True clinical trial feasibility includes strategic, scientific, operational, and patient recruitment considerations. In this article, we will focus on «enrollability» for a clinical trial. Due to the timely and effective evaluation of recruitment feasibility, not only the sponsor companies will benefit, but the entire clinical research industry.
Initially, it is worthwhile to understand what cases sponsors can be misinformed and misled — both independently and through strategic partnership. This can occur in one of the following steps:
- medical specialists confirm the protocol design.
- sponsor/CRO assesses logistical considerations.
- sponsor/CRO survey sites to determine potential patient numbers for recruitment success.
So, study planners must consider each of the following factors through a recruitment lens:
- protocol design
Selection of the right investigator sites and the target patient population are key to conducting effective clinical trials.
Patient surveys are often used to pre-identify prospective trial participants and test draft protocols. Questionnaires address:
- inclusion/exclusion criteria
- therapy schedules
- willingness to participate in clinical trials
Responses can also be used to better understand a “day in the life of” patients with specific condition or diseases to optimize patient care.
X7 Research assesses the suitability of sites for a specific trial based on protocol inclusion and exclusion criteria. The data obtained from the feasibility screener provides:
- recognition of critical inclusion/exclusion criteria
- predictions of screening failure and drop out rates, based on patient feedback to protocol/therapy
- prediction of recruitment rates
- identification of non-performing and high performing sites prior to initiation
- calculation of the number of sites required to complete the study on time, or more accurate calculation of study duration
Our company provides full services to assess the possibility of recruiting patients. Always X7 Research provides comprehensive information at the sponsor’s request on time.