Transparency as a Means to Increase Clinical Trial Enrollment
- PDF / 6,447,750 Bytes
- 6 Pages / 612 x 792 pts (letter) Page_size
- 5 Downloads / 170 Views
265
Transparency as a Means to Increase Clinical Trial Enrollment Barbara J. Godlow, RW, BA Leader. DIA CTR Working Group; President and Principal Analyst. The FAIRE Company, LLC, Tolono, Illinois Patricia Frrlomg Founding President and CEO, Parent Project Muscular Dystrophy, Middletown, Ohio
Koy Words Patient advocate; ClinicalTrials.gov; Recruitment; Duchenne muscular dystrophy; Cancer Corrrspo~domcoAddross Barbara I. Godlew, The FAIRE Company, LLC. 112 East Walnut St.. Tolono, IL 61880 (email: barbara.godlew~faireIlc.com).
In this age of mandated d i n i d trial wgisirics vocacygroyps wen key drivers in the passage of and d t s datakes, pharmaceutid, biddthe Food and Drug AdministrutionAmendments ndogy and m d d dcvicc companirs stnggfe Act (Section IU),which fddin the m of to disseminate infonnaton abact p m t d and tmnspmwrcy. This artide highZights how adve trial rcsuIfs in ways that patients can uasily uncucy otganizatim @nction as a d i d conduit dastand. Patient advocacy graqps am d d m to spexializd patiazt populations and how ~dwkcndinidtrid~tocds~adcvd- these grarps can p n i d e a communication o p c d a l v h e n M a l ~ a n d d y c t k chmrnd to mch thtwands of potential d i n i d trial pcuticipmrts. gracps ?Epwsalt tens of thousands ofpaticnts with disearcsand d i s d e r s . In fact, patient ad-
I N T R O D U CTl O N In this age of mandated clinical trial registries and results databases, pharmaceutical, biotechnology, and medical device companies struggle to disseminate information about protocol and trial results in ways that patients can easily understand. These companies spend valuable time and resources on interpreting regulations and determining how best to present the data in a patient-friendly but nonpromotional manner when, in fact, clinical development programs seem to overlook one obvious alternative: patient advocacy organizations. Patient advocacy groups are seldom consulted when clinical trial protocols are developed or when trial results are released (l),yet these groups represent tens of thousands of patients with diseases and disorders that run the gamut of the alphabet from atopic dermatitis to cancer to obesity to Zellweger syndrome. Currently, only 5% of patients with cancer are enrolled in a clinical trial at any given time (2). Advocacy organizations function as a direct conduit to specialized patient populations. From providing patients and their families with information about the relevant disorder to actually funding research, advocacy organizations can provide a communication channel to reach thousands of potential clinical trial participants. Pharmaceutical, biotechnology, and medical device industries often underappreci-
ate and inadequately utilize advocacy organizations in meeting the challenges of patient recruitment and participation for clinical trials. The need to disseminate clinical trial information for both enrolling and completed trials is urgent. New treatments are under development, yet much of this information is not getting out past the industry itsel
Data Loading...
