Synchrogenix, a unit of Certara, has partnered with the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP) in an effort to expand lay language summaries for patients who participate in clinical trials. The two will provide more plain language accounts of a clinical trial’s design, objective and findings, also meeting sponsors’ clinical data transparency requirements.
The agreement also aims to get a jump on increasing the U.S. and European pharmaceutical industry associations’ transparency commitments and the pending European Union requirements for layperson summaries. Beginning in May 2016, sponsors must submit a summary of clinical trial results to the European Medicines Agency (EMA), accompanied by a summary written “in a manner that is understandable to laypersons,” according to the EMA. The FDA reportedly is a few steps behind the EMA in its drive for lay summaries.
“We see this agreement with CISCRP as bridging the gap between clinical trial information and the various audiences within the public domain,” said Kelley Kendle, president and CEO of Synchrogenix, which is the writing consultancy unit of Certara, a consulting company spanning the discovery, preclinical and clinical stages of drug development. “The data integrity, accuracy and consistency across various outlets that include healthcare providers, payers, clinical trial participants, advocacy groups and an aggregate of researchers also is important, as it improves overall compliance.”
Although 90% of clinical trial participants expect to be told the overall results of their trials, 77% never hear back, according to a 2013 study in The New England Journal of Medicine. Since 2010, CISCRP has developed and tested a program to help sponsors address patients’ requests for lay language clinical trial summaries. Working with an editorial panel of medical and health communications experts, along with patient advocates, CISCRP “translates” the technical results of clinical trials into scientifically accurate, non-promotional lay summaries written at a validated 6th to 8th grade reading level.
CISCRP’s field testing showed volunteers’ comprehension of trial results improved dramatically after independent review of a lay language summary. More than 90% of volunteers indicated satisfaction with their level of understanding.
“We’ve worked with more than two dozen industry sponsors developing lay summaries that have gone to trial participants in 37 countries, mostly in North America, Europe and Asia,” said Zachary Hallinan, CISCRP’s director of patient communication and engagement programs, citing Pfizer and Eli Lilly as early users of CISCRP’s summaries. “By partnering with Synchrogenix, a leader in medical and regulatory writing services, we can dramatically expand our ability to meet sponsor requests while ensuring non-promotional and scientifically accurate communications through our proven process and independent, neutral nonprofit status.”
Synchrogenix’s medical writers will develop the text and images for each lay summary and will implement its quality control process to ensure data and message accuracy. It then will forward it to CISCRP, which will provide an unbiased review of the report. CISCRP also will manage production, dissemination and communication of the summary report, engaging and interacting with the investigative sites, which have the participants’ contact information.
Hallinan cited a Mayo Clinic study of 400 participants in which two-thirds received a lay summary report. Asked if they would participate in another trial, 90% of the approximately 268 participants who had received a summary said they would. Of the patients who did not receive a lay summary, only 30% said they would consider participating in another trial.
Typically, trial participants receive an eight-page lay language summary report—about 1,500 words with images, tables and charts—about a year after the trial ends. During that period the sponsor will develop analytics, ensure scientific accuracy and seek to publish the results in a peer-reviewed journal, and then develop the lay summary that will be accessible to patients.
That means for a clinical trial that takes three years to complete, participants in the early phase II will have to wait a while. Hallinan said those participants will receive updates about the trial’s continuation as part of the ethical obligation to keep them informed until the trial’s completion.
Information about patient participation will not include specific patient information including un-blinding, which would reveal whether a trial patient was in the placebo or the active drug group.
“Few sponsors are releasing this level of information to patients, as the summary provides the overall results,” said Hallinan. “However, those specific findings are not terribly difficult to answer and may change in the next couple of years.”
Until then, Synchrogenix says its regulatory writing services for the pharma, biotech and medical device industries will expand to meet the needs of the EMA’s, and soon the FDA’s, lay summary requirements.
“The opportunities ahead are enormous,” said Kendle. “We see lay summaries reaching a wide audience, and working with CISCRP enables us meet these upcoming regulations head-on and gives us a way to get in front of the whole clinical data discussion.”
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