According to Verified Clinical Trials (VCT), a worldwide clinical trials database registry to prevent dual enrollment in clinical trials, the incidence of dual enrollment per trial is 2%-10% depending on the therapeutic area and phase of the study. For Phase I units, VCT reports that up to 25% of clinical research volunteers attempt multiple simultaneous clinical trial enrollment.
If you are thinking of enrolling in multiple clinical trials at once, or back-to-back trials, you should know that every clinical trial has a washout period, which is the pre-determined number of days during which study volunteers must not receive any treatments.
In addition to the clinical research facility’s washout policy, the sponsor may impose a longer washout period. Typically, Phase I trials require a 30-day washout period before participants can enroll in a new study, but may vary from study to study depending on the half-life of the drug i.e., the time it takes for a substance (for example a metabolite, drug, signaling molecule, radioactive nuclide, or other substance) to lose half of its pharmacologic, physiologic, or radiologic activity.
The Risks of Not Respecting the Washout Period
There are a number of reasons why participating in simultaneous or back-to-back studies within a short timeframe is risky.
Risk for the volunteers — Although Phase I investigators estimate the rate of serious adverse events to occur in fewer than 1% of healthy volunteers, dual enrollment in clinical trials can increase participants’ risk of harm. Even if the volunteer hasn’t taken a study drug, they may still be putting themselves at risk due to the procedures involved in various studies. For example, in studies requiring multiple blood draws, subjects may have too much blood drawn.
Risks for the research site and the sponsor… When someone is enrolled in more than one study protocol at the same time, it can profoundly affect both studies. Drugs from past clinical experiments lingering in the blood could result in research volunteer safety issues, compromise data quality, and increase time and cost to finish a trial and bring a medicine safely to the market.
Preventing Dual Enrollment
By participating in the VCT program which tracks volunteers who do a study to ensure the next study meets washout periods, many clinical research facilities, such as Altasciences’ sites, have made a serious commitment to preventing duplicate enrollment in clinical trials and other protocol deviations, while promoting subject safety and improving data quality. So if you’re thinking of participating in multiple studies at once, we suggest you think again.
The right trial for you will undoubtedly be available shortly!
To find out more about our clinical research studies, or if you are looking to participate in one of our studies, visit our Participant Page today!
Post created by Amy Sikora, Director, Communications & Marketing | Studied Translation at Concordia University | Mom | Reality TV Addict | Gym Rat