IPI - Editorial

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IPI Patient recruitment and retention in clinical trials Patient recruitment and retention is the leading problem drug companies face in developing their new pipelines. As recruiting becomes more diverse and complex, pharmaceutical companies are striving to discover new innovative ways to facilitate recruitment and keep patients enrolled in the clinical trial. With more and more clinical trials being done on a global level, it is imperative to have an understanding of both government regulations and social protocol that accompany these new markets. Patient recruitment and retention remains one of the most significant challenges faced by the pharmaceutical industry today, and accounts for hundreds of millions of Euros being spent due to delays in the clinical development process. Speeding up clinical trials is one opportunity to cut costs, improve efficiency and bring new drugs to market faster. Operational delays in clinical trials reduce patent exclusivity time and shorten the most commercially productive phase of a product’s life cycle. The primary source of such delays is the recruitment and retention of patients who fit the trials’ requirements. More and more drugs on trial have been designed to attack very specific biological targets. This necessitates the need to identify, recruit and retain patients who fit an increasingly narrow medical profile. Therefore, pharmaceutical companies and clinical research organisations are seeking new ways to optimise recruiting operations and gain a competitive edge. Patient Recruitment and Retention in Clinical Trials is a new report from Business Insights that provides a comprehensive review of patient recruiting strategies, focusing on successful approaches and emerging trends from across the globe. Use this report in patient and physician recruitment and to identify successful strategies to combat the clinical trials productivity crisis. The principles of successful patient enrolment involve the blending of sitefocused support strategies with a clear value proposition delivered with personal communication expertise. Building a relationship of understanding with the investigative site team and the participant is the ultimate goal. Recruitment Survey Site surveys indicate that CROs know less than sponsors about recruitment and retention. CROs have little internal expertise in recruitment strategy, budgets and timelines. The surveys also demonstrate that sites want specific tools: they do not want paid media campaigns or call centres, but rather they want at least an hour of recruitment training at the study launch meeting, and they want a point of contact to resolve their challenges with enrolment and retention. Subject Recruitment Subject recruitment is critical to the success of clinical research, both for scientific return and financial viability. Research studies that fail to meet recruitment goals provide minimal scientific return and may have a negative financial impact on the institution. There is substantial up-front institutional investment in the initiation of each of these protocols (institutional review board [IRB] review, contract negotiations, administration). Inadequate recruiting may increase study costs, delay time to completion, and possibly invalidate a trial due to insufficient study power. Thus, even modest improvements in the subject recruitment process may pay large dividends in accelerating the bench-tobedside cycle of new drug therapies or medical devices. Extramural Recruitment Efforts: • Providing clinicians with multi-language flyers that are easy to read and IRBapproved • Providing clinicians with brochures that are available on the internet and for office distribution • Providing sample letters to clinicians and introducing them to this trial • Providing educational opportunities to clinicians and nurses introducing them to this trial • Providing information to pathologists regarding this trial including how they may contact physicians with a potential study subject • Announcements in newsletters and websites available to participants • Presentations at participant meetings Intramural Recruitment Efforts: • Providing IRB-approved, multi-language flyers and brochures to the offices of PIs and associates for distribution • Providing laminated charts with inclusion/exclusion criteria for PIs, colleagues, study coordinators and nurses • Reviewing medical records in order to identify potential subjects • Encouraging primary physicians to inform potential subjects about the study • Encouraging PI to maintain open communication with associates in order to capture potential new subjects Steering Committee Efforts: • Collecting data on failed screens • Continual evaluation of barriers to recruitment The Principal Investigator’s Toolbox: 1 Flyer for potential subjects 2 Brochure for physicians to display in office 3 Letter to referring investigators 4 Letter to area physcian 5 Laminated chart with inclusion/exclusion criteria 6 Primer on subject recruitment 7 Primer on consent process 8 Primer on subject retention 9 Subject handbook Primer on Subject Recruitment • Avoid approaching potential subjects until trust and rapport has been built 26 IPI www.ipimedia.com
IPI • Appropriate introductions to a potential subject must be done if PI is not the primary physician This is necessary to build trust in the PI and to reassure the subject that the primary physician supports enrolment and study plan • Assure subject and family that continuity of care is not contingent upon participation • Fully explain compensation for travel, parking, meals, etc while attending study visits • Explain opportunity to receive some primary care under the auspices of the study, with potential of medical costs • Explain opportunity to receive closer medical attention and exposure to newer medications • Highlight opportunity to contribute to the advancement of medical knowledge Primer on Consent Process • Consent and assent should be available in primary language of the subject • Ideally the PI and study coordinator should be present • Allow enough time to speak with the subjects • Have both parents present if a minor is the subject • Go over all items in the consent and assent forms with as much explanation as possible • Allow time for questions in each section • Provide a copy of forms to take home for discussion and thought • Provide a realistic assessment of time, procedures, length of trial, benefits and risks involved in participating in the study • Emphasise that voluntary withdrawal from the trial at any time will not affect relationship with physician • Provide copies of signed forms to subject Extramural Centre Recruitment Efforts Include: • Announcements in journals, newsletters, websites • Presentations at medical meetings Steering Committee Centre Recruitment Efforts Include: • Reimbursement analysis with modification as needed and supported • Training support Clinical Cores Centre Recruitment Efforts Include: • Training support • On-site support as needed • Help with IRB submission Developing and Implementing an Effective Recruitment Strategy • Improve patient motivation, creating and communicating the study’s value proposition to patients • Providing positive reinforcement at every visit • Acquiring and utilising educational/ support study materials for patients and their families • Comparing incentives, what patients say they need and what an ethics committee will allow • Improving listening skills for site staff The Impact of Protocol Design on Patient Recruitment • Designing with the patient in mind • The quantitative and qualitative data required to accelerate patient recruitment • Analysis of clinical trial durations in accordance with therapeutic areas • Screening systems for recruitment • Chief investigator and responsibilities • Impact of changing inclusion and IPI 27
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