By the American Institute for Medical Research
Clinical research sites increasingly face the challenge of managing patients who are eligible for more than one clinical trial at the same time. This scenario—sometimes called trial competition—is especially common in specialty networks and acute conditions such as stroke, where multiple investigational therapies target overlapping populations. Without clear policies, sites risk introducing bias, overburdening patients, and undermining the validity of trial outcomes.
Why This Matters
When a patient qualifies for more than one trial, questions quickly arise:
- Which study should be offered first?
- Should patients be told about all available trials?
- How can sites ensure fairness across sponsors and protect patients from information overload?
If handled inconsistently or left to individual investigator discretion, trial competition can skew enrollment patterns, diminish generalizability, and prolong study timelines.
Regulatory Perspective
Federal regulations require that patients be told about clinical care alternatives when considering trial participation. However, there is no requirement that patients be informed about other research studies at the same institution. The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) emphasize that consent must provide the information a reasonable person would need to decide, but allow local policies to determine how competing trials are disclosed.
International frameworks—including the Declaration of Helsinki and ICH-GCP E6(R3)—similarly stress scientific validity, transparency, and respect for patient autonomy, but do not mandate disclosure of concurrent research opportunities.
Emerging Best Practices
Several national networks have adopted policies to guide competing-trial enrollment. For example, NIH StrokeNet recommends that institutions use one of the following approaches:
- Rotating grids: alternate which trial is offered first to balance enrollment.
- Time-block allocation: assign trials to specific days or weeks.
- Prioritizing narrow-eligibility trials: ensure rare or time-critical trials are not starved of participants.
- Patient-choice approaches: offer all trials, with caution in acute care settings.
Importantly, these methods are pre-specified, auditable, and reviewed by local IRBs—ensuring transparency for patients, investigators, and sponsors alike.
A Patient-Centered Model
The American Institute for Medical Research recommends that site networks adopt a Competing Trials Management Plan (CTMP), filed as an SOP with their IRB. At minimum, such a plan should include:
- A documented allocation rule (e.g., rotation, time-block, or prioritization of rare populations).
- Back-up pathways so patients who decline or screen out of one trial can be considered for another.
- Consent language that explains the institution’s process in plain terms, without overwhelming the patient.
- Equity monitoring to ensure demographic subgroups are not systematically disadvantaged.
- Sponsor transparency so that all stakeholders understand and agree to the site’s approach.
The Bottom Line
Clinical trial competition is not a sign of dysfunction—it is evidence of a vibrant research ecosystem. But without clear policies, sites risk bias, inefficiency, and ethical blind spots. By adopting a structured, IRB-approved management plan, research institutions can protect patients, ensure fairness across studies, and generate reliable scientific knowledge.
At AIM Research, we believe that site enablement and patient-centered design are the cornerstones of sustainable clinical research. A proactive approach to managing competing trials is no longer optional—it is an ethical and operational imperative.
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