METHODS OF PATIENT RECRUITMENT

To get appropriate subjects within the specified time frame :

Recruitment strategy

Budget

METHODS OF PATIENT RECRUITMENT

1. Investigators database:

Investigators site chosen because of expertise in particular therapeutic area

Investigators generally tend to overestimate the no. of patients he would be able to enroll as he tend to look for overall diagnosis without weighing the exclusion criteria.

2. Clinician Referrals:

For pre study promotions, presentations, meetings and forums are arranged

Clinicians are made aware of eligibility criteria and recruitment materials

Recruitment material- posters, flyers, mail shots, which clinician can send to subjects

Material should be approved by IEC and letters should have “Opt –in” or “Opt- out” option.

METHODS OF PATIENT RECRUITMENT

3. Advertisement

Mass media campaigns – newspaper advertisements, radio or TV advertisements, press releases, mailings billboards, public announcements

All approved by IEC before used

Advertisements should follow a criteria:

• Should not be misleading

• No claims for safety/ efficacy/ superiority

• No terms as ‘new treatment’ / ‘new drug’ without explaining that the test article is investigational

• Advertisements should not promise ‘free medical treatment’ when intent is not to charge the subjects

METHODS OF PATIENT RECRUITMENT

Key elements of Advertisements:

• Name of the research facility

• Purpose of research and Eligibility criteria(Briefly stated)

• Time commitment

• Contact person for more info

• The word “research”

• If monetary compensation is offered, it must not be presented as an inducement to participate

4. Community based:

Recruitment through organizing health camps which will target the populations having the disease under study

Speaking at a meeting for disease specific support group would increase awareness

METHODS OF PATIENT RECRUITMENT5. Web based:

Companies listing clinical trails on web. centrewatch.com and clinical trails.gov

Online partnerships with search engines yahoo and Google enable sponsors to provide lead to subjects

Web sites are used to post the pre qualifying questionnaire and to pre screen subjects online through a secure network setup.

6. Call centers:

They form the first point of contact for a patient in the recruitment process and health information data is obtained through telephone screen. Data can be rapidly processed and filtered to spread recruitment to several sites

Call centers can help by giving first appointment to patient at a convenient centre

Limitations- training to operators, language specialists in multinational studies, confidentiality of data.

RECRUITMENT MATRIX

• Recruitment success is to be measured and accountability is designed:

• Accountability includes-

– complete tracking of each point of contact

– pre screeing call

– scheduling of first screening visit

– Recruitment enrollment

– Retention

– linking these actions to referral source

RECRUITMENT FUNNEL Prior to starting recruitment campaign, an investigators needs to project how many

patients he would need in order to get ‘n’ no. of patients for screening and what percentage of that the would ultimately be able to enroll for a particular study

• Patients identified 1000

• End of prescreening 400

• End of screening(incl/exl) 250

• Randomized 150

• Qualified/ evaluable 100

From previous studies:

Average only 1 in 20 patients who responds to recruitment promotion ever complete the study and 1 out of 5 who respond ever show up for initial creening

Recruitment funnel is the basis of setting up budget for the trial