Thinking of Participating in Multiple Studies at Once?
February 14,2017 asikora

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.

 

 

 

 

 

The Washout Period

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!

Leave a Reply

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.

Subscribe to our Blog

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

About Our Blog

Welcome to VA Confidential, the official blog of Vince & Associates Clinical Research. Don't know us? In a few words, we are a premier clinical research site combining the power of physician-led study teams and the luxury atmosphere of our state-of-the-art, multi million-dollar clinical pharmacology unit.

We're lucky to have a staff of smart, passionate people doing incredible things in areas like Phase I-II Proof-of-Concept, adaptive clinical trial design, First-in-Human, Single and Multiple Ascending Dose, and a host of other early phase clinical trials. We use this blog to share some of the cool things going on around here, share knowledge and innovation in clinical pharmacology and promote health and wellness.

Of course what makes this blog really exciting is YOU — so join the conversation!