The history of biomedical research in the United States has long been plagued with ethical problems. Writer Rebecca Skloot details a famous example of this history in her book, “The Immortal Life of Henrietta Lacks.” The non-fiction work recounts the origin of the HeLa cells—derived from the tumor of a Baltimore woman named Henrietta Lacks. A poor, African American woman, Lacks was suffering from cervical cancer when she received treatment, including a tissue biopsy, at Johns Hopkins University. Violating the principle of informed consent, university researchers cultured the cells from Lacks’ tissue without her knowledge or permission. She succumbed to her disease in 1951, at the age of 30.
The breach of trust in creating the eponymous HeLa cell line caused lasting trauma to the Lacks family. Part of their distress may have also been rooted in the failure of the research community to share with them the incredible positive impact that their mother’s cells had on biomedical research and health outcomes. One of the things that may have brought them a sense of closure was visiting the lab of a Johns Hopkins University researcher to learn about his use of HeLa cells. Skloot described the scene wherein Henrietta’s daughter, Deborah, first saw a cryovial of HeLa cells:
“…she raised the vial and touched it to her lips. ‘You’re famous,’ she whispered. ‘Just nobody knows it.'”
While ethical conduct of clinical research has improved tremendously over the past sixty years, we can still do better. When volunteers participate in clinical trials, they entrust pharmaceutical researchers with their bodies. In return, we have an ethical obligation to share with them the results of clinical trials.
Studies consistently show that 90% of clinical trial volunteers expect to be told the overall results of their trial. Unfortunately, most never hear anything back from the sponsor or research center after the last study visit, leaving many volunteers wondering if their participation mattered or was appreciated. In this blog post, I’ll discuss our recent partnership with the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP) to help pharmaceutical companies “Do the Right Thing” by developing lay summaries of clinical trial results to inform the general public.
The ethical imperative to inform and educate clinical trial volunteers
While clinical research volunteers want to know that their participation mattered, it’s not easy for them to find out the results of clinical trials. Section 801 of the Food and Drug Administration Amendments Act (FDAAA) requires sponsors to register and report results at ClinicalTrials.gov. However, these trial results summaries are written in highly technical language that is not accessible to the general public. There is a need for an infrastructure that supports the creation and distribution of lay summaries—brief, plain-language accounts of a clinical trial’s design, objectives, and findings.
The growing call for public disclosure of research results
The Pharmaceutical Research and Manufacturers Association (PhRMA) and European Federation of Pharmaceutical Industries Association (EFPIA) have made commitments to transparency initiatives for layperson summaries. Likewise, there are similar pending European Union requirements. With increasing and impending regulation, sponsors are feeling the pressure to proactively address the demands of disclosure to the community.
Supporting clinical data transparency initiatives
Synchrogenix & CISCRP—an organization dedicated to educating and informing the public and patients about clinical research— have entered into an exclusive partnership to provide lay language clinical trial results to clinical trial volunteers. Through this collaboration, Synchrogenix, Certara’s regulatory writing consultancy, significantly increases global medical writing capabilities supporting an initiative that CISCRP pioneered four years ago. This new partnership combines Synchrogenix’s technology-enabled operational expertise and clinical writing talents with CISCRP’s unbiased governance and dedication to engaging patients and the public in the spirit originally intended of the clinical research process. Indeed, more than two dozen industry sponsors have begun implementing lay-language communication programs with CISCRP. Partnering with us enables CISCRP to dramatically expand their ability to meet sponsor requests while ensuring non-promotional and scientifically accurate communication through CISCRP’s proven process and independent, neutral nonprofit status.
Educating volunteers on clinical trial results, increasing public trust and support
Over the past five years, CISCRP has developed and tested a program to help sponsors address this unmet need. Working through an editorial panel of medical and health communications experts as well as patient advocates, CISCRP “translates” the technical results of clinical trials into scientifically accurate, non-promotional lay summaries written at a validated 6th-8th grade reading level. User- and field-testing in the context of global trials shows that volunteers’ comprehension of the trial results improves dramatically after independent review of a lay-language summary, and over 90% of volunteers indicate satisfaction with their level of understanding. The program was recognized in 2013 with a Human Research Protection Best Practice award by the Health Improvement Institute.
Synchrogenix’s medical writers will develop the text and images for each lay summary, leveraging our artificial intelligence technology platform, and implementing our quality control processes to ensure data and message accuracy. CISCRP will deliver a critical, unbiased review of the report, engage and interact with investigative sites and manage production, dissemination and communications of the report. Working together, we have developed a consistent, sustainable delivery model that will help to ensure that all the stakeholders in a clinical trial are fully informed.
All information presented derive from public source materials.
Learn more about meeting transparency and disclosure initiatives
Disclosing clinical trial information and creating transparency around the data are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur new products or therapeutic approaches and potentially avoid unnecessary trials. Are you struggling to integrate these initiatives into your processes? Please read a white paper that we’ve written on this subject. Let me know what you think in the comments!