SUBJECT RECRUITMENT AND RETENTION AT THE TRIAL SITE
BARRIERS OF RECRUITMENT AND RETENTION
Barriers are classified in four broad groups:
· Subject-related barriers
· Investigator-related barriers
· Protocol-related barriers and
· Other barriers.
Subject-related Barriers: Long waiting times associated with clinical visits and inconvenient scheduling of appointments is the main in this type of barrier. Subjects who have unrealistic expectations of the clinical trial may be reluctant to complete the study protocol.This may result in reduced retention, with subjects dropping out prior to trial completion.
Investigator-related Barriers: This may be divided into logistical factors and personal factors. Investigator’s underestimation of the workload involved in a clinical trial is the main cause here. This could reflect a poor choice of investigator to undertake the study, and could also imply poor communication between the sponsor company and the investigator as to the amount of work actually involved in the trial.A lack of time and resources to undertake the study may cause investigators to lose their motivation to recruit the patients which results in failure of the study.
Protocol-related Barriers: Lack of full support and keenness for the design or aims of the study protocol on behalf of the investigator are the main causes here.A protocol design whose eligibility criteria is rigid that do not qualify for entry of the potential study subjects and protocols that are too difficult for investigators to follow due to overly complex study designs are one of the major protocol-related barriers.
Other Barriers: The main other barrier are the negative influence of the media, ethical approval process that delay subject recruitment and trial commencement and the poor choice of study site by the sponsor.The importance of involving key opinion leaders in clinical trials has to be mentioned as a strategy to help endorse products.
According to a recent Center Watch report, dropout rates of 15-40% in clinical trials are not uncommon, and 86% of all U.S. clinical studies fail to recruit the required number of subjects on time. Participant recruitment to clinical trials has been called “the most difficult and challenging aspect of clinical trials,” and the blemishes in recruitment is identified as one of the main reasons for the failure of clinical studies.
CURRENT CHALLENGES IN CLINICAL TRIAL PATIENT RECRUITMENT AND ENROLLMENT
This can be measured from three perspectives namely:
- Sponsor perspective
- Principal Investigator perspective
- Clinical research volunteer perspective.
Sponsor Perspective: A research participant enrollment goal is established far in advance of trial initiation.The target number that is documented in the trial protocol for the number of desired participants is N and the number is small.Those who design the study plan must specify a larger number “N” in the protocol than the number of participants expected to be evaluated at study closure.
Principal Investigator Perspective: The Principal Investigator is the link between the patient and the sponsoring pharmaceutical company. Therefore a prime goal of the sponsor is to successfully recruit qualified Investigator. Commonlydrug companies and contractors offer large payments to doctors, nurses and other medical staff to recruit patients,some getting finder’s fees for merely referring patients to the study. This activity is strongly frowned upon in academic institutions and absolutely discouraged. In some rare instances the referring physician (usually a resident) will be given a ‘low-cost’ gift certificate to the medical bookstore.
Clinical Research Volunteer Perspective: Common barriers that potential volunteers consider in regards to clinical trial participation are lack of awareness of clinical trials, lack of access to trials,distrust or suspicions of research,practical or personal obstacles,Insurance or cost problems, Unwillingness to go against personal physician’s wish,long-standing fear, apprehension and skepticism. People from various cultural or ethnic backgrounds hold different values and beliefs that may be different.
RECENT ADVANCES: According to following prospects
- Professional recruitment providers
- Increased use of market research
- Centralized recruiting
- Development of Metrics
Professional recruitment providers: These are the companies that can structure media campaigns, designs and place advertisements and follow up the strategy as the study stretches out.
Increased use of market research: Market research can sort out populations based on demography, geography, psychology and behavior.With the help of market research, the sponsor can gain access to media behavior of their flock of patients and therefore focused media campaigns can be developed for the targeted population.
Informatics:It is a database-driven approach in finding potential subjects.It provides de-identified data obtained from pharmacies, physicians, hospitals and insurance companies etc. Once the population is defined, they would target the population with direct mail campaigns.
Centralized recruiting: It means that there is one centralized location for all information regarding potential subjects and it facilitates accurate tracking and analysis of recruitment services.
Development of Metrics:“The Leaky-pipe Analysis”
The metrics evaluate the effectiveness of a recruitment program.Through continuous measurement of methods of patient recruitment,meaningful metrics will take shape.The Leaky-pipe analysis is a visual aid.Once the leaky areas of the pipe are identified, then it is needed to be repaired.This not only helps in tracking the recruitment process but also helps to repair when damages are done.
At present time, as the number of trials is increasing, the number of patients required is also increasing.As the traditional recruitment and retention methods have failed to meet the goal, the recruitment of patients has become partnering process between the Sponsor, Investigator and the CRO.Exploring the difficulties of recruitment and retention and carefully planned design,implementation,and follow-through of sound recruitment and enrollment strSategies contribute to the efficiency and success of clinical research trials from initiation to study close-out.
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