In a regulated environment, regardless of the type of healthcare product development pursued (for example, of a drug, biologic or medical device), studies need to be conducted to demonstrate the healthcare product’s quality, safety and effectiveness/efficacy with respect to the proposed indication.
Although the exact data requirements may vary depending on the product design, the proposed indication and/or the targeted jurisdiction, studies that support submission applications must be carefully designed, conducted, analyzed and recorded in compliance with relevant regulatory requirements and good industry practices (e.g., Good Laboratory Practice [GLP], Good Manufacturing Practice [GMP], Good Clinical Practice [GCP], and Good Documentation Practices [GDP]).
Studies to be included in regulatory submissions should follow a written protocol that outlines the purpose and details of how the study will be conducted and the justification for the approach taken. Record the study results and data analysis in a study report. These documents should be appropriately reviewed and approved by relevant personnel prior to finalization of the document. Any amendments introduced after the document sign-off should be properly evaluated, documented and approved.1
The types of studies to be included in a regulatory submission may include the following:
Consider developing the template of your study report while building the study protocol. By having the end in mind, you can plan and design the study (for example, the duration, patient population, sample size, statistical analysis plan) so that specific data and results (for example, the meaningful clinical end point) that answer particular questions (for example, whether healthcare product A effectively prevents disease X) can be collected, anaylzed and reported. By clearly defining all of these elements in the protocol, the study can be properly conducted and the results will avoid censure related to bias or data manipulation. The study protocol is crucial to establishing the foundation for the results and conclusions of individual trials―and ultimately, those reached in the licensing application.2
Should the study protocol or the finalized study report need to be changed, generate an amendment that includes:
In the case of a clinical study, if a study application has been approved under Investigational New Drug (IND), Investigational Device Exemption (IDE), Clinical Trial Application (CTA), or Investigational Testing Application (ITA), any significant amendment (that is, changes that significantly affect the safety of the trial subjects, or quality of the investigational product) should also be submitted to the corresponding ethics board(s) and regulatory agency(ies) for approval prior to its implementation.3 Make sure to review all the submission requirements for amendments relating to the conduct of clinical trials in all relevant jurisdictions.
Tips: The use of protocol and report templates allows upfront research to be conducted and recorded in compliance with regulatory requirements and guidance documents. When compiling information, organize it into sections and subsections, with logical groupings of related data clearly identified through the use of headings.1
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012