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Recruitment in cancer trials
 

Recruitment in cancer trials

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    Recruitment in cancer trials Recruitment in cancer trials Presentation Transcript

    • Recruitment in Cancer Trials Dr. Bhaswat S. Chakraborty VP, R & D, Cadila
    • Patient Participation in Cancer Trials A 1999 press release from the American Society of Clinical Oncologists  only 3% of adults with cancer participate in clinical trials  far fewer than the number needed to answer the most pressing cancer questions quickly Up to 80% of clinical trials are estimated to experience problems with recruitment
    • A Survey on Clinical Trial Barriers A survey of almost 6,000 people with cancer conducted in 2000  85% were either unaware or unsure that participation in clinical trials was an option  75% said they would have been willing to enroll had they known  of the aware ones of clinical trial option, most declined to participate because of common myths about clinical trials:  The medical treatment they would receive in a clinical trial would be less effective than standard care  They might get a placebo  They would be treated like a "guinea pig"  Their insurance company would not cover costs Source: www.harrisinteractive.com/harris_poll/
    • A Survey on Clinical Trial Barriers People who received treatment through a clinical trial found it to be a very positive experience:  97% said they were treated with dignity and respect and that the quality of care they received was "excellent" or "good"  Eighty-six percent said their treatment was covered by insurance Source: www.harrisinteractive.com/harris_poll/
    • Barriers & Promoters Barriers mainly 3 types  barriers to opportunity to participate (most)  barriers to awareness or acceptance of clinical trials  cultural factors Promoters mainly 3 types  awareness  transport  altruism
    • General Recruitment Issues Cancer trials require years to complete, and subject recruitment and enrollment can be a lengthy process Planning and pilot testing of recruitment methods Monitoring of patient accrual with respect to a priori targets Regular feedback of recruitment progress to recruiting centres Development of a risk management plan to respond to failure to achieve targets
    • Methodology to Particular Study Recruitment Issues and Solutions Identify patient recruitment barriers through an extensive review of the factors that hinder recruitment and retention  eg. complicated protocols, over-rigorous inclusion and exclusion criteria, etc. Identify solutions that work  illustrated by extensive review and numerous case histories of strategies and tactics that have been shown to improve recruitment and retention Obtain a thorough understanding of the circumstances in which advertising can still offer a highly cost-effective means to recruit patients and improve the quality and quantity of patients enrolled.
    • Methodology to Study Recruitment Issues and Solutions Get an in-depth look at the technological and other innovations introduced by CROs and IT companies  management of clinical trials generally and recruitment and retention more specifically Understand why a growing number of clinical trials are performed in countries like India  cost benefits  large populations  pharmacogenetic profiling  issues that sponsors to consider Gain reliable and thought-provoking insights into key factors influencing patient recruitment
    • Main Barriers to Recruitment Patient age Comorbidity Disease stage Mistrust of research method and researchers Lack of physician/care giver awareness about trials Communication Method of IC presentation Community based approach versus Institution based approach
    • Recruitment Strategies Hospitals, specialized hospitals The use of occupational and targeted screening Registers of trials Clinicians Mass media Direct mailing to access patients Specialized interventions Community camps
    • Barriers for Health Care Professionals Lack of awareness of appropriate clinical trials  physicians are not always aware of available clinical trials, local resources  some may assume that none would be appropriate for their patients Unwillingness to "lose control" of a persons care  relationship with patients is very important  doctors fear they may lose control of the persons care Belief that standard therapy is best Belief that referring and/or participating in a clinical trial adds an administrative burden Concerns about the persons care or how the person will react to the suggestion of clinical trial participation
    • Specific Barriers Long-standing fear, apprehension, and skepticism Doctors may not mention clinical trials as an option for cancer care. People from various cultural or ethnic backgrounds hold different values and beliefs that may be different than principles of Western medicine. Language or literacy barriers may make it difficult for some people to understand and consider participating. Additional access problems confront many people
    • Cost Barriers The costs associated with clinical trials can be a barrier for many professionals and the public Physicians are often concerned about reimbursement related to the expense of either caring for people enrolled in trials or offering trials within their practice Potential trial participants often fear that their insurance company will not cover participation Those who are uninsured will need to know how their participation in a trial will be covered.
    • Differences Between Passive and Active Recruitment Patients were employees In the passive employee contact arm  employees were contacted from a list of employee names and telephone numbers provided by the company In the active employee contact arm  employees actively signed up to participate While lower enrollment and higher attrition were observed in the passive recruitment arm, the passive method enrolled a more diverse group of participants than did the active recruitment method Source: Linnan LA et al Ann Behav Med 2002;24(2):157-66
    • Effect of an Intervention Program Intervention program consisted of the installation of a rapid tumor-reporting system  to improve data quality and to expedite the receipt of information on cancer patients from physicians  a nurse facilitator who would notify physicians of clinical trials  a quarterly newsletter mailed to physicians about cancer treatment and clinical trials  a health educator who trained lay health educators and provided community-based information about cancer screening, treatment, and clinical trials The rates of enrollment into clinical treatment trials did not improve significantly in the intervention communities Source:Ford Met al Clinical Trials 2004;1:343-51
    • Successful Recruitment Detailed understanding of the stages in the recruitment process Identification of steps where potential patients are lost Development of alternative tactics to enhance recruitment. Timeliness & cost containment Ability to detect subtle treatment effects Meeting ethical responsibilities to patients and clinicians Employment of an enthusiastic, committed and talented staff Initiative and adaptability to recruitment problems
    • Successful Recruitment Invitation of keen and successful investigators Development of a comprehensive investigators manual Organising investigator recruitment meetings Provision of numerous study aids to the centres Maintaining contact with the centres via the telephone Regular monitoring of recruitment progress and strategies (with subsequent feedback to the centres via the study newsletter and meetings for both the investigators and study nurses).
    • Strategies for Successful Recruitment (Hospitalized Patients) Provide checklists on patient charts with eligibility criteria Placing posters with open protocols listed Using abridged "protocol pocket cards" with key inclusion and exclusion criteria Dedicate one research nurse or research assistant  to identifying and screening participants  coordinating pre-enrollment tests  educating participants about the protocol and process  and initiating the informed consent and enrollment process Access funding for clinical trial support
    • Successful Recruitment One particular study  the study nurse being employed for longer hours (P<0.001)  the use of a coronary care register to identify eligible patients (P=0.001)  a systematic recruitment plan with targets and timetable (P=0.02)  the invitation of patients by both a personal letter and follow- up phone call (P=0.09)  regular contact with the patients usual doctors and adequate funding of centres Source: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia
    • Another Study: Recruitment Facilitation Factors Interest in the research question, participation did not require any unusual management practices Toll-free telephone randomisation and a simple one-page outcome form each took only a few minutes to complete Well-organised and committed principal nurses Ongoing staff training Investigators’ meetings Regular communication and target setting Barrier  minimal financial recompense for staff time  many potentially eligible patients could not be recruited because of the lack of staff time to dedicate to research Source: Clinical Trials Research Unit, University of Auckland, Auckland, New Zealand
    • Three Critical Issues Risk to participants Practicality of Periodic Review of a Trial Scientific Validity of the Trial
    • Risk to Participants The study endpoint is such that a highly favorable or unfavorable result, or even a finding of futility, at an interim analysis might ethically require termination of the study before its planned completion There are a priori reasons for a particular safety concern, as, for example, if the procedure for administering the treatment is particularly invasive There is prior information suggesting the possibility of serious toxicity with the study treatment The study is being performed in a potentially fragile population such as children, pregnant women or the very elderly, or other vulnerable populations, such as those who are terminally ill or of diminished mental capacity The study is being performed in a population at elevated risk of death or other serious outcomes, even when the study objective addresses a lesser endpoint The study is large, of long duration, and multi-center
    • Practicality of a DMC If the trial is likely to be completed quickly, the DMC may not have an opportunity to have a meaningful impact In short-term trials with important safety concerns, however, a DMC may still be valuable
    • Scientific Validity of the Trial Recommendations to change  inclusion criteria  the trial endpoints  or the size of the trial Scientific validity best evaluated by an unbiased oversight committee  with the exception of changes the Committee might recommend on the basis of emerging safety concerns
    • A tt ention f or Y ourTh a nks