Social media — Facebook, LinkedIn, etc. — have infiltrated every aspect of our life, so it should be no surprise that these virtual connectors are changing the clinical trial arena. Recruiting patients for clinical trials, and retaining them once they’ve entered those studies, remain two of the toughest challenges for drug developers. Efficient patient accrual for each critical-path trial in a Phase I-through-III clinical development program can shave months, sometimes even years, off the timeline from clinical development to product registration and commercial launch. Nathaniel Brown, M.D., chief medical officer and senior VP, clinical development, at Presidio Pharmaceuticals, told Carolyn Gretton, editor of this Forum, that the rate of patient accrual is the key timeline-related unknown factor for every clinical trial. Dr. Brown notes that the plethora of electronic communications media available to clinicians, particularly e-mail and Web-based communication tools, have made it easier to communicate trial availability to targeted audiences. For example, the U.S. National Institutes of Health’s ClinicalTrials.gov Web site is being increasingly used by U.S. and international pharma and biotech study sponsors to provide relatively detailed descriptions of available Phase I to IV trials. While technology, the availability of data, and the ability to communicate more effectively enable developers to reach out more broadly to potential investigational sites for recruitment, Maria Smith, global head, operations — affiliate management, product development, at Roche, believes a more patient-centric approach is needed. “In many cases, the focus has been on identifying and meeting the needs of the investigators and site staff," she says. “There is an opportunity to further identify and communicate the value of clinical trials to patients and their caregivers." It is also increasingly common for sponsors to give information about trial availabilities on their Web sites, and to support announcements related to trial availability in hard-copy magazines and journals, as well as Web sites relevant to the target population. Dr. Brown says it is clear that the current trend toward increasing use of electronic media and Web-based communication modes will continue, due to the ability to quickly reach large and global audiences with relatively low costs. However, some believe that the free-flowing, no-holds-barred nature of social media can be problematic from a regulatory standpoint, given that recruitment messages to potential trial participants are often subject to review by the sponsor’s internal regulatory department and multiple external committees and government regulatory bodies. According to Jeffrey Kasher, Ph.D., VP for global clinical development at Lilly, the multitude of traditional and online media currently available to drug developers has added new levels to the patient recruitment process, and it is too early to tell if the benefits of adding social media to the mix outweigh the risks. “It is vital that we determine how we can use social media to put information about a study out there so that people can access it, and then ensure that all of their information is protected and appropriate privacy standards are in place," he says. Social media is just one of more than 25 special topics, including oncology, biosimilars, pediatrics, as well as comparative effectiveness and multiregional clinical trials, that will explored in depth at this year’s annual DIA meeting. See you in Washington, D.C. Taren Grom Editor Social media and clinical trials Publisher Lisa Banket Editor Taren Grom Creative Director Marah Walsh EDitorS Carolyn Gretton Denise Myshko Kim Ribbink Robin Robinson design associate Ariel Medel national account manager Cathy Tracy Copyright 2010 by PharmaLinx LLC, Titusville, NJ Printed in the U.S.A. Volume Eight, Number Two VIEW is published as a supplement to PharmaVOICE, which is published monthly except joint issues in July/Aug. and Nov./Dec., by PharmaLinx LLC, P.O.?Box 327, Titusville, NJ 08560. Periodicals postage paid at Titusville, NJ 08560 and additional mailing offices. Postmaster: Send address changes to PharmaVoice, P.O. Box 292345, Kettering, OH 45429-0345. VIEW and PharmaVoice Coverage and Distribution: Domestic subscriptions are available at $190 for one year (10 issues plus VIEWs). Foreign subscriptions: 10 issues plus VIEWs US$360. Contact PharmaLinx at P.O.?Box 327, Titusville, NJ 08560. Call us at 609.730.0196 or FAX your order to 609.730.0197. Contributions: The VIEW and PharmaVoice are not responsible for unsolicited contributions of any type. Unless otherwise agreed in writing, The VIEW and PharmaVoice retain all rights on material published in The VIEW and PharmaVoice for a period of six months after publication and reprint rights after that period expires. E-mail: [email protected]. Change of address: Please allow six weeks for a change of address. Send your new address along with your subscription label to PharmaVoice, P.O. Box 292345, Kettering, OH 45429-0345. Call us at 800.607.4410 or FAX your change to 937.890.0221. E-mail: [email protected]. Important notice: The post office will not forward copies of this magazine. The VIEW and PharmaVoice are not responsible for replacing undelivered copies due to lack of or late notification of address change Advertising in VIEW or PharmaVoice: To advertise in a VIEW or PharmaVoice please contact our Advertising Department at P.O.?Box 327, Titusville, NJ 08560, or telephone us at 609.730.0196. E-mail: [email protected]. www.pharmavoice.com Volume 8 • Number 2 Send your letters to feedback@pharmalinx.com. Please include your name, title, company, and business phone number. Letters chosen for publication may be edited for length and clarity. All submissions become the property of PharmaLinx LLC.
An article from
Letter from the Editor
Filed Under:
Research & Development