Over the years I have written documents of all types and all lengths, ranging from a one-page clinical overview to a 300-page, single-spaced CSR (not including post-text tables and listings, of course). Some studies can be large and complex, with multiple doses and treatment groups, dozens of exploratory analyses, and acrobatic statistical maneuvers. It takes meticulous patience and tenacity to build a long document, brick by brick, sentence by sentence, one table at a time.
The complexity, however, goes beyond the writing. It is the project management aspect that can often pose greater challenges. The writer has to balance the shifting needs and priorities of various team members, some of which are conflicting or incompatible. One lesson I've learned from these projects is that things almost never go as planned. The bigger the document and the longer the timeline, the more likely that some unforeseen glitches will happen.
To minimize the risk of significant delays and ballooning costs, not to mention staff burnout and team dysfunction, the medical writer has the opportunity to step up and, if necessary, gently lead the team back on track. It takes courage and dedication, and some good planning. Below are some tips for the medical writer before embarking on a long and complex project involving many collaborators:
1. Build a little cushion into the timeline. Do not construct or agree to a timeline that allows zero breathing room. If you think you can revise a draft in a week at maximum capacity, you should add a day or two to allow for an unexpected event, such as a slight delay in statistical data delivery, a team reviewer being out of the office, different opinions between reviewers, a computer or network outage, or, if all goes well, for you or (better yet) a colleague to do a read-through for quality.
2. Communicate, communicate, communicate. Before and immediately after receiving the data, try to chat up key team members as much as possible, especially the biostatistician, lead physician, and safety physician or pharmacovigilance lead. Get a feel for the overall results and what they mean. Explore potential problem areas, such as a particular type of SAEs, that may cause controversy or debate down the road. Alert relevant team members of problem areas as early as possible, so that they have more time to think and discuss.
3. Identify one or two persons who will be in the position to help you reach a quick resolution, should the need arises. For example, one team member insists on combining several tables into one big table, while a couple of other people disagree. Or, an upper management reviewer extensively rewrites the conclusion that the entire team has spent weeks to write and approve. In every team there is one or two people that I consider to be a "nexus" or a central person. He or she does not necessarily have to be in a powerful position in the organization but is well connected and has a deep understanding of the project. If you enlist this person's help, the problem can be solved much more efficiently than you alone.
4. Consider a backup plan. Sometimes, a project simply expands beyond the original plan, while delay is out of the question. If you have an inkling that this may occur, you can preemptively request more resources, such as a secondary medical writer or an editorial assistant, on the standby. An honest assessment of risks and continued monitoring are the key to overcoming hurdles, whether they are expected or unexpected.
The complexity, however, goes beyond the writing. It is the project management aspect that can often pose greater challenges. The writer has to balance the shifting needs and priorities of various team members, some of which are conflicting or incompatible. One lesson I've learned from these projects is that things almost never go as planned. The bigger the document and the longer the timeline, the more likely that some unforeseen glitches will happen.
To minimize the risk of significant delays and ballooning costs, not to mention staff burnout and team dysfunction, the medical writer has the opportunity to step up and, if necessary, gently lead the team back on track. It takes courage and dedication, and some good planning. Below are some tips for the medical writer before embarking on a long and complex project involving many collaborators:
1. Build a little cushion into the timeline. Do not construct or agree to a timeline that allows zero breathing room. If you think you can revise a draft in a week at maximum capacity, you should add a day or two to allow for an unexpected event, such as a slight delay in statistical data delivery, a team reviewer being out of the office, different opinions between reviewers, a computer or network outage, or, if all goes well, for you or (better yet) a colleague to do a read-through for quality.
2. Communicate, communicate, communicate. Before and immediately after receiving the data, try to chat up key team members as much as possible, especially the biostatistician, lead physician, and safety physician or pharmacovigilance lead. Get a feel for the overall results and what they mean. Explore potential problem areas, such as a particular type of SAEs, that may cause controversy or debate down the road. Alert relevant team members of problem areas as early as possible, so that they have more time to think and discuss.
3. Identify one or two persons who will be in the position to help you reach a quick resolution, should the need arises. For example, one team member insists on combining several tables into one big table, while a couple of other people disagree. Or, an upper management reviewer extensively rewrites the conclusion that the entire team has spent weeks to write and approve. In every team there is one or two people that I consider to be a "nexus" or a central person. He or she does not necessarily have to be in a powerful position in the organization but is well connected and has a deep understanding of the project. If you enlist this person's help, the problem can be solved much more efficiently than you alone.
4. Consider a backup plan. Sometimes, a project simply expands beyond the original plan, while delay is out of the question. If you have an inkling that this may occur, you can preemptively request more resources, such as a secondary medical writer or an editorial assistant, on the standby. An honest assessment of risks and continued monitoring are the key to overcoming hurdles, whether they are expected or unexpected.
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