As discussed in a previous posting, the initial aspect to understand is the Continuity of Care for each patient population in question. This means that the basis of each plan should be founded on the knowledge of how and where a patient receives their treatment and medical information. In essence, the plan must be very patient oriented in order to be successful. Once this important aspect is understood, the second phase of the process is to lay down the foundation of your strategic and tactical plan…in that order. Given the challenging timelines associated with clinical trials, a heightened sense of urgency can often lead to the implementation of tactics without the basis of strategic thinking. This may lead to misguided recruitment outreach that will not have the same kind of impact as a structured campaign. Once the strategy is in place, the tactical plan should be developed and executed in a targeted and repetitive manner. Remember…it takes 4-5 touches for a given individual to properly retain information that he or she was exposed to.

Lastly, a detailed analytical plan with robust metrics should be in place at the outset of a campaign. This is truly the only means of determining if your plan is on target and will be the basis of initiating the “early warning signals” in the event that recruitment is not going as anticipated. Hence a solid set of metrics will allow a sponsor/recruitment firm to quickly get the plan back in alignment with the patient population.

In summary, it is prudent to take some time upfront to carefully outline your patient recruitment plan and utilize this as your blueprint for a successful campaign.

Traditional internet based tools such as websites, search engine optimization, directory links and banner ads tend to serve as the foundation for a sound internet based campaign. A well crafted campaign will help potential trial participants find your web site and have access to the key pieces of information about the trial, as well as having the potential to be pre-screened online. However, one should also consider the virtues of social media as an additional element to this type of campaign. The use of social media has grown at an amazing clip. This has led to the development of additional forums that clinical researchers can bolt on to their traditional internet initiative and enhance the awareness of their clinical trials. More specifically, the advent of social media has enabled researchers to bring the information to the patients as opposed to hoping that prospective participants find their respective web site.

Twitter and facebook are key examples of social media channels that are optimal for disseminating study information and educating potential participants about a particular clinical trial. Many companies can enhance their outreach with facebook, which can be done under a company page or specific trial. Twitter is also a powerful tool in getting the word out about a particular trial and linking back to the study website. Regardless of the application used, all efforts should be aimed at directing the participants back to the main web site for pre-screening and triaging to the study site nearest to the patient, if appropriate.

As with the traditional forms of outreach, social media initiatives need to be approved by the requisite Institutional Review Board (IRB) and should not be executed without client review and approval. Additionally, the messages should be both objective and succinct and crafted in a legitimate and professional manner.

In conclusion, the appropriate use of the internet and social media can provide for a powerful means of outreach for a given clinical trial. If done correctly, one may find that the utilization of these tools help reach out to those potential participants who may have previously been inaccessible.

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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.

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.

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.

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!