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IFAPP Academy Executive team at MAPS Global Conference in Miami

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IFAPP Academy Executive team at MAPS Global Conference in Miami - IfappAcademy.org
From left to right: Honorio Silva (IFAPP Academy CEO), Mary Alice Dwyer (MAPS Chair Executive Program Committee), Jacob Coots (IFAPP Academy Program Manager), Ana Salgado (IFAPP Academy Strategic Director), Susan Hanf (MAPS Manager), Gustavo Kesselring (IFAPP Academy Vice President) and Travis Hege (MAPS CEO)

At the beginning of March, IFAPP Academy’s Executive Team was able to attend the MAPS Global Conference in Miami. The Academy in partnership with MAPS (Medical Affairs Professional Society) will develop and deliver an online course, “Introduction to Medical Affairs in Medicines Development, ” to be launched this year, 2020.

If you are interested in learning more about this new course, sign up for the IFAPP Academy’s Newsletter to receive the latest updates.

Clinical Trial Guidance for use during COVID-19 Pandemic

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Important Clinical Trial Guidance for use during COVID-19 Pandemic

We know that Medical Affairs and Medicines Development Professionals around the world have been working non-stop to develop vaccines, treatments, testing, and medical devices in response to the COVID-19 pandemic. To aide in the distribution of information, we have provided below important clinical trial guidance from different sources for use during this pandemic.

We wish everyone health and safety during this difficult time!

The below document was released by ACRO – Association of Clinical Research Organizations

Considerations to Support Clinical Trial Monitoring Oversight During COVID-19, 13 March 2020

The emerging coronavirus (COVID-19) situation is increasingly impacting clinical trial oversight, particularly on-site monitoring. The Association of Clinical Research Organizations (ACRO) recommends that sponsors, CROs and sites introduce emergency interim measures so that clinical trial monitoring is maintained during this period. These guidelines will ensure that data quality is unaffected, clinical trial sites are supported and that the patients enrolled in clinical trials are kept safe.
The use of centralized monitoring tools and technologies can supplement and support the recommendations outlined below. These practices and tools are already in place and do not require any additional sophisticated analytical tools or dashboards. Care should be taken that any remote monitoring activities implemented are proportionate to the risks identified. Further, they should not place any extra burden on clinical trial sites.

These recommendations should be considered in the following situations:
• When sites have suspended or restricted all visitors (including clinical research associates (CRAs)) from accessing medical facilities, but where patient visits are still occurring
• When local health officials have implemented regional quarantines
• When local CRAs are unable to travel to the sites (for personal health reasons or because of travel restrictions)

Click the following download button to view the entire document: ACRO-Statement-on-Monitoring-Oversight-FINAL-3.13.20Download

The below document was released by the European Medicines Agency (EMA).

Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic Version 1 (20/03/2020)

The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA)), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities) and the European Commission (EC) acknowledge the impact of COVID-19 on the health system and broader society, and the impact it may have on clinical trials and trial participants1. Extraordinary measures may need to be implemented and trials adjusted due to e.g. trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infections, and health care professionals being committed to critical tasks. Therefore, EMA, EC and HMA strongly support the efforts of the GCP Inspectors’ Working Group for developing harmonised EU/EAA-level guidance to mitigate the negative effects of the COVID-19 pandemic on the conduct of clinical trials.

The situation is evolving, and pragmatic actions may be required to deal with the challenges of conducting research, and in ensuring the rights, safety and wellbeing of participants. The points mentioned below are intended to provide guidance for all parties involved in clinical trials during this time.

Due to the urgency, this guidance is issued without prior public consultation. The sponsors should note that due to the rapidly evolving situation further updates to this guidance are possible and likely.

Click the following download button to view the entire document: EMA-guidanceclinicaltrials_covid19_enDownload

The below document was released by the FDA (Federal Drug Administration)

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

Guidance for Industry, Investigators, and Institutional Review Boards (March 2020)

I. Introduction The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.
FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.

Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

Click the following download button to view the entire document: FDA-COVID-19_FDA-17Mar2020Download

Gustavo Kesselring Appointed New CIOMS Executive Committee Member Representing IFAPP

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Gustavo Kesselring Appointed New CIOMS Executive Committee Member Representing IFAPP - IfappAcademy.org
(far right) Dr. Gustavo Kesselring, IFAPP Academy VP with CIOMS group in Geneva

Gustavo Kesselring, MD, IFAPP Academy Vice President & International Affairs, IFAPP, has been appointed CIOMS Executive Committee Member on behalf of IFAPP as of 18 December 2019. As well known, CIOMS (Council for International Organizations of Medical Sciences) is a non-profit organization associated with UNESCO and WHO. The CIOMS mission is to advance public health through guidance on health research including ethics, medical product development, and safety. More information about CIOMS is available at www.cioms.ch.

IFAPP Academy Vice President of External Affairs, Module Chair Gustavo Kesselring

“This is a great honor and a valuable recognition of the global effort IFAPP & IFAPP Academy have been doing in the past years engaging several stakeholders in competency-based education and training in Medicines Development and Pharmaceutical Medicine. By no means, this achievement would have been possible without the teamwork and great contributions done by many colleagues working in academia, pharmaceutical companies, regulatory agencies, and government”, underlined Dr. Kesselring.

Gustavo Kesselring, MD, IFAPP Academy Vice President & International Affairs

Congratulations to Dr. Silva, IFAPP Academy’s President, on being awarded the FPM Honorary Fellowship FFPM(Hon)

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Congratulations to Dr. Silva, IFAPP Academy's President, on being awarded the FPM Honorary Fellowship FFPM(Hon) - IfappAcademy.org
Figure 1, left to right: Honorio Silva, IFAPP Academy President, Tim Higenbottam, current President of FPM, Ichiro Uchida (https://icpm2018tokyo.com/data/speaker26.pdf_and Aya Nakae (Osaka University)

Each year, The FPM (Faculty of Pharmaceutical Medicine) Fellows are invited to nominate exceptional individuals for Honorary Fellowship. According to the FPM’s website, Honorary Fellowship is the highest honor FPM can bestow, it recognizes the recipient’s eminence within their own field and their outstanding contribution to pharmaceutical medicine.

On the recommendation of the Fellowship and Awards Committee, the Board of Trustees, may bestow Honorary Fellowship on persons of eminence who may or may not be members of FPM, and who have made exceptional contributions in the fields of research, teaching or the practice of pharmaceutical medicine, or medical or general science, or society. Such honours are strictly limited.

On November 13, 2019 during the FPM’s Annual Awards Ceremony, held at the Royal College of Physicians, London, Dr. Honorio Silva, IFAPP Academy President was awarded with the prestigious FPM Honorary Fellowship FFPM(Hon).

Congratulations to Dr. Silva, IFAPP Academy's President, on being awarded the FPM Honorary Fellowship FFPM(Hon) - IfappAcademy.org
Figure 2: Past Presidents of the FPM Professors Peter Stonier and Alan Boyd with Dr. Honorio Silva (on right)

The below citation was delivered by Professor Peter Stonier FRCP FFPM for Honorary Fellowship of Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of UK.

“Professor Honorio Silva is president of the IFAPP Academy and immediate past president of IFAPP. IFAPP is the international umbrella organisation for pharmaceutical medicine, coming to its 45th anniversary next year.

After graduating in medicine at University of Buenos Aires Honorio Silva had postgraduate training in clinical pharmacology and internal medicine and conducted his clinical practice in these disciplines in his home country of Venezuela becoming assistant professor in the Department of Pharmacology Central University of Venezuela in Caracas.

However, it was in joining Pfizer in 1978 that Honorio’s professional and international career really took off. His early work focused on emerging countries in fostering a clinical research infrastructure and key projects together with medical education initiatives. This important and much needed effort soon took him beyond his day job, and into the world of academia and professional organisations. Here he gained national attention and with it many national awards for his achievements in clinical research, the development of new medicines and in medical education.

His international industry career also developed as Vice President Medical and Regulatory Affairs for Japan, Asia, Africa and Latin America. Honorio completed 30 years with Pfizer as Vice President Science and Medical Professional Development, with the global External medical affairs group.

Honorio’s career has been immersed in the international development and recognition of medicines development sciences and pharmaceutical medicine, and more recently through IFAPP in creating standards for certification in order to consolidate the discipline and profession.

None of this comes without considerable personal abilities and skills in teamwork and collaboration, building global cross functional teams, developing effective managerial and technical processes and analysing complex business and technical issues to achieve state of the art deliverables and solutions. Not to mention the dedication, energy and drive for his burning ambition – to Get The Job Done!

These qualities and attributes have not been lost on the Faculty with whom Honorio has been increasingly connected. The Faculty would like to cement this friendship and to ensure that Honorio’s important work in pharmaceutical medicine and professional development is conducted well within the tent rather than outside of it. For this reason Mr President, members and guests of the Faculty, in recognition of all his many accomplishments and a continuing expectation for more to come, I am delighted to present Prof Honorio Silva for Honorary Fellowship of the Faculty of Pharmaceutical Medicine.

Professor Peter Stonier FRCP FFPM

IFAPP Academy partners with MAPS (Medical Affairs Professional Society)

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IFAPP Academy and MAPS partner for medical affairs education and online cpd
From left to right: Kirk Shepard, MAPS Director; Travis Hege, MAPS CEO; Gustavo Kesselring, IFAPP Past President & IFAPP Academy Vice President; and Danie du Plessis, MAPS EMEA President

The IFAPP Academy is dedicated to providing high-quality education for medical affairs professionals. To achieve this goal, we have partnerships with two well known and highly respected academic institutions, King’s College London and Tufts CSDD in Boston. However, in effort to continue expanding our impact and support of the various functions in medical affairs, we have joined forces with MAPS for some exciting new initiatives.

MAPS and IFAPP Academy have signed a mutual agreement to facilitate the coordination and implementation of joint projects for the benefit of biomedical professionals in the development, testing, and monitoring of medicinal products. These undertakings will empower biomedical professionals to leverage their roles in the research, development, and commercialization activities conducted by the global biopharmaceutical industry. Initiatives will be developed to foster ethical conduct and the maintenance of professional autonomy to protect the safety and dignity of patients and research subjects.

Dr. Honorio Silva, IFAPP Academy President

“At the IFAPP Academy, we are enthused with the potential for this synergistic collaboration. This cooperative effort will allow biomedical professionals, serving in Medical Affairs related functions, better access to online, state of the art, competency-based education for professional development,” said Honorio Silva, MD, IFAPP Past President & IFAPP Academy Chief Executive Officer. “This opportunity could result in leveraged competence and improved performance in their functions for the benefit of patients, the sponsoring institutions, and society at large.”

Honorio Silva, MD, IFAPP Past President & IFAPP Academy Chief Executive Officer

MAPS and IFAPP Academy will cooperate in other areas of mutual interest, in particular, those concerning education and competency building in Medical Affairs. Soon both organizations will be able to work together on projects related to the capacitation of the various functions related to Medical Affairs within the biopharmaceutical and device industry and ensure that better medicines are available worldwide.

Travis Hege, MAPS CEO

“This collaboration partners two global non-profit organizations with similar visions, experienced leadership, and proven track records of promoting excellence and fostering capability building for the Medical Affairs function. MAPS is excited to work with IFAPP Academy in the production and delivery of the highest quality competency-building offerings for our members and the Medical Affairs Community at large.”

Travis Hege, MAPS CEO
IFAPP Academy partners with MAPS (Medical Affairs Professional Society) - IfappAcademy.org

About the Medical Affairs Professional Society

MAPS (https://www.medicalaffairs.org) is a global non-profit [501(c)(3)] organization of Medical Affairs professionals with nearly 2,000 individual members from over 160 life sciences companies, as well as those who provide valuable support to Medical Affairs organizations. Its mission is to advance the Medical Affairs profession and increase its impact across the life sciences industry by:

  1. Promoting excellence across Medical Affairs functions
  2. Developing guidelines to support industry standards and best practices
  3. Fostering advocacy for the Medical Affairs position
  4. Providing education and encouraging professional collaborations that support the practice of Medical Affairs
IFAPP Academy partners with MAPS (Medical Affairs Professional Society) - IfappAcademy.org

About IFAPP Academy

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy (https://ifappacademy.org/) is a non-profit organization based in the USA and affiliated with IFAPP. The Academy is a unique partnership between academia, industry, and professional associations to foster competencies and improve performance in medical affairs and medicines development. The IFAPP Academy-Kings College London, Medical Affairs in Medicines Development, Certification Program was created to achieve this goal. The online Program aims to provide the core cognitive competencies for effective performance in medicines development and medical affairs. The certification program is of particular value for those individuals already working in (or interested in joining) pharmaceuticals, academia, and regulatory agencies. Students completing the course receive a Certificate granted by King’s College London and IFAPP Academy, a Professional Certification issued by IFAPP and the IFAPP Academy, and the use of post-nominal letters (CMD) to attest certification.

Want to learn more about the IFAPP Academy – King’s College London, Medical Affairs in Medicines Development, Certification Program?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

Click here for the IFAPP Academy’s program brochure.Download

IFAPP & SIMeF present the 20th International Conference on Pharmaceutical Medicine (ICPM)

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Save the date for the 20th International Conference on Pharmaceutical Medicine

IFAPP (the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine) and SIMeF (the Italian Association of Pharmaceutical Medicine) are proud to announce the forthcoming 20th ICPM (International Conference on Pharmaceutical Medicine). The Conference, Patients Centered Medicines Development: Facts and Expectations, will be jointly organized with the first SIMeF National Conference in March 2020 in Rome.

Mark your calendars for March 25 – 27, 2020 for the 20th ICPM and 1st National SIMeF

IFAPP President, Kyoko Imamura, MD, DrMedSci, PhD

“ICPM has been the important opportunity for us as professionals in pharmaceutical medicine, and we are delighted to develop it in Rome, where decades-long efforts have generated dedicated pharmaceutical physicians and medicines development scientists.”

IFAPP President Dr. Kyoko Imamura

20th ICPM: Patients Centered Medicines Development: Facts and Expectations

The International part of the Conference will cover the first two days, with 2 keynote speeches (CIOMS Secretary and Telethon Director), a round table of education in Pharmaceutical Medicine, 2 plenary sessions on the role of patients in drug development and the modern vision of Medical Affairs, and 8 parallel sessions during the two afternoons.

IFAPP President-elect, Marco Romano

“I have the privilege and the pleasure to host both the XX ICPM and the I SIMeF Conference in Rome: it is a unique opportunity for my country and especially for my Italian colleagues who may meet international speakers and collaborators.”

Dr. Marco Romano, SIMeF President, and IFAPP President-elect

1st National SIMeF Conference

The National part of the Conference will be held on the third day, March 27, and will have a morning session devoted to a round table on the status of clinical research in Italy. In the afternoon the General Assembly will take place, with the nomination of the new SIMeF President, and then a session devoted to Medical Devices.

See you in Rome, March 2020!

International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine

About the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) is a non-profit organization based in The Netherlands, whose mission is to promote Pharmaceutical Medicine by enhancing the knowledge, expertise and skills of pharmaceutical physicians and medicines development scientists world-wide.  The IFAPP Academy is a non-profit organization based in the USA affiliated with IFAPP and is responsible to run its educational activities.

The National Institute of Health: All of Us Research Program

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A study that will provide much-needed insight for healthcare providers and pharmaceutical companies, allowing for a truly patient-centric approach with precision medicine.

“The ultimate goal of the All of Us Research Program is to collect information to lead to incredible discoveries in biomedical research and precision medicine, but along the way, we are going to transform lives. We are going to provide opportunities for people that historically have not had the opportunity to participate in research, and I think that’s a really important part of the program, and something that I feel really honored to get to be a part of.”

—Amy Taylor, regional vice president, Community Health Center, Inc.

What is the Precision Medicine Initiative?

The Precision Medicine Initiative (PMI) is a bold research effort to revolutionize how we improve health and treat disease. The PMI aims to leverage advances in genomics, emerging methods for managing and analyzing large datasets while protecting privacy, and health information technology to accelerate biomedical discoveries.

What is the All of Us Research Program?

NIH’s All of Us Research Program is a major piece of the PMI. All of Us will engage one million or more volunteers living in the U.S. to contribute their health data over many years to improve health outcomes, fuel the development of new treatments for disease, and catalyze a new era of evidence-based and more precise preventive care and medical treatment.

The above information, videos, and quotes were provided by the NIH, All of Us website. For additional information please visit: https://allofus.nih.gov/

Tufts CSDD Partners with IFAPP Academy to Develop an Innovative Online Course: “Leadership in Medical Affairs”

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Tufts CSDD partners with IFAPP Academy to create online course, "Leadership in Medical Affairs."
Figure 1: From left to right: Robert Franco, Lead Facilitator; Honorio Silva, CEO of IFAPP Academy; Ken Kaitin, Director of Tufts CSDD; Ana B Salgado, IFAPP Academy Director of Strategic Operations; and Gustavo Kesselring IFAPP Academy VP

Tuesday, August 13th, 2019 — Tufts Center for the Study of Drug Development (Tufts CSDD) will partner with IFAPP Academy to create a new course, “Leadership in Medical Affairs”, that will be offered in 2020 as a complement to the IFAPP Academy-King’s College London-Tufts CSDD Professional Certification Program “Medical Affairs in Medicines Development.” The planning activities for this innovative approach to education and training, in this critical area for the medical role within the biopharmaceutical industry, have already started.  Dr. Kenneth Kaitin, Professor of Medicine and Director of Tufts CSDD and Dr. Ana Salgado, IFAPP Academy Director of Strategic Operations will coordinate the initiative.  Dr. Kaitin has also been appointed a member of the IFAPP Academy’s Advisory Council. 

The partnership with Tufts CSDD will provide IFAPP Academy students and alumni the option to attend the six-week Course “Leadership in Medical Affairs.” This specialized leadership course will combine theoretical leadership principles, with relevance in Medical Affairs, and practical applications. Students will have the opportunity to learn from industry leaders while participating in business case discussions, lectures, webinars, forums, and panel discussions, entirely online.

IFAPP Academy President/CEO, Module Chair

“This new Course will help in leveraging leaderships skills to provide strategic medical direction to the organization” said Honorio Silva, MD, IFAPP Academy Chief Executive Officer, “and enhance the stakeholders perception of the medical function as a key contributor to improving patient outcomes.“

Benefits for Medical Affairs Professionals

There are also numerous benefits of this collaboration for Medical Affairs professionals. Individuals will be taught the steps needed to evolve from leading themselves to achieving results through others. They will gain the understanding needed to transition from a medical/science contributor to a company leader. The course will provide professionals with the principles needed for creating and leading highly effective teams; including specialized teams (matrixed, cross-functional, cross-geographies). Students will understand how to provide value to an organization by translating real-world data, clinical outcomes, and other data insights into innovative solutions for patient needs and pharmaceutical challenges to allow for improved business development.

IFAPP Academy Advisory Council member, Ken Kaitin

“Tufts CSDD is excited to partner with IFAPP Academy in offering this new online course on Leadership in Medical Affairs,” said Dr. Kenneth Kaitin, Professor and Director of Tufts CSDD. “The program will be a fitting compliment to Tufts CSDD’s annual two day in-person course on Leadership for Drug Development Teams, now in its 18th year. Additionally, I look forward to serving on the IFAPP Academy’s Advisory Council and working with the organization’s staff as we develop this exciting new online program.”

Tufts CSDD partners with IFAPP Academy for Leadership in Medical Affairs

About Tufts Center for the Study of Drug Development (Tufts CSDD) at Tufts University

The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides data-driven analysis and strategic insight to help drug developers, regulators, and policy makers improve the efficiency and productivity of pharmaceutical R&D. Tufts CSDD also offers professional development courses, hosts workshops and public forums, and publishes the Tufts CSDD Impact Report, a bi-monthly newsletter focusing on critical drug development issues.

IFAPP Academy online medical affairs course

About IFAPP Academy

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy (https://ifappacademy.org/) is a non-profit organization based in the USA, affiliated with IFAPP, and is comprised of a unique partnership between academia, industry, and professional associations to foster competencies and improving performance in medical affairs and medicines development. The IFAPP Academy-Kings College London, Medical Affairs in Medicines Development, Certification Program was created to achieve this goal. The online Program aims to provide the core cognitive competencies for an effective performance in medicines development and medical affairs. The certification program is of particular value for those individuals already working in (or interested in joining) pharmaceuticals, academia, and regulatory agencies. Students successfully completing the course receive a Certificate granted by King’s College London and IFAPP Academy, a Professional Certification granted by IFAPP and the IFAPP Academy, and the use of post-nominal letters (CMD) to attest certification.

Lay Summaries of Clinical Study Results: An Overview

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Lay summaries help to provide transparency and understanding of clinical study results to the general public

Benefits of lay summaries and how to write one

The below article was originally published online: 14 June 2019 https://link.springer.com/article/10.1007%2Fs40290-019-00285-0#copyrightInformation

Amber Barnes1, Susan Patrick 1 © The Author(s) 2019

Abstract

The European Union Clinical Trials Regulation (EU CTR) 536/2014 includes a requirement for the submission of lay summaries. Study participants, advocacy groups, and, to a lesser extent, the general public have called for greater transparency in their quest for information on clinical studies. As a complement to other forms of clinical study disclosure such as registry postings and scientific publications, lay summaries may aid in the transparency of a sponsor’s clinical study results, thereby promoting trust, partnership, and patient engagement throughout the clinical study process. The data transparency field is changing rapidly; therefore, data owners should strive to stay abreast of the changes and deliver meaningful tools to their study participants and the public. Points to consider when developing lay summaries of clinical study results include regulatory drivers, the target audience, communication of complex data in a lay manner, and efficient processes for the development of lay summaries within one’s company.

Lay summaries help to provide transparency and understanding to the general public

Plain Language Summary

There is a rule in Europe that clinical studies (experiments in humans) must have a summary written in plain language. Summaries written in plain language help people who are not scientists or doctors understand complex medical information. People who participate in clinical studies, and others, may want to know information about clinical study results. Lay summaries are a way to share clinical study results, but they do not replace other ways that information is shared. Lay summary writers must think about how they can help readers understand the information. It is hard to describe the results of clinical studies in a way that everyone can understand. This article gives some ideas to think about when writing lay summaries.

Key Points
Lay summaries of clinical study results are a complement to other forms of clinical study disclosure that aid in the understanding of complex clinical study results.
The initial requirement for lay summaries began as a result of the EU Clinical Trial Regulation; however, evolving regulations and policies around the globe are shaping the future of clinical study disclosure.
Ensuring patient value should be of paramount importance when developing lay summaries.

1. What are Lay Summaries and Why are They Needed?

Lay summaries (also called layperson summaries, plain language summaries, lay language summaries, simple summaries, and trial results summaries) are plain language descriptions of the design and aggregate results of individual clinical studies (Fig.1)

Example of a lay summary

Fig. 1 Excerpted pages from a published lay summary

Lay summaries are one way for industry to provide greater transparency to those interested in learning about clinical study results [2]. These documents are written specifically for study participants and the general public who have an interest in clinical study results, but who may have limited health literacy or scientific expertise. Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions [3]. The goal of a lay summary is to aid study participants and the general public in understanding clinical study results. Not only does this effort help to demystify the clinical study process but it also provides the main results of clinical studies in a manner directed specifically towards people with low health literacy. The target audience is any person interested in research, and, as such, the audience is broad and may include study participants, healthcare professionals, caregivers, and the general public.

Companies providing lay summaries in advance of requirements are communicating respect for the needs and desires of the community

The data transparency field is changing rapidly, with recognition that the desires of patients and the general public may go beyond those driven by regulatory requirements. Although regulatory agencies do not currently require submission of lay summaries, some agencies have provided additional statements on the topic, as summarized below, in preparation for when the regulations come into effect. The commitment of a sponsor company to provide lay summaries in advance of regulatory requirements provides a meaningful way of communicating respect for the needs and desires of the community, particularly study participants.

The push for increased transparency in the clinical study space has presented industry and academia with an interesting choice—to proactively engage or only meet regulatory requirements. Currently, some transparency activities are not required per regulations and are implemented solely based on a company’s own policies on clinical transparency and data sharing. For example, the proactive release of clinical documents and datasets can occur through various mechanisms such as portals (e.g. clinicalstudydatarequest.com, yoda.yale.edu), registration and results disclosure (e.g. clinicaltrials.gov), or posting lay summaries of clinical study results to publicly available websites. Other transparency activities are regulatory driven, such as the release of redacted or anonymized documents for European Medicines Agency (EMA) Policy 0070.

2. What are the Current Regulatory Requirements?

2.1 European Medicines Agency: EU Clinical Trial Regulation 536/2014

The EMA initiated the call for the submission of lay summaries through the European Union Clinical Trials Regulation (EU CTR) 536/2014. Among other elements described in the regulation, sponsors must submit a summary of the results of the clinical study, together with a summary and the Clinical Study Report (CSR), irrespective of the outcome of the study. The summary must be provided in a ‘format understandable to laypersons’, with posting to the portal 1 year after the end of the trial (EoT) for studies in adults, and 6 months after the EoT for studies in the pediatric population, in all the EU languages in which the study was conducted (Fig. 2).

EU Clinical Trial Regulation 536/2014 potential timeline
Fig. 2 EU Clinical Trial Regulation 536/2014potential timeline. EoT end of trial (defined as the last visit of the last participant in all concerned member states, or at a later point in time as defined in the protocol), LS lay summary, Peds pediatric patients, mos months

Once the regulation is in application, all new interventional clinical studies will need to comply; however, the regulation includes three phases of implementation. Assuming the dates currently projected by the EMA, this would provide the following timescale for sponsors to submit lay summaries:

  • Phase 1: A 1-year introductory period where regulations are optional.
  • Phase 2: Spanning the second and third year of the transitory period; the regulation will be mandatory for new studies.
  • Phase 3: After the 3-year transitory period described
    above, the regulation will be mandatory for all studies (both ongoing and new studies).

To read this entire article you can download the PDF here:

8.7.19_post_Barnes-Patrick2019_Article_LaySummariesOfClinicalStudyResDownload

Frequently Asked Questions

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Learn more about the IFAPP Academy/King’s College London, Medical Affairs in Medicines development, Certification Program

Presented by Dr. Gustavo Kesselring

Want to learn how to expand your skill set and continue your professional development in Medical Affairs?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.