Author: Reeshav Mittal, Associate Director, Clinical Operations, Cloudbyz Inc.
Table of Contents
- What is RECRUITMENT? – SOME DEFINITIONS
- Major Critical Barriers to Patient Recruitment
- Retention in Clinical Trials
- How to Remove Recruitment & Retention Roadblocks
Nothing is of more importance to a clinical research study than recruitment and retention of participants in the study. In addition, losses to follow-up can destroy a study. Even those that succeed often have a homogenous participant sample which can lead to biased outcomes.
Numerous efforts and approaches have been employed to recruit an adequate number of participants as well as to ensure diversity and inclusion in the clinical trials. Despite these efforts, the metrics are not reassuring and clinical researchers across the world continue to face challenges in recruiting and retaining participants . Digitization has been identified by industry experts as the best way to drive efficient and cost-effective recruitment and retention across the clinical trials space. This discussion will focus on digital recruitment solutions and strategies to empower sponsors and sites to provide better patient engagement and experience while boosting both recruitment and retention.
What is RECRUITMENT? – SOME DEFINITIONS
Clinical trial participant recruitment is an entire process which consists of pre-screening, screening, and enrolment.
- Recruitment: The process where potential participants are identified and contacted for further discussion (based on preliminary eligibility), provided informed consent, and are screened and (where eligible) enrolled in a study
- Pre-screening: The evaluation of generalized characteristics prior to consent and screening to determine initial eligibility
- Screening: Refers to information collected specifically to assess eligibility for the study (i.e., in addition to clinical care).
- Enrolment: Participants who have provided informed consent, have been screened for study eligibility and have been deemed eligible are considered enrolled in the study, except in clinical trials where participants are considered enrolled only after they have been assigned to the intervention.
Critical Barriers to Patient Recruitment
The primary reason for a study failing to recruit the adequate number of participants is the lack of participant engagement. Research sites often do not have adequate tools to recruit and motivate participants to retain them in a study. The situation is compounded by the location of the sites. This is especially true as it is becoming increasingly difficult to find a diverse population close to the research sites.
Furthermore, we have the protocol or trial level factors – complexity of trial design, inclusion exclusion criteria, sample size – all determine the ease of recruitment and retention. It is very important to have a clearly defined informed consent procedure as it can have a huge bearing on patients’ decision to accept or decline participation in a trial.
Retention in Clinical Trials
While patient recruitment is key to starting a clinical trial, patient retention may be more critical in ensuring the trial moves through the phases. Retaining participants in a trial ultimately helps keep a study on track, saving the site time, money, and resources in the process. Some common reasons for non-retention are:
- Side effects of study medication
- Lack of clarity on participation requirements
- Inconvenient location of site
- Schedule conflicts
- Personal/family matters
- Fear and anxiety
- Medical Condition not improving
Patient retention is the strategy and tactics designed to keep patients enrolled in clinical trials, and from discontinuing participation and “dropping out.” Some of the elements of a Successful Retention Strategy are:
- Clear and thorough Informed Consent Process.
- Treating the participant with respect.
- Identifying and overcoming barriers to retention.
- Accommodating/ adjusting visits based on participants availability wherever possible
- Providing information to subjects on how to manage their condition/ lifestyle tips
- Providing travel compensation or accommodation to patients who have to travel far
- Being accessible to patients to answer their questions in a timely manner
How to Remove Recruitment & Retention Roadblocks
Effective recruitment presents one of the greatest opportunities to stem climbing clinical costs and accelerate the trial process. Producing more efficient marketing campaigns and new ways of attracting patient populations will provide an edge. The sponsors and sites are taking the following steps to overcome the recruitment and retention roadblocks:
- Trial design consideration
- Careful calculation of Sample Size
- Relaxation of the inclusion criteria
- Planned Randomization schemes
- Dedicated Patient Recruitment Budget
- Recruitment Strategies
- Methods of Recruitment
- Digitization of the Recruitment Process
- Extend time for recruitment or, in the case of multicenter studies, to add recruiting centers.
- Patient Motivators
- Remote visits
- eConsent, ePRO, eSource
- Dedicated Patient Portal
- Site Factors
- Proper Selection Process
- Telehealth for better patient engagement
- Streamlined pre-screening and screening Process
One of the most difficult tasks in a clinical trial involves obtaining adequate study participants within a reasonable time. Time is a critical factor. There is an optimal window of time within which a clinical trial can and should be completed. Changes in medical practice, including introduction of new treatment options, may make the trial outdated before it is completed. Lagging recruitment will also reduce the statistical power of the trial. Costs increase, frustration, and discouragement often follow.
Successful recruitment depends on developing a careful plan with multiple strategies, maintaining flexibility, establishing interim goals, and engaging patients to remove barriers of physical location. The changing landscape of the clinical research space suggests that digitization of the entire recruitment process will eliminate the major roadblocks, improve the patient experience and hence will result in healthier recruitment and retention rates across the studies.