Question18: Please list all of the important things to consider regarding volunteer recruitment. For example, you should consider advertisement, incentives, gender of candidates etc?


Question18: Please list all of the important things to consider regarding volunteer recruitment.  For example, you should consider advertisement, incentives, gender of candidates etc?

Answer :In order to get a new drug approved for market, a pharmaceutical company typically has to conduct trials involving more than 3,000 patients. Recruiting an adequate number of patients to satisfy the FDA is one of the biggest hurdles a pharmaceutical company faces when bringing a new drug to market. Poor patient recruitment is the number one reason that trials fail or are delayed


Following are the important things to consider regarding volunteer recruitment:


1. Right Estimation of subjects required by the Trial:


One of the most important pre-study activities a CRA has is to help sites accurately estimate the number of subjects that they can reasonably expect to enroll in each trial. Sponsor companies may recruit the right sites, but these sites may have over-estimated their potential enrollment. Over-estimating enrollment is a serious mistake for the investigator. When a site estimates its ability to participate, the project team counts on it to produce to that level. If the site does not, then the project team looks bad in front of those higher-ups at the company to whom they report.


2. Incentives to Research subject:

There are a number of ways that a site can encourage patients to remain in a study until the end. Any and all efforts to treat patients as special will go a long way to achieving this goal. Here are some other practical tips:  The stipend for the study should cover a patient’s out-of-pocket expenses and perhaps provide a small payment for the patient’s time. A typical stipend may pay for $15 to $25 per office visit. Although this isn’t much, for some people it still can provide an extra financial incentive for enrolling in a trial and completing all study visits.

The site should ensure that volunteers’ transportation needs are met. This may involve paying for taxis or even operating a van to transport elderly patients to and from the office. Some volunteers may not own cars and must rely on public transportation; a site should be aware of this and take steps to provide the necessary transportation or cover the associated expense.

If a protocol requires the enrollment of women volunteers, a site may need to provide some type of on-site day care. This is particularly true if the protocol will require the patient to stay in the office for an extended period. Even if the visits are short, a site needs to provide appropriate reading or play materials in the waiting room for the children.

3. Selecting the Right Sites:

Because of the many difficulties in enrolling patients, sponsors place a premium on selecting sites that have a good track record of filling their studies. The site that excels at patient recruitment {and also provides good quality data) can be assured that it will get repeat business from sponsors and that its clinical research business will grow. Sponsors are increasingly looking for sites that demonstrate they can enroll a diverse range of patients. The FDA is putting pressure on sponsors to test their investigational therapies on the full range of patients who will eventually be using the drug (if it is approved for marketing). As a result, sponsors need to recruit different ethnic groups, men and women, and often people of all ages. The site that fully enrolls its studies, and demonstrates that it can recruit diverse patient groups as well, will quickly win favor with sponsors.

4. Patient Recruitment via Advertisement:

In recent years, it has become more common for investigators to use radio and newspaper ads to enhance patient recruitment. The fact that sponsors are willing to pay for this type of expensive advertising exemplifies the importance they are placing on accelerating the clinical development of their new drugs.

A few sponsors are now taking their patient-recruitment efforts a step further and hiring advertising agencies to develop television ads to support their sites. Again, the television ad is developed in a flexible manner so it can be easily adapted for local use. When a sponsor employs a patient recruitment firm to do mass marketing, the site must make sure that it interfaces appropriately with the marketing firm.

The downside to advertising in general media outlets is that often most of the people who respond don’t qualify for the study. A well-placed radio or television spot may generate 100 calls to be screened, but only one or two patients eligible for the study. If this happens, the site incurs significant expense answering the calls and bringing prospective volunteers in for screening visits. In order to be cost-effective, radio, newspaper and television ads need to communicate, as much as possible, the specific therapeutic category involved, since this will help reduce the number of inappropriate calls.

In order to make the best use of advertising dollars, a site should track all patient inquiries and determine how the responders heard about the trial. The tracking will help a site evaluate the effectiveness of advertising in different mediums and how effective advertising can be for different types of studies.

A relatively new avenue for reaching patients is the Internet. The Internet has become a popular resource for people with chronic illnesses searching for medical information. Advertising on the Internet is also much less expensive than radio, news- paper or television advertising. However, it is not likely to generate the same volume of inquiries as radio, newspaper or television ads. Posting information about your research on the Internet should be seen as a way to supplement your regular patient-recruitment efforts.

5. Prompt Scheduling of appointments:

A patient calling with a complaint relevant to the trial can then be immediately scheduled for a visit. This prompt scheduling is important for two reasons. First, it provides the patient with preferred treatment, and this may encourage the person to volunteer for the trial. Second, it may be required as part of the protocol. For example, a protocol may require that patients be enrolled into the study within 24 hours of the onset of lumbosacral pain. In that case, the receptionist needs to immediately schedule an appointment for anyone calling with a complaint about lower back pain.

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