Patient recruitment is arguably the most difficult step when conducting clinical trials or studies, as public perception of the clinical trial process is largely negative. This is disconcerting as investigators need an adequate amount of participants for their study to be successful; without participants research cannot be carried out. When initiating clinical research, be sure to be as transparent as possible as individuals are more likely to participate if they feel knowledgeable about the process.

There are a variety of options investigators can utilize when recruiting for clinical trials, including newspaper, radio and television advertising, physician contacts, patients' public health records and medical brochures. Before beginning to recruit patients for a clinical trial, consider the following barriers that investigators often face:

1. Lack of awareness: Patients may not understand that a study is appropriate for them or are unaware that clinical trial recruitment is taking place.

2. Fear of "losing control": Personal or family physicians may not want to lose control of their patients to an investigator, as they often believe they know whats best for their patient.

3. Administrative burdens: Paperwork and additional fees put off many prospective participants who do not want to deal with red tape.

Action Steps
The best contacts and resources to help you get it done

Order clinical study recruitment information online

Educate yourself about the ins and outs of clinical trial patient recruitment during the planning stages of your trial or study to allow yourself time to really understand what needs to be done in order to be successful. Because a lot of time is usually devoted to patient recruitment, having a firm grasp of proven techniques and challenges will benefit you and your study. Many agencies offer informative articles and reports for purchase online.

I recommend: Thomson Healthcare offers two informative white papers discussing successful patient recruitment clinical trials information and techniques that may be helpful before you start the recruiting process. You may also find Pharmalicensing to be a beneficial resource. Purchase a report that extensively details international strategies for patient recruitment and retention.

Obtain the services of a patient recruiting agency

Recruiting patients for clinical trials is never easy, so do not hesitate to ask for help from a patient recruitment agency that has experience recruiting for clinical trials and studies. These agencies specialize in patient recruitment advertising and marketing, and have access to a broad spectrum of resources. You will have more time to devote to the trial itself if you do not have to spend time or be concerned with patients recruitment.

I recommend: Take a look at client success stories at Academic Network to understand the benefits of hiring patient recruitment specialists. You may also be interested in the list of patient recruitment agencies provided by Center Watch, a clinical trials listing service.

Learn about new techniques in patient recruitment for clinical trials online

Maximizing clinical trial recruitment is often the most difficult aspect when conducting a clinical drug trial or study. In order to catch the attention of prospective trial participants, trial investigators and patient recruitment agencies are improving existing techniques and trying new marketing strategies to maximize their returns. You can learn more about these innovations by checking out reports and articles online for free.

I recommend: Check out the article at BNET concerning new marketing strategies for clinical trial patient recruitment to ensure you remain up-to-date on successful techniques. Innovations Report highlights the use of electronic medical records as a means of clinical trial recruiting, demonstrating the ever-changing landscape in clinical trials patient recruitment.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  Patient recruitment can take up the majority of the time allocated for a clinical trial, so make sure to get help from an agency specializing in the field or additional resources to ensure you are not wasting time and money.

Patient recruiting is the most important part of a clinical trial. Each clinical trial has specific requirements for patients. If a trial is unable to recruit enough patients to complete the clinical trial, it can derail the entire project. It is not enough to recruit patients, they must remain in the study. Proper patient selection increases the retention rate.

Clinical trial recruitment is a multiple staged process, and each step has its own difficulties.

1. Patient recruitment includes feasibility studies and media analysis to determine the best way to target the study population.

2. Healthcare information specialists conduct patient pre-screening, gathering data from study candidates to determine if they meet study qualifications. The internet and telephone are often used in the pre-screening process.

3. Convert pre-screened applicants into study participants.

4. Use retention planning to ensure that study participants continue to show up for study visits.

Action Steps
The best contacts and resources to help you get it done

Use a patient recruitment agency

There are agencies that specialize in patient recruitment for clinical drug trials. Because this is all that they do, they have the advantage of knowing how to effectively pre-screen patients, find study participants for difficult to fill trials and maximize participant retention.

I recommend: ThreeWire and Inclinix are both established patient recruitment agencies. Using an established firm eases the stress of patient recruitment. Clinical trials rely heavily on these agencies to fill their studies.

Purchase patient recruitment advertising on the radio, in magazines and newspapers and on television

Clinical trials patient recruitment is tedious. To increase the likelihood of filling a study, cast a wide net. Media advertising allows you to reach people that would otherwise know nothing about clinical drug trials.

I recommend: A patient recruitment advertising company, such as Clinical Trial Media, has experience targeting specific demographics and conducting media analysis to receive the best return on your investment. If you prefer to handle the media purchasing yourself, there are guidelines for determining what type of media will best meet your needs.

Use a phone screening service to simplify patient recruiting

The most work intensive part of developing a clinical trial is patient recruitment. Clinical trials are necessary for drug approval, so it is important to expedite the process as much as possible. A phone screening service narrows the field of candidates. The participants that pass this pre-screening are more likely to convert from candidates to study participants.

I recommend: PhoneScreen provides over the telephone screening for prospective participants in clinical trials. Pre-screening is a specialized skill, and you should be well versed in the requirements if you choose to do the pre-screening yourself.

Find patients that are actively looking for clinical trial recruitment

There are two types of people that actively look for clinical trials, the ill, searching for a new type of treatment, and the healthy, looking for a stipend.

I recommend: If you are looking for people to fill a clinical trial, post information on your trial at Clinical Connection. Center Watch also provides a listing service that people seeking clinical trials can visit.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  If you choose to hire a patient recruiting agency, inquire about their average per patient cost.
• •  Clinical trials patient recruitment is big business. Verify that the agency you work with is HIPPA compliant, and any information about your subjects remains with your company.
• •  You can use patient recruitment agencies for some or all of the study set up. You can handle initial recruitment, and contract the patient retention, or have an outside company handle pre-screening.

Clinical trials patient recruitment is a complex process that requires adherence to protocol and knowledge of recruitment strategies. Consequently, researchers shouldn't blindly jump into patient recruitment for clinical drug trials. Education and training opportunities abound, providing novice researchers and companies with adequate training opportunities.

Your company can opt for on-site or the convenience and cost effectiveness of web based training opportunities. In addition to trainings, you can educate staff by hiring consultants to assist with initial projects. Here are a few things to keep in mind before commencing with patient recruiting.

1. Patient recruitment for clinical trials begins by reviewing past enrollment performance metrics for similar studies.

2. Once the subject target group has been established, it's imperative to complete subject source mapping, which delineates sources of subjects.

3. Effective patient recruitment advertising is the next key component of patient recruitment process.

4. Unique strategies are necessary for clinical study recruitment of underrepresented populations.

Action Steps
The best contacts and resources to help you get it done

Contact a consultant to guide you through your first clinical trial patient recruitment

A consultant, specializing in clinical trial recruiting, can guide you through the patient recruiting process. Consultants are familiar with protocol as well as patient recruitment advertising.

I recommend: Consider contacting Hashimoto Consulting Services. This company offers patient recruitment strategies, vendor selection, tactical support and training support. P & E Associates specializes in recruiting underrepresented subjects including African American and minority patients.

Participate in face-to-face clinical trial recruitment training

Various companies, including patient recruitment agencies, provide training seminars that cover various aspects of clinical trials patient recruitment. Trainings may be done at your company or at another location.

I recommend: The Center for Professional Innovation and Training offers a two-day training course to help your company maximize global patient recruitment and retention. D. Anderson and Company offers an on-site 60 minute training session that covers patient motivation, decision making factors, enrollment challenges and good customer service.

Look for online patient recruitment clinical trials training

If you want more flexibility in training options, consider taking an online course. Fortunately, there are many options for online clinical study recruitment training.

I recommend: The National Institutes of Health provides an excellent overview of clinical research, which covers ethical issues regarding human subjects research. ClinfoSource also offers an online training program that instructs researchers in Good Clinical Practice (GCP) guidelines. Barnett Educational Services also offers an excellent web seminar course called Subject Recruitment for Clinical Research Sites. The course covers participant recruitment practices, subject retention, management of susceptible populations and much more.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  Network with other researchers or companies engaged in recruiting for clinical trials. They may be able to provide you with strategies that have been successful.

If you're new to the business of clinical drug trials, gaining a strong understanding of patient recruitment is key to ensuring a successful study. Patient recruitment is much more than a word-of-mouth process, and it requires careful planning. Understanding the key terms of patient recruitment for clinical drug trials will give you a better understanding of the scope of this important step. Additionally, knowing terms like "study branding" and "global patient recruitment" will help you choose providers to offer you the support you need for your specific drug trial.

Action Steps
The best contacts and resources to help you get it done

Patient recruitment campaign

A patient recruitment campaign is a unified approach to recruitment, which generally incorporates media advertising. Marketing specialists develop these campaigns to help target the population that you want in your clinical drug trials.

I recommend: Read an article about how a successful patient recruitment campaign helped Praxis saved over a year’s worth of time in its clinical trials.

Study branding

Study branding is the process of creating a unique look and feel to your clinical trial's promotional and informational material. Creating an identifiable brand to express your study allows potential participants to understand not just what you're doing but the overall experience they are likely to have within the clinical trial.

I recommend: Healthcare Communications Group offers study branding for clinical drug trials, as well as a range of other recruitment services.

Global patient recruitment

With the focus on outsourcing and globalization in other industries, there's no reason why it shouldn't be incorporated into clinical drug trials. With global patient recruitment, you expand your base of potential participants to a global scale, which can potentially help you complete your study more quickly and at lower cost.

I recommend: Read about the basics of global patient recruitment at Xtalks.

Patient screening

Patient screening is the process by which you determine which potential participants are good fits for your study and is often completed in multiple tiers.

I recommend: Read about the three-layer process that TKL Research uses for patient screening.

Projected vs. actual recruitment rates

At the beginning of the clinical trial process, you establish the projected recruitment rate-the number of participants you expect. The actual recruitment rate reflects the number of viable participants that your patient recruitment strategy actually attracts.

I recommend: The Clinical Research Group addresses the difference between projected and actual recruitment rate and offers an overview of how to help ensure that the two match.

Participant retention

Though the actual practice of participant retention comes after you've recruited patients for your clinical drug trial, a plan for retention has to be in place from the beginning or you may lose those patients you've worked hard to recruit.

I recommend: TMS Health offers participant retention services that focus on following up with participants.