#21 Practical RWE – Patient Recruitment


Patient recruitment for clinical trials and non-interventional studies differs in several key aspects, largely due to the nature and objectives of each type of study. Here’s a breakdown of the main differences:

Clinical Trials

(i) Purpose: Clinical trials are conducted to test the efficacy and safety of drugs, or medical devices. These are typically experimental in nature and are carefully designed to answer specific research questions.

(ii) Recruitment Criteria: Participants must meet specific inclusion and exclusion criteria that are relevant to the study’s objectives. These criteria can be quite strict, as the goal is to ensure that any observed effects are due to the drug or device being tested and not external factors. The research participants are recruited based on the condition or conditions they have, rather than they drugs they are taking,

(iii) Interventions: Participants are typically assigned to specific intervention groups (e.g., a new drug vs. a placebo). The allocation can be random (randomized controlled trials) and often blinded to reduce bias.

Non-Interventional Studies

(i) Purpose: Non-interventional studies (observational studies) aim to observe outcomes in a natural setting without attempting to modify the behaviour or condition of the participants. These studies can help identify patterns, causes, and effects in real-world settings.

(ii) Recruitment Criteria: While there may still be inclusion and exclusion criteria, these are generally less stringent than those for clinical trials. The aim is often to obtain a sample that is as representative of the general population or a specific population as possible. Crucially, the patients need to be taking the drug of interest to be eligible for inclusion in the study.

(v) Interventions: There are no assigned interventions (drugs or devices) in non-interventional studies. Instead, researchers collect data on the impact (safety and effectiveness) of the drug of interest that they are already taking as they occur naturally (in real life).

Patient recruitment for clinical trials versus non-interventional studies presents distinct challenges and methodologies, primarily due to the differing goals and structures of these research approaches. Clinical trials, which are experimental, aim to evaluate the efficacy and safety of drugs or medical devices through well-defined protocols and strict participant criteria to isolate the effects of the intervention. These trials often involve randomization and blinding to mitigate bias. On the other hand, non-interventional (observational) studies seek to understand outcomes in a natural setting, focusing on the real-world effectiveness and safety of treatments without altering participant behaviour or conditions. Recruitment criteria for these studies are more lenient to capture a broader, more representative sample of the population or specific patient groups, with participants being observed based on their existing treatment. This fundamental difference in purpose and methodology underscores the varied approaches required for patient recruitment in clinical trial versus observational research settings.

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