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

Big Challenges ahead/new Ideas to try- Need these five steps to Evaluate and Learn

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 the Investigational Products but in the methods used by individuals. I have observed several times that whenever we came up with new design, we failed to test our prototype, and not testing the design with users and end users.

Patient Enrollment Challenges for Clinical Trials Industry:

Clinical Trials provide access to the latest treatments. For some patients that means drugs which might save their lives. But trials are not just about new drugs- they are also about better data. The data from every trial is collected and organized, helping researchers learn about the efficacy of new and existing therapies. Only 4 percent of all cancer patients are in clinical trials. The other 96 percent of cancer treatment data is unavailable to doctors and researchers who might use it to better understand the disease and better treat future patients.

This kind of challenge – wanted to make trials available to anyone who was eligible, hoped to build software tool to help cancer clinics match patients to trials- a painstaking job to do manually, and perhaps the biggest hurdle to trial enrollment. Patients with common forms of cancer might qualify for trials reexamining the efficacy of standard treatment. Patients with rare forms of the disease might qualify for a new, highly targeted therapy. There were so many unique patients and so many trials that it was too much for any human to track.

This process an unconventional approach that focuses on the whole customer experience instead of individual components or technologies. Nobody is sure whether their solutions to the company/industry are good, at the end of the process we get the answers.

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Risk Based Monitoring/Centralized Monitoring Model for Clinical Research

It is an evolving paradigm and which require new skills and thinking part of stakeholders across the clinical research spectrum. While changes can be difficult, it is incumbent on the industry to embrace a methodology that promises to enhance patient safety and improve data integrity. We must assess and refine their research process to identify and develop optimal monitoring strategies. We must take interviews to research coordinators at the sites on what they feel and how they react to our prototype and learn. Need to assess very carefully observe the reactions, then we need to believe what we see. This test makes the entire sprint worthwhile: at the end of the day, we will know how far we have to go, and we will know just what to do next.

When you get into regular rhythm of listening to users, it can remind you why you are working so hard in the first place. After each process draws us closer to the people you are trying to help with product/service.

A winner every time:

And this is the best part about SPRINT that you cannot lose. If you test your prototype with customers, you will win the best prize of all- the chance to learn in just five steps/days, whether you are on right track with your ideas. Results do not follow a neat template, you can have efficient failures that are good news, flawed success that need more work, and many other outcomes. Let’s look at enrollment task and their results after this and what need to decide to do next.

Would cancer clinics change their workflow to use new tool? If they could convinced research coordinators to switch, they could enroll more patients in clinical trials. Coordinators did not love every part of the prototype, but their enthusiastic reaction to concept gave the confidence to continue designing and developing software.

More articles related to Clinical Trials

Please follow on LinkedIn Smit Shah

Twitter: @Smit_Shah21

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.

Risk Based Monitoring and it’s impact on Quality

RBM requires the ability for CRA to prioritize task and evaluate the performance of site which may involve auditing approach in monitoring.
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Auditors for identifying error and risk in clinical trials and they find the issues which missed by monitors. And that’s why auditors focus on identifying error with critical data and they are not pre occupied with less impactful activities like 100%SDV.

In five to 10 years, I believe that monitors will be trained to think and perform like auditors and relationship managers. Monitoring will still remain a necessary part of the industry, as important GCP concepts such as delegation of PI responsibilities and drug accountability cannot be performed remotely. However, monitors will be trained to evaluate the operations of a site, thus providing a far more reliable and valuable input into risk-based systems.

Training aspects are lacking with CRAs, and Impact on Clinical Trial Quality

Many years ago, in order to be a monitor, you had to go through several types of training. There was therapeutic training that provided baseline knowledge of the anatomy and physiology one should know in order to read medical charts. Training was provided on the investigational product so that the mechanism of action, anticipated side effects or other scientifically relevant information was shared.  This training also included a review of non-clinical and clinical data known to date.

Monitors were educated about the scientific measures used in a study, such as a rating scale, a clinical lab or a pathology outcome. Aside from the more therapeutically focused training, monitors were taught job skills such as how to review a medical chart so that the review not only ensured the data on the CRF was accurate but also required some logic checking. I do not sense that operations teams are conducting these types of trainings today.

To elaborate, I have seen trials where blood pressures of 180/110 were verified by the monitor, and the monitor didn’t ask the PI if that BP should be considered an adverse event. No clinical significance was recorded in the source. The monitor didn’t think to see if there was a history of hypertension in the medical history or to see if the blood pressure had been within normal limits initially but gradually increased. Could this be a drug effect? Today, monitors are being trained simply to verify that the data in the source matches the data in the CRF.

Additionally, monitors aren’t trained on time management. There has to be clear understanding that the six to eight hours on site cannot be spent strictly performing SDV. Monitors must be able to quickly evaluate if there have been changes in site personnel, ensure the associated training and regulatory documents have been updated, ensure the drug accountability is being performed, ensure patients were consented properly, assess how work is being delegated, ensure the source meets ALCOA standards and that adverse events are being evaluated and reported in a timely manner. Without this kind of training, the quality of monitoring diminishes significantly.

Consolidate RBM with Quality Management

I think the industry has to move in this direction; people in quality management see it but I think something is lost in translation when it comes to the functional areas such as clinical operations, data management, programming and pharmacovigilance. Timelines are becoming more and more aggressive.  Headcount and budgets are growing leaner, yet the regulatory standards are not being reduced. The system has to be more efficient.

The switch is going to require a proactive approach to understanding where the data is being collected and how to access it. Very little of the key primary and secondary endpoints are being collected at the site. With the development of electronic diaries to capture rating scales, patient reported drug compliance and other endpoints such as clinical labs and pathology, we can get at the data much sooner than an on-site monitoring visit. Through programming, we can pull out outliers and trends. However, nothing can replace a monitor going on-site, periodically, to ensure the overall performance of a site is acceptable with regards to GCP standards.

The industry needs to redefine the roles we have working on clinical trials. We need programmers who can pull this data out well before programming tables, listings and figure/graphs and we need medically qualified people reviewing data outliers and trends, weekly and monthly, not at database lock. We also need hybrid roles that are doing some cross logic checking and evaluating the data for any safety trends or errors in interpretation of the protocol, which could be detected through these types of efforts.

Before we can do any of that, though, we need to think about how we are capturing the data in order to fully leverage eClinical technologies. CRFs need to be designed to capture information, so that errors and outliers can be found. Through proper EDC programming and RBM, the sponsor can easily determine if the data support compliance. This approach allows study teams to detect and alert sites to issues early, such as a patient over- or under-dosing sooner than the site might realize or sooner than that eight to 12 week monitoring visit.

 If monitors were trained to work like auditors, the input would be more robust.  If we are having a failure on the front line, so to say, where the monitoring is failing to detect the risk, then the input into the Quality Management is not thorough or accurate and risk cannot be appropriately or adequately assessed. Without proper training and leveraging the technology, we will continue to struggle.

I don’t want believe that this was the spirit and intent encouraging from regulatory agencies for risk based approach. Risk based Monitoring has not succeed the way name was derived, it certainly reduced Monitoring Visits and that’s it.

Risk Based Monitoring- Opportunity or Obstacles

Risk Based Monitoring- Opportunity or Obstacles

“Analyst have been manually examined thousands of data points in clinical research but with the vast and ever increasing amount of data available, the human brain is unable to do it all.”

Data are coming from operational and laboratory which requires technology to bring these together into something meaningful and actionable. What are these technology which enables to work more efficiently on actual performance?

Applicable steps for Risk Based Monitoring

Let’s break the process into steps,

  • Determine risk at both protocol and site level
  • Define performance brink
  • Determine key risk indicators
  • Determine action and response plans
  • Define communication plans
  • Ensure continuous review and reassessment
  • Adjust the plan when necessary
  • Provide midterm performance indicators showing how site compare, enabling action or escalation of action as needed
  • Trend long term site performance, showing what to monitor, and how much to monitor, whether performed on site or remotely

Risk based monitoring has gained considerable scrutiny in recent years hesitation still remains around the approach. In some cases, risk based strategy could replace the need for such frequent site visits to quarterly or even once a year instead of industry standard of every four to six weeks. A risk based approach with good judgment and sound reasoning can greatly curtail the need for CRAs to be road warriors.

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What are the things that any mid-size CRO can appliance for RBM?

  1. Develop monitoring plan appropriate for the trial
  2. Conduct early dispute with team members to clearly define
  • How to assess risks
  • Outline statistical analysis
  • Identify what monitors review
  1. Develop robust risk management plan at the beginning of the study
  2. Potential risks and strategies to mitigate them should be reviewed regularly with sponsor/CRO partners throughout the life of trial to optimize efficiency decision making and in taking action when risks become reality.
  3. Establish solid communication pathways for issue discussion and escalation with key team members.
  4. Pull together different values and presptives from various team members and start with the end in mind.
  5. Be actively involved in identifying triggers, trending and modeling and programming for data as it is ongoing.
  6. Frequent ongoing communication with PM, DM CRAs and Biostatician.
  7. Focus less on source verification and more on source data review and analysis.
  8. Support clinical sites in developing their own internal quality management plans.

Obstacles for slower adoption

  • Commercial Interestrsz_changesahead
  • People concerns
  • Technology hurdles

 

 

Commercial Interest

Wait for others to move which is first common strategy, effort to reduce risk as you can learn from others mistakes. And most of the CROs are dependent on monitoring visits to generate their revenue, and scared that they will have to face long term losses until it’s established. Let me tell you in very simple language why anyone wants to change wheels while it is already moving?

People concerns

This is something related to industry people, as they are well experienced and have to face process change. Everyone has to be part of change, writing metrics too and most importantly “Expertise” tag. “Expertise” tag is going to change in “learning new model”.

Technology Hurdles

Powerful challenge among all, development of whole new system needs strong IT team which is lacking in every Indian CRO or hire third party developer to establish data integrated system. Clinical trial data are to be regularly reviewed for outliers, errors, or other non-compliances, and large volumes of data need to be processed, and it would be require the use of validated and well-designed computerized to minimize the workload.

Conclusion

Risk-Based Monitoring (RBM) is changing the way companies are conducting clinical trials. Adopting RBM requires changes to a company’s processes and tools for monitoring. Risk Based Monitoring is one solution to combat the continually rising costs of conducting effective clinical trials.  Shifting the costs away from onsite visits and 100 0ercent source data verification toward centralized data collection and monitoring, limited sources and budgets can be better utilized to ensure data quality.

Implementing technology will be critical in strategies to increase efficiency and deliver accurate analyses of clinical study site performance and data quality. However the challenges of moving toward an alternative monitoring approach have slowed industry-wide implementation, the future looks bright for Risk Based Monitoring. The word “risk” is going to reduce risk with “Risk Based Monitoring”.

Clinical Trials Awareness – Spread the word in India

Clinical Trials Awareness – Spread the word in India,

International Clinical Trials Day, 20 May 2015

You feel lucky when you take medicines when you are suffering from any medical illness. Or even you feel better when you take biological products like vaccine to prevent major illness diseases. But wait a moment when was your last thought that how medicines are made and available in markets? What did you think how much efforts and care are being taking for any drug development process. Before any drug approvals, it has to pass several phases of clinical trials which are part of drug development and in these phases volunteers are required to participate in clinical trials. So in that case “without volunteers there are no cures

I ask everyone to take moment to thank thousands of volunteer participants that have contributed to the advancement of medical science. These heroes are the reason for life saving or life enhancing medicines which are available in market. It calls to mind that we all owe an enormous debt of gratitude to participating patients and their families. We all are beneficiaries to drug development process. There is so much that goes into R &D well before you even get to clinical trials.

From the 7000 to 10,000 molecules looked at as being potentially useful as a new medicine, only one ever makes it all the way for patient use. Clinical trials are carefully designed to test the benefits and risks of specific medical treatment or intervention, such as new drug or any behavior change like in your diet or thinking process.

On this day (international clinical trials day), I feel it is an ideal time to raise awareness about the importance of clinical trial participation and recognize the individuals who have made new, innovative treatments a reality for patients worldwide. There are lots of misperceptions about clinical trials in India, and I hope that on this day it will provide an opportunity to learn more facts about clinical trials. India was the hub of clinical trials it also means that Indian population are the ones who receives the latest medical treatment and advance medical technologies among the world. India is still hub of clinical trials if we asked to forget some unethical issues over the last 3 years. Beyond that regulatory and laws are strengthen to conduct clinical trials and prevent unethical moves.  However another consideration when thinking about the drug testing and approval process is that clinical trials have become more complex. During the last 10 years clinical trials design and procedures have become increasingly complicated, demanding more attention and effort with the unintended effect of discouraging patient enrollment and retention.

There are many common myths were created for clinical trials but facts should be know eventually. I am directing several myths over clinical trials in India.

·         Clinical trials volunteers are merely human guinea pigs

 

Strict guidelines are in place to ensure that you and all other clinical trial volunteers are treated fairly and ethically.  Before an investigational drug can be given to people who volunteer to participate in clinical trials, scientists must complete a rigorous screening and preclinical testing process, which can take up to six years to complete. Additionally, every clinical trial also has a thorough informed consent process to help you understand your rights as a participant, including the right to leave the trial at any time if you change your mind about wanting to participate.
·         Clinical trials are dangerous because they use new medicines and practices.

 

Clinical trials are designed for research purposes, and as a result, some level of risk is involved. However, investigational drugs are given to clinical trial participants only after the drugs have gone through a rigorous testing process and scientific evidence indicates that the drug is likely to be effective and safe for use in humans. In addition, keeping you safe when you volunteer to participate in a clinical trial is a top priority for everyone involved in the trial. For example, all clinical trials are reviewed before they start by an institutional ethics committee (IEC), a committee made up of doctors, scientists and community members who have the responsibility to protect clinical trial participants.  The purpose of IEC review is to ensure both before and during the trial that appropriate steps are taken to protect your rights and safety. During the clinical trial, researchers frequently and rigorously assess and monitor participants’ safety. These are just some of the ways in which your safety and well-being are prioritized before a clinical trial begins and throughout the trial process.
·         Informed consent is just reading and signing a piece of paper

 

Informed consent for a clinical trial involves much more than just reading and signing a piece of paper. Rather, it involves two essential parts: a document and a process. The informed consent document includes all the information you will need to help make a decision about taking part in the clinical trial, including all the known information about the safety and potential efficacy of the investigational drug being studied in the trial.  The informed consent document also describes the purpose of the clinical trial, explains the visits and procedures to be done, and includes the possible risks and benefits of participating in a way that is easy to understand.  The informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Researchers and health professionals know that a written document alone may not ensure that you fully understand what participation means. Thus, informed consent is an ongoing, interactive discussion, rather than a one-time informational session. 
·         If I join clinical trial, I might get a sugar pill or placebo instead of real drug.

 

A placebo is a product that looks exactly like the investigational drug but does not cause harm or good. The decision about whether to use a placebo in a clinical trial is based on how serious the illness is, whether an existing treatment is available and other considerations that ensure a high standard of ethics. If you have a serious or life-threatening disease, the best available treatment (called “standard of care”) will be used instead of a placebo.
·         Clinical trials may include painful or unpleasant parts

 

Like all medical interventions, clinical trials have potential benefits and risks, such as side effects or pain. Processes and procedures can be different for each clinical trial.  Some, like in general medical care, may be unpleasant or carry risks. However, the doctor will talk to you about what to expect, and the procedures and risks will be listed in the informed consent document for you to consider while you are deciding whether to participate.  The IEC will also ensure that the benefits and risks are carefully weighed and that the trial is reviewed for unnecessary harm or discomfort before it starts.
·         Being in a clinical trial is expensive and isn’t covered by medical insurance.

 

Volunteers for clinical trials rarely have to pay any costs related to participating in the trial.  There are two types of costs associated with a clinical trial: research costs and patient care costs. Research costs are those associated with conducting the trial, such as data collection and management, research physician and nurse time, analysis of results, and tests performed purely for research purposes. These costs are usually covered by the sponsoring organization, such as the biopharmaceutical company, and are not the patient’s responsibility. Patient care costs are costs that are not covered by the research sponsors doing the clinical trial, such as the costs for routine care including doctor visits, hospital stays, clinical laboratory tests, x-rays and other clinical trial-related activities that would be done even if you were not in the trial.  Many health insurance carriers will cover patient care costs, but you should ask the clinical trial research team which costs will be your responsibility and also check with your health insurance carrier about the coverage they provide for clinical trial participants before making the decision about participating in a clinical trial.
·         Being in a clinical trial won’t help me.

 

Before you decide to participate in a clinical trial, you should speak with your doctor or the research team about the trial design and the possible risks and benefits of participating. If you choose to participate, you may have the opportunity to receive an investigational drug that is not available to people outside the trial.  The clinical trial research team will watch you closely, perhaps even more closely, than your own doctor or nurse during your regular office visits.  And, because trials have detailed treatment plans (called protocols), you may get additional tests and lab work that might not be part of your usual care.  Some trial volunteers also report great personal satisfaction in the fact that they have played a key role in advancing medical science and helping scientists find new treatments that will help more people live longer, better lives
·         I have heard that some people who try to volunteer for a clinical trial are told by the research team that they are not eligible to be in the trial. The process seems unfair. Every clinical trial has a protocol, which is a plan that describes what will be done during the trial, how the trial will be conducted and why each part of the trial is necessary.  The protocol for the clinical trial also includes eligibility criteria which includes guidelines for who can and cannot take part in the trial.  Common eligibility criteria include age group, gender, having a certain type or stage of cancer, having received (or not received) certain medicines in the past, medical history and current health status. It is important to note that eligibility criteria are not used to reject you personally. These guidelines are used to identify the people most likely to benefit from the clinical trial.  The criteria are also necessary to help ensure that researchers will be able to answer the research questions about the investigational drug that they plan to study.

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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.