRL will not provide clinical value to your customers, perhaps it shouldn’t be written. For example, you may find the pharmacodynamics of the drug fascinating, but unless it represents a paradigm shift in a therapeutic area, it’s unlikely to be requested by your customers.
If the product is already on the market, information on common questions should be readily available to you. If not, SRDs on efficacy are a common requirement, as are those on specific populations (e.g. pediatric, elderly, renally-impaired, hepatically-impaired, etc.). Beyond this, consider developing responses on any serious undesirable effects which are likely to be of concern. Also, questions are likely to be received related to the use of product in combination with other agents used to treat the same condition. Likewise, comparisons to similar or competing products are often asked.
For an actively-marketed product, liaising with Marketing on the key promotional messages would be useful, as it is often the marketing materials that prompt inquiries into Medical Information. Similarly, Marketing should be able to advise on the position of the product in the marketplace.
Review and update periods
The initial generation of the SRDs is only the beginning. An important requirement of SRDs is that they are balanced and up-to-date. Therefore a schedule for review and update is essential. A common approach is to review all SRDs annually for mature products and more frequently for novel products when new data is published on a regular basis. Another decision to make which will impact resource is whether to update the SRDs proactively at the review period or to wait until that SRD is next required to respond to an inquiry before updating.
Finally, in order to avoid an ever-growing collection of SRDs which require an annual update, some sort of monitoring system should be put in place to assess whether responses are being utilized. Based on this assessment, a decision can be made to ‘retire’ an unused SRD and avoid needless future updates.
Over the coming installments, we will explore considerations to take into account when planning SRD content, as well as potential solutions to the various SRD requirements of different pharmaceutical companies. By the end of the series, we hope that you will discover how appropriate planning of the scope and content of your SRD project can better equip your Medical Information teams, increase efficiency, and provide a better service to your customers.