Patient recruitment

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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.

Contents

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 [1] per year. [2]

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. [3] 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" [4] 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. [5] [6] [7]

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: [11]

  1. Patient Recruitment Agencies: These agencies specialize in identifying and engaging potential participants for clinical trials. They use a variety of tactics, such as social media advertising, targeted email campaigns, and physician referrals, to reach potential patients.
  2. Site Management Organizations (SMOs): SMOs provide a range of services to clinical trial sites, including patient recruitment. They have a network of sites across multiple therapeutic areas, allowing them to quickly identify potential participants and enroll them in trials.
  3. Contract Research Organizations (CROs): CROs offer a wide range of services to clinical trial sponsors, including patient recruitment. They typically have a large network of clinical trial sites and can help sponsors identify potential patients and enroll them in trials.
  4. Technology Vendors: These vendors offer technology solutions to help sponsors manage patient recruitment. They may provide services such as patient matching algorithms, patient engagement platforms, [12] and data analytics tools to help sponsors optimize their recruitment efforts.
  5. Patient Advocacy Groups: Patient advocacy groups may partner with clinical trial sponsors to help identify and recruit patients for clinical trials. These groups can provide valuable insights into patient needs and preferences, as well as help sponsors develop recruitment materials that resonate with patients.

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. [13]

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. [14] It is similarly unethical for a physician to pressure a patient into joining a clinical trial. [15]

When the research subject is unable to understand the difference between research and regular care, this is described as therapeutic misconception. [16] 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. [17] [16] This brings up concerns about the validity of informed consent because therapeutic misconception hinders informed decision-making. [16]

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. [15] 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. [15] Confusion can arise due to language barriers, so communication must be in a manner that will be clearly understood. [15] [18]

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. [18] 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. [19] 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. [19] When discussing research with a child, all aspects of the study must be communicated in a clear way that they can understand. [18] Any written consent must be placed at an age-appropriate reading level. [19]

Globalization

As clinical trials begin to spread to developing countries, ethical concerns emerge regarding the validity of the informed consent process. [20] [21] 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. [21] 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. [21] There are ethical concerns about the power gap between patients and their physicians and how this could affect decision-making. [21] A benefit of the globalization of clinical trials is that the recruitment process can be faster in some countries, making research more timely. [21] Due to cultural differences, recruitment processes in one country may not be applicable in another and alterations should be made accordingly. [21]

Related Research Articles

The Nuremberg Code is a set of ethical research principles for human experimentation created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War.

<span class="mw-page-title-main">Informed consent</span> Need and process for obtaining subject approval prior to treatment or research

Informed consent is a principle in medical ethics, medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclose a person's medical information.

Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics. However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation. Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.

<span class="mw-page-title-main">Clinical trial</span> Phase of clinical research in medicine

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.

<span class="mw-page-title-main">Human subject research</span> Systematic, scientific investigation that involves human beings as research subjects

Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.

<span class="mw-page-title-main">Off-label use</span> Use of pharmaceuticals for conditions different from that for which they were approved

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB reviews is to ensure that study participants are not harmed. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances. Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with national and international norms, regulations or codes.

An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).

Clinical equipoise, also known as the principle of equipoise, provides the ethical basis for medical research that involves assigning patients to different treatment arms of a clinical trial. The term was first used by Benjamin Freedman in 1987, although references to its use go back to 1795 by Edward Jenner. In short, clinical equipoise means that there is genuine uncertainty in the expert medical community over whether a treatment will be beneficial. This applies also for off-label treatments performed before or during their required clinical trials.

<span class="mw-page-title-main">Caregiver</span> Person helping another with activities of daily living

A caregiver, carer or support worker is a paid or unpaid person who helps an individual with activities of daily living. Caregivers who are members of a care recipient's family or social network, and who may have no specific professional training, are often described as informal caregivers. Caregivers most commonly assist with impairments related to old age, disability, a disease, or a mental disorder.

A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).

Therapeutic misconception is a common ethical problem encountered in human subjects research. It was originally described in 1982 by Paul Appelbaum and colleagues. The idea was introduced to the bioethics community in 1987. The formulation given by Appelbaum et al. in 1987 was the following: “To maintain a therapeutic misconception is to deny the possibility that there may be major disadvantages to participating in clinical research that stem from the nature of the research process itself.”

<span class="mw-page-title-main">Children in clinical research</span>

In health care, a clinical trial is a comparison test of a medication or other medical treatment, versus a placebo, other medications or devices, or the standard medical treatment for a patient's condition.

A glossary of terms used in clinical research.

Patient participation is a trend that arose in answer to medical paternalism. Informed consent is a process where patients make decisions informed by the advice of medical professionals.

A clinical trial portal is a web portal or enterprise portal that primarily serves sponsors and investigators in a clinical trial. Clinical portals can be developed for a particular study, however study-specific portals may be part of larger, clinical sponsor or Contract Research Organization (CRO) portals that cover multiple trials. A clinical portal is typically developed by a sponsor or CRO to facilitate centralized access to relevant information, documentation and online applications by investigational sites participating in a trial, as well as for the monitors, study managers, data managers, medical, safety and regulatory staff that help plan, conduct, manage and review the trial.

In the clinical research trial industry, loss to follow-up refers to patients who at one point in time were actively participating in a clinical research trial, but have become lost at the point of follow-up in the trial. These patients can become lost for many reasons. Without properly informing the investigator associated with the clinical trial, they may have opted to withdraw from the clinical trial, moved away from the particular study site during the clinical trial, become ill and unable to communicate, are missing or are deceased.

The term informed assent describes the process whereby minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.

Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.

<span class="mw-page-title-main">Clinical trials in India</span>

Clinical trials in India refers to clinical research in India in which researchers test drugs and other treatments on research participants. NDCTR 2019 and section 3.7.1 to 3.7.3 of ICMR guidelines requires that all researchers conducting a clinical trial must publicly document it in the Clinical Trials Registry - India.

References

  1. ↑ Outcome Health. "Outcome Health Introduces Clinical Trial Solution to Boost Patient Recruitment". PR News Wire (Press release). Retrieved January 15, 2019.
  2. ↑ "Delay No More: Improve patient recruitment and reduce time to market in the pharmaceutical industry" (PDF). IBM Institute for Business Value, IBM Global Business Services. 2003. Archived from the original (PDF) on August 4, 2016. Retrieved January 31, 2019.
  3. ↑ Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success, Joan F. Bachenheimer, Bonnie A. Brescia, Gower Publishing, 2007
  4. ↑ The Will & Why Survey, a Harris Interactive/BBK Healthcare Poll, 2001
  5. ↑ Cramer, Joyce A (1993). "Patient recruitment and compliance issues in clinical trials". Epilepsy Res Suppl. 10: 211–22. PMID   8251099.
  6. ↑ https://www.ohsu.edu/sites/default/files/2019-12/Forte_Patient_Recruitment_ebook_2017.pdf
  7. ↑ "Patient Recruitment".
  8. ↑ Zhou, Eric S.; Dunsiger, Shira I.; Pinto, Bernardine M. (August 2013). "Proactive versus reactive recruitment to a physical activity intervention for breast cancer survivors: Does it matter?". Clinical Trials. 10 (4): 587–592. doi:10.1177/1740774513480004. PMID   23515464. S2CID   1948030.
  9. ↑ Pharma's Facebook, Newsweek, March 10, 2009
  10. ↑ Whispering Tweets into a Patient's ear: Top Ten Suggestions for Clinical Trial Recruiters, March 2009
  11. ↑ "Patient Recruitment and Retention Services Market, 2019-2030". www.marketresearch.com. Retrieved May 3, 2023.
  12. ↑ "Find Promising New Treatments Through Clinical Trials". www.withpower.com. Retrieved May 3, 2023.
  13. ↑ Narender Dureja, Nidhi Bajpai (2014). "Patient Recruitment and Retention Strategy in Clinical Trials: Data-drivenand Evidence-based Approach" (PDF). www.hcltech.com.
  14. ↑ Al, Pepijn; Hey, Spencer; Weijer, Charles; Gillies, Katie; McCleary, Nicola; Yee, Mei-Lin; Inglis, Juliette; Presseau, Justin; Brehaut, Jamie (March 28, 2023). "Changing patient preferences toward better trial recruitment: an ethical analysis". Trials. 24 (1): 233. doi: 10.1186/s13063-023-07258-4 . ISSN   1745-6215. PMC   10044713 . PMID   36973759.
  15. 1 2 3 4 Natale, Patrizia; Saglimbene, Valeria; Ruospo, Marinella; Gonzalez, Andrea Matus; Strippoli, Giovanni FM; Scholes-Robertson, Nicole; Guha, Chandana; Craig, Jonathan C; Teixeira-Pinto, Armando; Snelling, Tom; Tong, Allison (June 2021). "Transparency, trust and minimizing burden to increase recruitment and retention in trials: a systematic review". Journal of Clinical Epidemiology. 134: 35–51. doi:10.1016/j.jclinepi.2021.01.014. ISSN   0895-4356. PMID   33515656. S2CID   231770677.
  16. 1 2 3 Lidz, Charles W. (July 2006). "The therapeutic misconception and our models of competency and informed consent". Behavioral Sciences & the Law. 24 (4): 535–546. doi:10.1002/bsl.700. ISSN   0735-3936. PMID   16883621.
  17. ↑ Kimmelman, Jonathan (2007). "The Therapeutic Misconception at 25: Treatment, Research, and Confusion". Hastings Center Report. 37 (6): 36–42. doi:10.1353/hcr.2007.0092. ISSN   1552-146X. PMID   18179103. S2CID   41822933.
  18. 1 2 3 Manti, Sara; Licari, Amelia (June 1, 2018). "How to obtain informed consent for research". Breathe. 14 (2): 145–152. doi:10.1183/20734735.001918. ISSN   1810-6838. PMC   5980471 . PMID   29875834.
  19. 1 2 3 Afshar, Kourosh; Lodha, Abhay; Costei, Adriana; Vaneyke, Nancy (September 2005). "Recruitment in Pediatric Clinical Trials: An Ethical Perspective". Journal of Urology. 174 (3): 835–840. doi:10.1097/01.ju.0000169135.17634.bc. ISSN   0022-5347. PMID   16093965.
  20. ↑ Thiers, Fabio A.; Sinskey, Anthony J.; Berndt, Ernst R. (January 1, 2008). "Trends in the globalization of clinical trials". Nature Reviews Drug Discovery. 7 (1): 13–14. doi:10.1038/nrd2441. ISSN   1474-1784. S2CID   42746883.
  21. 1 2 3 4 5 6 Lang, Trudie; Siribaddana, Sisira (June 12, 2012). "Clinical Trials Have Gone Global: Is This a Good Thing?". PLOS Medicine. 9 (6): e1001228. doi: 10.1371/journal.pmed.1001228 . ISSN   1549-1676. PMC   3373653 . PMID   22719228.
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