Patient recruitment includes a range of services - usually performed by Patient Recruitment Service Providers - to increase enrollment to clinical trials. Currently, the patient recruitment industry is claimed to amount to $ 5.9 billion per year.
Patient registration is the most time consuming aspect of the clinical trial process. The main cause of a missed clinical trial deadline is patient recruitment, taking up to 30 percent of the clinical time line. Increasing the level of patient recruitment offers pharmaceutical and medical equipment companies one of the greatest opportunities to accelerate the clinical trial rate - allowing to reduce time to market. As the number of patients needed for clinical trials increases - as safety and regulatory issues push the trend toward larger and longer trials - demand for patient recruitment services is increasing.
Clinical trials were conducted to collect data on the safety and efficacy of new drug and device development. They are performed in a series of phases, each designed to address a separate purpose:
- Phase I: Researchers tested new drugs or treatments in a small group of people (20-80) for the first time evaluating their safety, determining safe dose range, and identifying side effects.
- Phase II: Drug or research treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. Phase III: Drug or treatment studies are given to large groups of people (1,000-3,000) to ensure their effectiveness, monitor side effects, compare them with commonly used treatments, and collect information that will allow medications or treatments to be used safely.
- Phase IV: Post-marketing studies outline additional information including appropriate risks, benefits, and drug use.
Pharmaceutical companies send trial data to the US Food and Drug Administration (FDA) as part of the New Drug Application, an application for FDA approval to market drugs in the US.
The patient recruitment service provider educates the public about the value of clinical trial participation and measures to protect the study participants. The 2001 "Will & amp; Survey" of more than 5,000 people in the United States shows that 81 percent of the population is unaware of the safeguards such as the Helsinki Declaration, Belmont Reports, the Institutional Review Board, and the informed consent process. However, after learning about this protective action, nearly 40 percent of respondents reported that they would be more likely to participate in clinical trials.
Video Patient recruitment
Origin
The patient recruitment discipline was formed more than three decades ago in the US to meet the challenge of successful registration on time. It has evolved into areas that include modeling and feasibility analysis; state elections; 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 an increase in the number of global clinical trials.
Technology has had an impact on the evolution of patient recruitment. Many companies have developed proprietary software to help make the process more efficient, and providers increasingly rely on the Internet not only for advertising and initial screening, but also for tasks such as tracking data and measuring site performance.
Maps Patient recruitment
Services
Patient recruitment
The purpose of patient recruitment is to raise awareness of the probability of clinical trials and to encourage enrollment. Services contracted for by pharmaceutical companies, biotech companies, medical equipment companies, contract research organizations (CROs), or medical research sites. Services include:
- Feasibility study: Evaluate whether research can be conducted in a particular country and how effective it is in enrolling a patient.
- Population research: Finding motivational drivers from target patient populations is usually collected through focus groups, and may involve caregivers and doctors.
- Site selection: Choosing an optimal recruitment location for study participation can play a role in the type of patient being recruited. For example, in breast cancer victims, evidence suggests that mail recruitment or at the oncologist's office will result in similar recruitment of patients.
- Site assessment: Investigate the operational, management, technical and clinical experience of participating sites help decide what support they will need to successfully recruit patients in research, improve forecasts and return on investment.
- Recruitment materials: Patient-directed communications designed to attract study referrals and improve enrollment. May include brochures, posters, letters, and leaflets.
- Media support: Whether addressed to patients and/or carers, advertising can increase learning awareness and encourage patient referral volumes. Some patient recruitment providers have an internal ability to develop, produce, and edit all content, while others rely on third-party vendors. Some popular media for patient recruitment advertisements are: television, radio, newspapers, the web (for example, banner ads and word links), outdoor (eg, bus stops), and social media (eg Twitter messages and YouTube videos).
- Media management: To achieve the greatest value of media advertising, media purchase services ensure placement in the patient's rich geographic area along with current market discounts and market opportunities.
- Site training materials: A specially designed instructional tool that helps site staff introduce research to patients, explain patient research procedures, and perform informed consent procedures with patients.
- Study Web Sites: Serve as an online link to information and sometimes pre-screening, study websites typically describe research, provide disease-related resources, and enable patients to demonstrate their interest in learning participation.
- Referral follow-up patients: When a site may be understaffed or overwhelmed by a patient referral surge, the PRO may offer administrative support by scheduling site appointments and following up with patients who may pose registration challenges (for example, patients who have recently moved and need location site closer).
- Translation: Provides translations of cultural and regulatory recruitment materials into different languages ​​according to country-specific requirements.
- Community outreach: To broaden learning awareness, outreach efforts can include participation in local health fairs or networks among community service groups, patient support groups, and other environmental organizations and agencies (eg church and barber).
- Doctors' outreach: When study recruitment is heavily dependent on physician referrals, outreach measures may include forums where physicians, specialists, and healthcare providers gather to view presentations on research and how their patient pool is eligible to participate. This may also include a direct mail program where a guarantee is sent to a doctor with the aim of increasing the referral volume.
- Site support: From resolving pre-test operational issues to customized support (e.g., referral processing, subject status updates, and protocol clarification), site support ensures that study challenges are addressed immediately.
- Monitoring and reporting: To assess the effect of patient recruitment activities on enrollment, ongoing monitoring is conducted. Assessing study metrics allows sponsors to tailor recruitment efforts as needed to ensure maximum return on investment.
Patient retention
If the trial is long or if it requires an invasive procedure, the greater the need for retention support to help keep the patients involved for the entire trial period. For those involved in global clinical studies, especially long trials with extension studies, the need for patient retention services is significant. Support services that are considered to be retention-specific include:
- Visit reminder: To stem the possibility of missed appointments, visit the warnings to ensure compliance as they contribute to keeping the study high. Reminders can be postcards, e-mails, text messages, or phone calls.
- Patient support items: With very long studies or where many of the invasive or extensive study procedures are involved, the patient's recognition items reflect rewards for study participation and encourage retention (eg, where long infusions are repeatedly required in research, pillow or blankets can be given to the patient to prevent discomfort).
- Caregiver support: In some studies, caregivers play an integral role in ongoing patient participation, as in many Alzheimer's disease research trials. Recognizing the needs of caregivers (eg, study guides, simple food cards to compensate lunch visits, overcoming skill resources, and home nursing visits) contribute to patient retention.
Current Process
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References
Source of the article : Wikipedia
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