Seeding studies, in the context of real-world evidence (RWE), refer to studies that were conducted by pharmaceutical or medical device companies after a product’s approval or market introduction. These studies aimed to promote/ increase the market presence of the approved drug. Regulators like the FDA and EMA view seeding studies as unethical for several reasons.

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1.  Misleading intent: Seeding studies were primarily conducted to influence prescribing habits, promote a specific product, and create a favourable impression among healthcare providers. This promotional intent conflicts with the primary objective of research, which should be to generate unbiased and reliable evidence.

2.  Methodological flaws: Seeding studies often lacked rigorous scientific methodology. Some were observational in nature and lacked control groups or blinding, making it difficult to draw valid conclusions about product safety and efficacy. The data collected was of poor quality, limiting its utility for meaningful analysis and decision-making.

3. Transparency and bias: Seeding studies were sponsored by the manufacturers of the products being studied. This created potential conflicts of interest and raised concerns about transparency and data integrity. The financial relationships between study sponsors and participating healthcare professionals potentially biased the study results and compromised the independence and objectivity of the research.

4. Publication bias: Seeding studies were susceptible to publication bias, where positive or favourable results were more likely to be published, while negative or unfavourable findings were suppressed or unreported. This selective reporting distorted the overall evidence base and misled healthcare providers and regulators in their decision-making.

5. Ethical considerations: Seeding studies raised ethical concerns regarding patient safety and informed consent. Participants were not adequately informed about the purpose, risks, and benefits of these studies.

Regulatory bodies, including the FDA and EMA, strive to protect patient welfare and ensure the integrity of the research process. They require studies to be conducted with scientific rigor, unbiased intent, and adherence to ethical principles. In the EU, it is a legal requirement that non-interventional studies are not promotional (Article 107m(3) of Directive 2001/83/EC).

It is important for researchers, industry sponsors, and regulators to maintain transparency, adhere to ethical guidelines, and prioritize patient welfare in the pursuit of real-world evidence. By doing so, the integrity of RWE can be preserved, and reliable evidence can guide healthcare decisions and promote the well-being of patients.