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Why speed of patient recruitment is a cost driver in Phase 1 clinical trials

By: Russell Hayward, CEO EtiraRx, Inc

The cost of Phase 1 Clinical trials can vary dramatically from trial to trial, due to several key factors driving cost, the most predominant one being speed of patient recruitment.

In clinical trials, the adage ‘time is money’ is never more accurate as the extensive team involved in conducting the trial include Project Managers, Medical Monitors, Safety Managers, Data Management and Quality control teams, all of which are on a monthly retainer with their fees racking up month after month throughout the trial. It goes without saying the longer the trial lasts, the more it costs, as a result the faster the trial can recruit qualified patients, the lower the cost of the trial.

As an example, the patient number required for a Phase 1 oncology study varies between 20-100 patients dependent on the objectives of the trial, the oncology indication being studied and the expected safety profile of the drug (the less tolerable the drug is in animal tox studies, the more patients are required to reach the drug’s projected therapeutic dose).  

Based on the industry standard recruitment rate between 0.5 and 1.5 patients per site, per month, a large trial for a drug with a poor safety profile, could run well over 18 months.  Additionally, if the targeted patient group is small, or multiple trials are targeting the same patients, the recruitment could be even slower, increasing the cost of the trial to well over the norm. Compounding this, with IP patent life disappearing daily, a long clinical trial can be devasting on the final commercial valuation and viability of a promising drug.

At Etira, we have designed the Phase 1 trial of our innovative treatment for therapy resistant cancers, ERX-315, to be highly efficient:

Preclinical work

Extensive, focused pre-clinical work was performed to develop a drug formulation that was highly tolerable in animal toxicity studies enabling our target therapeutic dose being administered to the second participant in the trial, thereby reducing months of administering the non-therapeutic doses a more toxic drug would have to encounter.

Regulatory approvals

Approval from regulatory bodies through poor or inconclusive pre-clinical studies can hold back trials for extensive periods while additional pre-clinical work is conducted and/or repeated. The thoroughness of the ERX-315 pre-clinical studies and depth of experience by the various teams involved moved our application quickly through regulatory approval.

Patient Group

Our pre-clinical work confirmed efficacy in a wide range of tumors, all therapy resistant, rather than one specific cancer indication, this strategy enabled the patient group to be broad and, as our drug treats patients that have no other options, there are minimal to no competing clinical trials, further enhancing recruitment pools. Our clinical trial sites have indicated recruitment expectations of 3 patients per month, double industry standard.

Study Design

Our study is designed to be highly specific in its outcomes over a short period (84 days) and uses accelerated dose escalation design to speed tolerability data at different dose levels, shortening the recruitment period of the study by 4-6 months.

Overall, the diligence we have built into our Phase 1 trial design will enable the trial to be completed within 6-8 months with a small number of patients over minimal sites ensuring a speedy cost-efficient study and minimal loss of patent protection period. The ERX-315 trial starts September 2024 and should be completed April 2025.

To learn more please contact Spotlight Family Office Group at Info@SpotlightFamilyOffice.com.