Training medical writers in today’s environment 1: The integrated medical writer

Training medical writers in today’s environment 1: The integrated medical writer

Watson, Virginia

The integrated clinical study report is the end product of a clinical trial and the culmination of multidisciplinary effort. A full understanding of the clinical development process is a fundamental requirement of a medical writer. We are developing a training program, part of which is intended to provide the writer with an understanding of the clinical trial process and the issues that may be encountered. The aim is not only to develop the individual writer but also to strengthen interdepartmental communication and to improve the flow of information to the clinical writing department during the course of a project.

Key Words: Medical writing; Training; Interdepartmental communication

WHEN I JOINED Omnicare Clinical Research, every new employee attended a company induction day; otherwise there was no other formal training. There were, however, monthly clinical research associate (CRA) meetings for our field-based and in-house monitoring staff and, periodically, a training session would be held to which other departments were invited. Thus, I attended sessions on regulatory updates, ethics committees, case report form design (not primarily a writing department function at present), and safety issues. I have also given sessions on the clinical study report.

I felt, particularly in the early days within the company, that medical writers were perceived as being people who tucked themselves away in a corner, working almost in isolation. Now we know that this is not the case. Whatever the document, we need to interact with our colleagues in other departments, for example, medical advisers, project managers, clinical monitors, statisticians, and data managers and, because we are working within a contract research organization (CRO), we need to work closely with the sponsor. Clearly, medical writers are part of the clinical development or study team.

With growth of the clinical writing department planned, it was necessary to develop a structured training program. First, we set up local United Kingdom training guidelines for medical writers and support staff under the generic global standard operating procedure for training.

Training needs are assessed and identified according to the following categories:

Core elements,

Cross-departmental training,

Information technology skills,

Therapeutic area training, and Other.

Training records were designed. Each writer is responsible for maintaining his/her training record, and review of the training records is part of the six-monthly appraisal process.

The cross-departmental training program aims to provide:

An understanding of the clinical trial process,

An understanding of problems that may be encountered and which have the potential to affect timelines, and

A deeper understanding of individual roles within the team, leading to improved channels of communication.

This is a two-way process, since the other members of the study team also need to understand the role and needs of the medical writer, for example: “please keep the medical writer in the project loop.”

Initially, to supplement the general company induction, arrangements were made for a new employee to spend time (one to two hours) with each department and for the writer to accompany a CRA on a site monitoring visit. This has proved valuable, but sessions may be postponed at short notice because of project pressures, with the result that cross-departmental training has sometimes taken place over a protracted period of time. In the last two years, Omnicare has standardized CRA training by setting up a European training course. It seemed to me that, if space was available, this course might be beneficial to our medical writers. An example of a CRA training course timetable is given in Table 1. From this, you can see that the course covers a number of disciplines.

I will not go through the course in detail, but I would like to pick out three separate sessions for further comment: International Conference on Harmonization Good Clinical Practices (ICH GCP), safety review, and clinical data management (CDM). The ICH GCP session is given by our Quality Assurance Department and covers informed consent, ethics committees, the Declaration of Helsinki, and the ICH GCP guidelines. When I was considering the appropriateness of this course, I asked our head of quality assurance what he thought a medical writer would gain from his session. His reply was that it provided “a detailed content of ICH of which the writer should be aware in order to understand the environment in which data has been obtained and quality issues.”

During the course of this session, “quality information” is defined as:

RELIABLE: truthful, supported by evidence gathered under the correct conditions,

ACCURATE: no transcription errors, typing errors, unauthorized changes or mistakes, and

COMPLETE: no missed facts or unreported incidents.

This definition is an excellent reminder to us all, whether we are experienced medical writers or fresh to the profession.

The aim of the safety review session is to provide an overview of the work of the department. It includes not only definitions of adverse events (AEs) and serious adverse events (SAEs) but explains, using examples, the difference between a serious and severe AE, why a mild AE can be an SAE, and so forth. A very useful part of the session is devoted to the SAE reporting procedures and to the role of the safety group in reviewing the AE pages of the case report form (CRF).

A half-day is assigned to clinical data management, and participants in the course are taken through the progress of a CRF, from the moment it enters the department until the data have been double-entered and the last query resolved.

One aspect of this half day which has been particularly well received by our writers is the section on coding during which our coding expert covers:

Reasons for coding,

The use of manual and automatic encoding procedures,

The different coding dictionaries which may be used, and

Dealing with terms which are difficult to code.

A necessary part of any moderntraining course is the evaluation questionnaire. I have analyzed the feedback provided by the three writers (yes, I know it is a small sample size and I cannot expect statistically significant findings) who have attended the course so far. Participants were asked to rate a number of items for each session using a scale of one (poor) to four (excellent). I looked specifically at the response to the questions: “the information presented gives you a better understanding of Omnicare procedure” and “the information presented is relevant to your role in Omnicare.” The results are summarized in Figures 1 and 2.

Scores for sessions on individual site visits have not been included in these figures since each writer scored differently and the general reaction was that these sessions were not particularly useful. Sessions on regulatory and ethics review, investigator recruitment, safety, and data management were considered to enhance the writers’ understanding of procedures, whereas sessions on regulatory review, protocol review, and project management were seen by the medical writers to be more relevant to their work. It should be remembered that these writers were inexperienced and new to the industry. Those of us with experience would probably consider most of the sessions to have some direct relevance.

So what are the advantages and disadvantages of these different approaches? The company induction is brief, very general, and of variable content and quality. Also, not all departments can always be represented. In addition, the company induction has become rather truncated of late, and has tended to concentrate mainly on personnel issues.

A departmental visit has the advantage of a one-to-one meeting, but it can easily be affected by time constraints and may be limited by the interaction of the individuals involved. For example, a new writer may not ask the most appropriate and useful questions, and may, therefore, not optimize the opportunity. However, during the time that we had a clinical trial supplies distribution unit, a visit to the unit proved to be invaluable and the opportunity to accompany a CRA on a study site monitoring visit has been appreciated.

The CRA training course provides a sound overall perspective and facilitates interaction between the medical writers, CRAB, and other team members. I have been told that CRAB participating have benefitted from this interaction: the presence of writers has stimulated discussion because of their different perspective. Writers were questioning things that were taken for granted by the CRAB. However, the course runs for three consecutive days and involves a greater time commitment than individual departmental visits.

I will now touch briefly on some other aspects of our training program. In the United Kingdom, medical writers come from diverse backgrounds and relatively few have a medical, pharmacy, or nursing background. Therefore, we need to look at providing therapeutic training and support. At Omnicare, we achieve this in three ways:

Lunchtime seminars by a medical adviser on a single topic, for example, Parkinson’s disease, skin disorders, or schizophrenia,

Project start-up meetings: it is now accepted by our project managers that for full service projects, a medical writer should attend the start-up meeting (a good example of how communication and interdepartmental awareness has improved), and Departmental training on specific or related

conditions targeted to new or potential projects (the difference between a CRO and the industry?). This is more extensive than lunchtime seminars and includes reference to Committee for Proprietary Medicinal Products guidelines, appropriate tools for measuring efficacy, and quality of life.

The therapeutic area is part of our continuous training program for all writers and is not solely for the inexperienced writer.

Of course, we do not rely solely on inhouse training. We make use of some of the excellent external training provided by such bodies as the European Medical Writer’s Association and the American Medical Writer’s Association. Writers are sent on external courses:

To enhance writing skills,

To receive tuition in the writing of specific study documents,

To improve information technology skills, and

For training considered necessary or desirable for the individual writer.

External courses have the advantage of providing the stimulus of interaction with others. This is particularly important when the course is designed specifically for medical writers and experiences and frustrations can be shared.

What is next? I believe that the format of our training program will continue to evolve to meet the challenges within our industry. For the foreseeable future, my view is that we shall use selected sessions of the CRA training course and combine this with individual departmental visits such as the site monitoring visits, and working alongside a data manager for a day.

We need to harmonize the training across our European offices but we must ensure that we retain a degree of flexibility to meet the differing needs and experience of staff entering our company or industry as medical writers.

Our aim is to provide our writing staff with the training necessary to maximize their potential and hopefully to increase their job satisfaction. A well informed, well trained medical writer will produce a quality product. I hope that we have gone some way toward providing this.

VIRGINIA WATSON, BSc, MPHARMS Head of Clinical Writing, Omnicare Clinical Research UK, Chippenham, Wiltshire, United Kingdom

This article was originally presented at the DIA 36th Annual Meeting, June 11-15, 2000, San Diego, California.

Reprint address: Virginia Watson, BSc, MPharmS, Head of Clinical Writing, Omnicare Clinical Research UK, Wessex Business Centre, Bumpers Way, Bumpers Farm, Chippenham, Wiltshire SN14 6NQ, United Kingdom.

Copyright Drug Information Association Jan-Mar 2001

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