SUBJECTS  RECRUITMENT  IN  CLINICAL TRIALS

INTRODUCTION :-

 Subjects recruitment is one of the most important criteria in clinical trials. It includes a variety of services which were only performed by the Patient Recruitment Service Providers. By doing this we can able to increase the enrollment of subjects into the clinical trials. Clinical trials are conducted on subjects to collect the data regarding the safety and efficacy of the drug. 

PATIENT RECRUITMENT:-

Patient recruitment is performed by Patient Recruitment Service Providers. The main goal of this is to raise awareness of the clinical trials in the people and encourage them to enroll in the clinical trials. The services are taken up by the Contract Research Organizations (CRO), Biotechnology companies, Pharmaceutical companies, Medical Research sites or Medical Device companies.

    

These providers include different services – Study Feasibility, Selection of the Site, Recruitment materials, Media support, Managing the Media, site training materials, Patient referral follow up, Translations, Community outreach, Physician outreach, Site support, Monitoring and Reporting. 

Patient enrollment into clinical trials is the most time consuming process. Due to this reason most clinical trial deadlines were missed and it takes upto 30% of the clinical timeline. This patient recruitment was formed three decades ago in the U.S to meet the successful on-time enrollment of the subject. It has evolved into a field that includes feasibility modeling, analysis, country selection, site selection, support, traning, marketing, media, public etc., The Patient Recruitment Sector has experienced a rapid growth in recent years and particularly in increasing the number of clinical trials.

STEPS INVOLVED IN RECRUITMENT PROCESS:-

• Inclusion/Exclusion criteria

• Adequately explaining the study

• Recruiting an adequate and representative sample

• Obtaining true Informed Consent

• Maintaining ethical standards

• Retaining participants until study completion

• Minimizing cost-benefit ratio and compensation 

VARIOUS METHODS OF PATIENT RECRUITMENT:-

• Advertisements

• Recruitment letters or scripts

• Random Digit Dialing(RDD) used in surveys and polling

• Honest broker system

• Newspapers, Local papers, Publications for parents

• Research registry 

• Dear Doctor Letters to encourage clinician referrals

• Television and radio

• Posters, Flyers: these are posted around campus, in public spaces with permission if necessary

• Pop-ups, banner advertisements with required Institutional Review Board (IRB)

THE SUBJECT WHO IS ENTERING INTO CLINICAL TRIALS MUST MEET ALL THE INCLUSION/EXCLUSION CRITERIA.

            The Inclusion/Exclusion criteria were explained by the Investigator to the subject in the Clinical trials.   

 

By-

Anusha Kapala

B. Pharmacy

Student at Clinosol Research