RWE 101 – Standard Operating Procedures

Standard Operating Procedures (SOPs) are critical for the operation of any business, particularly in regulated industries like pharmaceuticals where precision, safety, and compliance with regulatory requirements are paramount. For a pharmaceutical company, SOPs for observational studies and clinical trials should be separated due to the distinct nature and objectives of each type of study. Here are the main reasons:
[1] Different objectives: Clinical trials are experiments designed to evaluate the safety and efficacy of a new drug or intervention. On the other hand, observational studies are non-interventional; they involve the collection of data without altering the patients’ usual treatment or environment, aiming to observe and analyse patterns, effects, or outcomes.
[2] Regulatory requirements: Clinical trials are highly regulated, with strict GxP requirements from bodies like the FDA or EMA. Observational studies, while still regulated, do not fall under the same stringent GxP requirements. Having separate SOPs ensures compliance with the correct set of regulations for each type of study.

[3] Study design and conduct: The design and conduct of clinical trials and observational studies are significantly different. For instance, clinical trials are generally randomized, controlled, and blinded studies. In contrast, observational studies may involve case-control studies, cohort studies, or cross-sectional studies. Different SOPs can specify the appropriate designs, methods and checks for data collection, storage, and analysis in each case.

[4] Patient consent and confidentiality: In clinical trials, patients provide informed consent for the specific interventional treatment they will receive. In observational studies, while consent is still required, it’s often related to access and use of their medical data rather than a specific treatment. Thus, separate SOPs can address these differing requirements.
[5] Risk Management: Risks and safety considerations also vary between clinical trials and observational studies. The risks of clinical trials often relate to the new drug or intervention being tested, while observational studies’ risks typically concern data protection and patient privacy.
[6] Reporting Results: Different types of studies may also have different reporting requirements, including timelines, formats, and recipients of the information (e.g., regulatory authorities, ethics committees, sponsors).
By having separate SOPs, companies ensure that all these aspects are appropriately addressed, leading to better quality, more ethical research, and improved compliance with regulatory requirements. It also helps in training and guiding staff effectively in their roles for different studies.

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