Meet Pharma Transparency Mandates & Engage Study Participants

Meet Pharma Transparency Mandates & Engage Study Participants

Most clinical study participants want to know the results of trials they participated in. However, few are actually informed. Lack of communication and transparency jeopardizes the success of the clinical research enterprise. In this blog post, I’ll discuss a new model for communicating trial results in lay language with minimum added burden on sponsors and study staff.

What is a lay summary?

The lay summary contains two parts: the clinical study design overview and the results summary. It has to be scientifically accurate, non-promotional, and easy to understand. Lay summaries are also a fantastic opportunity to thank patients for their participation and contribution to scientific discovery. Finally, they must comply with the latest guidance from regulatory bodies and plain language standards, which are constantly evolving.

A new model for engaging patients as clinical research partners

Synchrogenix and the Center for Information and Study on Clinical Research Participation (CISCRP) have partnered together to provide the industry’s preeminent model for lay summary development and global distribution.

Synchrogenix’s regulatory writing expertise complements CISCRP’s lay language expertise. This synergy is complimentary to Synchrogenix’s complete, integrated service that supports all transparency and disclosure activities, including clinical trial results registration and postings, redaction and anonymization of private information to fulfill Policy 43 and Policy 70 requirements, and lay language summaries.

The CISCRP mission

CISCRP― a nonprofit founded in 2003― is dedicated to engaging the public and patients as partners in the clinical research process. They provide resources, programs, and services that assist clinical research stakeholders in understanding both the public and patient attitudes and experiences in research, as well as in improving volunteer participation, experiences, and satisfaction. In addition, CISCRP promotes greater awareness and understanding of the role that research engagement plays in advancing public health.

Since 2011, CISCRP has partnered with dozens of sponsors to address the critical unmet need to disclose lay language trial results to study participants. To develop lay language standards, CISCRP has consulted with regulatory agencies and stakeholder groups such as TransCelerate, the National Institutes of Health, the National Cancer Institute, and the Pharmaceutical Researchers and Manufacturers of America (PhRMA).

The regulatory landscape for lay summaries

Regulators also support communicating trial results to patients. The EU Clinical Trials Regulation was adopted in April of 2014 and will replace the EU Clinical Trials Directive. Beginning in mid-2016, this regulation will require the posting of lay language summaries to an online public database.

Likewise, U.S. regulators indicate support for increased transparency but noted in the 2014 Notice of Proposed Rulemaking that narrative summaries of clinical trials must not be misleading or promotional.

Current practices are letting patients down

Sharing clinical trial results with participants should be an industry standard. It’s the right thing to do. It demystifies clinical research for volunteer patients and participants. And it helps establish a rapport between volunteers and the research site staff.

In 2013 and 2015, CISCRP conducted global studies on patient perceptions of clinical research. These studies provide information about the motivations and experiences of research participants:

  • 90 percent of patients want to know the results of the clinical trial, yet 77 percent never hear back
  • If not informed, many volunteers would never participate again
  • Being informed about research results is one of the top five enrollment factors that patients consider globally

The ethical obligation to share clinical trial results

Both PhRMA and EFPIA (European Federation of Pharmaceutical Industries and Associations) support sharing data with study participants and healthcare professionals. The World Healthcare Organization’s Declaration of Helsinki, guideline 26, indicates that all medical research subjects should be informed about the general outcome and study results. Finally, Section 801 of the Food and Drug Administration Amendments Act of 2007 requires sponsors to submit the results of certain clinical studies to ClinicalTrials.gov.

However, the information in ClinicalTrials.gov is out of reach for study volunteers without internet access. In addition, ClinicalTrials.gov uses a tabular format that is difficult to understand without having specialized scientific and medical training.

The lay summary process

The lay summary process developed by CISCRP and Synchrogenix incorporates our best practices. Patient expectations are first set within the informed consent document. We draft communications for sites to provide to their patients at the last visit and can even provide brief annual communications until the study results are ready. The annual communication includes updates on the timing of trial results. Even if the timelines change during the trial, we can continue to reset that expectation, if needed, through interim communications. Every communication sent to volunteers also thanks them for their participation.

Regulatory and medical writing experts develop the lay summary in consultation with an editorial panel composed of writers, editors, patient advocates, and specialists. Having patients or a representative population review the materials that you intend to provide to patients is a long-standing health literacy best practice. The sponsor’s review focuses on the documents’ scientific accuracy. We work with sponsors to balance scientific accuracy and lay language clarity for patients. If the lay summary is needed in languages other than English, we can handle translation. Next, CISCRP distributes the lay summaries. This streamlined process minimally impacts sponsors’ operations.

Considerations in developing lay summaries

Our lay summaries use a template that lays out clear answers to the questions that patients typically have about trial results. This template was developed through extensive user testing that CISCRP conducted in focus groups with representative patient and public populations. Its design follows lay language and patient communication standards. The format has plenty of white space between lines and paragraphs. Using larger fonts is also helpful for patients. Graphs and charts should be included in lay summaries, and they should also stand alone to accommodate for various patient learning styles.

Readability formulas are a good tool to follow. However, often the only way to know that the material you’re providing to your patients is understandable is to test it with the affected population. CISCRP’s editorial panels include patients, as well as patient advocates with experience in the relevant therapeutic area.

Lay summaries can be provided in various formats. Patients prefer a printed copy of the materials. To accommodate different learning styles, online and video formats should also be considered.

Evaluating the patient communication program

Patients appreciate being informed about studies. They’re not upset when the study completion date changes. They just want to know when they’re going to receive its results. Providing a thank you communication reinforces the expectation that they will receive the results summary and reminds them when the results will be available.

Lay summaries test well with patients. Pre- and post-tests reveal high levels of understanding of the information. Patients report satisfaction with the level of information that is provided.

Moreover, site staff are highly receptive to this program. By providing patients with the information that they ask for, site staff strengthen their relationship with patients. They also state that the program places minimal burden on their operations. Expectations that a lay summary initiative will be taken should be set early with sites, so that they can keep patient contact information readily available.

Creating a virtuous cycle of study volunteer engagement

Sharing trials results with volunteers has the potential to be more than just another regulation. Showing volunteers that they are valued by sharing trial results creates a virtuous cycle of engagement and reinforces their positive experiences. Results from CISCRP’s global survey, which included over 12,000 respondents, show a substantially higher rate of communication among patients when their expectations are met. Recruitment and retention continue to be critical considerations in conducting research. When we put patients first, meet their needs, and appreciate their contributions to clinical studies, value is returned to the research enterprise.

All information presented derive from public source materials.

Learn more about transparency and disclosure of clinical trial data

To learn more about engaging the public in the clinical research process, please read a white paper we’ve written on the subject.

Behtash Bahador

About the Author

Behtash Bahador

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Behtash Bahador is a Senior Project Manager for the non-profit Center for Information and Study on Clinical Research Participation (CISCRP). With a background in health communication, Behtash leads global implementation of programs for communicating clinical trial results in plain language for a wide range of industry sponsors. He works directly with sponsors to align best practices in patient education and health communication with regulatory and industry guidelines.