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How a good plan and hot lunch can spell success for sponsors. Attention to detail can help boost dwindling subject enrollment and retention, saving both time and money.
According to a recent study from Cutting Edge Information, a leading market researcher, poor subject recruitment can slow a clinical trial down significantly. The process of screening and enrolling subjects can consume as much as 30% of the clinical timeline, and the cost of delays can be enormous.
Gary Velasquez President and CEO Synarc Inc.
If a new compound is a potential blockbuster, a drug's sponsor can lose as much as $8 million each day due to delays in subject recruitment. This is one of the key factors in turning subject recruitment into a cottage industry, where the competition for patients is at its highest level in years. And rightly so, because without the appropriate patient groups in a trial, millions of dollars and countless resources could be wasted by the pharmaceutical and biotechnology industries.
The approach to subject recruitment should be a laser one—not a shotgun. The path to efficient subject enrollment should begin with targeting specific populations across fewer select sites.
Clinical site initiation efforts should be well coordinated with prestudy activities, tracking of ongoing performance measured against enrollment targets, and overall site performance to ensure that all sites are qualified, staffed, and equipped adequately to manage all clinical study activities. Should any of these critical success factors be compromised, the risk of subject dropout increases significantly.
Subject retention is equally important to the overall success of conducting a trial. The processes employed to retain subjects should be as robust and thoughtful as those used to recruit subjects into a study at the outset.
Grassroots techniques are proving to be beneficial for companies targeting subjects in European countries that do not have the benefit of the robust mass media outlets available in countries like the United States. For example, in Denmark there is a government-sponsored public database that CROs can access to identify subjects that meet protocol specific requirements. With the help of this public database, a CRO running an osteoporosis trial in Denmark could easily find the names of local women who are over age 65 and who might be eligible to participate in the clinical study.
In Estonia there is no form of public advertising, so recruitment at social gatherings has proved effective in this particular country. Companies that are market sensitive are seeing greater and quicker results because they understand the geographical, social, and political landscape of the countries in which they are focusing their recruiting efforts.
In addition to these recruiting approaches, a number of other methods should be employed by sites to ensure both quick enrollment and long-term retention of study subjects.
One important factor is making sure the patient is comfortable with his or her surroundings. Clinic staff should always have a strong understanding of the communities from which they draw subjects. The clinic staff should not only be courteous and respectful, but also should pay close attention to the small details that are equally vital in keeping the study participants engaged.
Small details to keep in mind include sending out clinic visit reminder letters, birthday and holiday cards, as well as invitations to social events. Another effective and practical way to engage study participants is to provide free meals along with transportation to and from the study site.
Efficient subject recruitment and retention is the key to timely completion of a clinical trial. Today, the pharmaceutical industry is faced with rising costs and is increasingly under constant scrutiny, both in and outside the United States. A well-planned and focused recruitment process will lead to compounds getting through the pipeline and into the marketplace faster.