Virtual Clinical Trial: A complete Remote Concept

Virtual Industry revenues will reach to $7.2 billion globally by the end of 2017 as in Greenlight Insight’s latest report. Anticipating modest growth in the short term, expects the Virtual industry to grow into a major global marketplace by 2021, reaching $74.8 billion in global revenues. Virtual industry remarkably uses cases including Tourism, Education, Sales and Marketing, designing and sports coaching.
How about on Clinical Trial Industry?
Clinical Trial industry is facing crisis, nearly 80% of trials do not meet enrollment timelines, and these delays can amount to $8 million in lost revenues per day, according to one estimate by Cutting edge information. But now the industry is preparing to bet on new trend: Virtual Clinical Trials. Virtual Clinical Trials represent a relatively new method of collecting safety and efficacy data from clinical trial participants. Imaging few scenario on this.

Patients do not travel to sites.
Devices (it can be mobile, watch, glass) link to the clinical research study and reporting general information including Adverse Events.
Device’s sensors record data like body temperature, blood glucose levels and which are sent automatically to EDC record.
Study personnel visits at patient’s home for drug administration and follow up.
Whenever visits are approaching, mobile device provide automated reminders and allowing them to reschedule according to protocol.
And this is just beginning of what the future is likely to hold for virtual clinical trials.
Evolve in Virtual Clinical Trial (VCT):
1. Pfizer evolved the VCT model with its Research on Electronic Monitoring of Overactive bladder Treatment Experience (REMOTE) trial in 2011. It was the first randomized clinical trial using web and smartphone based recruitment, enrollment and collection of study data without requiring patients to visit a site.
Experiences: It was halted in 2012 because of poor recruitment. Patient recruitment (most members of the target patient group were older), so the use of technology based trial was an unknown.
2. Sanofi announced its intention to support a virtual diabetes trail (VERKKO) to be conducted remotely in Europe in 2015. Instead of testing drug, Pfizer’s trial did, Sanofi’s tested a wireless glucose meter in diabetes patients. Also it is the first clinical trial using an electronic ICF approved by European regulatory agencies.
Experiences: 97% retention rate and are completed at least 30% faster than a traditional trial.
Although totally remote research is still a relatively new concept and still has limitations. VCT can be inappropriate for phase I and other acute problems like strokes which are probably a bad idea to monitor at home. FDA is seeking on specific issues like how the FDA could encourage adoption of such tools, how new models of research will affect patients. FDA has established docket to gather feedback on how researchers are using technology and what are the barriers which are stopping.
Forthcoming of VCT:
- Patients who were previously excluded can now participate, for example patients living in rural areas would finally have a chance to enroll without travelling to a central center.
- Pfizer case study and FDA docket suggest multitude of challenges to come in the journey to make VCT a viable choice for study sponsors.
- Need to think differently on patient privacy and protection.
- Recruitment and retention of patients with low computer literacy is a major concern that can greatly impact the trial and data it generates. These are the scenario which seems convincing.
- Perhaps VCT can be used in rescue studies where traditional models have failed. Example: for geographically dispersed groups or rare disease populations.
- It will not be an easy road, but it is one likely to offer significant benefits for certain studies and select populations.
- Biggest roadblock to VCT adoption is the industry itself, which is highly regulated and slow to adopt new things.
- With supportive technologies and the right Virtual trial model, VCT is sure to become more popular in Pharma and medical device developers in near future.
If you make the trial easy, satisfying and rewarding for patients, they will want to take part. What is your opinion on VCT model?

Comments

CORONIL exposing drug development process/approval in India?

CORONIL exposing drug development process/approval in India? CORONIL has launched in India from Patanjali and no formal authority is aware on this on 23 Jun 2020. Paid media showing live coverage of launching of CORNIL and friends and family members celebrated. Main stream media does not know anything about clinical trials or drug development process as we know their main focus would be on religions, Indo-Pak thats it. Hence main stream media did not ask any relevant questions to Baba ji who sits in laboratory with raw materials and as usual media did not involve any relevant panelist. On 23 Jun 2020 evening, AYUSH ministry finally informed (after launching and completing of this coverage )that this scientific study are not known to ministry and asked Patanjali to stop this advertisements of Ayurvedic drugs and are regulated under the provision of Drugs and Magic Remedies Act 1954 and rules thereafter and the directives issued by the central government in the wake of COVID

A Landmark Revolution: The I-SPY 2 Trial's Transformative Impact on Breast Cancer Treatment

Background: A Visionary Scientist's Mission: In the early 2000s, breast cancer was a relentless adversary, affecting millions of women worldwide. Dr. Laura Esserman, a distinguished oncologist, emerged as a beacon of hope in the battle against this formidable disease. Driven by her unwavering commitment to improving outcomes for breast cancer patients, she embarked on a mission to transform breast cancer care. Dr. Esserman's unique background as both a clinician and researcher provided her with invaluable insights. She saw the urgent need to revolutionize the traditional clinical trial model, which often moved at a snail's pace. Her vision and dedication paved the way for a groundbreaking study that would leave an indelible mark on the clinical trial industry. The I-SPY 2 Trial: An Innovation in Design : The I-SPY 2 Trial was no ordinary clinical trial; it was a groundbreaking endeavor characterized by its innovative and adaptive design. Here's why it became a game-cha

SPRINT in Clinical Trials Industry

Nobody knows everything: Nobody knows everything, not even the CEO. Need to incorporate information from many sources. Instead, the information is distributed asymmetrically across the team and across the company. In this process, we have got to gather it and make sense of it and asking the experts is the best and fastest way to do that. With luck, we chose our work because of bold vision. We want to deliver that vision to the world whether it is a message or service or an experience software or even a story or an idea. But bringing a vision to life is difficult. It I s always easy to get in endless emails, deadline that slip, meeting that burn up day, a long term projects based on questionable assumptions. It does not have to be that way. If there is any idea, big challenge and not quite enough time and if we could not prove that idea was viable in that time, then it switches to different projects/ideas. We need encouragement in Clinical Trial industry on experiment not only in th

Transforming Risk Management and Stakeholder Engagement in Clinical Trials: A PM's Journey

ABC Pharmaceuticals, a pioneering biotech firm known for its cutting-edge research in therapeutic innovations. Amidst their quest for groundbreaking treatments, they encountered a pivotal juncture during a Phase IIb/III cardiovascular trial. Regulatory shifts, supply chain vulnerabilities, and safety concerns cast a shadow over their aspirations. This is the story of how the Clinical Project Manager, redefined risk management, embracing challenges as catalysts for innovation while transforming stakeholder conversations. ABC Pharmaceuticals, driven by innovation, harbored a risk-averse culture—prioritizing safety and efficacy without aggressively embracing uncertainties. CPM recognized the need for a paradigm shift. He envisioned risk not merely as a hurdle but as a potential driver of transformative change within the trial landscape. The Evolution of Risk Management: Identifying the Challenges: ABC Pharmaceuticals’ initial risk assessments identified potential disruptions: Evo

Unraveling the Challenges of Unstructured Site Management Organizations (SMOs) in India's Clinical Trial Sector with a Unified Approach

Clinical research in India has witnessed substantial growth in recent years, with Site Management Organizations (SMOs) playing a pivotal role in conducting trials efficiently. However, challenges arise when dealing with unorganized SMOs, which lack regulatory oversight and financial transparency. This case study explores the issues stemming from such SMOs and offers a comprehensive strategy to mitigate risks and ensure successful clinical trials in India. Understanding the Unorganized SMO Landscape : Insights into the Growth of Unorganized SMOs in India and the Reasons Behind Their Frequent Closure: The landscape of Site Management Organizations (SMOs) in India has witnessed exponential growth in recent years, with multiple SMOs often operating within a single research site. This proliferation can be attributed to several factors, primarily the absence of robust regulatory oversight and accountability mechanisms specific to SMOs in the clinical research ecosystem. Lack of Regulator

The Impact of Genetic Differentiation Across Regions: The Case of Drug Responses and Clinical Trials

Genetic differentiation across regions can significantly impact how populations respond to drugs. Variations in genetic makeup mean that a medication might be effective for one group but less so, or even harmful, for another. This variability underscores the importance of tailored clinical trials and has implications for the recent CDSCO notification on waiving clinical trials. Here, we’ll explore examples where genetic differences have influenced drug efficacy and safety, highlighting the importance of considering these differences in drug approval processes. Warfarin and Genetic Variability Case Study: Warfarin is a widely used anticoagulant prescribed to prevent blood clots. The drug's dosing is highly individualized, and genetic variations play a crucial role in how patients metabolize it. Variants in the CYP2C19 gene and the VKORC1 gene influence Warfarin’s effectiveness and risk of bleeding. Genetic Differentiation:In populations of European descent, certain genetic variants

Identification of Risk - Clinical Trials

Potential Risks is an essential part because Clinical Trials projects tend to be time constrained, post huge technical challenges and suffer from adequate resources. Not all the risks are equally important, should focus on risks that can materially affect project objectives or uncertainty that matters. There are numbers of factors can be internal, such as available resources, skills level of human resources, funding availability, management approach, time constraints etc. Risks also vary depending on the stakeholder: subjects, study team, sponsor, competent authorities, target population and that is why stakeholders education, awareness, engagement and support are critical success factors for project risk management. Organizational and stakeholder risk attitudes and risk tolerances must be explicitly identified and managed before and during the project. Clinical Trials process may be divided into three main steps, each of these steps can be associated with number of more or l

From Darkness to Light: The Stanford Prison Experiment and the Ethical Evolution of Modern Clinical Trials

Once upon a time, in the early 1970s, a young psychologist named Philip Zimbardo embarked on a groundbreaking experiment at Standford university that would forever change the way we look at human behavior and research ethics. It began with an ad in the classifieds. Male college students needed for psychological study of prison life. $15 per day for 1–2 weeks. More than 70 people volunteered to take part in the study, to be conducted in a fake prison housed inside Jordan Hall, on Stanford’s Main Quad. The leader of the study was 38-year-old psychology professor Philip Zimbardo. He and his fellow researchers selected 24 applicants and randomly assigned each to be a prisoner or a guard. Zimbardo encouraged the guards to think of themselves as actual guards in a real prison. He made clear that prisoners could not be physically harmed, but said the guards should try to create an atmosphere in which the prisoners felt “powerless.” The study began on Sunday, August 17, 1971. But no one knew

Six Sigma in Clinical Trials

Process improvement techniques increasingly have been applied outside manufacturing for examples software development and healthcare . I Concerns the potential use of lean and six sigma to improve the process involved in clinical research. Improving quality, avoiding delays and errors and speeding up the time to implementation of biomedical discoveries is primary objective. Reducing the time between biomedical research discoveries and their adoption into clinical practice requires increased co-ordination, systematic planning. Better co-ordination, timeliness, efficiency and value of clinical research can be achieved by applying the set of principles, practices and method represented by Lean and Six sigma. Lean thinking involves a set of principles, practices and methods or designing, improving and managing process. Lean process reflects the goal of continually reducing waste and improving work flow to efficiently produce a product or service that is received to be or high val

Eyes On Trials

Search This Blog