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Blinding Is Seeing: A Single-Centre Study Into the Viability of Auto-Injectors for Blinded-Drug Administration in
Vishal Aggarwal1, Jorg Taubel2, Ulrike Lorch1
1Clinical Research, Richmond Pharmacology Ltd, London, GBR.
Cureus
|September 29, 2023
Summary
Auto-injector systems (A-INJ) effectively maintain investigator blinding in randomized controlled trials (RCTs) by delivering both active and placebo injectates without modification. This study demonstrates A-INJs improve blinding integrity compared to conventional syringes.
Area of Science:
- Clinical Research
- Pharmaceutical Science
- Medical Device Technology
Background:
- Investigator blinding in randomized controlled trials (RCTs) is crucial for unbiased results.
- Maintaining blinding during subcutaneous (SC) and intramuscular (IM) investigational medicinal product (IMP) administration presents challenges due to differences in injectate viscosity and appearance.
- Current methods to ensure blinding, such as altering placebo formulations or using unblinded personnel, have limitations.
Purpose of the Study:
- To evaluate the efficacy of auto-injector systems (A-INJ) in preserving investigator blinding during RCTs.
- To compare the performance of A-INJs versus conventional syringes (CS) in delivering placebo and active IMPs.
- To assess the impact of A-INJ use on investigator ability to differentiate between injectates.
Main Methods:
- A single-centre experimental study compared A-INJ (Owen Mumford, Autoject 2) with CS for 1 ml IMP and placebo delivery.
- Injectate delivery percentages were compared between A-INJ and CS groups for both placebo and IMP.
- Eight research physicians assessed safety and effectiveness after serial A-INJ injections into a human-tissue analogue, evaluating their ability to differentiate solutions.
Main Results:
- Mean injectate delivery was comparable between A-INJ and CS for both placebo (95.38% vs. 96.00%) and IMP (94.715% vs. 94.74%), with no statistical significance.
- Investigators using A-INJs could not differentiate between placebo and active IMP solutions, reporting no concerns about unblinding.
- The mean administration time was 8.5 seconds; audio cues from A-INJs were noted as potential challenges.
Conclusions:
- Auto-injector systems (A-INJ) significantly enhance investigator blinding in RCTs by enabling administration of unadulterated active and placebo injectates.
- A-INJs offer a viable alternative to conventional syringes, eliminating the need for placebo modifications and improving blinding integrity.
- While minor challenges like audio cues exist, A-INJs present a promising advancement for administering injectable compounds in clinical trials.
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