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By Jeppe Guilford Manuel, principal R&D data privacy specialist, Novo Nordisk A/S Behind the clinical data collected and used in the pharmaceutical industry are people — research participants whose data is an invaluable resource for research. Clinical data is personal data and must be treated as such. This implies that data privacy or data protection laws and regulations apply when using clinical data, on top of the other regulations and laws that apply for clinical research (e.g., GCP). However, the purpose of processing personal data as part of clinical research in the pharmaceutical industry is to increase scientific knowledge that can lead to new discoveries, provide better therapies, and enable availability of medicines and/or devices to patients. Although clinical data, as used in the industry, are not utilized to make decisions that can affect an individual’s rights and freedom, we must still respect the rights, confidentiality, and integrity of the research participants’ data when conducting research. We have an obligation to maximize the value and utility of this resource. Great value for both patients and sponsors can be derived from the reuse of existing data sets, which is why clinical data reuse is an area of increasing interest across the pharmaceutical industry. For example, tapping into historical clinical data can maximize the value of existing research, potentially reduce the size of the control group, allowing more patients to be on active therapy, and improve the safety of clinical trials. However, there is a high degree of uncertainty when it comes to interpreting privacy regulations surrounding data reuse, which has impeded reuse of clinical data. Lack of Regulatory Guidance Regulatory language around clinical data reuse often uses ambiguous terms like “fairness,” but how do you determine what’s fair?”  It can be a very subjective concept. As an example, the General Data Protection Regulation (GDPR) in the European Union (EU), states that data can only be used for secondary uses when compatible. Beyond that, a limited description is offered for how to assess that compatibility and abide by it specifically, so that scientific research should be considered compatible. This ambiguity implies that companies must be able to define when and under what circumstances reuse of clinical data would be considered a legitimate compatible use and must ensure they can demonstrate accountability for that position. The consequence is that companies and research organizations have to make their own individual assessments, resulting in a lack of harmonization across research institutions and making it challenging for researchers to collaborate and share clinical data. For instance, it has taken more than 10 months for one university hospital in Denmark to secure approval by the Data Protection Agency (DPA) to share clinical samples with another university hospital in Denmark. If individual companies were able to align on a position for clinical data reuse, such obstacles could potentially be removed, benefiting patients and research. Resolving the nuances and ambiguity of privacy rules for research being conducted on a global scale can be overwhelming. But the COVID-19 pandemic demonstrated how necessary and powerful data reuse can be. Industry stakeholders came together to find new ways to share data, collaborate, and, ultimately, accelerate treatments at an unprecedented level. Still, privacy challenges persist. The Organisation for Economic Co-Operation and Development (OECD) highlighted privacy rules as one of the primary challenges surrounding COVID-19 research, stating, “Providing access to personal health record sharing needs to be readily accessible, pending the patient’s consent.”  Legislation aimed at fostering interoperability and avoiding information blocking are yet to be passed in many OECD countries. Access across borders is even more difficult under current data protection frameworks in most OECD countries.” However, legislation on its own is not enough, as demonstrated by the U.K.’s  NHS data-sharing initiative, “The General Practice Data for Planning and Research” scheme, which was put on hold after more than 1 million people opted out in a single month.  Guidance must be developed that fosters trust in how clinical data is used for research activities and ensures the rights, confidentiality, and integrity of the research participants. A Common Approach Agreeing on a set of common principles for clinical data reuse, would make it easier for research companies to share and leverage historical research data, while respecting the rights and freedom of research participants. To address the challenge of data reuse, members of TransCelerate Biopharma’s GDPR Data Reuse working group recently published “A Privacy Framework For Secondary Research,” which aims to decrease the time companies spend addressing privacy issues by suggesting a more harmonized approach. The framework outlines six core principles that aim to bridge the gap between competing ethical, scientific, and legal considerations regarding how personal data can be reused for other research activities: Principle #1: Ensure a Governance Framework A strong governance framework will detail the scope of acceptable secondary research activities, enforce best practice processes, and designate experts to evaluate the scope and risk profile of the research activities. Principle #2: Assess Compatibility for Data Use A two-tiered approach is recommended: 1) a company should define a list of compatible uses of clinical data based on their contextual integrity for collecting and using the data. Companies should use this list to confirm individual research activities are aligned and that the notification to participants does not prohibit the use of data for those purposes; and 2) any legacy data or new reuse purposes not covered on the compatible uses list would require a more comprehensive assessment of compatibility. The best practice is for the data protection lead to establish a cross-competence working group. Principle #3: Ensure A Fair Balance of Interests The study team should conduct a risk assessment that includes any risks related to processing the clinical data, also from the research participants’ perspective and relevant mitigating actions that should be implemented. Principle #4: Apply a Sound Scientific Approach Companies must apply the basic elements of sound scientific research when conducting secondary research to ensure the integrity of the data and its scientific validity, including documentation of how and for what purpose clinical data has been used. When data is shared with external researchers, the company should conduct a basic review to ensure that those receiving the data have a legitimate scientific purpose and are using a sound scientific approach. Principle #5: Protect Privacy and Confidentiality Researchers must ensure their use of secondary data is consistent with the individual participants’ reasonable expectations (e.g., as clarified in the informed consent) and implement measures to keep participants’ personal data unknown to others to the extent possible. Researchers must be properly trained on local and global privacy standards and standards for processing personal data. Principle #6: Demonstrate Oversight and Accountability It must be possible to continuously monitor how clinical data has been processed for a given research activity. Relevant decisions and processing activities must be documented. Companies should also ensure that the way they process clinical data—for instance, what data is used and where it is stored—is traceable. The TransCelerate framework also details a Best Practice Model for conducting secondary research, detailing relevant steps that research organizations should consider to ensure legitimate compatible use of clinical data for secondary purposes. Moreover, the framework provides a number of tools that can help companies ensure a more harmonized approach to clinical data reuse. While the best practices provided in TransCelerate’s framework aim to provide general guidance, individual companies should decide how best to implement relevant safeguards inside their own organization. Privacy Must Be Front and Center Too often, limitations are imposed on how clinical data can be reused, purely because privacy considerations were not a part of the planning process from the initial planning stage. Even though privacy regulations have been around for more than two decades, it’s still a relatively new concept for researchers to have top of mind. They need to consider using standard operating procedures that enable research to have a continuous, structured approach throughout the life cycle of data and think about how they will address the different privacy regulations around the globe from the onset of the research. It is much easier to establish good privacy (Privacy by Design) before initiating data collection and include considerations around secondary use than trying to backtrack and establish legitimate compatibility for reuse after the data has already been collected and used for its primary purpose. Above all else, the industry must be willing to work together to address privacy challenges and create clarity around the secondary use of clinical data. Coming together to develop a common approach to the way clinical data is used and collected can help everyone realize greater value from the work that has already been done and potentially also limit the need for interventional studies. Building common principles and processes to facilitate clinical data reuse would not only be a win for the industry but also potentially reduce the burden on research participants and help foster trust in clinical research.

Legislation aims to mandate the inclusion of diverse populations in clinical trials On February 3, 2022, Rep. Anna G. Eshoo (D-CA), Chairwoman of the Energy and Commerce Health Subcommittee, Rep. Brian Fitzpatrick (R-PA), and Rep. Robin Kelly (D-IL) introduced the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, a bill to strengthen diversity in clinical trials. This legislation aims to increase diversity in clinical trials by requiring enhanced data reporting on clinical trial participant demographics and provide resources to underrepresented communities to improve access and participation in clinical trials. The DEPICT Act requires Investigational New Drug (IND) and Investigational Device Exemption (IDE) applicants to report clinical trial enrollment targets by demographic subgroup, including age, race, ethnicity, and sex, and provide a rationale for those targets. Additionally, applicants will need to provide a Diversity Action Plan detailing the actions the sponsor will take, such as outreach and engagement strategies, to reach these enrollment targets. Diversity Action Plans may include demographic-specific outreach and enrollment strategies, study-site selection, clinical trial inclusion and exclusion practices, and any diversity training for trial personnel. This act will also provide FDA with the authority to mandate post-market studies when sponsors fail to meet diversity enrollment targets and do not provide a sufficient justification. The FDA will be required to publish an annual report aggregating and analyzing the data provided by sponsors on their progress toward and strategies for improving diversity in clinical trials. Workshops will be held by the FDA to assess how sponsors utilized the clinical trial flexibilities started during the COVID-19 public health emergency and their impact on improving access to clinical trials in underserved populations. As part of this act, NIH will receive funding for community engagement and outreach efforts to increase inclusion of underrepresented minorities in clinical trials and research. It will also supply grant funding to Community Health Centers to increase their ability to participate in clinical trials and research. The bill text for the DEPICT Act can be found here. The need to increase diverse patient participation in clinical trials has been a critical industry-wide need for many years. Requests from sponsors and CROs are already increasing for sites with diverse enrollment experience. SCRS highly encourages research sites to participate in the Diversity Site Assessment Tool (DSAT), a first-of-its-kind assessment to help sites understand their knowledge in recruiting and meeting the needs of diverse patient populations in clinical trials. Based on legislation such as the DEPICT Act, sites that have more experience in this key area may receive preference from sponsors and CROs. It is imperative to continue collaborative discussions between industry, sites, and regulators to address how to take action to ensure diverse representation in clinical trials. At the Diversity Site Solutions Summit, industry leaders will come together to share innovative best practices for engaging diverse populations as regulatory and sponsor directives require more inclusion in trials. SCRS encourages sites and industry to attend and share their input through solution-focused discussions at the Summit. The SCRS Talks podcast discusses the DEPICT Act further below

Signant Health’s Bill Byrom discusses the FDA’s most recent guidelines regarding DHTs, such as sensors and wearables as well as general computing platforms, when collecting health data from clinical trial patients. Readers will learn: The FDA’s position on BYOD in the context of DHTs The evidence supporting the use of sensors & wearables Data integrity considerations in the context of minimizing missing data and device, firmware, or software update Download Now

The Sites NOW January discussion, featuring panelists Peter Fredette of IQVIA, Rosemary McQueary of Quality Cancer Care and Alliance, and Alexa Florea from Roche Genentech, highlighted insights gathered from recent oncology research site surveys, acincluding trends and issues impacting the future of research. Peter Fredette, who has worked in oncology research for nearly two decades, kicked off the conversation. “The oncology research industry is incredibly resilient. Anyone in this field can feel the urgency to get back to work, whether we do it remotely or standing on our heads. But more importantly, we’re going to try and do it better.”  Within oncology clinical research, some things were put on hold, delayed or canceled due to the pandemic, but recovery has been swift: there are currently 740+ companies focused on oncology R&D and more than 500 of those are focused exclusively on oncology R&D.  Despite disruptions with COVID-19, there were 1,600 clinical trial starts over the last two years, which is an all-time high. There are also ~3,500 new drugs in the pipeline to be studied, which is unprecedented. This is up approximately 75% from 2015 numbers.  How has oncology research changed over the last few years? For starters, protocols are more complex. Procedures and data collection are increasing. Many trials are now requiring smaller subsets of patients. Additionally, oncologists are spending 20% of their time discussing COVID with their patients, which is adding to their already increased workloads. (Information on these statistics is available in the annual IQVIA Oncology Trends Report). What are the biggest issues facing oncology sites today?  Staffing Issues Remain a Challenge  According to WCG survey of site leaders, three out of four said that staffing is the most prevalent challenge in research with 1 in 5 stating staff turnover rates are 30% or higher.  In one Sites NOW January meeting poll, 80% of sites said staffing is not where it needs to be for effective operations, and 55% of sites have turned down studies due to staffing issues. Because of these challenges, 70% of staff said they have experienced a significant reduction in time available to manage patients.  The number of PIs has also dropped significantly in the past couple of years from about 15,000 to 10,000. The main causes cited include burnout and the work to do study start-ups is becoming too burdensome. Sponsors are prioritizing established investigators and may overlook new investigators, but it’s imperative to get new PIs involved in research.  At the 2021 Global Site Solutions Summit, this was a hot topic of discussion where speakers suggested reaching out to medical schools, starting internship programs, training staff from within, and offering classes as suggestions to get started.  Technology  Clinical trial technologies – wearables, eConsent, eCOA, etc. – are being piloted in trials more than ever before. Many sites have participated in decentralized trials (DCTs), but panelist Rosemary McQuery commented that remote visits still require the same amount of attention and work as onsite visits. This is especially important to note as a recent SCRS survey showed that only 7% of sites feel they are being adequately reimbursed for time and effort in DCT implementation.   How will the CRA role evolve? McQuery shared, “We have a practice that just hired a screener who will be working remotely from another state. How much pre-screening can we do in a patient record without physically being onsite? AI has been helpful for oncology sites to narrow down patient lists and conduct pre-screens in a more focused way. However, no AI will be able to tell 100% accurately if a patient does or does not qualify for the study.”  Despite the efficiencies tech creates, we also must consider how they are implemented. Required staff training for new clinical trial technologies and platforms is creating an increasingly time-consuming burden on sites. Sites NOW panelists reiterated that digital competency is not an issue for site staff; the issue is the number of platforms and technologies being introduced which require separate training for each. More open communication between sites and industry is needed to address opportunities to improve training and budgeting for new technologies as they become more widely used.  McQuery would also love to see an assessment tool to analyze staff workloads. How much do you need to increase staffing to increase workload? How many people do we need to conduct these trials?  Looking Ahead  Oncology sites are exploring using mobile nurses and hiring outside of the clinical research industry to address the present issue of staffing. Increased collaboration will be huge to develop a better future for oncology research. This includes site network partnerships, site-CRO partnerships, and working with regulators and regulatory agencies. Panelist Alexa Florea urged sites to speak up and share feedback to sponsors and CROs. “Teach others what you need. Sites, be adamant about what it takes to run a trial,” said Florea. “Partnership is a way out of the muck. But you have to speak up.” Research is hard and ever-changing. There are many opportunities for learning, growth, and efficiencies. Starting conversations now to ideate how we can move forward together will improve research for all. Plan to join us at the 2022 Global Oncology Site Solutions Summit May 21-22, 2022 at the Hilton Austin in Austin, Texas.  Watch the recording of the January Sites NOW session

An excerpt from a white paper developed by MRN  The Covid19 pandemic has clearly highlighted challenges of “traditional”, site-centric clinical trial designs. More than ever, people are talking about direct to patient, decentralized or community-based clinical trials, buzzwords that have appeared in our vocabularies only just recently, but as the organization that pioneered these kinds of studies, over 15 years ago, we know that it isn’t an easy process. This isn’t about taking the complex and making it simple, it’s about making the complex happen efficiently and safely for patients.  Ensuring patients are safe, cared for and comfortable during treatment isn’t simple; making sure data is collected on schedule and accurately, so that the study either proves the efficacy of a treatment or disproves it quickly isn’t simple; coordinating medical professionals, patients, investigational medicinal product to a single point in time and location isn’t simple; managing sample collection, on site processing and shipping to central laboratories from multiple, domestic, locations isn’t simple. Pulling this all together across multiple patients, locations and visits is very complex. Our operational teams bring together the best in the industry to coordinate each and every study touchpoint and ensure your clinical trial can be run in the patient’s communities in an efficient and safe manner; but it isn’t simple.    What do you need to consider? Here are some of the points you should consider if looking to run community-based clinical trials:   What does the protocol entail?   What can be done within the protocol in a home/ work/school environment? Which visits should happen outside of the site? Is the protocol very visit intensive –frequent visits or intensive assessments? What patient centric recommendations can be made to best fit the recruitment, enrollment and retention for the study?   Who are your patients?  Consider your target population; where are they, who are they, what is the prevalence of the disease and how close are those patients likely to be to the sites? “Currently, 70% of potential clinical trial patients live more than two hours from a study center…” (Parexel, 2019)  If regular, in-person interaction between the patient and their physician is required, then visits to the site make sense for a patient relatively close to site. If those patients aren’t near to a site, they are going to struggle to meet the visit demands of the protocol and they’ll either not enroll or not be retained for the full duration of the trial.   Developing the protocol with the patient in mind is absolutely key. Speak to patient advocacy groups for the disease state, they know what it’s like from the patient perspective to take part in a clinical trial, they know how onerous it can be and understand the difficulties of the disease state that they’re trying to manage.   Family often have to take the patients to their visits so that should also be considered. Location is key to reduce the burden on the patient and their caregivers or families. Patients shouldn’t be expected to travel hundreds of miles to see a physician for every trial visit if some can be done at home.   If you are looking at using technology to facilitate virtual visits you must consider the age of the patient population. Will they know how to use a heart rate monitor or a tablet?   To be applying technology to a protocol you need to consider the infrastructure of the countries that you will be working in; how good is the WIFI, the broadband? Will 5G be supported? Do the patients have a WIFI network that can be used?  Who or what do you need?   A lot of detail is required around the actual scope of what needs to be delivered. Nurses conducting visits have a higher success rate if trained properly. What training and equipment is required for the research activities required? What experience do the nursing professionals require to deliver the research assessments? How do you ensure all research nurses are vetted appropriately? What training materials and support must be created to ensure all activities can be undertaken correctly?  Are there country-specific regulations that need to be considered? There may be country-specific regulations that may complicate the running of clinical trials in the community. For instance, in some countries, we know the administration of certain drug types is forbidden outside of a clinic or hospital environment, or it may require a physician rather than a nurse to perform either the assessments or the administration. It’s not just the clinical research regulations that you need to familiarize yourself with, you need to broaden your understanding of the healthcare landscape in all countries that are being used for the study. As well as regulatory differences from country to country, there are also cultural differences to consider as well. In some countries, it isn’t polite for patients to invite professionals other than their physician into their home and that would extend to nurses. Many people will hear the word “decentralized” and think of technology, such as telemedicine or wearables, but it’s so much more than that.  Performing a clinical visit outside of a site requires a trained healthcare professional, a delegate of the PI, to care for the patient and understand clinical research and the protocol. We know from experience that utilizing decentralized solutions isn’t a one size fits all solution. . The right solution should be determined by what is right for the patient.  When you use the right tools, decentralized trials can be successful for all stakeholders.    Download the Full Whitepaper from MRN

In November, we reconvened for Sites NOW to discuss the 2021 SCRS Global Site Solutions Summit and some of the highlights from popular sessions. Lindsey Morales of Labcorp Drug Development, Ana Marquez of Clinical Site Partners, and Karin Gulbrandsen of Janssen joined us to share lessons learned and hot topics of discussion in each session.  It’s Not You, It’s Me: How to Manage Long Term Partnerships As the pipeline of clinical trial work evolves and changes over time, the importance of quality relationships between sites and sponsors and CROs will increase. Sponsors and CROs will engage sites that align with current and mid-term projected opportunities and remaining in contact over the long-term will become even more important. Attendees gained insight into navigating clinical trial evolution to position their sites for success. Chris Hoyle of Elite Research Network facilitated the session with panelists Silvina Baudino of Teckro, Lindsey Morales of Labcorp Drug Development, Robyn Schmidtke of Merck.  Fundamentally, this session focused on communication. As we know, partnerships of any type are all about communicating with and learning about one another. But, what does it mean to communicate? What does it mean to be honest and build trust with one another?    Sites, speak up! Sponsors and CROs want sites to share information and challenges because “if they don’t know about it, they can’t help you with it.” Keep conversations going about training as the industry looks for solutions to minimize the amount of training needed for new technologies and reduce overall technology burden for sites. Be open and candid and transparent about the things we’re learning with each other.   One popular point of discussion sites shared was that CRO databases seem to be places where information just goes into a black hole. Industry is incorporating site feedback and working on better databases to keep everything in one place and reduce redundancies, so please continue providing feedback.   We also shared how crucial it is for our industry to attend meetings and conferences to take communication to a new level by putting a face to a name and building a personal connection.  Industry conferences, virtual meetings, site advocacy or focus groups, and community forums are a great place to foster relationships and provide value to one another throughout the year. Continue reaching out to sponsors and CROs to find people you can partner with and who will be an advocate for your site. They want to know you and help you as much as they can, so don’t be afraid to ask for assistance or contacts if needed.  Hybrid Decentralized Trials: Critical Considerations   It’s no secret that digital innovations are here to stay, especially in the form of decentralized trials. While there are important considerations to be made from an administrative and process perspective, it is equally critical that we consider how patients will be affected. This session discussed how decentralized trials affect patient interaction so we can ensure patients’ needs are addressed.  Facilitated by Todd Albin of Cedar Health Research, panelists included Deena Bernstein of Datacubed Health, Nicole Latimer of Medrio, Scott Connor of Signant Health, and Karin Gulbrandsen of Janssen.  Understandably, sites remain concerned about building and maintaining patient relationships when using DCTs. However, the intent of decentralized clinical trials (DCTs) is to engage patients where they are and increase retention. Many opportunities remain to build relationships with trial subjects in different ways and may be nourished through a combination of phone calls, video calls, texts, and in-person visits.  Sites are also apprehensive about PI oversight specific to DCTs due to lack of understanding of regulations. PIs still need to make sure they are delivering quality expected from in-person visits, while industry needs to provide guidance for investigators as they navigate these new expectations.   It was also shared that sponsors and CROs need better understanding of financial liabilities for sites regarding implementation of new technology. Sites expressed that budgets are often poor with DCTs, yet add a lot of work for the site.  Additionally, many digital platforms ask for specs, then other sponsors or studies ask the same information again. Communicating these challenges can help industry to create a uniform way for sites to provide technical authentication pieces in the future. It’s important to remember that adding new technologies to trials is not one-and-done; as we implement different elements, we need to continue to get the feedback on what’s working and what’s not. It’s an ongoing learning process that will only be successful if sites and industry work together to find solutions that benefit all.  FDA Audits: Yes, That Really Happened!  FDA audits are an inevitable reality that all sites should be prepared for before they are audited. This session included perspectives from those who have experienced FDA inspections to share how they prepared for the audit and what measures they have implemented to ensure future inspection-readiness.   Ana Marquez of Clinical Research Partners facilitated the session with panelists Shivani Shah of DM Clinical Research, David Vulcano of HCA Healthcare, Rick Arlow of Complion, and Lisa Kodis of Illingsworth Research Group.  This session discussed recent FDA audit need changes and what the FDA is looking for, such as informed consent issues and delegation log issues. How do sites prepare for audits? Panelists noted that it is critical to prepare site staff by discussing specific steps to take after being notified of an audit. Sites should identify a key team for inspection and minimize involvement of too many people as much as possible. One option may be to hire an expert to assist you with the process, especially if you have been issued a 483. Investing in the proper individual to guide you through it can make it a much easier process for your site.  It’s also important to note that sites can set limits in their contracts when it comes to FDA inspections regarding communications protocols,  such as only notifying the sponsors whose trials will be affected by an audit.   SCRS will continue to host workshops, webinars, and provide resources for sites to self-monitor and be as prepared as possible for FDA inspection. FDA also offers an audit manual online that industry can pull which shares every question to anticipate the auditor asking.  The meeting then separated into breakout sessions to discuss  takeaways from these sessions and the 2021 Global Site Solutions Summit. We hope you will join us for the next Site Solutions Summit and encourage you to get your tickets as early as possible to secure the lowest rate! For the full November 2021 Sites NOW discussion, watch the Sites NOW meeting recording here. 

Ready or not, patient-centric trials fueled by technology and new best practices are here to stay, says David Vulcano, LCSW, MBA, CIP, RAC, vice president for Research Compliance & Integrity with HCA Healthcare. “We’re building the plane while it’s flying,” he notes.  The COVID-19 pandemic has forever changed the way clinical trials are going to be conducted, Vulcano believes, beginning with greater usage of decentralized clinical trial (DCT) tools and technology. “Patients are demanding the infrastructure be built around them” after technology demonstrated it could bring many aspects of clinical trials to a patient, rather than forcing them to come to a brick-and-mortar site every step of the way, he says.  Trials in a post-COVID-19 world will be increasingly patient- and not site-centric, Vulcano says. “Patients will want to keep much of that choice,” he notes, especially the ability to use FaceTime and other remote technologies to communicate with clinical trial professionals and other healthcare workers.  With privacy and security regulations relaxed during the pandemic to help maintain critical trials and care, Vulcano thinks patients won’t want to lose those new ways of participating in studies. “When the [pandemic] is declared over, will [regulators] tighten those regulations again?” Vulcano asks. “Patients will want to keep” the convenience and option of remote communication, he believes.  Regulators will need to work with industry to find effective ways to ensure patient safety and data integrity when using remote tools, Vulcano says. “There are privacy and security concerns, and we have to think about how principal investigator oversight and adverse events are handled, among other issues,” he adds.   Ready…Fire!…Aim. How We Got Through the Pandemic and What’s Next  Join Vulcano at ACRP 2022 on Saturday, April 23 as he gives an overview of how the pandemic forced many sites into decentralizing their studies and the effects on site cash flow, workforce safety, and increased flexibility. Examine how we can all help each other through these challenges, and how we as a workforce can maintain compliance while working in a remote environment.  The clinical trial industry is moving from the “Blockbuster to the Netflix model,” Vulcano says. In the old days, going to a brick-and-mortar site was about the only way to rent certain kinds of new entertainment content, but Netflix and others adapted that model to offer consumers different ways to get what they wanted without leaving their homes. “I can still get a DVD in the mail or Redbox or Walmart or other places, but I can also get it streamed to my phone while I’m home or traveling,” Vulcano says.  While he’s optimistic about this future, he notes it will put new demands on the clinical trial workforce, too. For example, it will require greater familiarity with using technology and remote tools, he says. “We’re also going to see new technology and new technology partners” become a more important part of the clinical trial delivery ecosystem, he explains.  “I can’t imagine us going back” to the way clinical trials operated before COVID-19, he says. “These trends were already here—COVID-19 just accelerated them.”  Originally published on ACRP by Michael Causey 

Sandy Smith, Senior Vice President of Clinical Solutions and Strategic Partnering at WCG Clinical and SCRS Global Oncology Summit Chair shares what she is most excited about for this year’s Oncology Summit, including some of the hot topics we will cover at the Summit. Learn what attendees can expect from the Summit and how to maximize your experience! Learn more about the Global Oncology Summit and register today at https://oncologysitesolutionssummit.com/  

Meet SCRS’ new Honorary President, David Vulcano, as we discuss what this new role means to him and SCRS. David shares his vision for the future of our organization and the clinical research industry as we look ahead to SCRS initiatives for 2022.

Tune in as Steven Geller, PhD, Medical Director at Centennial Medical Group, shows you the patient recruitment strategy that earned the 2021 SCRS Site Patient Recruitment Innovation Award (SPRIA), which celebrates one site that has demonstrated innovation in its patient enrollment. Dr. Geller also shares insights on industry recruitment challenges and how sites can achieve and exceed enrollment goals. Learn more about SPRIA at https://sitesolutionssummit.com/

What does it mean for sites to be patient-centric? Learn from Ellen Price, Director of Patient Engagement at Meridian Clinical Research, the recipient of the 2021 Excellence in Patient Centricity Award. Ellen walks us through the programs that grew her organization despite the challenges of COVID-19 and how other sites can establish consistent patient-centric practices. Learn more about the Excellence in Patient Centricity Award at https://sitesolutionssummit.com/

The Christine K. Pierre Site Impact Award recognizes an industry leader who has made tremendous contributions to the site community through their dedication, actions and innovation. They exemplify the mission of SCRS to unify the voice of the global clinical research site community for greater site sustainability and uphold the pillars of SCRS by supporting the education, advocacy, mentorship and connection of clinical research sites. Michele Cameron, BSN, MBA, CCRC, Director of Clinical Research at Clearwater Cardiovascular Consultants, embodies the essence of this award. We sit down with Michele, this year’s CKP Site Impact Award recipient, to learn about her site, how she has grown that organization to what it is today, and how winning this award has impacted her and her site.