"Conducting Clinical Trials A-Z"

Recruit and retain study volunteers – The Ultimate Challenge:

Some Facts from the Center for Information and Study on Clinical Research Participation (CISCRP):

• Currently there are approximately 50,000 clinical trials taking place in the United States, 90% are delayed because of unfulfilled enrollment. (Source: Federal Drug Administration)
• An overwhelming majority of people (77%), say that they would consider getting involved in an appropriate clinical research study if asked; only 10% of those eligible to participate in clinical trials do so in the United States. (Source: Harris Interactive)
• In a recent poll, 94% of people recognize the importance of participating in clinical research in order to assist in the advancement of medical science. Yet 75% of the general public state that they have little to no knowledge about the clinical research enterprise and the participation process. (Source: CenterWatch)
• There is a lack of balance in representation in popular media with two times as many negative as positive articles in 2002.

Overcoming the challenges will require more public education about clinical research and it’s inherent protections and more outreach to market trial opportunities. The UKCRO maintains a For Clinical Trial Volunteers website and posts research education and advertising in-house, in area publications and on line. 

Recruitment Planning – Investigators should develop and implement a subject recruitment strategy that is effective but not coercive in any form.  Contact UKCRO marketing or education for assistance with developing a plan and/or advertising.  You will need to provide your recruitment plans in your IRB submission (item number 5 in the research description) to allow review for human subject and HIPAA compliance. 

Internal Recruitment:

Most internal recruitment, such as data-bases or chart review will fall under the HIPAA designation of Prepatory Research (Use or disclosure of PHI for the purposes of recruiting possible subjects, doing feasibility, etc.)

Use – happens within an organization or covered entity and is under direct control of that organization.

Disclosure – when information is shared with someone who is not part of the work force (students, monitors).   If have individual who is not member of workforce, must get a waiver of authorization from IRB for that individual to access PHI. See the ORI HIPAA webpage for guidance.

As a member of the workforce, you can contact potential subjects, but IRB will need to approve the method to ensure you maintain patient confidentiality. The best practice is to go through or obtain permission of the patient’s primary care provider.

If you are recruiting subjects from your own patient population, be aware of the “therapeutic misperception” and clarify that this is research, not clinical care and that you are now wearing your investigator, not clinician hat.  

The UK IRB will not approve finder’s fees for referring individuals to research studies.

External Recruitment

For trials that are appropriate to recruit from the community, accessing multiple outreach outlets can be effective (grassroots outreach, media interviews, direct advertising, web postings, etc.).  Approximately 2/3 of enrolling patients are self-referred.  If you track the response from each, you can identify the best methods that provide results.

Advertising Clinical Trials:

Recruitment materials (flyers, posters, newspaper, radio and television ads, public service announcements, dear-doctor letters, Web announcements) for human subjects require IRB approval and may be submitted as part of the application for initial review.

UKCRO will produce your recruitment materials upon request (Human Subjects Recruitment Request Form). Allow for a two-week turnaround time.  UKCRO will also arrange for placement of your advertising.

If you produce your own recruitment materials, UK PR will serve as your editor to review all materials before submission to the IRB. Allow for three-day turnaround time. UK PR can help get your news out in other ways.

Guidelines for advertising:

• Ads must state clearly that the program of study is Research.
• Ads must provide contact information:

1. Investigator's name
2. Person to contact
3. Contact's phone and/or e-mail. If research site has a web site address, please include URL. Example: Browse UKCMC Research Areas and Centers http://www.mc.uky.edu/research/clinicaltrials.htm

• Ads must list purpose of study.
• Ads must not make claims or promises of safety, efficacy, or superiority.
• Ads must not include coercive language.
• Ads may list benefits and may state that subjects will be paid, but should not include dollar amounts to be paid.
• Ads may summarize criteria that will be used to determine eligibility.
• Ads may list time or other commitment required.
• Ads may list location of research.

FDA Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators 1998 Update

NOTE: Sponsor's National Advertising Campaigns
Clinical trial recruitment material and related research information supplied to multi-site study locations does require IRB approval, but does not need review by UK. This applies to recruitment material that does not identify the University of Kentucky, informational brochures about drugs/devices, educational materials about the disease, dietary guideline booklets or other study-related information.

Funnel Concept:

1 out of 20 who respond to promotion complete a clinical trial

Careful pre-screening can improve recruitment effectiveness.  Have an informed staff member available to answer self-referral phone calls and complete a pre-screening questionnaire to determine potential eligibility and schedule those who meet initial criteria for a screening visit.  For those scheduled, the best practice would be to provide an appointment letter with directions and details on what to expect, a brochure or general information on clinical research and contact information.  These first communications are key to removing the “unknowns” and making the subject feel welcome and informed.  According to an analysis in CenterWatch, 40% of all pre-qualified volunteers fail to enroll due to inconvenience and lack of responsiveness from the study site personnel.

Monitoring your progress:

Utilize a screening and enrollment log (see sample for use if not provided by sponsor) based upon the study inclusion/exclusion criteria to collect screening information on all potential subjects. Note if individuals were enrolled in the study and if they were not enrolled, document the reason.  For those subjects enrolled, document if they completed the trial or withdrew and for what reason.

Sample Screening Enrollment Log (PDF)

Monitor progress and assess results of the recruitment strategy. Develop appropriate alternative strategies and implement if enrollment projections lag.

Subject retention – Treating Study Volunteers as Customers:

After investing time, effort and dollars to recruit, you want to retain good subjects through completion of the trial.  For long-term trials this can be a challenge, but it is possible.   Retention Strategies are rooted in principles of customer service:

• respect & honesty = retention
• being informed
• convenience
• perceived value in care
• education and counseling
• special treatment – holiday cards, token gifts
• availability & responsiveness (24/7 access for high risk trials)
• connection – get to know the volunteer
• Utilize compliance enhancers (study drug logs, pill dispensers, appointment reminder cards, wallet cards with study information, etc.)
• Follow-up on open adverse events to both sponsor and subject satisfaction
• Document and track reasons for volunteer drop-out
• Utilize an end-of-study feedback questionnaire
• Follow-up after the trial  - 79% of study volunteers report NO follow-up after study completion (un-blinding or results when available, volunteer newsletters to past subjects, etc.)

Lost to Follow-Up – What to do?

Attempts to contact subjects lost to follow up to complete a termination or final visit should be documented.

• Document in subject’s progress notes attempts to contact subject via phone.

• Send registered letter, keep a copy of letter and postal receipt.

• E-mail attempts if applicable