CROs are key to bypassing recruitment pitfalls and Lasagna's law according to study

CROs have a vital role in helping sponsors to complete recruitment goals and avoid “Lasagna's law” according to the CEO of US contractor Cromos Pharma.

For the uninitiated, Lasagna's law is the idea that “the number of patients available to join a trial drop by 90% the day the trial begins” and then the patients “re-appear as soon as the study is over.”

It was mooted decades ago by Louis Lasagna - an US physician and professor of medicine who is known as “father of modern pharmacology” – to describe the challenges sponsors and CROs face when recruiting for studies.

A recent study – published in April – looked at pharmaceutical industry efforts to sidestep Lasagna's law found that while planning, protocol development and interaction for clinics is important, clinical research organizations (CRO) are the key to successful recruitment.

According to author Vladimir Bogin, CEO of US trials contractor Cromos Pharma, “Over 40 years after Dr. Lasagna came up with his law of progressively diminishing returns in patient recruitment, Lasagna Law still looms large over clinical trials and drug development.

“The role of CROs in mitigating the impacts of Lasagna's Law cannot be overestimated.

“Many CROs can perform a more thorough feasibility assessment and suggest better trial sites than even an experienced in-house team can. If there is a chance to bring in a CRO early in the study development cycle, its input on study design can be very valuable.”

CRO choice

However, as Bogin points out, choosing the correct CRO is key, and sponsors must take time to ensure contractors really can deliver on their recruitment promises.
“Clearly the goal of any CRO is to attract business, and sponsors rightfully view some CRO's optimistic recruitment projections as a marketing strategy.

“Therefore, devising a risk-sharing model with selected CROs can have a significant impact on their projections. Agreeing upon and instituting financial penalties for under recruitment and conversely devising a bonus structure for high enrollers, can be a very powerful tool.”

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