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.

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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”.