of Patients Will Fail to Meet Pre-Screening Criteria
of Patients Decline the Opportunity to Participate in a Trial
of Patients Will Fail The Screening Criteria
of Patients Will Drop Out Trial for Preventable or Unpreventable Reasons
Pre-screening for Clinical Trial Recruitment & Enrollment
In serving you we encourage pre-screening subjects to determine their initial eligibility and interest in your study. Of the entire criteria, we agree with Forte Research’s analysis that suggest on average about 2/3rds or 63% of the criteria for enrollment can be determined at pre-screening. When pre-screening we protect the privacy of the potential subject and the confidentiality of information collected about him/her in accordance to HIPAA protocols, standards, and practices.
Be mindful “pre-screening” is different than “screening”. For IRB purposes, “pre-screening” is the term used to describe activities before obtaining informed consent (i.e., before enrollment). Pre-screening may not include any research procedures. “Screening” is the term used to describe activities performed after obtaining consent to ensure subjects are qualified for the study.
At the pre-screening stage we can address the specific inclusion/exclusion criteria for the study and other issues of suitability, for example, an individual’s ability to come to the research site multiple times. It is not appropriate to gather information that is not directly related to assessing eligibility and suitability. Administering eligibility tests and medical exams is considered research activity and may not be conducted during a pre-screening but rather only after the participant has been deemed eligible, agreed to participate, and has signed a consent form.
Recruiting the right study participants under tight timelines requires strategic thinking and critical analysis. We’ve cultivated enduring partnerships with medical practices, therapeutic clinics and medical institutions – and a proficiency in optimizing social media to to consistently meet rapid recruitment goals. Micro-targeting subject populations according to diverse categories such as geographies, stages of disease states, and access to information about patients’ current therapies helps our partners to dramatically accelerate the trial recruitment process. Our HIPAA-compliant enrollment procedures and screening tactics relieve sponsors’ financial burden for screening, help to increase efficiencies and shorten enrollment periods.
Our pre-screening methodology is orchestrated entirely online and the guidelines for the conduct are the same as if it were performed in person or over the phone. Only information pertaining to the participant’s eligibility is gathered during a pre-screen. In some cases we retain information from individuals who are pre-screened but not enrolled and that would be only non-identifying information about individuals who are pre-screened for a study, but do not actually pursue the study or enroll. In fact, this is often desirable or requested by sponsors to obtain information about the entire pool of individuals interested or potentially eligible for the study.
All pre-screening activities are considered part of the subject selection and recruitment process and must be reviewed and approved by the IRB prior to initiation. Pre-screening procedures should be described in the protocol document. In addition, the specific inclusion/exclusion criteria for the study should be stated. The IRB will compare the screening tools with these inclusion/exclusion criteria, to ensure that the questions asked during pre-screening are not beyond the scope of the criteria. The questionnaires, checklists, or other screening tools that will be used must be submitted for IRB review.
For the Collection of Identifiable Health Information: The following guidelines for handling identifiable new healthcare information became effective on April 14, 2003: Under the “preparatory to research” provision of the HIPAA Privacy Rule, an investigator may maintain identifying information at the end of the screening engagement until the subject meets with study staff to discuss the study further and sign the consent form. (If identifiable health information is collected on persons who are not enrolled, there are two options: (1) destroy the information or (2) if a failure log must be maintained, the PI must obtain informed consent and authorization in writing from each individual – see V. below). During this meeting, the subject must be asked to sign the written authorization to use and disclose his/her identifiable healthcare information and be given a copy of the hospital’s Privacy Notice unless s/he has previously received one during interactions with the hospital. For subjects who do not ultimately pursue the study, the pre-screening information should be handled as outlined in Section V below (Retaining Information from Individuals who are Pre-Screened but not Enrolled).
We accelerate patient recruitment through targeted digital marketing. Platforms like Facebook, Twitter, and Instagram enable us to direct recruitment ads toward regional and demographics enrollment goals, resulting in higher response rates within scheduled timelines. Learn more here.
The Recruitment Journey Forecasted: If have no historical data available consider Forte Research’s guidance of what to roughly expect in terms of clinical trial recruitment forecasting:
- 69% of patients will fail to meet the pre-screening criteria
- 58% of patients will decline the opportunity to participate in a trial
- 32% will fail the screening criteria
- 18% will drop out of the trial for preventable or unpreventable reasons
On average, the data suggests that the typical conversion ratio is about 10:1. For every patient to be randomized, the site (or the study overall) will need to identify or reach about 10 patients. While the conversion ratio and losses will vary for a particular indication or phase, this benchmark dataprovides a good reference point. If in doubt, plan to be more conservative in your estimates to ensure a realistic recruitment funnel.
Pre-screening Questions, Where and How To Start? Map out which inclusion and which exclusion criteria can be determined at pre-screening (i.e., pre-consent) versus those criteria that can only be determined post consent.
- First assess the core inclusion criteria. If the patient passes this criteria then…
- Evaluate any permanent exclusions that could rule a patient out. If the patient has NO permanent exclusions then…
- Assess whether the patient has any of the “transient” exclusions (i.e., the criteria that are associated with a given time line such as recent infections, or amount of time on a stable dose of medication).
- If the patient has any transient exclusions, add them to a “watch and wait” list and follow-up with the patient at the appropriate time frame to re-evaluate their eligibility
- If the patient has NO transient exclusions, then this would be a pre-qualified patient who could be approached about the study to explore their interest. Upon receiving appropriate informed consent, the remaining screening criteria could be evaluated (along with verification that nothing has changed based upon the pre-screening evaluation).
- A word of caution. A common challenge in recruiting patients for clinical trials is considered to be unrealistically restrictive inclusion and exclusion criteria. Research from the National Cancer Institute shows that 40% of oncology trials fail to meet minimum patient enrollment, and more than 60% of Phase III trials fail to meet minimum patient enrollment – with many feeling this is due to impractical and inconvenient protocol requirements. Just something to be mindful of and consider as you develop your own criteria.