Beruflich Dokumente
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Joubert
Silvia M. Rogers
Strategic Scientific
and Medical Writing
123
Strategic Scientific and Medical Writing
Pieter H. Joubert Silvia M. Rogers
Need to write a short, succinct paper, a report which will capture the attention of the
reader and influence the outcome? Help is at hand in this punchy manual written by
two knowledgeable scientists and teachers with experience in the worlds of aca-
demia, industry, and regulation.
This book is written in easily accessible sections, each dealing with the practical
problems that a newcomer to the field may experience and seasoned writers need to
be reminded of. It is written with a lightness of touch, combining common sense
with illustrative examples of how to address different types of situations.
An attractive feature is that you, the reader, can test yourself on your planning
skills and performance and detect the errors you may not even have been aware of,
thereby improving your success rate in making important submissions.
But as the authors say, while learning these skills requires care and attention, it does
not need to be all drudgery and can also be enjoyable once the basic principles have been
mastered. Having read the book, you may say but I knew all these things before.
Good! So now is the opportunity to put them into practice, and by reading and noting the
plans outlined in this book, you will become an even better communicator.
v
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Why Bother with Writing Skills? . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 The Key Components of Good Medical/Scientific Writing. . . . . . . . 2
1.2.1 Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.2 Science . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.3 Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.4 Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2.5 Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 How to Plan a Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3.1 The Nature of the Document . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.2 The Desired Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.3 Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.4 Target Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3.5 Key Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3.6 Sources of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 Using a Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2 Written Communication in Drug Development . . . . . . . . . . . . . . . . . . . 9
2.1 Where Is Written Communication Used in Drug Development? . . . 9
2.1.1 Recording Nonclinical Findings . . . . . . . . . . . . . . . . . . . . . . 10
2.1.2 Preparing Drug Development Documents . . . . . . . . . . . . . . . 10
2.1.3 Communicating with Regulatory Authorities and Other
Important Institutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3 Written Communication in Academic Settings . . . . . . . . . . . . . . . . . . . 13
3.1 Where Is Communication Used in the Academic Setting? . . . . . . . . 13
3.2 Scientific Papers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.3 Theses and Dissertations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.3.1 Masters Thesis/Dissertation . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.3.2 Doctoral Dissertation/Thesis . . . . . . . . . . . . . . . . . . . . . . . . . 15
vii
viii Contents
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Glossary of Abbreviations Used in This Book . . . . . . . . . . . . . . . . . . . . . 137
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Books . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Published Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
List of Tables
xiii
xiv List of Tables
Table 8.1 Age, mass, height, and body mass index in four groups of professional
athletes
Table 8.2 Trough plasma concentrations in healthy volunteers after a single dose
(750 mg) of four different formulations of a new drug intended for a
phase III clinical study
Table 9.1 ICH quality guidelines
Table 9.2 ICH safety guidelines
Table 9.3 ICH efficacy guidelines
Table 9.4 Multidisciplinary guidelines
Table 9.5 ICH multidisciplinary guidelines
Table 9.6 Key regulatory guidelines
Table 10.1 ICH guidelines on the Investigators Brochure
Table 10.2 Contents of the Investigators Brochure
Table 10.3 Template for planning an IB in conjunction with a specific study proto-
col, aimed at the investigator and staff
Table 11.1 FDA guidelines for IND submissions
Table 11.2 Key elements of the IND application
Table 11.3 European Commission guidance on CTA submissions
Table 11.4 Key elements of the CTA application
Table 11.5 Suggested preparation template for CTA (IMPD) or IND
Table 12.1 Regulatory guidance on Module 1 of the CTD
Table 12.2 Components of Module 2 of the CTD
Table 12.3 ICH guidance on preparing an electronic CTD
Table 12.4 Proposed planning template for the CTD
Table 12.5 Regulatory guidance on nonclinical overview preparation
Table 12.6 Structure of nonclinical overview
Table 12.7 Regulatory guidance on clinical overview preparation
Table 12.8 Structure of clinical overview
Table 12.9 Common mistakes when compiling a CTD
Table 13.1 Regulatory and other guidance on protocol preparation
Table 13.2 Template for planning a study protocol
Table 13.3 Regulatory guidance on studies in children
Table 13.4 Example of a simple schedule of assessments
Table 13.5 Guidance on ethics and informed consent
Table 13.6 Contents of a clinical study report according to the ICH3 guideline
Table 13.7 Suggested numbering of study report contents
Table 13.8 Regulatory guidance on abbreviated studies
Table 14.1 Impact factor for the top 10 medical journals in 2015
List of Figures
xv
xvi List of Figures
Fig. 8.9 Kaplan-Meier plot showing survival in patients with a specific type of
cancer receiving either standard treatment (ST) with an investigational
drug or placebo added to their treatment
Fig. 8.10 Average number of cases of carbon monoxide poisoning seen per
month (average of 5 years) in an African village with no electricity
Fig. 8.11 Data shown in Fig. 8.10, broken down into age groups
Fig. 8.12 Responder rates for drug A and drug B. An inappropriate Y-axis scale
is misleading and makes a small difference appear large
Fig. 8.13 Plasma concentrations in dogs receiving identical doses directly into
the stomach, small bowel, or large bowel (a log Y-axis makes the differ-
ences between the absorption sites appear smaller than they really are)
Fig. 8.14 Cmax versus dose, shown as the mean Cmax versus dose (left graph) and
individual values of Cmax versus dose (right graph). Using the mean
data makes the linear relationship appear clear and statistically signifi-
cant. Using all the individual data points shows that there is no statisti-
cal significance
Fig. 9.1 Organization and numbering of the ICH topics and guidelines
Fig. 10.1 Development of the Investigators Brochure and changes over time
Fig. 10.2 The IB viewed primarily as a GCP document
Fig. 11.1 Summary of the planning information required in IND and CTA
documentation
Fig. 12.1 Components of the common technical document (CTD)
Fig. 12.2 Summary of the overall approach for planning and producing the clini-
cal overview
About the Authors
xvii
xviii About the Authors
There is wide consensus that the writings of William Shakespeare are of a high
literary standard that has survived the test of time. It is clear that if text of the scene
from the Merchant of Venice would be used as a bedtime story for a 3-year old, with
the intention of imprinting on a young mind the concept that compassion and
sympathy are useful attributes, it simply would not work. On the other hand, a story
in simple contemporary English of the mouse that took out a thorn from the
elephants foot would work as a bedtime story with a message on compassion.
In the area of medical and scientific writing, the underlying science in a document
may be solid and the use of language perfect, but if the text does not convey the
intended message to the target audience, the document might be a dismal failure. A
good document should not only be based on solid medical/scientific data but should
additionally convey the correct messages to the target audience to achieve the
desired outcome.
As the authors of this book we aim to assist you in becoming successful medical
and scientific communicators, on top of being good writers. The key factor in
achieving this is to imagine yourself as being in the shoes of the target reader(s) of
your document and to pre-empt their response.
In most cases, we will discuss medical/scientific writing in the context of
pharmaceutical medicine and drug development. The principles, however, also
apply to academic fields and other areas of medical/scientific writing, as well as to
non-written means of communication.
Science
Tools
Guidelines Language
1.2.1 Strategy
The key to writing successful documents is to use the correct strategic approach. To
plan and execute a successful strategy, you have to familiarize yourself with the type
of document you wish to produce. You need to identify and understand your target
audience so that you can convey the key messages clearly, convincingly, and
concisely and achieve the desired outcome.
Documents always have to be reader-friendly. If you antagonize, bore, confuse,
or irritate the reader, your chances of a successful outcome are greatly diminished.
Documents should be well organized with appropriate headings and skillful use of
graphics. There should be a natural and logical flow, and the reader should not have
to hunt for information. If your document is easy to read and captures the attention
of the reader, you have a high probability of a positive outcome.
1.2.2 Science
1.2.3 Guidelines
There are guidelines for most documents. Examples are internal company guidelines,
guidelines of regulatory authorities, or journal guidelines for authors. In general, it
is advisable to follow guidelines closely, as they represent the expectations of your
target reader(s). Guidelines are, however, exactly what the word suggests, namely,
the mere guidance for the preparation of a document. They cover the general
requirements but are usually not cast in stone. Sometimes, the guidelines do not fit
the issue you are concerned with, and you may have to make some adjustments.
However, any deviation from the guidelines should be made clear upfront, and your
decision should be justified and well motivated. Any deviation from a guideline
should add value, make the key message clearer, and enhance your chances of a
successful outcome.
4 1 Introduction
1.2.4 Language
In this book, we focus on English as it is the most widely used scientific language,
but the principles we cover are universal, irrespective of the language you use for
producing a document.
Many scientists like using complicated and impressive scientific jargon, forgetting
that the people they communicate with do not necessarily have the same scientific
expertise and might not be proficient in the language they use. In general, the
language you use should be simple, correct, clear, and unambiguous. A helpful
principle is to use simple words and keep sentences short. You might communicate
with regulatory authorities, for example, where most of the staff members are
nonnative English speakers. For them, English might be a second, third, or even
fourth language. I once heard a politician speak about the first exposure of the young
mind to the formal educational process. He meant when children start going to
school, but for nonnative speakers, this may not have become clear at once. Sloppy
and overblown language will plant the seeds of doubt in the readers mind; they may
ask themselves whether the scientific work underlying the document may have been
as careless as the language used to describe the findings. Thus, the credibility of your
medical/scientific message may be jeopardized on the grounds of sloppy language.
1.2.5 Tools
Your planning is driven by strategy. Assuming that you work with solid data, your
chances of success will be determined by the way you manage the key elements as
discussed below.
1.3 How to Plan a Document 5
The major determinant of how you will proceed is the nature and purpose of the
document you aim to produce. Many types of documents are integral parts of the
drug development process, such as the Investigational New Drug (IND) document,
Investigational Medical Product Dossier (IMPD), Investigators Brochures (IB),
study protocols, study reports, the Common Technical Document (CTD),
publications in a scientific journal, etc. Once you know the type of document you
need to write, the following are key considerations:
1.3.3 Guidelines
If you work for a pharmaceutical company, there will be internal guidelines and
templates for documents such as study protocols and reports. The current guidance
documents of regulatory authorities are readily accessible on their websites. Before
starting to write a document, you should familiarize yourself with the appropriate
guidelines. Sometimes you will find that you need to deviate from a regulatory
guideline because it does not entirely fit your situation. This is fine, provided you
make the deviation clear upfront and can justify your approach. It is also important
to decide whether your document is a final document, such as a final study report,
or a living document, such as an IB, where changes should be made as new
information becomes available. A good medical/scientific writer will not only add
new information but will also remove information that has become irrelevant to
prevent the document from becoming too large and difficult to read.
A common mistake is the urge of some authors to write something under a
particular heading at all cost. If no clinical data are available at the time you are
writing an IB (see Chap. 10), Section 7.3.6 of the ICH guideline (Effects in
Humans) should not include any speculation on what may be found, but should
merely contain a simple statement that no data in humans are available at the time
of writing the document.
6 1 Introduction
Your target audience may vary greatly. For example, the audience may include
employees of regulatory authorities (with varying backgrounds in terms of scientific
and/or medical training), ethics committees (which usually include lay members,
people with legal background, scientists, and clinicians), or journal editors and
reviewers. It is imperative to consider the background of the target audience in
choosing the appropriate style of language and the use and explanation of scientific
and clinical terminology. A sentence such as Deposition of hydroxy apatite in the
intima, irrespective of the presence of atheromatous changes, impacts on vascular
compliance and tissue perfusion might be fine for a clinician, but for a lay person in
an ethics committee, a more appropriate sentence would be: When calcium crystals
form on the inner surface of blood vessels, the blood vessels may become stiff and
hard or blocked, and this can decrease the blood supply to important organs.
The key messages should convey the essential information needed to convince the
responsible person(s) to make a decision in line with your desired outcome. For
example, when compiling an IND application for the first study in humans, you
would primarily like to tell the regulatory authority that you have sufficient and
convincing nonclinical data to justify a study in humans and that all potential safety
issues are addressed in the proposed protocol.
Using a suitable template (Table 1.1) helps you to compile a document that follows
a logical train of thought and covers all important issues. The template we
recommend resulted from years of trial and error. In our experience, the template
1.5 Final Thoughts 7
We hope that your journey through this book will be pleasant and informative and
that sharing our experience with you will help you to optimize your communication
skills, both verbally and in writing.
Exercise
Before proceeding to the next chapters, try to compile the following document
templates:
A scientific publication: You are working for a company that has developed
a novel antihypertensive drug (use your imagination to create a target
profile), and the CTD has been submitted. Your target prescribers will be
general practitioners and you would like to establish your drug as first-line
therapy. You have the data from two major pivotal studies in patients with
mild to moderate essential hypertension. Plan a scientific publication that
will be complimentary to your marketing campaign.
An IB
A study protocol
A study report
Retain these templates while reading the book and repeat the exercise
when you have finished, without looking at your first set of templates. Then
compare. Have fun!
Chapter 2
Written Communication in Drug Development
Imagine what happens with your experiments or studies if you fail to record their
outcome in writing. No one would know of your important findings, and it will be
almost impossible to prove to others that you had actually carried out the research.
Painstaking efforts and elaborate work may be lost, simply because there is no
written account of them. Essentially, nonclinical findings form the basis of future
studies in humans.
It follows that written communication in drug development is of critical
importance. For this reason, it should be our main concern to document new findings
efficiently, effectively, and truthfully. A concise summary of the documents written
during the preclinical stages of drug development is provided by Rogge and Taft [1].
As pointed out in Chap. 1, the drug development process encompasses many types
of documents, such as IBs (Chap. 10), INDs and IMPDs (see Chap. 11), CTDs (see
Chap. 12), study protocols (see Chap. 13), study reports (see Chap. 13), and
manuscripts intended for publication in a scientific journal (see Chaps. 3 and 14).
In drug development, failure to document our findings inevitably results in delays
in obtaining marketing authorization of a new drug. This translates into substantial
sums of money being lost by the sponsor company.
Although many factors influence the speed and efficiency of a drug development
program, the value of effective communication during the drug development and
approval process is unquestioned, especially for the development of novel
medications for which regulatory guidelines have not yet been established [10].
While early consultation with the authorities is indispensable, other bodies relevant
to the target indication may have to be addressed. Such consultations should,
however, only be undertaken when the pertinent medical and drug information data
are available.
The FDAs Center for Drug Evaluation and Research (CDER) typically approves
more than 100 new medications every year. In 2014, as many as 41 of the newly
approved agents were novel molecular entities or new therapeutic biologics, which
is considerably more than in previous years [11]. Many of these new drugs are
expected to make a significant contribution to the management of serious or
life-threatening diseases. In addition, an exceptionally large number of drugs
(n = 17) to treat so-called rare diseases were approved in 2014. This achievement is
of particular merit because there are often no (or insufficiently effective) drugs
available to treat diseases occurring in small populations.
Early and regular communication between drug developers and health authorities
allows the authorities to apply tailor-made review and approval procedures, with the
aim to ensure the fast availability of important new medications. In the USA, such
regulatory procedures include Fast Track, Breakthrough Therapy, Priority Review,
and Accelerated Approval [11]. Fast Track and Breakthrough Therapy designations
are intended for drugs to treat serious conditions with unmet medical needs, while
Priority Review is granted for drugs expected to provide a significant advance in
medical care. For such medications, CDER shortens their review period from 10
months to 6 months. The Accelerated Approval program allows early approval of
drugs to treat serious or life-threatening illnesses for which less effective treatments
are available. In these cases, approval is based on a surrogate endpoint (e.g.,
laboratory value or biological marker) or intermediate clinical endpoint that is
thought to be reasonably likely to predict clinical benefit [11]. After approval of
such drugs, additional clinical studies are usually required to confirm the predicted
clinical benefit [11].
There are special areas where there are timeline and/or financial incentives to
encourage drug development:
Obtaining orphan drug designation encourages the development of drugs for rare
diseases. Incentives include free advice and possible acceptance of innovative
study designs.
Pediatric population: Many adult diseases have a small subpopulation in
pediatric patients (e.g., rheumatoid arthritis, essential hypertension, type II
diabetes). The FDA encourages pediatric studies as part of drug development
in adults by offering an additional 6 months of marketing exclusivity, for
example.
12 2 Written Communication in Drug Development
Early contact with the regulatory authorities helps to expedite the development
process, and regular communication between the authorities and drug developers is
instrumental in streamlining the review of new products. Thus, health authorities
encourage regular exchange with drug developers and are usually prepared to
provide guidance at an early stage. Responsible professionals in the pharmaceutical
industry should make use of this opportunity; in this way, issues in connection with
manufacture, formulation, and/or testing of the new drug candidate can be addressed
at an early stage, thus preventing unexpected delays.
Chapter 3
Written Communication in Academic Settings
As pointed out in Chap. 14, publishing data in medical and scientific journals is the
most important means of communicating research results, both in the academic and
commercial settings. In either environment, authors are faced with the main three
questions, namely, why they wish to publish, what journal should be chosen, and
how they are going to unveil their scientific story.
While the reason for publishing in the commercial setting is usually connected
with marketing strategies, academic publishing primarily aims to advance scientific
and medical knowledge. In the academic environment, the publishing procedure is
usually less regulated than that in the commercial environment where company
policies oversee the publication strategy (see also Chap. 15). Thus, academic
researchers bear sole responsibility for their publishing efforts a fact that can be
an advantage or a disadvantage.
Chapter 14 provides detailed guidance on the planning and preparing of a
scientific manuscript intended for publication.
For many students, the masters thesis (also referred to as masters dissertation)
represents the first attempt at writing a formal scientific document. Although the
Internet supplies ample advice on how to write a thesis and universities tend to
supply good templates, most students face a major challenge when embarking on
their masters thesis. They are aware of the importance of this document in that it
represents the formal product of their studies, on the basis of which their
performance and achievements can be assessed.
Ideally, the masters thesis is written in a manner that renders it suitable for
subsequent publication in an appropriate scientific journal. For scientists, the
publication track record is of fundamental importance, and the sooner they can
establish themselves in the scientific community, the better are their chances of
advancement. However, not all masters projects are suitable for eventual publication,
and this may not necessarily reflect on the students ability to address a scientific
question. Some projects simply do not deliver publishable results, or they just form
a part of a larger study that will be published by other authors. Students whose
masters projects involve collaboration with a pharmaceutical company may
additionally be faced with confidentiality issues that prevent them from making
their findings available to a broader audience.
In any case, the masters thesis has to meet high standards in terms of contents,
format, and writing style, but there is no general consensus on how to present and
structure the data. The type of structure chosen depends primarily on the nature of
the study, as well as on guidelines and example documents provided by the university
or other institution at which the research was conducted. If the outcome of a masters
project is suitable for publication, the structure of the manuscript is essentially
guided by the specific author instructions of the chosen journal. Most journals
3.3 Theses and Dissertations 15
follow the classic IMRAD structure (an acronym based on the first letters of
Introduction, Methods, Results, and Discussion), or a modification of this. For
example, Introduction may be replaced by Background, Methods by Procedures,
and Results by Findings. Clearly, this simplifies the task of writing a masters thesis
to some extent because author guidance tends to be concise, and novice writers can
consult examples of papers published by the journal in question.
If you do not intend to publish the data generated within the study for whatever
reason, the thesis should be written in the form of a book consisting of chapters.
Although the number and nature of chapters depends on the specific research project
and extent of information accumulated, the structure suggested in Table 3.1 can be
applied to most situations.
In a section placed before or after the main text, you may wish to acknowledge
any help you have received during the studies. This may include supervisory efforts,
laboratory assistance, statistical help, or even editorial support.
The doctoral dissertation (also termed doctoral thesis) constitutes a more extensive
treatise than the masters thesis, reflecting the prolonged research period involved.
Commonly, doctoral projects last at least 3 years; occasionally, they can take
considerably longer. If funding of the project is limited to 3 years (as is typical in
certain countries, e.g., the UK), students and supervisors have a vested interest to
complete the studies within a reasonable time frame. However, funding for a limited
time period may put students under undue pressure to complete their studies more
quickly than would be appropriate to solve the research question. Such constraints
are liable to mislead students into careless or even sloppy work, which severely
impinges on the quality and credibility of the generated data. Even worse, students
may be tempted to falsify results or copy data from other authors, thus making them
guilty of plagiarism (see Sect. 6.3.3).
The doctoral dissertation constitutes an exposition of original research and
should reflect not only mastery of research techniques but also ability to deal
competently with an important research question. In addition, the writing of a
doctoral dissertation challenges your skills as a scientific communicator. It would be
unforgivable to present your hard-earned results in a dissertation that is difficult to
read and understand. As is true for any type of scientific treatise, the doctoral
dissertation aims to inform rather than confuse the reader. Although writing a
doctoral thesis may be a daunting task, it is perhaps the most important investment
into your future as a scientist. It will be a passport to acceptance into the scientific
community, and the nature of your work will set the scene for your future scientific
endeavors. For these reasons, it is more than worth your while to invest sufficient
time and energy into the completion of your thesis.
Table 3.1 Suggested structure of a masters thesis
16
While in former times, a doctoral thesis followed roughly the same format as the
one used for a masters thesis (see Table 3.1), a more popular approach nowadays is
to structure it as a series of articles suitable for publication in scientific journals. As
pointed out in Sect. 3.3.1, scientific endeavors live from sharing information and
contributing to the knowledge pool. Moreover, a scientists success hinges on his
or her publication track record, and early visibility in the scientific community is
clearly advantageous. Moreover, the thesis structure based on individual manuscripts
spares students the effort of having to write the thesis and articles for publication
separately. Nonetheless, not all universities support this approach, and your
institution and/or supervisor will have to advise you on this.
The Internet provides ample advice on the preparation of a doctoral thesis, but
the most appropriate inspiration usually comes from good examples written by
members of your group or department. There is no hard and fast rule on the
composition, contents, and structure of a doctoral thesis; you are the author and the
expert!
For most science students, the writing of a laboratory report constitutes their very
first attempt at presenting data in a structured and logical manner. Therefore, it is
not surprising that the quality of laboratory reports ranges from clumsy compilations
of methods and materials to rather sophisticated scientific papers. Universities and
other research institutions often provide insufficient advice for novice writers, thus
leaving students alone with a difficult first encounter with scientific communication.
This effort may be additionally impeded by language hurdles; most laboratory
reports are written in English, but this may not be the native tongue of the author
(see also Chap. 5).
Although laboratory reports are written for several reasons, the main reason in all
cases is to communicate the experimental work to your instructor, supervisor, or
other interested reader. Without the written record of your laboratory experiments,
there is no proof of your findings, and your efforts may be lost forever. Much
unnecessary time goes into repeating laboratory experiments if we fail to archive the
work. In the pharmaceutical industry, such deficiencies translate into serious delays
in the development of new drugs and unnecessary (and costly) prolongation of the
time to market.
Like all scientific expositions, laboratory reports should be brief, concise, and to
the point. This may be easier said than done; inexperience and language problems
invariably lead to wordiness and redundancies. Students are often tempted to
compensate for their lack of expertise with inappropriate detail and awkward
descriptions, thus making it hard for the reader to work out the story. A useful tip
is to rely on short sentences and commonly known words rather than obscure terms
18 3 Written Communication in Academic Settings
that are not understood by your readers. A good laboratory report lives from clear,
transparent, and logical messages that can be grasped on first reading!
Structural organization of a laboratory report is dictated to some extent by the
nature of the experimental work, but the conventional IMRAD (see also Sect. 3.3.1)
is, at least, a good start. Table 3.2 provides a suggestion for organizing your report
if the IMRAD structure can be applied.
Research proposals may be written at various stages of your scientific career. Here,
we focus on those you may have to write early on in your development as a scientist,
e.g., when elaborating a scientific question for your masters or doctoral studies.
A research proposal does not only aim to sell the research project; it additionally
serves as an advertisement for your capability as a scientist and scientific
communicator. You may have an impressive research idea, but if you fail to convince
the financial sponsor and/or your project supervisor(s), the proposal is likely to be
turned down. On the other hand, a well-prepared proposal may stand a good chance
of being approved even if the research idea is not groundbreaking. The quality of
your research proposal depends not only on the quality of your proposed project, but
also on the quality of your proposal writing. Therefore, the writing should be
coherent, clear, and compelling.
3.4 Other Student Papers 19
In the academic setting, grant applications play an important role at various stages
of a scientists career. The earliest encounter with grant applications may even be
before you enter university if you apply for a study grant. Here, we are primarily
concerned with applications for research grants, although the points made may
apply to other grant forms as well.
Why would you want to write a grant application as a researcher? Most of us are
aware that grant applications are hard work, demanding, laborious, and time-
consuming so why would anyone invest their precious time into such an
undertaking?
The answer is obvious: research is costly, and university funds are limited. Thus,
academic institutions depend on financial support from other sources. As pointed
out in Sect. 3.2, advancement and success of a researcher primarily depend on his/
her publication track record, and how can you publish in the absence of data? In
other words, grants enable you to pursue an interesting research question that you
could not have addressed without financial support.
22 3 Written Communication in Academic Settings
When applying for a research grant, you are expected to hand in a detailed and
precise description of the planned study or research proposal, as well as any previous
studies or other information of particular relevance to your project. It is also useful
if you include a realistic budget proposal. Your application for funding should
convince the sponsoring organization that your scientific question is of interest to
the scientific community and that you are able to answer the question on the grounds
of your training, experience, and technical facilities. Moreover, the proposal should
entail a realistic time frame and reasonable expenses. Open-ended proposals tend to
be suspect in the eyes of reviewers as it will be difficult to estimate the overall
costs.
A grant application that stands a reasonable chance of being successful must
fulfill a number of criteria. First, the research topic in question must be creative,
novel, and of interest to the scientific community as a whole. Second, your
experimental plan must be realistic, sound, and compelling. Finally, you must make
sure that the information is organized in a logical structure and that the wording of
your text is clear, unambiguous, and free of language mistakes. As with all good
writing, a grant application stands the highest chances of being successful if you are
able to anticipate the reviewers questions and work around them. Table 3.4 list the
most pertinent issues reviewers tend to bring up.
The format and extent of your proposal may vary, depending on the complexity
of the proposed topic and the level of detail expected by the sponsoring organization.
If guidelines for the specific grant application are available, make sure your
document complies with them in full. Many organizations provide forms and
templates that facilitate the process of completing a grant application. In the absence
of such guidance, your best bet is to use a layout similar to that suggested for a
research proposal (see Sect. 3.4.2). In addition, it is good advice to consult an
internal advisor with experience in writing successful grant applications. Bearing in
mind that you are asking for something (i.e., financial support), a favorable decision
on the part of the jury or selection committee is much more likely if your proposal
is enticing, legible, and well structured.
In both their learning and teaching roles, members of academic institutions have to
pay great attention to the quality of their texts. Poorly written or disorganized
student papers will hinder the advancement of the student, and manuscripts, research
proposals, or grant applications whose contents, structure, or style are deficient will
not be approved.