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.


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.

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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.