Initially, pharmaceutical companies incur a budget cost of about $500 million or more to introduce a new, safe and effective drug into the US market. Prior to marketing and launching a new drug into the marketplace, there are several steps taking place.
First, the investigational drug is tested on animals in a lab. Later on, it is tested using human participants for investigational drug safety and efficacy in various Phase II, Phase III, and Phase IIIB trials. However, the most important step is the recruitment and retention of human participants into the clinical trial. Without recruitment of human participants, there is no viable clinical trial. A pharmaceutical company or the contracted CRO can have the best protocol to follow for the clinical trial, but if recruitment continues to lag, or if there is an abundance of trial participants, then the trial fails to meet its target data numbers, deadlines, and protocol goals.
The recruitment of human participants can be tricky business. Recruitment can be called a situation of ‘damn if you do; damn if you don’t.’ This is when the rubber meets the road where the protocol and recruitment must work synonymously. In essence, the protocol dictates who, what, and how recruitment will take place. If the trial protocol is not adhered to in nearly its entirety, then human participant recruitment can breakdown. For example, if a clinical research associate (CRA) observes for several weeks that a trial is recruiting human participants at a fast-pace, then that clinical research associate might want to visit the site to observe and monitor in finding out if the protocol is being adhered to. Sometimes, recruitment is taking place quickly and resulting in large enrollments, but therea protocol deviation could be taking place that has not been reported to the sponsor and/or to the Institutional Review Board (IRB). An example of a protocol deviation is when the inclusion and exclusion criteria are not being followed.
To remedy a recruitment problem at a clinical site, the CRA must work closely with the clinical research coordinator (CRC) to implement a Site Recruitment Action Plan(SRAP) as well as a Recruitment Strategy Plan(RSP). The CRA must develop ongoing assessment of recruitment and retention issues and proactively escalate action early and plan and write escalation plan if the site is not meeting its target enrollment. The CRA and CRC need to analyze the following key components of the SRAP.
The following components can guarantee a successful clinical trial recruitment.
1) Protocol/study issues impacting recruitment
2) A Remedy for site barriers and challenges
3) Recruitment methods and prior experience
4) Monthly enrollment forecast
5) Action planning for potential enrollment issues
6) Recruitment escalation procedure
When any, all, or a combination of these components breaks down, the clinical trial can possibly get canceled or is severely delayed to the point that it costs the pharmaceutical company bottom-line. For these reasons, it is vitally important to visit the site at least every 4-6 weeks and follow a site monitoring plan to ensure reliability and integrity of data and subsequently resulting in a successful clinical trial.