Lack of Diversity in Clinical Trials – How Sponsors Are Planning to Increase Representation

By Karen Ledesma

Diversity and inclusion are imperative pieces when conducting clinical trials, but they continue to fall short at representing the diverse population. Factors such as differences in age, ethnicity, race, and gender may yield distinctive results in people when responding to the same treatment. When including a diverse population, one will be able to see where results may or may not be effective or safe in certain populations. Inclusion of all these groups is paramount as it provides findings that are more generalizable to the whole population. When all diverse populations are included, it will validate that the drug or medical device is efficacious and safe for all and not just for one population.

Specific groups have been underrepresented for many years in clinical trials, especially people of color. For instance, in an article from JAMA oncology, it was found that only 145 trials of 230 reported any information about the participants' race for FDA oncology drug approvals. According to the same article, Whites represented 76.3%, Asians 18.3%, Blacks 3.1%, and Hispanics 6.1% of trial participants and from 2013 the proportion for each race enrolled changed minimally with the Black participants enrollment decreasing slightly as Hispanics increased by a little over one percent. Compared with their proportion of US cancer incidence, Blacks and Hispanics continue to be underrepresented, while Asians are overrepresented, and Whites are represented correctly.

According to an article posted in PharmaVoice, African Americans account for 13% of the US population, but only make up 5% of clinical trial participants and Hispanics account for 16% of the US population, but only make up 1% of clinical trial participants. On the other hand, Caucasians account for 67% of the population and 83% of research participants. Additionally, PharmaVoice mentioned Census Bureau’s prediction that racial and ethnic minority populations in the United Stated will grow to become half of the U.S population in three decades, by 2050. As a result of the increase in the minority populations, it is expected that clinical trial studies will begin to include participants of all races to better represent the population at large. 

Strategies sponsors are considering to increase representation

Although the importance of diversity and inclusion has been known to sponsors, not much has been done to increase the representation of minorities. There are many approaches sponsors can take to guarantee that the study population better reflects the entire population who will be administered the new treatment.

Dr. Jonathan Loree, a Medical Oncologist and Assistant Professor at the University of British Columbia, told Medical New Today (MNT) that  “[physicians] need to listen to [their] patients and understand how they feel about research and the barriers each patient faces to participating in clinical studies.” Communication between physicians and patients plays a crucial component in clinical studies. it will help physicians better understand their patients as well as their concerns and challenges they face.

Another important aspect is including the patient's voice during the planning of clinical trials. Dr. Kanwal Raghav, an Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, communicated to MNT that patients themselves can influence the demographics of future trials by “regularly inquiring about their possibilities of participating in clinical trials.” Furthermore, he mentioned that researchers should “educate patients on how researchers design and run trials and involve them to help develop strategies to reach more diverse populations.” Additionally, Rear Admiral, Richardae Araojo stated “identifying site locations where there are more racial and ethnic minorities and diverse study team staff are also efforts that support recruiting minority populations.” A site having diverse staff, researchers, investigators, and sponsors can most certainly increase the amount of minority participants by virtue of availability of studies in these areas.

The Food and Drug Administration has been working on practices that will lead clinical trials to better reflect the whole population. The FDA has been “hosting public meetings, developing tools, and issuing guidance documents” said RADM Araojo. Araojo also indicated that the FDA’s Office of Minority Health and Health Equity is working towards more cultural and linguistic strategies and resources. These include campaigns, educational material, public service announcements, and social media programs to raise awareness on the need for minority groups to participate in clinical trials in both English and Spanish.

What sponsors can do to increase representation

Sponsors play an enormous role in helping to increase diversity in clinical trials. Dr. Coleman Obasaju, a Global Leader for Clinical Diversity at Eli Lilly and Company, wrote in PharmaVoice.  A forum called diverse site centers of excellence was created and serves as a means for them to “reach out to stakeholders to have productive discussions around tactics that can be scaled up to have a bigger impact in the country.” This forum will help them collaborate with other pharma companies and groups as an effort to increase diversity in clinical trials.

In 2016, Biogen launched MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions), a network of healthcare practitioners and neurologists to gather data from 17,000 patients from more than 50,000 patient visits to allow a 360-degree disease assessment. Recently, Biogen did a study with Tufts Center for the Study of Drug Development to investigate ways to help improve clinical trials and how to remove barriers that potential participants face in joining. Similar to the actions of the FDA, Biogen is also forming a Community Advisory Board consisting of African Americans and Latino members to help develop educational materials for the minority population. Additionally, Biogen is creating a diversity and cultural sensitivity training to help clinical trials expand the inclusion of diverse populations.  

Another solution to increase diversity, as Hopkins Biotech Network suggests, is to implement “mobile health (mHealth) applications and flexible trial design to promote trial diversity.” Hopkins says this will reduce the frequency of study visits and make patients more amenable to financial reimbursement for participation. Sponsors could also use the app to advertise the description of the study and provide a secure link to enroll in the study. This app may help raise awareness and reach more diverse populations, therefore, ensuring that participants in clinical trials do in fact represent the whole population. Using technology and software systems analytics, as LINEA System is improving on, will pave the way to launch clinical trials efficiently and accurately representing a more diverse population to support research and development of a new drug.   

LINEA System is Officially Certified as a Minority/Woman-Owned Business Enterprise

PARSIPPANY, NJ — LINEA System, a leader in accelerating clinical study start-up, announced today that it has been certified as a Minority/Women-Owned Business Enterprise (MWBE) by the State of New Jersey. 

“Earning our Minority/Women-Owned Business Enterprise certification is representative of the values and standards we hold ourselves to, and of those to which we hold vendors and partners.” says Leticia Bidó, VP, Client Success & Strategic Operations at LINEA System. “We are excited to be able to strengthen the supply chain and open up new opportunities with clients who are committed to supporting supplier diversity.”

LINEA System, and businesses from all industries who have been certified, can be found on the New Jersey Selective Assistance Vendor Information (NJSAVI) database by searching here

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About LINEA System, LLC

LINEA System, LLC is a leader in accelerating clinical trials by leveraging data and technology in a completely new way. The company specializes in site identification, feasibility assessment, and site activation. LINEA System’s cloud-based Study Start-up Management System (SSMS), AcceleTrial™, enables teams to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and accelerate patient recruitment.

Press contact:

Sarah Hof

Marketing Associate, LINEA System

shof@lineasystem.com

GlobalData Conducts Comprehensive Survey of Clinical Professionals

By Sarah Hof

Countless aspects of clinical trial operations have been disrupted in the last 10 months. To explore new pain points and shifts in trial planning across the industry as a result of the pandemic, GlobalData conducted a survey to gather metrics from professionals across the world, as reported by Pharmaceutical Technology.

Overall, GlobalData found that patient recruitment was the most significant challenge to clinical teams across the world. Over 20% of all respondents from each region (North America, Asia Pacific (APAC), Europe and Rest of World (RoW)) reported that patient recruitment due to safety concerns was the biggest challenge they face, with nearly a third (32%) of all APAC participants saying so. 

A significant portion of respondents noted that the pandemic was forcing them to cancel or delay their studies. Nine percent of APAC participants, 16% of European participants, 21% of North American participants, and 22% of the participants from RoW reported as such. 

You can read the full article and see all survey results here

The Future of Decentralized Trials

By Sarah Hof

Decentralized trials are here to stay, and major pharma companies have already bought into their effectiveness, as reported by FierceBiotech. While the operational component of decentralized or remote trials once posed a logistical hindrance, the pandemic has forced rapid advancements in the means to ensure an increasingly smooth experience for both patients and investigators. 

A lesser-known boon to remote trials’ wider adoption was how during the spring of 2020 when the pandemic was nearing its height, the FDA issued an announcement urging sponsors to shift to remote operations wherever possible in trials in order to continue research. 

Paul Kirchgraber, M.D., who is the CEO of Covance was quoted saying that “We anticipate that by the end of 2021, the majority of our new studies will include a decentralized component.”

Read the full article here

A Look Inside Clinical Trials During COVID-19

By: Sarah Hof

It’s no longer surprising to hear that many aspects of the pharmaceutical industry have been disrupted due to the far-reaching effects of COVID-19. Clinical trials are no exception, due to the myriad of moving parts it takes to conduct a clinical trial effectively. Hospital maintenance, doctor availability, and the willingness of patients to participate are areas impacted and if one of these factors is unreliable for whatever reason, a trial can be usurped and critically delayed.

We wanted to get an inside look at how clinical trials are running nowadays, so we invited Dr. Niaz Ausaf, the Principal Investigator of Auzmer Research in Lakeland, Florida to share some of his observations and insights.

Regarding his staff, Dr. Ausaf reported that in the spring everyone had to work remotely, and for a period of two weeks back in March his office was not permitted to see patients in the office. Now, approximately 80% of Dr. Ausaf’s staff are back in the labs resuming work.

Of the current workload in his office, Dr. Ausaf stated that “the flow of clinical trials is at the same ferocity as before.” Also, he notes that patient compliance in terms of completing diaries and attending onsite visits is close to 100%, reflecting the pre-pandemic rate.

A definitive change Dr. Ausaf has seen is the newly necessary budgeting for PPE, or personal protective equipment. He reported that his office now plans for six times the cost of PPE before COVID-19, and nearly all sponsors have been readily accommodating.

Another difference reflects the reluctance of some patients to leave their homes for unnecessary purposes, especially to spend time inside of a medical clinic. To be more accommodating towards patients, Dr. Ausaf sees the potential in new collaborations between sponsors and local pharmacies, allowing study subjects to pick up investigational product in a more convenient manner.

Of these collaborations, they are a new commonality offered for patients in clinical trials. A global survey conducted earlier this year by Medidata found that 45% of clinics and hospitals had transitioned near fully from in-person visits to virtual visits (source). 

As Dr. Ausaf looks to the future of clinical trials, he sees plenty of opportunity for innovation that have been made obvious by the new necessities brought by COVID-19. For example, he believes that the “virtual trial” model is not something that will go away, but rather will take hold in the space. In fact, the same survey found that a third of respondents have amended study protocols to include some degree of telemedicine (source).  

To that end, he sees sponsors potentially partnering with the home healthcare industry to facilitate different aspects of conducting a virtual trial. Sponsors may send nurses to patients’ homes when necessary, and team up with online recording software such as e-diaries, and consumer-facing medical devices such as Bluetooth-enabled stethoscopes. These devices and other home monitoring technologies would enable a patient to monitor and report his or her own vital signs.

Dr. Ausaf has helped forge a viable plan for his clinic, Auzmer Research, should these predictions come to fruition. He noted that his clinic has already been presented with two virtual trial opportunities.

On a macro scale, he believes that hospital networks with the means to do so will start buying independent research sites, which will mitigate the risks of using unknown or unverified sites. Sponsors have seen the negative effects of scrambling for doctors and clinics in the wake of COVID-19, and the experience is not one that sponsors would be willing to repeat.

It is clear that while the world of clinical research is evolving at a rapid pace, we must adopt innovative digital tools and collaborative platforms to be best positioned to meet these challenges and drive the best possible outcomes for patients.

To further your learning about the application of innovative technology in study start-up, please visit www.lineasystem.com.

LINEA System teams up with Trial By Fire in fully-integrated partnership

 

PARSIPPANY, NJ and OAKLAND, CA - LINEA System, LLC and Trial By Fire Solutions, LLC have begun a partnership to offer their clinical trial solutions, AcceleTrial™ and SimpleTrials, respectively, as a fully integrated solution. This partnership will allow sponsors to take advantage of AcceleTrial™’s study start-up benefits to select and activate the right sites, and of SimpleTrial’s robust clinical trial management system (CTMS) capabilities.

LINEA System’s Study Start-up Management System (SSMS) provides access to a built-in global database of over one hundred thousand objectively-ranked investigators and sites as well as an intuitive and automated workflow to ensure study start-up progresses efficiently. SimpleTrials provides end-to-end study management functionality, including eTMF, electronic visit reports, and site payments, fully validated and available as the industry’s first on-demand subscription based CTMS offering.

“Having LINEA System as a partner enables our clients to more effectively identify and qualify sites based on specific criteria” said Nancy Cecchettini, Co-founder and Chief Product Officer of Trial by Fire Solutions. “For more than a decade, we have provided comprehensive CTMS functionality to manage study start-up through closeout and this partnership will enable our clients to quickly move through the site selection and document completion aspects of their studies with one end-to-end service.”

The synthesis of LINEA Systems’ and SimpleTrials’ technologies will result in a more seamless execution of clinical trials from beginning to end. When a trial is optimized and proceeds efficiently, vital medicines reach patients who need them most.

“The current climate demands that clinical teams approach trials in an advanced way, considering all the hurdles to speed availability of critical treatments to patients” said Kathleen Colatrella, Founder and President of LINEA System. “I’m excited to begin the partnership with SimpleTrials and share the value of an SSMS with more clinical teams, and ultimately, make an impact on how trials are conducted.”

Colatrella and Cecchettini are excited to launch their partnership at such a time when efficiency and accuracy of clinical trials are more crucial than ever.

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About LINEA System, LLC

LINEA System is a leader in helping accelerate clinical trials by leveraging data and automated technology in a completely new way. The company specializes in clinical site and investigator identification, feasibility, and site activation. LINEA System’s cloud-based Study Start-up Management System (SSMS), AcceleTrial™, enables sponsors to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and patient recruitment. For more information, visit http://www.lineasystem.com.

About Trial By Fire Solutions, LLC

Trial By Fire Solutions is a global leader in web-based clinical trial management solutions focused on innovative applications to improve planning, execution and tracking of clinical studies. With its SimpleTrials CTMS product, along with an experienced clinical technology team, Trial By Fire Solutions provides affordable eClinical solutions to teams of all sizes. For more information, visit http://www.simpletrials.com.

Press contact:

Sarah Hof
Marketing Associate, LINEA System
shof@lineasystem.com

Why is a Study Start-up Management System the vital tool sponsors need?

By: Sarah Hof

 

Countless industries are shifting to virtual and remote operations, and the realm of clinical trials is no exception. In fact, COVID-19 has only accelerated our industry’s dependence on technology to efficiently and successfully run trials. This shift has prompted the field to accept virtual or decentralized clinical trials as a trusted means to conduct research of such vital importance.

As teams become empowered to work from anywhere in the world, it is necessary for all stakeholders in a trial to have readily-available access to information on the clinical trial in real-time. The proper tools and technology to navigate a decentralized clinical trial ensures a successful outcome for the sponsor, and more importantly, an accelerated timeline for patients to gain access to life-changing medicines.

What is a Study Start-up Management System?

A Study Start-up Management System (SSMS) is an essential tool to efficiently accelerate clinical trial start-up. Throughout all steps in the start-up process including targeting the right sites, assessing site interest, conducting feasibility, collecting essential regulatory documents, obtaining approvals and contracts, and finally, enrolling patients, an SSMS ensures that a trial launches on-time and with the optimal sites.

There are three hallmark features of an SSMS:

  1. A built-in database of investigators. To deliver the optimal sites, every SSMS includes a built-in investigator database.
  2. An automated workflow. By design, the system’s automated workflow enables a sponsor to quickly move from task to task and ensure that the start-up is progressing with no hold-ups.
  3. A cloud-based structure. The cloud-based nature of the system provides readily available access to data, metrics, and reporting anytime and anywhere.

Differing from other trial management software, an SSMS assists in the launch of a trial, while others such as a CTMS, manage separate aspects of a trial after it has been launched and patients are being enrolled.

How can an SSMS help sponsors?

It is well-known that the most common source of delays to a trial is patient recruitment. This stems back to sponsors selecting initial sites that either prove unreliable once patients have been enrolled, or fail to enroll patients all together. In fact, according to the Tufts Center for the Study of Drug Development, 37 percent of sites selected under-enroll, and 11 percent fail to enroll a single patient. These routinely poor start-up metrics can lead to delayed trial timelines, and a 20 percent or higher increase in the originally projected trial budget.

When a sponsor selects the optimal sites first, patient recruitment is realized, the trial can proceed on-time, and the sponsor gains approval of vital medicines sooner. This efficient sequence of the events is possible using a Study Start-up Management System, with the built-in database of ranked investigators and an automated workflow to effectively launch the trial.

How does AcceleTrialdrive clinical trials forward?

AcceleTrial™ was created with the founding principle that nearly all clinical trials can avoid delays by selecting the right sites initially. Not only does AcceleTrial™ have a database of over 100,000 global expert investigators, those investigators are all ranked objectively. Its proprietary algorithm pulls hundreds of data points from multiple sources based on clinical expertise, access to patients, and former clinical trial experience, among other metrics. This powerful ranking system ensures that ultimately, the most effective and optimal investigators and sites are selected for the trial, thereby mitigating the chance of delay.

The “push and pull” workflow ensures a steady momentum, tracking each step and keeping the process seamless. To add transparency, both the sponsor and the investigators are able to access the platform and complete their respective tasks while monitoring the full scope of the process. AcceleTrial™ is designed to be intuitive and make a significant and immediate impact on a trial’s launch time and operational costs.

When a trial progresses smoothly, the greatest value is the potential to make available life-changing medicines for patients who need them most.

Learn more about AcceleTrial™ here

 

LINEA System: Advanced Technology for Accelerating Clinical Trial Launch

 

LINEA System is proud to have been recognized by MD Tech Review as a Top eClinical Trial Management Solution Provider for our work to accelerate clinical trials! To read the full story and see the spread, please visit their website, or click the PDF below.

 AcceleTrial™ identifies sites based on objective data validating therapeutic expertise, clinical trial experience, and access to patients that provides transparency for sponsors in choosing the right site. This model takes the guesswork out of clinical trial site identification and combined with an automated workflow, accelerates clinical trial start-up.”

-Kathleen Colatrella, Founder and President