Welcome to the December issue of InFocus, where we provide insights and solutions to help sites and other stakeholders ensure site sustainability.
A Year in Review
As 2019 comes to an end, the SCRS team extends our sincerest thanks and appreciation to our member sites, global impact partners, leadership council, committee members, and all those who have played an active role in increasing the sustainability of the global clinical research site community. This is a goal and reality that, simply put, cannot be realized without your support.
The last two years have included tremendous change for SCRS, with many highs and a few lows. Losing our founder, Christine Pierre, was incredibly difficult. However, just as Christine would have wanted, the team has worked diligently to build and grow her vision to better serve the global site community. And the effort has paid off:
In February 2019, we hosted our first-ever Global Oncology Site Solutions Summit in Austin, TX. Christine envisioned this Summit years ago, and it is SCRS’ very first Summit specific to a therapeutic area. More than 250 attendees joined us in spearheading needed change and development in oncology clinical research.
It was at the Oncology Summit that we announced Casey Orvin’s presidency with SCRS – a change that was also facilitated by Christine. The support we have received since has been deeply appreciated.
We listened to attendees of our European Site Solutions Summit and made an exciting change as a result – next year, the Summit will move to Lisbon, Portugal!
Our Asia-Pac Site Solutions Summit has shifted to become the Australia-New Zealand (ANZ) Site Solutions Summit. This change will create space for a future Summit held in an area that is more accessible for Asian sites.
Our headquarters office has moved! As our team expanded, we outgrew our cozy space in Ellicott City and relocated to a beautifully designed office in Hanover, MD.
This year’s Global Site Solutions Summit moved to a lovely oceanfront resort in Hollywood, FL. More breakout sessions were added, each day featured a different keynote speaker, and the Summit saw record-breaking attendance. We had the opportunity to honor Christine in a beautiful tribute on Friday and introduced the Christine K. Pierre Site Impact Award, which will be awarded each year to honor an individual who has made a significant impact on the site community.
SCRS representatives attended, exhibited at and spoke during dozens of industry events on behalf of the global site community.
Finally, the SCRS team is organizing a new summit to recognize the tremendous change and shift that technology has facilitated within the clinical research industry in recent years. We hope you will all join us for SCRS West – Research on the Edge. We are excited to share information about the location and dates of this new Summit soon.
The changes and growth won’t stop here. We look forward to welcoming 2020 alongside all of you and pioneering change to further unite and amplify the voice of clinical research sites globally.
The SCRS team wishes you a happy holiday season and a prosperous new year!
SCRS Diversity in Clinical Trials Project
The SCRS Diversity in Clinical Trials Project: A Year in Review
The SCRS Diversity in Clinical Trials Project, launched in 2016, remains focused on moving the needle to increase the awareness and understanding of clinical research sites across the globe about the inclusion and enrollment of diverse patient populations. The complexity of the work plan and multi-faceted approach to this important issue have elicited the contributions of several funding sponsors since the project began. Contributors to the mission for 2019 included Janssen, GSK, Medidata, Genentech/Roche, Parexel and VirTrial. Past contributors include Merck, Acurian, PhRMA and Lilly.
The working group’s targeted accomplishments were achieved in 2019 according to the timelines established by the group. Some of the highlights include:
- A bi-monthly webinar series that has reached more than 500 attendees since 2018.
- Publication of two articles in the SCRS journal, Insite.
- Multiple presentations by the SCRS team to clinical research stakeholders at the following meetings:
- SCRS European Site Solutions Summit: London, England, March 17-19, 2019
- DIA Global Annual Meeting: San Diego, California, June 23-27, 2019
- SCRS Asia-Pac Site Solutions Summit: Melbourne, Australia, July 16-17, 2019
- OECT Summit: Toronto, Canada, September 18-19, 2019
- SCRS Global Site Solutions Summit: Hollywood, Florida, October 9-11, 2019
- Completion of a pilot study to establish the initial validity and reliability of a site assessment tool designed to help sites and sponsors access the knowledge and best practices of sites related to the inclusion of diverse patients in studies. The results of this project have helped sites identify what areas they need to improve upon in order to reach a more diverse patient population. This is a helpful tool for sponsors to use to support enrollment/recruitment practices and for CRAs to understand how sites can be supported.
A representative from Brisq Konsultancy conducted the pilot program on behalf of SCRS. Ten site participants completed both parts of the project, which featured a survey and interview process. In the interview session, the participants were asked for their thoughts on the tool and to elaborate on the reason for their selections in the survey.
The next stage in the development of the tool is to administer a survey to a larger sample of 400-500 sites to establish sub-analysis.
- The development of a paper evaluating the impact of telemedicine on diversity in clinical trials. In 2020, SCRS GIP VirTrial will conduct a study to assess the impact of innovative virtual strategies on the recruitment of diverse participants.
- Participation by the Office of the Commissioner of the FDA was initiated in 2019 and will be ongoing in 2020. Captain Richardae Araojo, Director, The Office of Minority Health and Health Equity, joined the working group and participated in a plenary session on diversity in clinical trials at the SCRS Global Site Solutions Summit in October, 2019. The government/regulatory perspective brings another element of information and advisement to the initiative.
- A work plan with a broader perspective on issues of diversity for research sites was launched. The NIHR and Asia-Pacific regions representing SCRS members outside the US have joined the working group to provide guidance and contribute to planning as the mission of the group expands to develop a better understanding of issues of diversity across the globe. Plans are underway to establish a sub-group in the Asia-Pacific region and to increase awareness with several global presentations in 2020.
The project will continue to address research sites’ responses to disparities in clinical trials now and in the future. As sponsors strive to obtain a broader cross-sampling of ethnic, racial and other diverse populations, this topic will only become more important to clinical researchers. Barriers that hinder minority participation include a lack of awareness of trials, lack of accessibility and lack of education and knowledge. Increasingly, the need and importance of diverse patient participation in clinical trials will require sites to broaden best practices, accessibility and staff make-up of diverse professionals, among other factors.
Funding is being sought for ongoing support of the group in 2020. If you are interested in supporting the group through funding and/or participation, please contact Diana Foster, PhD, at firstname.lastname@example.org or 214-263-1094.
Diana Foster, PhD
VP, Strategy and Special Projects
Lead, Diversity Work Stream
A Consistent Approach to Risk-Based Quality Management: Collaboration is Key
Developing, executing and overseeing clinical trials is a complex process, but it is essential to gain reliable evidence from clinical trials to inform decisions about trial participants’ safety and the reliability of trial results. As clinical trials have become more complex, sponsors must identify ways to proactively incorporate quality into study design rather than taking a reactionary approach of only monitoring quality during clinical trials.
While there is an abundance of quality management guidance from various organizations, including the International Council for Harmonization and the FDA, each sponsor has historically interpreted and implemented this guidance differently. These variations have led to inconsistent and potentially inefficient approaches.
To support consistent industry-wide practices, ACRO’s CRO Forum spent much of 2019 developing a recently released paper entitled Risk-Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight, which aims to ensure greater collaboration and efficiency through a shared vision of RBQM.
ACRO’s cross-company team of subject-matter experts authored the piece to share perspectives that will help sponsor organizations create a RBQM system in partnership with CROs and technology vendors. When sponsors, CROs and vendors can work from a shared, proactive plan, they can then tailor their oversight strategy to support improved quality and safety of clinical trial execution.
Creating a system-based, holistic, risk-based approach to clinical trial management and oversight supports key decision-making activities and reduces clinical trial complexity. Together, sponsor companies and CROs must work closely to implement the following four steps of RBQM:
- Plan: Assess the risks and develop a monitoring strategy. This includes determining who will be responsible for quality oversight and whose standard operating procedures to follow, which should be determined as early as possible—ideally during the request for proposal stage. Sponsors should consider the pros and cons of each approach, whether the sponsor fully outsources the oversight to a CRO, manages it all internally, or takes a hybrid approach.
- Do: Perform monitoring activities according to the agreed-upon protocol, documenting and sharing information appropriately along the way. This should include risk-based monitoring to pinpoint with the greatest speed and accuracy the information needed to protect patients and secure quality data much faster.
- Check: Review leading indicators of quality to inform monitoring activities.
- Act: Adjust monitoring activities in response to quality indicators.
The clinical trial community has a responsibility to get quality management right; the well-being of patients’ who rely on our life-saving therapies depends on it. That’s why we need to work together through a collaborative oversight model to achieve the best results. ACRO members invite sponsors to join us in this shared vision for the future of clinical research.
Download “Risk Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight” to read the paper.
Successful Techniques for Accelerating Recruitment (STAR)
Recruitment remains a hurdle that sites, sponsors and CROs alike are challenged to overcome. SCRS publishes regular articles sharing techniques to boost recruitment for sites. Below is a summary of some of our top articles from 2019.
Social Media: When Too Much is Too Much
Social media comes with a variety of pros and cons that differ depending on the person and their intended use of the platform. According to this article, there are possible concerns related to the “unintended consequences” of connecting clinical trial patients who, in the past, wouldn’t have had the ability to communicate with each other. The author writes about the potential for patients (or family members) to share information that leads to unintentional “unblinding” of the study, impacting the outcome of the study and leading to unnecessary speculation.
The scientific validity of a trial is important, but if participants are required to endure extreme discomfort, if they learn through communication with other trial participants that what they thought was happening, isn’t, or if they see in their online patient group that other trial participants are experiencing the same negative outcomes, their collective voice is more likely to inspire a lack of trust in the trial and the site.
The takeaway: How sites navigate these issues is of utmost importance. Prioritizing patient trust and comfort will pay off in dividends in both the short and long term.
Utilizing Connection as a Recruitment Tool
As clinical trials increasingly move toward incorporating virtual visits and various technologies, it is even more important that physicians prioritize quality relationships with their patients. People invariably trust people, and while the incorporation of telemedicine is undeniably necessary, so too is the connection between doctor and patient.
As your site adopts telemedicine practices, are you continuing to prioritize quality relationships between your doctors and their patients? This can be as simple as personal follow-ups after a remote visit, allowing 5 more minutes to address concerns or questions after an in-person visit, or even eye contact and not rushing through the visit.
The takeaway: Quality patient engagement will allow your site to succeed in the telemedicine space and is one of the best business practices your site can utilize to boost recruitment and retention.
Recruiting for Decentralized Trials
Considering the importance of human connection to the quality of clinical trials, a hybrid approach to integrating virtual visits is ideal. It can vastly improve access to care by achieving three things:
1) Increased flexibility and convenience for patients. Being able to treat patients virtually for some visits provides the patient with more flexibility to participate in studies and enables sites to reach important populations who can benefit tremendously from participation.
2) Sites can reach a broader patient pool. Patients that sites normally wouldn’t be able to reach or who may have difficulty traveling regularly become a prospective for clinical trials. An Alzheimer’s patient whose caregiver’s schedule does not allow them to attend regular office visits or a patient with mobility issues may now have the opportunity to participate in life-changing clinical trials.
3) Sites can access and treat more diverse populations. When a trial includes a virtual component and the site is capable of accommodating virtual visits, the site can recruit from a much broader geographic area and reach a more diverse population than they could from their typical reach when 100% in-person visits to the physical site are required.
The takeaway: Reaching a broader population than is possible without the inclusion of virtual visits is a key benefit of decentralized trials. Keeping the doctor-patient connection in mind when evaluating which trial visits can be conducted remotely is important for success.
Diverse Patient Recruitment
There are several things that a site can do to position itself to better recruit more diverse populations for clinical trials.
Some sites experience difficulty recruiting diverse patient populations due to their geographic location. In this case, commitment can be demonstrated by providing transportation for potential patients or providing staff with access to a vehicle to make patient visits.
When done appropriately and within ethical guidelines, certain incentives can help bring patients in and keep them while also motivating staff to recruit more effectively. Hiring staff who are diverse, culturally sensitive and speak the necessary languages also has a significant impact on a site’s ability to recruit diverse patients.
Prioritizing a connection to the community has also been shown to be a successful method for increasing trial diversity. This connection to the community opens up a new potential recruitment source and establishes an additional level of trust among diverse populations within your own communities.
The takeaway: A site that has demonstrated a commitment to increasing diversity in their trials is more likely to access these populations. Commitment is key.
Founded in 2012, SCRS is a global trade organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, connectivity and mentorship. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community.