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You Discovered Duplicate Subjects at the End of Your Trial. Now What?

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Your clinical trial is complete.
Enrollment is closed.
The database is locked.

Then you uncover something serious:

Several duplicate subjects were enrolled in your study.

Not suspected. Confirmed.

And you only learned this at the end.

Here is the uncomfortable truth:

If you found several duplicate subjects, there are not “possibly” more.

There are more.

Duplicate enrollment does not occur in isolation. It is behavioral. It is patterned. And it is systemic.

And what you detected internally represents only what your processes were capable of seeing.

The Reality You Cannot See

If duplicate subjects entered your study:

  • There are definitively additional duplicate subjects within the same protocol.
  • There are definitively professional research subjects who were not identified.
  • There are definitively cross-sponsor, cross-therapeutic dual enrollments occurring beyond your visibility.
  • There are likely additional protocol violations tied to undisclosed prior participation.

Why?

Because duplicate and professional subjects in clinical trials operate across studies — not within one sponsor’s line of sight.

Without a cross-sponsor research subject database, you are seeing only a fraction of the exposure.

What you uncovered is not the anomaly.

It is the sample.

Ramification 1: Your Efficacy Signal Is Distorted

Duplicate subjects introduce systematic noise:

  • Prior drug exposure may not be disclosed.
  • Inclusion criteria may be manipulated.
  • Subjects may alter responses based on experience.
  • Washout periods may be violated.

This is not random error. It is structured distortion.

A marginally positive study becomes inconclusive.
An inconclusive study becomes negative.
A negative study may mask a viable therapy.

You will never know how much signal was lost.

Ramification 2: Your Safety Dataset Is Compromised

If a subject is dually enrolled:

  • Concomitant investigational products may overlap.
  • Adverse events may be misattributed.
  • Drug interactions may be invisible.
  • Cumulative exposure risk increases.

This is not just data integrity risk.

It is patient safety risk.

Ramification 3: Financial Exposure Multiplies

Direct costs:

  • Replacement subjects
  • Reanalysis
  • Monitoring investigations
  • Potential protocol amendments

Indirect costs:

  • Delayed milestones
  • Increased burn
  • Competitive delay
  • Lost market opportunity

And if signal dilution causes program failure?

The cost is not incremental.

It is existential.

Ramification 4: Regulatory and Internal Credibility Risk

When duplicate subjects are discovered post-hoc, difficult questions follow:

  • Were identity controls adequate?
  • Were enrollment safeguards sufficient?
  • Was this preventable?
  • How extensive is the exposure?

Even if no formal regulatory action occurs, internal confidence erodes — among executives, boards, investors, and regulators.

The Hardest Truth

If you identified duplicate subjects at database lock, you did not “solve” the issue.

You proved it exists.

And if it exists within your study, it exists beyond it.

Duplicate subjects and professional research subjects operate across sponsors and therapeutic areas. They rotate. They learn. They repeat.

Without cross-sponsor visibility, detection is partial by definition.

Prevention must occur at screening.

Anything else is forensic analysis after damage is done.

The Question Leadership Must Ask

If duplicate and professional research subjects can materially affect:

  • Data integrity
  • Patient safety
  • Regulatory standing
  • Financial outcomes
  • Program viability

Then preventing them is not optional risk management.

It is infrastructure.

Final Thought

Finding several duplicate subjects at the end of your trial is not an isolated event.

It is a signal.

And if you found several, there are definitively more.

The most expensive duplicate subject is not the one you discover.

It is the one you never see.

Verified Clinical Trials exists to prevent duplicate and professional research subjects — across sponsors and therapeutic areas — before they compromise your trial.

Because prevention at screening is the only point in the process where the damage can truly be avoided.