Comprehensive Policies & Role of Technology in managing the Clinical Trials

R. Chandra Sekhar Deputy Drugs Controller (India) CDSCO Archana Ramanakumar Vice President & Global Delivery Head Cognizant Life Sciences Ms.Uma Janapareddy Managing Director Achiral Systems Dr.Sanjeev Hegde Head Clinical Operations Mylan Ms.Ravinder Kaur Regional Research Manager Wipro GE Healthcare Dr.Chetan Desai Chief Medical Officer and Head of Medical Ethics IQVIA (Quintiles) Dr.Narendra Maharaj VP & Head Clinical Development Dr.Reddy’s Laboratories Raghuram Janapareddy (Moderator) Director – Lifesciences & Healthcare NASSCOM iot in india

Context

Clinical Trials is a very significant step in reaching the new inventions in medicines, medical devices, nutraceuticals and cosmeceuticals to the public. With global clinical trials market growing at an approximate 6% CAGR, Indian Clinical Trials market tend to gain substantially. Subject safety being the primary objective, policies and guidelines are becoming more and more stringent and comprehensive from the Regulatory. Rapid changes in technology and improvised systems/devices are playing a key role in enhancing the conduct of the clinical trials.

This Round Table session was organized as part of the BioAsia19 Conference held at Hyderabad, to explore the challenges and opportunities in conducting the clinical trials in India (both for local and global market) and how technology adoption is viewed and supported by the regulatory.

Regulatory View Point

1. Safety of the Patients is the primary focus of the Regulatory Body. The Informed Consent Process needs stringent adherence, especially in the context of the after effects in case of a serious adverse event resulting out of participation in the Trials.
2. After taking the Ethical Committee approvals, it is possible to inform the public about possibility of participating in any given Trial, where the Informed Consent Process is strictly adhered to.
3. There is always a challenge for the Regulatory to maintain a balanced view about the regulatory environment. The expectations from the Public and the Industry vary from time to time and mostly diverse in nature. While the Public and the NGO Groups expect stringent measures and well-defined trial guidelines, Industry seeks certain allowances in the study population requirements and compensation guidelines in-case of adverse events. It is tight rope walk for the Regulatory to keep all the parties happy.
4. Regulatory works relentlessly with multiple agencies such as Indian Society for Clinical Research (ISCR), Indian Council for Medical Research (ICMR), Industry Bodies, Industry Representatives to monitorthe clinical trials environment and provide guidance at a regular interval. With wide variety of trials becoming relevant for the Indian market, it is not easy to release the guidance, without going through adequate due diligence measures.

Knowledge about Clinical Trials Domain

1. Investigator (Doctor) at the Sites are the key personnel who actually execute the trials as per the defined study objectives and the approved protocol. However, many of them have little or no appreciation about the processes to be adopted. Many of the Doctors do not have the Drug Development Life Cycle Process (more specifically the clinical trials process) as part of their curriculum. Even those who completed their Post-Graduation, hardly focus on this topic. Therefore, very few trained or experienced Investigators are available in the market, who can execute the trials.
2. In advanced countries, many doctors focus on research as an integral part of their career, by engaging the research scholars and students. They initiate the research projects on their own, without the need for a Sponsor initiated clinical trials. These research projects immensely help the Pharma Industry and Med-Tech Industry. This culture should be encouraged in India as well.
3. There are no incentives for the Indian Fraternity for undertaking such research projects. The Healthcare Institutions are hard pressed for meeting the demand from the patient-care and it hardly leave any time for their Doctors to focus on research initiatives. However, the research initiatives with large amounts of data accumulated by these institutions, can help improvise their healthcare delivery. The Round Table is of the opinion that there should be a mandate from Medical Council of India, asking the Doctors to allocate certain time for research initiatives.

The Computer (IT) skills are not adequate enough at the Sites, to help use electronic tools for conducting the clinical trials. Even though the initial trainings are conducted by the CROs during the site initiation process, there is a major churn of resources at the sites, putting pressure on the data capture during the trial conduct phase.  Another perspective from the Round Table participants is that the multiple systems from multiple CROs for multiple studies are used at any given site. Even if the Site resources are stable, use of multiple systems throws open the challenge of these resources using the systems effectively, especially when multiple studies are going on at the given site.

Registries for Subject Recruitment

1. Many key trials are afflicted by the non-availability of suitable subjects’ population (patients and healthy volunteers). With out having the right no of subjects, it is difficult to achieve the Study objectives. With minimum subject population mandates from the regulatory bodies, the trials take longer time to complete.
2. The Round Table felt the need for having a national level registry on the Patients who participated in the trails as well as potential candidates that could be contacted to participate in the trials. However, there should be systematic and secure approach to collect this information from various medical research institutions and Hospitals. Hospitals have neither have the incentive nor the authority to share the patients’ profiles for the Pharma Companies. Even if there is a consortium of Hospitals interested in conducting the Clinical Trials, their EHR systems are not uniform and data collection is a challenge. However, an attempt should be made by the industry, to help the growth of Clinical Trials in India.
3. CDSCO suggested that institutions like NASSCOM should spearhead the standardization of EHR systems across the country making use of government agencies such as NeHA and C-DAC and also some of the private institutions working in this space.

Registries for Subject Safety

1. Subject Safety is of paramount interest for the Regulatory Bodies. Cross study participation validation is a mechanism to prevent, uncalled for participation of certain individuals in multiple studies across the country.
2. CDSCO is formulating a plan to build a nation-wide Registry for Patients Participating in the end-point studies and also healthy volunteers in BA/BE Studies. The modalities for technical architecture for a suitable solution and associated commercial implications for the CROs/Sponsors are being finalized.
3. The proposed system should also capture the AE/SAEs linked to the Subjects participating in these studies.

Role of Technology in Clinical Trials

1. Technological advances in IoT india and AI are changing the way the Clinical Trials are conducted. While the basic data collection through eCRF remains the main objective during the study conduct, technology can play a significant role in the data collection methods, ease of data collection and quality of data.
2. Use of ePRO in is envisaged for some time, but the adoption levels are very low as it opens up the data access to wider no. of participants, whose data is getting into the study database. The system integration challenges must be considered while implementing the ePRO. Predominant uses cases for ePRO are Prescription Compliance, Adverse Event Reporting and Self-Monitoring Notes.
3. Technology can also play a role in monitoring the Patients who are lost-to-follow-up. It is not clear, why a subject is lost to follow-up: is it due to subjects’ disinterest to participate further in the study or due to adverse events resulting into withdrawal or death. Using Technology solutions, the Sponsors/CROs can do an analysis of all such cases and arrive at steps to prevent frequent drop-outs. This saves a lot of time and money for the Sponsor.
4. Using Artificial Intelligence and Machine Learning algorithms, clinical trial management systems should be able to predict the success of the trial early-on into the study, using the data already collected. It is better to ‘Fail-Fast’ than ‘Fail-Later’.
5. Electronics submissions of trial/study data for approval by Indian regulatory is slowly gaining momentum. CDSCO is focussing on training its staff in evaluating the submissions electronically, but still a long way to go. Industry expressed the challenge of maintaining huge volumes of paper-based source data and printed paper submission for approvals. Regulatory feels that the review of electronic submissions is feasible, if standardized software is available.
6. Technology can also play a role in real time data entry, in lieu of off-line data entry. Many a times, it is difficult for the Regulatory to check the data submitted to them vis-à-vis the source data, through the audit trails. The audit trails data has no meaning and relevance in case of off-line data entry into the systems. Especially in case of an adverse events, examining the sequence of events based on paper-based source data is difficult.

NASSCOM CoE fostering Innovation and Thought Leadership on Technology for better home healthcare

Owing to lower doctor-to-patient ratios, poor healthcare infrastructure, spiralling costs and long-distance travel for patients, especially in the context of rural India, availing timely healthcare is a challenge today. But fret not. Having a hospital at your doorstep is now a reality, thanks to technology.

The home healthcare market is still in its nascent stages in India but can grow to more than $6.2bn by 2021 . Currently, the industry is serviced by a multitude of healthcare start-ups, healthcare aggregators, diagnostic centres, radiology centres and even some of the major hospitals. Advancements in information technology and medical electronics are bringing high quality healthcare at the door step and at affordable price.

According to CB Insights , the new healthcare clinic will be in the comfort of your home largely propagated by healthcare start-ups offering innovative state-of-the-art care kits. The report states that companies are launching kits for everything ranging from sequencing the microbiome and DNA testing for healthcare risks on one end of the spectrum, to low cost standard diagnostics on the other end.

Deep-Tech Start-ups at NASSCOM Centre of Excellence are providing innovative healthcare solutions

NASSCOM COE, in its true sense of fostering innovation and being a trendsetter, has been working with some innovative start-ups that are directly addressing critical healthcare issues. These start-ups are working on some of the common challenges in the society such as; Diabetes, Blood Pressure, Cardio Vascular Diseases, Chronic Obstructive Pulmonary Diseases, Maternal Mortality, Infant Mortality, Cataract, Glaucoma, geriatric care etc. where the services are offered through clinically certified and highly mobile diagnostic devices. Besides diagnostics, these start-ups are also providing Personal Health-Records (PHR) to the individual customers on their mobile devices.  Layered with AI assisted insights, the subjects (individuals) are driven towards preventive health and wellness. The innovations are also helping the doctors and hospitals in monitoring their patients from their own homes.

“Home Healthcare is still in its nascent stages but soon it is going to grow exponentially, mainly due to increased awareness campaigns and mobile penetration across the country. Players such as Nightingale and Portea are ahead of the others but haven’t yet dug deep. Rise in aging population is another reason the market is going to see the growth towards north. Interestingly, this market is going to have a ripple effect on micro-entrepreneurship and job creation. Evangelization of the need for wellness by the Government, is also catalysing the growth in this market. Health Insurance companies are also observing this market and may soon come out with new collaboration models to minimize their risk. But the Home Healthcare market needs regulatory guidance and standard delivery models.”

Raghuram Janapareddy

Director – Lifesciences & Healthcare

NASSCOM CoE-IoT

LHIF – Lifesciences & Healthcare Innovation Forum is a flagship program of NASSCOM iot india, providing a collaborative platform for catalysing the transformation of healthcare in India.

The Evolution of Bluetooth: From Entertainment To Smart Buildings

For most of us urbane mobile users, Bluetooth is a reminder of the “good old days” of the Internet through which we would exchange MP3 files and pictures. Today, it is commonly used in fitness bands, cars and even headsets. But the utility of this piece of technology goes much further.

Experts are reckoning the application of Bluetooth in smart buildings.Although the adoption is not largescale just yet, it is on the rise.

At the recently held IoT in India Expo in New Delhi, there was a session held on the rising significance of Bluetooth mesh as a basis for connectivity in smart buildings. This is a networking structure that uses low-energy networking technology to interact and exchange information. A mesh network is where every single node is connected, allowing the effortless relay of data. While its largely used in industrial automation, it is becoming a reliable alternative for smart buildings as well.

More specifically, the current successes are being seen using lighting as the foundation for Bluetooth connectivity.

Let’s see how this works with LED lights, which are a common feature in homes and offices today. LED lights are an energy efficient alternative, but with the proliferation of IoT, lights are now embedded with IoT sensors as well. Buildings today are coming equipped with Ethernet cabling, which makes it way easier to connect sensor-embedded LED lights. With an interconnected lighting system using SIG-qualified Bluetooth mesh, these LED lights can be easily lit up without having to reorient a building’s wiring. Since mesh networking involves several nodes, each one acts like a gateway for the original net connection, constantly communicating with one another and amplifying the signal. Unlike range extenders that will likely slow down Internet speeds, mesh networks amplify speed and ensure the entire building is powering on at optimal speeds at all times.

The benefits of this efficient system of mesh networking are many. Bluetooth mesh networks can provide a wide range of coverage, interoperability, device monitoring &control, low energy consumption and most importantly, compatibility with mobiles, tablets, PCs and laptops.

For instance, the Van Gogh Museum in Amsterdam recently replaced their halogen lighting systems with Bluetooth-enabled LED modules. Now, the museum’s lighting is controlled by Bluetooth switches. In addition, the museum also added Xicato sensors which use Bluetooth technology to broadcast data including occupancy, lux levels, temperature and humidity levels – parameters whose management is critical to retain the quality of the priceless works of art.

US-based retailer Target, during the revamp of its stores, is installing Bluetooth beacons in its new LED light fixtures to enable location and navigation. Once completed, this will be one of the largest deployments for a lighting-based indoor positioning system.

Scalability of Bluetooth Mesh

At the IoT Tech Expo in Amsterdam, Bluetooth SIG Technical Program Manager Martin Woolley spoke about the introduction of Bluetooth Mesh in 2017 and how it is a wise choice for smart building deployments. As of 2018, there were 10 million Bluetooth devices being shipped everyday and 34,000 companies support the use of the technology. A Bluetooth Mesh can support up to 32,767 nodes per network, sending hundreds of multicast messages per second. This range of scale can be achieved through multiple techniques including multi-hop messaging – where messages can “hop” across the network to the furthermost edges. According to Woolley, these devices can communicate with one another even when out of radio range.

Security Concerns

With the exponential proliferation of iot banglore comes the concerns regarding security. Reports of malware attacks and cybersecurity lapses in businesses make headlines every day. The industry is cognizant of these concerns, and Bluetooth Mesh offers a reliable solution. Bluetooth products essentially must support same security features, and a single compromised device cannot debilitate an entire network. Moreover, only members of the same network can communicate, mitigating the chances of a rogue device to connect.

So far, the lighting industry has seen the success of applying Bluetooth Mesh to lights. According to ABI Research, annual commercial smart lighting equipment shipments are expected to increase fivefold by 2022. 40% of all connected end points will be smart lighting based by 2021. Already, industries like retail, healthcare and travel are testing this technology in pockets, and furthering the use of Bluetooth Mesh for smart buildings.

With security, safety, connectivity and reliability being paramount to the success of a technology like Bluetooth Mesh, industry experts are optimistic that it will play a transformative role in the smart buildings industry in the near future.

Driving Digital Awakening Across Enterprises Today

Digital technologies are rapidly reshaping every industry today, and a digital transformation plan is imperative for a company to retain and possibly enhance market share, customer base and shareholders’ interest. The global spend on digital transformation initiatives reached $1.3 trillion in 2017, with the amount expected to near double by 2021.

A digital transformation plan involves multiple parameters, and involves several complexities. An assiduously charted digital transformation plan is prone to undergo several changes due to the dynamic nature of technologies shaping the industry. Some core aspects of technology components leading change in the industry include advanced analytics, IOT india, mobile technologies, AI & Robotics, RPA & chatbots,cloud computing,AR & VR, etc

The coupling of granular, real-time data collected through smartphones, connected devices, smart appliances, wearables, mobile commerce, video surveillance, with digital technologies such as cloud native apps, big data architectures, hyper-converged technologies, artificial intelligence, blockchain help to enhance product design & performance, customer experience and faster business decisions through, essentially driving the wave of digital transformation.

Data, Mobile & Other Technologies Spearheading Digital Transformation

Data analytics is one of the foremost aspects of digital transformation today. A company’s most critical asset is data — which is now being understood with alacrity now that scientists have understood how to analyse data, extract insights from it and drive a company’s growth in new, undiscovered territories. Gartner says that every major company is wielding data and analytics as competitive weapons, and by 2022, 90% of corporate strategies will explicitly mention information as a critical enterprise asset and analytics as an essential competency. This is because data provides a lot of action points on behaviours and trends of customers, allowing for businesses to process, predict and plan future strategies with precision and accuracy.

The mobile phone was perhaps one of the most versatile inventions of our time, and has served as a canvas for almost every major transformative technology known to man today. Be it apps, chatbots or technologies enabling connectivity — it all happens on a mobile phone. Being the cornerstone of digital transformation, companies understand the power of a handheld devices in accelerating their growth. Some of the biggest companies today in every major industry are capitalising on the mobile phones and telecom networks. The rapid and continuous communication between a company and its customers is facilitated through the mobile, which is also playing a major role in capturing data.

The cloud is another transformation technology offering that has changed the way data is stored, and now plays a pivotal role in driving digital transformation. Information and customer data on the cloud is being harnessed by companies to drive and shape strategies. Cloud offerings like Software as a Service, Infrastructure as a Service and Platform as a Service has led the way for business models built on and driven by the cloud.

Other technologies like AI, robotics & robotics process automation (RPA), and chatbots are now being explored extensively for applicability across domains. AI-driven technologies are playing a major role in the way companies, with a focus on information capture and process automation. This has fueled the way for Robotic Process Automation — the catalyst for smarter business decisions today. RPA is redefining the way processes like risk, compliance, accounts & invoice processing, and customer onboarding, and experts believe this is the tip of the iceberg.

Challenges In Digital Transformation

Digital transformation programs need the support from the top management and participation from all the functions within the organisation and other stake holders in the ecosystem like customers, and suppliers among others. This is more of a change management process and transformation in the business processes and model. It is a long journey, probably a decade for large organisations. But it is important now to persevere, reassess strategies and embrace digital intervention methods, if companies hope to be change-makers of the future.

Excerpts of speech by Nagarajan Rao, Director, CoE IoT DSAI, Chennai at the BITS Pilani (Goa) 3rd PGP-IoT cohort