Patient recruitment is the process of finding and enrolling suitable participants for clinical trials. It is a crucial aspect of drug development and medical research, as it affects the validity, reliability, and generalizability of the results. Patient recruitment can also be challenging, time-consuming, and costly, involving various ethical, regulatory, and logistical issues. Many factors influence patient recruitment, such as the design and complexity of the trial, the availability and accessibility of the target population, the awareness and motivation of the potential participants, and the competition and collaboration among different stakeholders. To overcome these challenges, patient recruitment service providers offer various solutions, such as public education, patient outreach, site support, and data analytics. These services aim to increase the enrollment rate, reduce the dropout rate, and improve the quality and diversity of the trial participants.

Patient recruitment in the US

Patient recruitment in the US includes a variety of services—typically performed by a Patient Recruitment Service Provider—to increase enrollment into clinical trials. Presently, the patient recruitment industry is claimed to total $19 billion per year. Patient enrollment is the most time-consuming aspect of the clinical trial process. The leading cause of missed clinical trial deadlines is patient recruitment, taking up to 30 percent of the clinical timeline. Improving patient recruitment rates offers pharmaceutical and medical device companies one of the biggest opportunities to accelerate the pace of clinical trials – making it possible to reduce time to market. As the number of patients needed for clinical trials rises – as safety and regulatory issues drive trends toward larger and longer trials – the demand for patient recruitment services grows. Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. They are conducted in a series of phases, each designed to address a separate purpose: Pharmaceutical companies submit trial data to the U.S. Food and Drug Administration (FDA) as part of a New Drug Application, the application for FDA approval to market a drug in the U.S. Patient recruitment service providers educate the public about the value of clinical trial participation and the measures in place to protect study participants. The 2001 "Will & Why Survey" of more than 5,000 people in the U.S. showed that 81 percent of the population was not aware of safeguards such as the Declaration of Helsinki, The Belmont Report, Institutional Review Boards, and the informed consent process. However, after learning about these protective measures, nearly 40 percent of respondents reported they would be more likely to participate in a clinical trial.

Patient recruitment in Europe

In Europe, patient recruitment is the leading cause of missed clinical trial deadlines, taking up to 30%of the clinical timeline. Improving patient recruitment rates offers pharmaceutical and medical device companies one of the most significant opportunities to accelerate the pace of clinical trials and reduce time to market. Many factors hinder the enrollment and retention of patients in clinical trials in Europe: some of these factors include lack of awareness and trust, complex and restrictive eligibility criteria, practical and ethical barriers, and regulatory and organizational challenges. Different actors and stakeholders in the clinical research field, such as pharmaceutical companies and patient advocacy groups, have proposed and implemented various strategies and initiatives to address these challenges and improve patient recruitment in Europe. Some of these include increasing awareness and trust, simplifying and expanding eligibility criteria, reducing practical and ethical barriers, and harmonizing and streamlining regulatory and organizational processes.

Origin

The discipline of patient recruitment was formed over three decades ago in the U.S. to meet the challenge of successful on-time enrollment. It has evolved into a field that includes feasibility modeling and analysis; country selection; site selection, training and support; metrics and evaluation; marketing communications, media; and public relations. The patient recruitment sector has experienced rapid growth in recent years, particularly in response to increasing number of global clinical trials. Technology has impacted the evolution of patient recruitment. Many companies have developed proprietary software to help make processes more efficient, and providers increasingly rely on the Internet not only for advertising and early screening, but also for tasks such as tracking data and measuring site performance.

Services

Patient recruitment

The goal of patient recruitment is to raise awareness of clinical trial opportunities and to encourage enrollment. Services are contracted for by pharmaceutical companies, biotechnology companies, medical device companies, contract research organizations (CROs), or a medical research site. Services include:

Patient retention

If a trial is lengthy or if it requires invasive procedures, the greater the need for retention support to help keep patients involved for the entire trial timeline. For those engaged in global clinical studies, particularly lengthy trials with extension studies, the need for patient retention services is significant. A variety of support services that are considered retention specific include:

Vendors

There are several types of vendors that offer patient recruitment services, including:

Current Process

E6-GCP guidelines suggest that an investigator should have adequate resources to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period. There are many different recruitment methods, including mass media (i.e., television, radio and newspaper), physician referrals, press releases, fliers, random mailings, cold calls and the internet. These methods must be selected before study start. Also, some common factors such as-sample size, suitability of the strategy as per study design and overall budgetary constraints must not be ignored.

Ethics

Forming a trusting relationship can be used as a method of increasing recruitment. Patients tend to trust their physician and are more inclined to consent to a study they recommend. However, it is not considered ethical to leverage trusting relationships due to the power gap between patients and physicians. It is similarly unethical for a physician to pressure a patient into joining a clinical trial. When the research subject is unable to understand the difference between research and regular care, this is described as therapeutic misconception. It is also therapeutic misconception if a research subject overestimates the benefits of a trial or underestimates risks due to a misunderstanding of the research process. This brings up concerns about the validity of informed consent because therapeutic misconception hinders informed decision-making. Avoiding bias is important when recruiting patients to maintain an ethical trial. Statistically, vulnerable populations, including women and ethnic minorities, are not as likely to be recruited to clinical trials. Patients who are part of ethnic minority groups often have reservations about joining trials because they fear discrimination, especially if there is a history of unethical experimentation involving their population. Confusion can arise due to language barriers, so communication must be in a manner that will be clearly understood.

Child Recruitment

Different ethical concerns must be taken into consideration when recruiting children for clinical trials. Children are described as legally incompetent and are therefore unable to provide credible informed consent. The informed consent of one legal guardian is required to recruit children for clinical trials. In some cases, parents do not understand randomization, do not know they can withdraw their child from the study, do not know they can decline participation in a study, or want their physician to make the decision to participate. These misunderstandings make it questionable whether parental consent was informed. If children are over the age of 7, it is required that the child assent (agree) to participate in the research in addition to parent approval. When discussing research with a child, all aspects of the study must be communicated in a clear way that they can understand. Any written consent must be placed at an age-appropriate reading level.

Globalization

As clinical trials begin to spread to developing countries, ethical concerns emerge regarding the validity of the informed consent process. When working with vulnerable populations, researchers must be sure to fully engage with potential patients and clearly explain the research to obtain valid informed consent. It is a legal requirement in some countries to obtain assent from children before they can participate in a study but this may be inappropriate if children do not normally have autonomy in those countries. There are ethical concerns about the power gap between patients and their physicians and how this could affect decision-making. A benefit of the globalization of clinical trials is that the recruitment process can be faster in some countries, making research more timely. Due to cultural differences, recruitment processes in one country may not be applicable in another and alterations should be made accordingly.