Patient Centricity, Engagement and Recruitment through Amazon for Clinical Trials

Dropout is a huge obstacle for a clinical research trial. Factors such as financial, social, altruistic or philanthropic could have a greater influence on a patient’s decision to participate in clinical trials.

A large number of patients are relying on socially available platforms such as technology, social media, and even self-education to entrust medicines which are seen as the crucial part of the industry.

Digital Patient Spot

Digital patient spot in patient centricity has the potential to increase the quality of discussions between physicians and patients to a significant level. Benefits incorporating the engagement of digital patients have been realized to a larger extent.

Boosting Patient Centricity

Competitions or contests will be run on a regular basis by pharmaceuticals to get the inflow of ideas and feedbacks on informed consent forms (ICFs), protocols and trial designs. Based on the responses received out of open discussions on draft protocols that are specifically focused on endpoints, visited structures are encouraged and updates are made accordingly.

Patient bond is the ultimate key to seeking patient inputs in informed consent forms. Those references could be used to build effective ICFs. Even though some kind of designed approach is used to build ICFs, a science-based approach will facilitate uncover patient insights since the former is behavioral.

Therefore as we have seen the aim of healthcare and its wide established access for the betterment of patient centricity the clinical research centers should have adapted to the growing needs and advancement. In the future, improved healthcare system and profits can be expected if the pharmaceutical industries and patients work symbiotically.

Patient Network

Probably the biggest benefit Amazon could offer to pharma is the ability to quickly identify many qualified patients for clinical trials. A related press release from Evidation Health, a Silicon Valley digital health startup, caught my attention — it reported that Evidation and its collaborator the American Sleep Apnea Association (ASAA) had enrolled a staggering 1,000 participants in the first 24 hours for the Sleep Health Web Study.  (Source:Evidation Health and ASSA Study)

Amazon is excellent at profiling its Prime members’ preferences. Assuming Prime members also participate in Amazon’s patient network (i.e., EHR) program, patient recruitment can be completed in days or weeks, instead of months or years. Recruitment would no longer be the bane of clinical trial timelines. (Source:Amazon’s Surprise)

Quite often the techniques followed may lead to a large number of costly and complex trials without addressing the patient’s convenience or needs. By 2018, it is estimated that the medical spending on medicines would increase by 30% ($1.3 trillion). Enhancing and adding new required features will make the technology more patient-friendly. This technology has huge potential if used effectively and would be an upcoming trend which will increase in the coming years.

Smit Shah

 

 

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Struggle for actual data vs Melodrama Data

We all know what is the value of data, we all fights for our whole life for actual data based on that we make our most important decision. But what if someone tell any vague data and spread wrong message all over the nation.

Do you really think 11,500 Children dead and 45,000 Children paralyzed forever due to clinical trials? Can you believe this numbers?

What if someone tells this numbers on big platform like Movie, what impressions people will have about clinical trials? We requires Clinical Trials for medical advancement, don’t we need?

We are not against for upcoming Movie (Umeed) we requires authenticate data if someone is proposing “Based on True Events”. We truly believe presented data (11,500 children dead and 45,000 children paralyzed forever) are not correct.  Its good if someone spread awareness on unethical drug trials but it should not be fictional just for the sake of making any melodrama movie.

I have filed Petition via Change.org to censor board, please sign this petition and spread among your networks.

https://www.change.org/p/central-board-of-film-certification-umeed-upcoming-movie-11-500-children-dead-48-000-paralyzed-forever-due-to-clinical-trial?recruiter=68451990&utm_source=share_petition&utm_medium=copylink&utm_campaign=share_petition&utm_term=share_for_starters_page

Please let me know your thoughts on how we can prevent this to mislead to our people.

Regards,

Smit

Virtual Clinical Trials: 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?AAEAAQAAAAAAAA2IAAAAJDgxYzI4MmQ4LTNkZjktNDJlOS05MzE5LTczMTFkMWFjYzRmZg.png

Lean and Six Sigma techniques 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 value. Lean assessment include “Value stream mapping” which is root for identifying opportunities to reduce waste & more highly integrate process, steps. Thus improving process efficiency. Lean focus on identifying ways to streamline process and reduce waste.

Six Sigma more live business management strategy used to improve the quality and efficiency of operational Process. Six Sigma focus on to make process more uniform and precise through application or statistical methods.

Examples of Lean strategies to the clinical research
•Research grant funding Protocol approval
•Biostatical consultation subject recruitment
•Availability of pilot data
•Informed consent form
•Minimize protocol amendment – Placebo really needed
•Strict subject monitoring consider database recruitment.

Examples of six sigma strategies into clinical research
•Select best endpoints – have qualified research team
•Treatment scheduling- statistical analysis of defects
•Inadequate enrollment
•Reasons for Protocol deviations
•Address of conflict of interest

Analysis start with determining sponsor needs, systematically evaluate each process step in detail and then identifying sources of inefficiency and waste, while also assessing organizational structure, culture and management. Analysis can be determined by on site observation and acquisition of process data for example relating to patient load, nurse staffing needs and protocol requirement. After repeated improvement cycles and field testing incorporates into computer assisted scheduling system. Training and support procedures should be develop to assure staff understands how to use the new system and to address any concerns they might have with the revised process.

These combined approach assert that organizations can benefit from utilizing both the customer orientation and focus on eliminating waste inherent in lean along with statistical tools and systematic defect reduction strategies referred in six sigma.

Approaches are proven the tools are Powerful, DMAIC guided problem solving methodology has improved business process and work process across industry including life sciences where it is now being applied in every stage of drug development and commercialization. It provides rigorous data driven techniques which reduce process variation, identity and eliminate root cause of problems and ensure improvement endure.

Modern piller of Clinical Trial Industry

                                  Modern Piller of Clinical Trial Industry
Compulsion of Jurisprudence:
Till now there was no act or law to monitor clinical research and drug trials in the country and “Jurisprudence” is the necessity to ensure that people who undergo clinical trials are not exploited and informed about the protocol. It was needed to enhance capacity building handle trial in more scientific and rational way. Awareness amongst patients is certainly increasing. 2012 to 2014 has been crucial for the clinical trial industry as an uncertain regulatory environment, however in recent months clinical trials has been found to be new momentum. Supreme Court laid down various principles of risk versus benefit to patients, need for innovation (existing therapeutic option), and the unmet medical needs in the country. These are the standards but to satisfying these standards there are lots of remains to be done. These standards give force to the clinical trial industry in India. The government is aware and has been making serious efforts to accomplish the same. New enactment of law will bring more professionalism. 

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Testimonial and Ethics:
Negative coverage in the media brought bad name to research, certainly there were the reasons to downturn the economic but the media attention over the last couple of years has also played a major role too and guinea pigs word is the vilify and invention of media. Food adulteration in India is common so the common men are called Guinea Pigs? 
Clinical research cannot stop in the country and then why not accreditation? On the other hand if you think of accreditation and ethics i.e. clinical trials in India to be put on firm foundation a structured accreditation process, accrediting investigators, trial sites and ethics committee, making ethics committee function effectively and concerning informed consent from trial subjects. Accreditation will become centerpiece of clinical trial industry. Accreditation does not only mean to registration but the developing such standard operating procedures, conflict of interest is the highlighted question for the ethics committee. And for that ethics committee members need to go under training and then it gears towards safe and effective trials where all ethical norms are followed.

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And now the accreditation is the key positive spin off to prevent the conflict of interest such as malpractice, unscrupulous decisions in clinical trials. A key offset of accreditation would be a strict adherence to finding independent persons to serve on ethics committee, and these could be achieved by randomized allocation of experts to particular ethics committee together with a supplementary check by accrediting body. Now we can imagine independence of the ethics committee and change the viewpoint of trial subjects too.

Welcome move:
CDSCO issued draft guidelines this year on audio visual recording of informed consent process in clinical trial. It is mandatory to take audio visual recording and safe storage for taking of informed consent from trial subjects.

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But the question stands for the privacy of patients who might not wish to be recorded however it is recommended such recording should be mandatory subject only to waiver by the trial patient or ethics committee. The industry is taking very as difficult task, and in present scenario where video recording are possible with smart phones and the second matter is confidentiality of the patients would be lost however it can only take as excuses, maximum numbers of patients don’t hide themselves while undergoing trials. Why the industry is not accepting the change and ready to compromise in Ethics very easily? 

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Stand-alone set of rules governing clinical trials promotes transparency. CDSCO proposed changes and brought together under consolidated umbrella of rules governing clinical trials. Nobody blames the US FDA because its decisions on science and Indian government tried to bring out based on science. And this is going to give you necessary certainty to undertake trials in India. And the later on benefits for India if you take for the development of new drugs, employment generation in clinical trial industry and would be safe environment for every citizen desirous of participating in clinical trials and that would be tremendous. With the growing number of diseases around the world, there is always need of well-structured policy which helps in saving life and will give impetus to grow medical and Para medical industry.