Revolution of Blockchain in the future of healthcare

For the 21st century technology newbie's, Blockchain can simply be described on a unique concept. An '' append only '' open ledger where very transaction that occurs within the network is added to this ledger once authenticated by the nodes in the network.

Challenges faced in implementing blockchain technology in healthcare industries

Healthcare care industry faces many challenges in this modern technological era such as timely access to patient data, fragmented data, cost efficiency, data security, access and data inconsistency, and system interoperability. These can be overcome by block chain that supports seamless information sharing that eliminate errors and inconsistencies that arise with traditional centralized data storage. Wide variety of solutions and opportunities include digitizing data security for transactions, eliminating third-party applications removes time lag in data access.

Emergence of organized and structured independent system provide healthcare professionals a powerful impetus for expanding opportunities in global e-health solutions. Despite its promising forecast, there are some ambiguities around blockchain which is being questioned for it s regulatory issues.

Theoretically, applications of blockchain in the healthcare ecosystems are immense. Elimination of third party applications would increase the efficiency and reduce the cost together with end user applications such as claims processing and go-to market strategies. however as the blockchain technology is being adapted in the new generation, healthcare industry has to adapt to its new delivery and financial models.

According to the forecast by Grandview Research (2016), blockchain technology market is expected to reach 7.74 billion USD by 2024. With annual constant growth rate of 61.5%, it is estimated that blockchain technology (in healthcare domain) market is expected to grow to 2.3 billion USD by  2021 from 340 million USD in 2017.

Various factors influence the growth of the technology include

a. limited access to population health data

b. Consumer engagement such in the form of diseases and management and clinical outcomes

c. Inconsistent rules and permissions for accessing electronic health data of patients

While there are many factors which also inhibit the development are immature infrastructure where the technology is not in experimental phase and increased developmental costs. Also, scalability constraints in terms off trade-off between volume of transaction and influence of computers for processing time of transactions.

To summarize, the applications of blockchain technology in healthcare industry forecast promising solutions in Electronic heath record (EHR) distribution of data and nationwide interoperability. However, Large scale Trials must be experimented to make sure that a secured and established systems is implanted on high level in healthcare. 

Clinical Trials Subject Enrollment - Important Elements

Enrolling subjects for a clinical study has been a long time hurdles for the companies to test the efficiency of the drug. Not only that in today's environment, there has been a bombardment of numerous media vehicles which have a varied role in subject's (patients) senses, thoughts and emotions.

These obstacles for the enrollment of the trial subject can be achieved by Access, Desire and Respect.

Access:

Access is associated with how easy it is to acquire something, and patients’ attention tends to veer towards the most convenient engagement option. In clinical trial subject engagement, accessing patients is a crucial hurdle that study teams need to overcome in order to reach and recruit patients, hence, determining the most appropriate medium to implement engaging tools is key towards recruitment success.

Moreover, patients exhibit familiarity and associate trust with healthcare professionals and related environments, which attribute towards environmental familiarity and maximizing engagement.  Implementing engaging campaigns at physical locations, such as pharmacies, is one of many ways in which study teams could access and engage patients, however, it is important for study teams to understand patient behavior and geolocation in order to access patients and yield favorable enrollment results.

Desire:

Desire is associated with addressing a need that is felt as lacking. It is a subconscious effect that sometimes is the result of having a need that has been missing for a long time, such as pain relief, energy, and social acceptance.  Scientifically, when the brain is presented with stimuli that address these lacking needs, the brain reacts immediately and positively by releasing dopamine.

While it is important to attract a patient’s attention, it is important for study teams to not only educate patients about the process of clinical trials, but also neither to over-exaggerate the benefits of clinical trials nor make any promises or guarantees. 

For instance in a clinical study site,  where many campaigns with flyers that exhibited images of overly happy people enjoying their lives. Unfortunately, these campaigns were misleading the reality of patients who had high expectations of getting better by participating in a clinical trial, but, were disappointed and chose not to enroll during the consenting process when explained the risks and benefits of the clinical trial; It was observed that patients were disappointed and they felt that their trust was violated. 

Study teams need to practice caution by understanding their target audience and setting realistic expectations by developing appropriate subject recruitment content and training study staff on how to best present potential risks and benefits of clinical trials.

Respect:

Respect is associated with the achievement of shared goals, and the feeling is developed by recognizing and rewarding this achievement. Scientifically, this behavior stems from the psychology of reciprocity and mirroring, as people tend to follow those who set directives, which fosters motivation and belonging.

Subject recruitment does not stop at the patient; it particularly involves interactions at the study site, and if study sites are not involved, subject enrollment initiatives fail. It was observed that there was a significant relationship between medical chart review frequency and high enrollers. This was achieved by conducting surveys and analytical assesments.

Training programs, Regular communications and toolkits to engage study sites aided in better subject enrollments

Clinical trials are highly dynamic in nature, and each clinical trial requires specific expertise and customized campaigns to reach patients and engage study sites.  Simply implementing one solution towards all clinical trials will not result in maximizing engagement and result in subject enrollment campaign failure. 

Reference: 

www.appliedclinicaltrialsonline.com

Data Sharing in Drug development - Benefits

Access to full, appropriately de-identified datasets from clinical trials can benefit the biopharmaceutical industry by improving the efficiency of drug development, enhancing comparative-effectiveness analyses and reducing duplication of effort among trial sponsors.

1. Not sustainable

Industry is right to be concerned about the sustainability of the existing drug-development and business model. 

In Pharma Industry, the timelines and costs of clinical drug development are increasing relentlessly, and the attrition rate of assets in development remains high.

At the same time, growing cost pressures in all healthcare environments are forcing restrictions on drug use, aiming to limit coverage only to patients who can be expected to benefit from a given intervention and for whom that intervention is clearly cost-effective. 

2. Design and analysis

Access to the full datasets of completed clinical studies would, in the first place, lead to improvements in the design and analysis of subsequent trials.

To quote an example, available information about numerous variables can be used to identify and validate prognostic factors. Relevant validated prognostic factors can then be selected for use in the stratification of subsequent trials to reduce unwanted variability, minimise type I and type II error rates, and inform pre-specification of statistical modelling and subgroup analyses.

The identification and validation of factors that predict treatment response also enable active sampling or population enrichment in subsequent clinical trials, to avoid having a treatment appear ineffective because the trial has been conducted in a diluted population.

Enrichment can reduce sample sizes as it makes larger treatment effects easier to detect. 

The inclusion of patient-level data can also generate comprehensive, quality-controlled databases with potential to inform future research projects and questions.

3. Heterogeneity of effects

Moreover, lessons from past clinical trials about the heterogeneity of treatment effects will not only streamline drug development but may also enhance a drug’s value in the marketplace. 

Identifying a population with high unmet need in which a new treatment may be more cost-effective than other available options can help sponsors during reimbursement negotiations.

4. Comparative effectiveness

They also emphasise the growing importance of comparative-effectiveness insights to patients, prescribers and positioning of new medicines.

Data from individual patients on both outcomes and co-variates can alleviate some of the weaknesses of this approach, such as the need to make assumptions about heterogeneity and consistency of effect on the basis of the summary data that are currently in the public domain.

Wider access to patient-level data from clinical trials will allow sponsors to present more robust comparative-effectiveness information about their product soon after licensing and at a very limited cost compared with head-to-head trials.

5. Doomed from the outset

Finally, one of the “inherent inefficiencies” of data secrecy is the repetition of trials and projects that are doomed from the outset. 

Drug developers may continue to pursue a given target even though clinical trials conducted by others have demonstrated the effort’s futility. With patient health at risk and limited resources for research, the high opportunity cost of clinical-data firewalls is difficult to justify. 

6. Addressing concerns

Given the array of potential uses for patient-level data in facilitating research and development, it is surprising that few drug developers have been sharing data voluntarily.

Commonly voiced concerns, they note, include the risk of jeopardising patient privacy, of clinical trials being misinterpreted due to “inappropriate” analyses, and of commercially confidential information being disclosed to competitors.

Secondary analyses

While a “truly open” approach to clinical-trial data does carry a risk of inappropriate secondary data analysis and conclusions, this risk “exists for any type of secondary analysis, regardless of the nature of the data.

Clearly, though, legitimate interests in intellectual property and the protection of private investments “must be weighed against other legitimate interests, such as transparency regarding the outcomes of clinical trials and the protection of public health”.

Striking the right balance of these interests, they insist, “is a duty for all responsible stakeholders involved, not just for regulators.

Technology Impacts in Clinical Research

Much advancement in technologies such as Open standards, Cloud computing,  Mobile access and tablets (computing devices) have been utilized in the life science sector especially in Clinical Research Industries. However, despite the cost and compliance advantages offered by many of these advancements, clinical research firms are still slow in adopting them. Research conducted across various analysts shows this dynamics is about to change.

Technology Shift:

In the recent years, many CRO’s and pharmaceutical companies are now meeting compliance regulations with less complexity and cost when compared to the past. There is also a technology shift that the peer organizations are starting to take advantage of. A very good examples is that Sanofi Aventis, when the company first adopted an open platform, it estimated the changes being made would remove over $9 million per year in costs associated with time wasted in managing documents.

Open Standards:

Various surveys were conducted to determine the impact of these technology shifts on clinical research. One of the main impacts was on Microsoft’s SharePoint and the other on adoption of electronic trial master files (eTMF). This shows us a very clear and increasing shift to open software platforms. Looking back, this trend started in 1990’s when clinical research industries started managing documents electronically ( REF: 21 CFR Part 11). This is a stark difference from the newer solutions hitting the market which now reside on open, non-proprietary platforms.

In its SharePoint for Life Sciences Survey, NextDocs asked if firms were scaling back on proprietary systems in favor of more open-standard platforms like Microsoft’s SharePoint. In 2012 only 22% of respondents said yes. By 2013 that number had grown to 35%. The survey also asked what system most firms were replacing when they made the switch to SharePoint. Almost half of those surveyed were replacing EMC’s Documentum, followed by Oracle WebCenter, OpenText Livelink, CSC FirstDoc, Master Control, and IBM Content Manager.

EMC’s Documentum is a multipurpose document management solution not specifically built for the life sciences industry. In Earlier days, pharma companies had large IT budgets and IT staffs, and were growing fast. Today that growth rate has been cut in half, and many applications no longer meet the needs of customers looking for mobile access and cloud computing capabilities. Those same firms are now finding commercial, off-the-shelf collaboration platforms from trusted vendors like Microsoft which can run applications purpose-built to manage clinical trials.

SharePoint And eTMFs Reduce Cost

A second trend is platforms like SharePoint managing regulated content, a space that hasn’t traditionally used SharePoint. Most life science companies have SharePoint running somewhere in the organization. Historically, companies have been using SharePoint to manage their intranets and create project team sites. While these applications were important for collaboration, they were not regulated.

It is been observed that the use of SharePoint in clinical trial document management, FDA submission documents, clinical trial activities, change controls, and complaint management has tripled when compared to earlier. These are areas where firms are required to show they have an audited process, and SharePoint can be used to prove compliance.

The third trend is the use of electronic trial master files (eTMFs) to manage the large volume of clinical trial documents. Over half of the companies participating in the survey indicated they were using some type of eTMF for all or part of their studies, or were currently evaluating it. Only one-third of respondents had no plans to use it, or weren’t sure.

This below example is the best one to show how important is eTMF and its reduced cost. 

In 2007 Sanofi looked at the paper generated from one of their trials. One trial can easily generate over 25,000 documents. When you consider that a company like Sanofi will run anywhere from 150 to 200 clinical trials per year, moving to electronic master files will result in a tremendous amount of savings both in cost and in human labor required to manage all of that paper.

Advantages of eTMF:

• Increased productivity.
• Improved audit results.
• Reduced time to prepare study milestones and events.

Mobile Devices & Cloud Computing Simplify Access

The fourth and fifth trends involved the increased use of mobile devices and cloud computing in clinical trials. While eTMFs will substantially reduce the amount of paper in clinical organizations, the content of those documents still has to be reviewed by investigators around the world. More and more, those investigators want to access content using mobile devices like iPhones and tablets. This trend creates additional challenges for firms.

Access to eTMFs has to be regulated, both in terms of who can access them and how they do so. A clinical study might take place at 50 different sites, and each site will have several investigators. These investigators, typically physicians, don’t want to have to log into a content management system. They just want to quickly find the document they need, sign it, and submit it. They realize the easiest and quickest way for them to do this is via a mobile device. The use of tablets in clinical trials is not common right now, but the industry believes it will soon be taking off.

Finally, the increased use of cloud platforms for regulation and compliance. For years companies were not sure if the cloud could be used for compliance, or if the FDA would accept its use. Now it is believed that more clinical firms are finally getting past the fear stage and adopting the technology. One of the big drivers of that change is the need and desire of clinical firms to collaborate with individuals outside the company, including investigators, CROs, universities, and pharmaceutical and medical device companies.

What is holding companies back is not the cost of these new technologies, but the fear of going to something new. But we are to the point where companies can see the advantages of going to an open, collaborative platform. Up until now, dealing with technology issues has been like playing Whack-A-Mole. Each time you knock down one issue, another one pops up. CRO’s are aware of the limitations of their systems, which is allowing market analysts to help them understand how open solutions fit their specific needs, and help them to finally get past that inherent fear of change.

Indian Pharmaceutical Industry - Main Hurdles

Main hurdles in Indian Pharmaceutical Industry

During the recent years, there has been serious concerns among US businesses and lawmakers over IP in India where Clinical Trials, Infrastructure and Policies are the biggest hurdles in driving research and development in Indian Health care Sector. While both global and Indian industry leaders opine that India's intellectual property (IP) situation needs to be addressed and clarified, they have highlighted that in fact clinical trials, infrastructure and policy are the biggest obstacles for India to meet its potential of driving R&D innovation at scale. 

Recent reports from 'Crossing the Next Horizon: Will India play a Meaningful Role in Global Biopharma Innovation?'. lays out the myths and facts about the biopharma innovation in India. The findings would help senior management of biopharma companies fine tune their R&D strategy and help leverage India's pockets of R&D strengths.

According to excerpts of the report, many global R&D heads and CEOs emphasise the need for Indian companies to shift from 'deals' that offer only cost arbitrage to alliances that focus on innovation, quality and service. The report notes that emerging markets such as India can play a significant role in collaborations, providing not only more cost effective innovation, but access to new talent, technologies and assets to fill currently dry pipelines. 

The Indian healthcare sector has tripled in size in the last decade from USD 23 billion in 2002 to USD 70 billion today, but India continues to lag peer countries in spending, outcomes, health manpower and infrastructure, it said. Within healthcare, the Indian pharma market has also shown strong growth from USD 6 billion in 2005 to USD 18 billion today and is expected to grow to USD 45 billion by 2020.

Discussions with several global and Indian industry leaders indicate a widespread acknowledgement of India's potential for R&D innovation and while the fundamental drivers of the 'India advantage' exist, the opportunity has not played out as expected.

India holds a vast and largely under-tapped pool of drug innovation resources and capabilities. 

While the report recommends that the Indian government fix and clarify relevant policies and regulations around clinical trials and IP; focus cross-border and cross-entity collaboration on building talent and infrastructure across clinical trials, PI training and basic research. These strategic partnership not only enhance to overcome the hurdles of healthcare sector in India but also improve the quality of life.

Greater use of electronic medical records could help pharma companies cut recruitment times for trials and reduce development costs.

Main Outcomes:

1. Use of patient data collected by healthcare systems can identify potential clinical trial participants more quickly and with better precision than traditional procedures.

Example: Dr Eriksson (pictured), a former senior director at Merck & Co, noted that a recent study by Parexel managed to knock 12 months off the estimated 24 month recruitment time.

2. Such efficiency has the potential to cut down research costs tremendously, with the price of getting a drug to market now well over the oft-quoted $1bn figure.

3. The use of electronic medical records – the medical history of a patient kept in a digital format – to support clinical trials has been encouraged by other prominent figures in healthcare, especially in the UK, which, in the NHS, has a healthcare system that covers the entire country.

4. Establishing EMR will attract new clinical studies across UK. 

5. Also, how use of this data can help, saying that researchers had the ability to use electronic medical records to accurately isolate a specific cohort of patients with a certain condition, and then run this cohort against patient profiles – such as demographic, age, gender, etc – to have representativeness in clinical trials.

6. Being a crucial development, said Dr Eriksson, considering that between 50 and 65 per cent of potential clinical trial participants fail at the screening stage because they are found not to meet one of the study's crtieria.

7. Ease of Market Access.

8. This protocol can then be used to run a report to find out where relevant patients are being treated and what patients are being treated by physicians registered as investigators, while electronic medical records can then be used to demonstrate suitable patients to investigators.

Drawbacks: 

One of the greatest burdens in using electronic medical records is uptake and compatibility among healthcare systems, which varies between different countries.

Alternates: 

This is changing, however, according to Dr Eriksson, who said that countries are now following the route of South Korea and Turkey who became the first two countries in the world to have a healthcare system with 100 per cent electronic medical records that are connected to each other and managed by a central office.

The situation is also improving in the US, where uptake has increased since President Barack Obama introduced an order that all healthcare providers need an electronic medical record system by 2014.

By 2020, I imagine the whole world will be using electronic medical records. Healthcare systems are also becoming more proactive in developing partnerships in clinical development, according to Dr Eriksson, who heads up a department at Parexel that is focused on building alliances between the CRO, industry and healthcare providers.

It is important to have partnership with healthcare and investigator networks to improve the services in the medical industry. 

New CRF in Dublin, Ireland

A €7 million clinical research facility has opened at St James' Hospital in Dublin, Ireland, to carry out early- and late-phase clinical trials across a range of therapeutic categories. The unit is a joint initiative between St James' and Trinity College Dublin, with funding from the Wellcome Trust and Health Research Board of Ireland, and launches with 25 research projects underway or at the planning stage.

These include an EU-funded project to develop a vaccine against hepatitis C in HIV-positive patients, as well as new therapies for oesophageal cancer, diabetes and Alzheimer's disease. This new facility is good news for patients as it will allow the testing of new and innovative therapies, technologies and products and should increase the speed at which these innovations and discoveries enter health care services.

The unit houses a research pharmacy capable of safely compounding cancer drugs and handling novel gene therapies and vaccines, in-patient isolation rooms to nurse patients with infections or compromised immune systems, and a neuropsychology suite that will enable high-quality studies of brain activity and cognition.

The Wellcome Trust provided €7.3 million in funding to construct the CRF, while the HRB has earmarked €5 million to cover operating costs and €8.2 million to fund projects carried out under the banner of the Dublin Centre for Clinical Research (DCCR). The DCCR provides the facilities and trained staff needed to support collaborative clinical research studies across Dublin involving the Trinity College, University College Dublin and Royal College of Surgeons in Ireland (RCSI) medical schools and their associated teaching hospitals.

The facility, placed at the interface between university and hospital, is an early model for the newly announced hospital groupings and academic medical centers. The unit will provide "greater integration between the healthcare agenda and the teaching, training, research and innovation agenda.