Medical writers help shape the narrative at every stage of drug development
Drug development is a complex, costly and time-intensive process; it can take years or even decades for a newly-identified promising compound to pass all the stages necessary to obtain regulatory approval. Many experts and health professionals are involved, including medical writers. They may not take part in the scientific exploration but they play a key role in distilling down and presenting the data produced during the drug development process for key audience groups.
Medical writers within a med comms agency, or working freelance, are instrumental in translating complex scientific data into compelling and compliant content for pharmaceutical drug launches. Their expertise in medical writing, scientific communication, and regulatory requirements ensures that accurate and impactful information reaches healthcare professionals and patients, supporting the overall success of the drug launch and its subsequent use in hospitals and clinics.
Let’s take a closer look at how medical writers are involved at each stage of the process.
Research and development
The process that leads to a new drug being used in hospitals, clinics and by patients at home begins with extensive research and development efforts. This stage involves identifying potential drug candidates, conducting preclinical studies, and selecting the most promising compounds for further development. Rigorous clinical trials are then necessary to evaluate the drug’s safety and efficacy, aiming to gather the necessary evidence for regulatory approval.
Essential clinical trial documents are created with the input of medical writers from the point at which a drug enters phase I clinical trials, through its journey into phase II/III trials. Medical writers produce clinical study protocols, investigator brochures, and informed consent forms. These documents provide the foundation for rigorous and ethical clinical trials.
Regulatory approval
Regulatory approval is a significant step in drug development. Pharmaceutical companies must present data from preclinical and clinical trials to regulatory bodies. Medical writers help compile this data into cohesive documents, including New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs), for submission to regulatory agencies.
The process involves close collaboration between the pharmaceutical company, medical writers within the company or within a medical communications agency, and the relevant regulatory body. That’s the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, the Medicines Research Agency (MRA) in the UK or various other regulatory bodies throughout the world. Successful approval paves the way for the drug to be marketed to healthcare professionals and patients.
Target market identification
Before launching a drug, a pharmaceutical company must identify the target market for its product. Extensive market research has already been conducted to understand patient needs, disease prevalence, and healthcare provider preferences during the drug development process. This information now helps medical writers involved in the preparation for drug launch to tailor their promotional strategies and messages to resonate with the intended audience.
Medical writers work closely with the brand and marketing teams within the pharmaceutical company to develop key messaging and scientific content for the drug launch. They translate complex scientific data and concepts into clear and concise language that conveys information to healthcare professionals and patients. This content forms the basis for promotional materials, including sales aids, product monographs, and educational resources.
Generating a strong brand identity and positioning the drug correctly in the market is critical for a successful drug launch. Medical writers help to create compelling brand names, logos, and messages that reflect how the drug is going to make a difference to patients, potentially fulfilling currently unmet medical needs. Medical writers also ensure that all promotional materials adhere to the codes of practice relevant to the country in which the drug is to be launched.
Pre-launch and launch activities
In preparation for the drug launch, medical writers develop slide decks, scientific publications, and conference abstracts that aim to educate healthcare professionals about the drug’s mechanism of action, clinical efficacy, and safety profile. They also prepare materials for specialised communication channels:
- Key Opinion Leader (KOL) engagement: Engaging with KOLs in the medical community is a strategic step in pharmaceutical marketing. KOLs are respected experts whose endorsement and support can significantly influence other healthcare providers’ and patients’ perceptions of the drug. Building strong relationships with KOLs helps to gain their advocacy for the drug before and after its launch.
- Compliance with national and international regulations: Throughout the pharmaceutical marketing process, strict adherence to regulatory and compliance guidelines is essential. Medical writers working within a medical communications agency must ensure that all promotional materials and activities comply with relevant laws and regulations governing pharmaceutical promotion. Failure to meet these requirements can lead to serious consequences for the company.
- Market access and reimbursement strategies: Securing market access and reimbursement is crucial for a drug’s commercial success. Pharmaceutical companies and medical communications agencies work closely with payers, insurers, and health authorities to demonstrate the drug’s value and negotiate favourable coverage and reimbursement terms. This step is especially important as it influences the drug’s affordability and accessibility to patients.
- Sales force training: A well-informed and competent sales force is essential to communicate the drug’s benefits to healthcare providers effectively. Sales representatives receive training using materials generated by medical writers to provide them with in-depth knowledge about the drug’s mechanism of action, clinical data, and appropriate target patient populations.
Post drug launch
During the drug launch and beyond, medical writers are involved in pharmacovigilance efforts. They contribute to adverse event reporting and safety communications, ensuring that any potential safety concerns are communicated promptly and accurately.
Medical writers may also be involved in the preparation of real-world data for the drug. This is collected in the months and years after the drug has become widely used. The number of participants in these studies often exceeds those included in the clinical trials prior to the drug’s launch, making the resulting information invaluable.