A literature search is a deliberate and efficient search from already distributed information to distinguish between a good quality reference on a particular topic. There are different reasons for conducting a literature search, including drawing information for making evidence-based reports, academic assessment, and a step in the research methods.
A thorough literature search is to form a research question by evaluating the available literature. A research hypothesis is a carefully created testimony of how you expect the research to proceed. It is one of the most important tools that aid in answering the research question.
A research problem is typically a topic of interest and some familiarity to the researcher. It needs to be channelized by focusing on information that is yet to be explored. Literature search can be exhaustive and time-consuming, but some simple steps can help you plan and manage your research. The most important is formulating the research questions and planning your search. It should be apt to contain necessary components and raise a question that can be tested and investigated.
FORMULATING THE RESEARCH QUESTION
The idea should be interesting and relevant to clinical research. It should either confirm, refute or add information to existing done research work. The entire research process should conform to the ethical principles of research.
A well-focused question should be chosen for research according to significance for patient interest and relevance to our knowledge. Dividing the questions into key components makes it easy to searchable. It should be divided into groups, such as patients, intervention, comparison or control arm, primary outcome, the timing of measurement of outcome (PICOT) is a well-known approach.
There are limited outcome research and relevant resources in India. Even when these factors are available, data about existing resources are not widely accessible.
With the upcoming transition to the EU MDR ( Medical Device Regulation (MDR) 2017/745) in May 2021, medical device manufacturers face constant monitoring and life-cycle management of their clinical data.
The Clinical Evaluation Report (CER) is critical to obtaining the initial CE-marking in the European Union. It is required to update it continuously throughout the lifetime of the device.
Frequently asked questions about literature reviews.
A literature review is a survey of scholarly sources (such as books, journal articles, and theses) related to a specific topic or research question. A literature review is an attempt to situate your work about existing knowledge. The literature review usually comes near the beginning of your thesis or dissertation. After the introduction and the introduction, it grounds your research in a scholarly field and leads directly to your theoretical framework or methodology. It is often written as part of a thesis, dissertation, or research paper. The literature review also shows how your work relates to other research and what new insights it will contribute to the reader.
METHODS and Types OF LITERATURE SEARCH
The Internet is now the gateway to the maze of vast medical literature. Conducting a literature review involves web-based search engines, i.e., Google, Google Scholar, etc., or using various electronic research databases to identify materials that describe the research topic or those homologous to it.
Physical literature exploration is an important component of any systematic review search process. With the advancement of technology, the Internet is now the gateway to much medical literature.
Depending on different the types of research and studies, there are generally 3 types of medical literature:
Primary sources include new evidence, conclusions, and proposals that are generally published in a peer-reviewed journal. It also includes preliminary reports, congress papers, and pre-prints.
Secondary sources include systematic review articles or meta-analyses where data derived from primary source literature are inferred and evaluated.
Tertiary literature includes the compiled information from primary and secondary literature sources.
What are the parts of a lit review?
Most lit reviews use a basic introduction-body-conclusion structure. If your lit review is part of a larger paper, it may be a few sentences.
The body is the focus in the introduction, and the conclusion part of the review body is discussed separately. For example, the Introduction is the body is first to discuss goals and research methods and conclude next to the body.
If you want to use the body to discuss the research in the first place you discuss your research, it takes up more space.
Fundamental for the success of your CER –
The literature review is a critical step in demonstrating the safety and compliance of your device. For Smaller and Medium Enterprises (SMEs) who do not manufacture devices with equivalents on the market, the literature search can comprise a large part, if not all, of the clinical data included in the CER. This data is what your CER writer will use to draft the actual CER submitted to your notified body.
Furthermore, Class Class II CERs and I rely heavily on clinical data from literature reviews and require emphasized focus on the literature search planning and execution.
Why should I hire an MDR literature search writer?
Even in medical device companies with a well-established regulatory and quality department, hiring an external literature search writer might be worth the expense.
The regulatory and quality department frequently comprises a single person or teams of one to three people for smaller companies.
In bigger companies with global reach, ensuring regulatory and quality compliance over several markets and product lines is complex and time-consuming, even in larger teams. In either scenario, internal staff might not have the time required for a well-planned and well-executed literature search.
Even if your employees have the time and willingness to take on the literature search, this labor-intensive task is likely not worth their time.
The literature search and review is a complicated process at best.
Each stage must be planned and executed correctly & systematically. Most regulatory people have scientific backgrounds and are well-versed in science and medicine. But might be lacking in analytical reading and writing skills.
For manufacturers in non-English speaking countries, requirements to avoid translation costs and write and submit the CER in English, adding a second layer of difficulties for staff who are not 100% comfortable with or qualified for writing in English.
Above all else, the requirements are getting tougher. Notified Bodies will be grading your CER with a much more critical eye than in previous years under meddev.
What should I look for in an EU MDR literature search writer?
The most enticing part of hiring an external literature search writer is finding someone who has hands-on experience with his latest regulations; Who has a good grasp on the process required to conduct a good literature search, and who know how to analyze the results and communicate them in an effective and precise manner? In short, you need a literature search writer with experience.
Most professional literature search writers are expert industry insiders who have worked within the regulatory and clinical sphere for years and are specialists within their field.
While professional literature search writers typically come from a scientific background. They also have significant experience writing scientific, medical, and technical content, making them perfect for the task.
A structured and systematic literature search lays the foundation for a strong CER and strengthens every stage of the clinical data.
Literature search protocols must be consistent and robust. Also, it is important to recreate the literature search during subsequent updates.
Process flow during the literature search planning and execution stage is vital. This is why it is important to choose a literature search writer who has a defined process (and can follow it) and someone who understands the applied methodology and can analyze results accordingly.
Organization/Attention to details
The ultimate goal of the literature search is to submit it to the notified body as part of the CER. Ideally, CER must be precise, coherent, thorough, and easily understandable.
In addition, your CER should be approved the first time it is submitted. EU MDR is going to cause a lot of delays with your notified body. And the last thing you want is to wait for months to get your changes for the final approval.
By hiring a CER writer with attention to detail, you will receive a beautifully written literature search that does not require additional edits.
This Clinical Evaluation Report needs to submit directly to the notified body. In return, you will not receive a long list of corrections from the notified body.
A professional literature search writer should be up to date on the latest regulations and requirements, be knowledgeable about medical devices and their therapeutic indications, and be strong on clinical knowledge.
Moreover, medical writers will have broad experience within the general therapeutic area of your device, if not the device type’s specific intended use. The knowledge base of the medical writer depends on what type of CER you need.
Suppose your device is Class I or Class II and relies heavily on clinical data from the literature and post-market surveillance data. Then you may need a writer with general clinical and therapeutic knowledge, but you may not need someone who is a specialist in clinical trials data and processes.
If your CER is for a Class III or a novel device, you will need someone with a good understanding of pre-clinical data and clinical trials.
Lastly, it would be best if you considered the timeframes & deadlines involved in your clinical evaluation. If you have to submit the clinical data within a short timeframe, hiring a literature search writer who can commit to the deadline becomes vital.
Most professional literature search writers can offer different time frames at different prices, so you can choose the solution that works best for your company.
How to find and hire a literature search writer for your Clinical Evaluation Report (CER)
First, you need to define the deadlines for your project.
Next, you want to define the estimated number of hours required for the project. This will depend on the novelty of your device, risk classification, and whether you want a partial or full solution.
Most medical writers today are either freelancers or part of a medical company. You can hire freelancers directly through freelance sites online or through local networks and social media.
They are usually flexible in terms of what you need and when. You can hire freelancers on a project basis, i.e., for a fixed fee.
Medical writing companies are available online or in your local community. They typically have staff who can provide package solutions for performing various services at once.
The safety of being backed by a company structure is preferable to some, and most medical writing companies provide continuous, high-quality, and professional service.
By hiring an external MDR literature search writer, manufacturers can produce high-quality CERs in short time frames. They can write a beautiful CER without damaging internal regulatory processes and compliance for their existing approvals.
Training internal staff can be expensive and time-consuming. Hiring an external literature search writer is the best way to a beautiful CER within your required timeframe.
Literary search provides insight into how analysts studied research. It helps to interpret ideas, detect shortcomings and recognize opportunities.
Well-organized research may help in designing novel research. In short, systematic and consistent research can be beneficial to develop new ideas.
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