Category: Industry News

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.   

Source: By Sumana Iyengar, CEO and Co-Founder of Goavega  

(Health Vision) -- In current challenging times of pandemic, technology has proved to be a vital lifesaver for several industries, including healthcare. With social distancing norms, a series of essential services have moved to the online platform to serve their consumers better, while avoiding physical contact. Healthcare has been one of the most crucial ones among these. While health technology has rapidly evolved over the past decade, it was limited to specific disease/ wellness plans or concentrated around patient treatment. The pandemic has allowed for the role of technology to go beyond the individual patient wellness and moved to the overall ‘digitisation’ of healthcare services – a vital step in the growth of B2B health tech. As per a report titled ‘Digital healthcare market in India 2019’, the sector was valued at INR 116.61Bn in 2018, and is estimated to reach INR 485.43 Bn by 2024, growing at a CAGR of~27.41% during the 2019-2024 period. However, areas around digitisation of data, large scale adoption by hospitals etc., continue to remain slow. In order to ensure a uniform and seamless healthcare technology, that can be a major enabler for the country, is in place, the following areas of technology adoption need to be explored:

 1. Clinical Registry: This is one area that needs immediate attention. Supported by positive government policies that work towards digitisation of health data across the country, tech providers can work towards creating customised solutions that can promote seamless exchange of credible healthcare data. The storage of integrated patient record can be useful incase of consultation with a different specialist, irrespective of the geographical boundaries. Further, it can allow data collection from multiple sources, put it in a common format and upload it into the system in an easily accessible manner. Data collection, management, and analytics can go a very long way in not just streamlining treatment but also in preventive healthcare, identifying disease patterns related to deficiencies or external pollutants or even help map and control the spread of an epidemic. On a hospital level, Clinical registry of patients can help easy paperless storage and quick access of data that can help reduce turn-around time for treatments and assist doctors to make quick and effective decisions.

2. Integrated Online Consultation: Online consultation has also proved to be of particular significance during these trying times of a contagious pandemic. However, an increasing number of patient-doctor engagement has been happening on generalised platforms like zoom, skype, google meet or whatsapp video calls, and while it is functional, there is a lot of potential for exploring integrated online consultation technology solutions. According to https://www.itransition.com/, the global market share of tele-health is expected to dramatically increase from $38.3 billion in 2018 to over $130.5 billion by 2025. Hospitals can rely on integrated online consultations for end to end patient engagement, including third party coordination and management. From scheduling appointments, receiving prescriptions, and accessing online history of patients to having access to external investigation reports, scheduling blood tests and having reports directly sent to the doctor, the solution can help hasten the procedure, create transparency and credibility while enhancing patient comfort as they do not need to physically visit the doctor with files of medical data.

 3. Mobile Health/ SaaS: Personalised wellness apps on smart phones have been gaining popularity during the lockdown, with people relying on them for daily exercise, yoga, diet and even sleep and water reminders. However, specialised healthcare apps that offer individual consultation and monitoring of patients, can be significant in case of elderly care, and in the wellness of patients with pre-disposed or serious medical conditions. Digital channels of healthcare allow facilities and patients to maintain contact remotely, and encourage daily/ fortnightly monitoring, easy payments, and check-up reminders etc., which can be programmed on a personalised level. Technology of IoMT (Internet of Medical things) can also provide patient care, especially in case of implanted devices like pacemakers etc.

 4. Hospital management – Digitisation of hospital management can go a long way in creating cost-effective, seamless, and efficient operations. Automation that can help across segments, from staff schedules and management, OT schedules, specialist visits, third party coordination, including vendors and partners like laboratories, insurance companies etc., to even monitoring and surveillance of hospital premises. Through integrated CCTV cameras, social distancing and mask protocols can be monitored, Critical care rooms and patient movement can be supervised while facial recognition and biometric attendance for staff can be linked with payroll management and account systems.

 5. Tech solutions for Pharma: While a lot of innovation in treatment and medical welfare is carried out by pharma companies, adopting technology for operations, data management, and analytics and also for identifying counterfeit batches, has a huge potential. Counterfeit medicines are not only dangerous for patient health but also pose an expensive problem for the pharma sector. Leveraging block-chain, pharma manufacturers can identify and report these fraudulent products and help arrest their spread. Apart from this, recording and storing data around clinical trials, monitoring the progress of new innovations and even collaborating with international scientists, patenting technology and monitoring correct use of drugs, etc., technology adoption can help boost the efficacy and transparency in the pharma sector.

While the above offer a broader perspective to digital adoption, customisation based on socio-economic, demographic and critical care conditions is the way forward for B2B healthcare tech adoption. Further, by collaborating with the numerous Tech and SaaS service providers across the country, hospitals and other medical institutes can easily avail cost effective, customised, and efficient digital infrastructure to suit their specific requirements. While we continue to march ahead with its ‘Digital india’, ‘Cashless economy’ and centralised registry of citizens, healthcare technology on a national scale will be the determining factor to ensure a healthier and robust population.