THE FOCUS OF EARLY-STAGE STUDIES
Most early phase studies focus on PK/PD, often performed in healthy volunteers, to
- determine a safe and tolerable dose
- investigate how the drug behaves in the body (PK) by measuring the rate and extent of absorption, distribution, metabolism and excretion (ADME)
- investigate how the body responds to the drug (PD)
For most Bioavailability & Bioequivalence (BA-BE) studies, the objective is to
- measure the rate and extent of absorption, etc. (ADME) of a test/generic drug or formulation to a reference version of a drug or formulation
- show there is no significant difference between the test and reference drug/formulation when administered under similar conditions and both test and reference drugs are better than the placebo
SCOPE OF WORK FOR MEDICAL WRITING
The scope of work undertaken ranges from
- initial document development of Protocols, Investigator Brochures (IBs), Informed Consent forms (ICFs) to
- periodic regulatory reporting needs for Development Safety Update Report (DSUR) or Periodic Safety Update Report (PSUR), to
- submission documents such as Clinical Study Reports (CSRs), safety narratives, and CTD Module 2 Summaries for Clinical and Non-clinical sections of a submission
EXPERIENCE AND TRAINING
Medical writers need to have solid scientific training and experience in order to produce technical documents, and interpret and describe the results in a Clinical Study Report (CSR). Most frequently this entails a PhD or MD degree, with relevant doctoral or postgraduate qualifications, in a field of scientific research or a pharmaceutical setting. Some training in pre-clinical research or pharmacology is necessary for understanding the goals of the study, to hold discussions with Sponsor researchers and clinicians, and ultimately being able to write the protocol and other technical documents. A working knowledge of statistical concepts and methods is called for to understand the Statistical Analysis Plan and to write-up the results in the CSR.
REGULATORY KNOWLEDGE
Knowledge of regulatory requirements is needed to conduct trials and submit findings to various countries, such as US (FDA), EU (EMEA), Health Canada, India (CDSCO & DCGI), and Australia (TGA). Regulatory guidelines for the conduct and reporting of clinical trials differ from country to country. Although there are efforts to harmonize guidelines and regulations, differences exist in how to initiate clinical trials for a new drug, biologic or device, and apply for marketing authorization and approval. Timelines, documents, analyses needed may differ and a Medical Writer with experience in the country’s regulations can help make the task smoother.
GOOD PRACTICES
Some practices can facilitate the handling of Early Phase Studies for the team and for the Medical Writer.
- Effective communications – necessary for the successful collaborative effort between team members
- Expert Project Management – successfully manage timelines, activities and costs
- Expert Resource Allocation – get the right people for the job
- Medical Writing specific: Provide Cost effective and high-quality services for early phase studies
- Standardized templates utilized up to Level 4 hierarchy that conform to guidelines
- Preparation of mock CSR in advance of results availability
- Ready-to-insert CSR in-text tables
- Flexibility and attention to detail
The Veranex Medical Writing/Regulatory Publishing team has successfully submitted more than 200 early phase studies. The group (formerly Quartesian) has an overall average of 12 plus years of experience, and demonstrated proficiency in handling these studies. Contact us to learn how we can help.