PATIENT RECRUITMENT TIPS AND SUGGESTIONS

In these tough economic times it is understandable that companies are doing everything they can to preserve capital. The issue of cost containment especially comes to light when budgeting for clinical trial expenses, which run in the millions of dollars. Therefore, it is not surprising to note that many important initiatives, patient recruitment included, are often not included in the final budget.

On the surface, it is understandable as to why patient recruitment isn’t a line item in the budget. After all, didn’t the study sites indicate that they can accrue the necessary amount of patients to adequately enroll the trial? It is true that clinical trial sites often contribute the majority of the patients; however, they often fall short of their goal for a whole host of reasons (i.e. stringent inclusion/exclusion criteria, difficult protocol, etc.). Therefore, it is most often always necessary to attract a good proportion of the required patients from outside of the immediate point of care. Additionally, it has been cited that 85% of completed clinical trials had patient enrollment delays. Further to that point, the opportunity costs associated with these delays greatly exceed the costs associated with implementing a strategically crafted patient recruitment program from the outset of a clinical trial. Therefore, with these facts in hand, one should consider implementing their patient recruitment program at the start of a trial as opposed to taking a “wait and see” approach. The upfront dollars may be more than initially anticipated but it will be well worth it in the long run.

As we all know, effective communications are imperative when implementing a clinical trial and successful patient recruitment campaign. Yet, despite best laid plans, the communications effort relative to the patient recruitment process can easily become fragmented. There are a number of fundamental factors that usually lead to these inefficiencies. First, for many clinical studies, clinical trial sites will develop and distribute their own material. For a large clinical trial, this can result in dozens of advertising pieces in circulation, all with different telephone numbers. This can lead to a lot of confusion in the event a prospective trial participant receives information about a clinical trial site that is not in their immediate vicinity. Secondly, it is not unusual for clinical trial sites and their respective clinical study coordinators to manage several trials at once. Therefore, despite the best of intentions, many of these clinical trial sites do not have the resources to adequately handle the call volume and effectively pre-screen the patients over the phone. This can be especially problematic given that many of the callers may not even have the specified disease state that the clinical trial is designed for. In essence, in most cases, there is not formalized process to properly receive calls and triage potential trial subjects to the appropriate clinical trial site.

Implementing a centralized call or triage center can greatly enhance the efficiencies associated with fielding calls and pre-screening prospective study participants. First, all incoming patient calls associated with a given patient enrollment campaign will be received via a centralized number for pre-screening. This process is invaluable in that it takes the burden off of the study coordinators and ensures that only the most eligible of potential study participants are triaged to the appropriate clinical study site. Secondly, a specially trained call center operator can be very effective in triaging patients to the appropriate study site, as well as following up with the study coordinator to ensure that the patient is scheduled for an appointment. This follow-up process is essential when it comes to minimizing the attrition rate of potential study participants. Lastly, this centralized process allows for a central repository of data and the ability to process valuable reports for the sponsor company.

In summary, there is a high cost associated with clinical trials in both time and money. The implementation of an effective, centralized call center program can effectively bring a sponsor one step closer to its corporate goal of recruiting their clinical trial on time and within budget.

Traditional advertisement and media based programs tend to be the foundation of the majority of structured patient recruitment programs. These communication channels usually include television, radio, internet and print media. These programs can reach a broad array of potential patients for your clinical trial but they can be untargeted and very costly. In order to optimize these resources, it is imperative that one implements a targeted approach for patient enrollment. More specifically, one needs to take the time to conduct the proper diligence to see how and where a particular group of patients accesses their medical information. Once these media channels are thoroughly researched, it is then possible to execute a media campaign in a strategic and targeted manner. Through this approach, one has a much better chance of recruiting their clinical trial on time and within budget.

This time tested adage certainly applies to today’s clinical research environment, especially as it relates to patient recruitment and patient enrollment.

In 2001, over 85% of completed clinical trials had patient enrollment delays; 34% were delayed for more than 1 month. In 2003, a month-long delay cost roughly $47 million in lost revenue. With over 22,000 clinical trials actively recruiting patients, many of which are for competing therapies, it is evident that clinical research teams will be continually challenged to meet their designated patient enrollment timelines for their clinical trials.

Given the complexities associated with today’s clinical research dynamics, a strategic, organized, professionally implemented recruitment campaign is warranted to ensure that clinical studies are enrolled on time and on budget.

Where are the patients?

How many times have you heard the question “Where are the patients?”  Unfortunately, this simple and straightforward question comes up all too often and is the bane of clinical operations and board room discussions. All too often this critical area is usually the key determining factor as to whether or not a clinical trial will be successful or not. According to Kathleen B. Drennan, Chief of Global Marketing and Strategic Business Development at Iris Global Clinical Trials Solutions, patient recruitment and randomization are major problems that impede clinical trials.

However, despite the pivotal nature of this activity, patient recruitment planning usually takes a back seat to other functional activities associated with the trial such as the clinical trial budget, study site initiation activities, data monitoring, etc. There are many reasons for this but it usually comes down to the fact that most sponsors (biotech, pharmaceutical and device companies, etc.) feel that either the clinical trial sites or Contract Research Organization (CRO) will handle this very important function. Although this is true to a certain extent, it is not always the case and should never be assumed or totally relied upon.

Prior to initiating a clinical trial, a lot of work goes into the site selection process. In many cases, the anticipated patient accrual rate will factor into the decision, but not always. Other reasons, such as the credibility of the site or Principle Investigator (PI) will play into the decision as well.  Therefore, many sites may not have the requisite number of patients for appropriate and timely accrual. Furthermore, a trial site initiated effort often leads to a local/random effort and nothing more. As far as CROs are concerned, they may or may not play a part in the patient recruitment process. If this activity is not stipulated in the contract, then it is best not to rely on them for patient enrollment activities.

By outsourcing your recruitment needs to a patient recruitment firm, you are more apt to experience a focused and centralized approach to patient recruitment, enrollment and retention. Your patient recruitment firm can provide all of the upfront research in order to target the appropriate message to the right people in the community. Furthermore, your patient recruitment partner can execute a wide array of outreach activities that can alert potential study subjects to your clinical trial. Such activities include, but are not limited to, advertising and media, advocacy development, physician referral programs and a variety of Direct to Consumer (DTC) activities. In short, the utilization of a focused effort using best-in-class activities will provide a far greater outcome than relying on the trial sites alone.

So, instead of dreading that inevitable question, “Where are the Patients?”—stay ahead of the curve by partnering with a patient recruitment firm at the outset of your trial. We’ll make sure your study is recruited on time and on budget!