Thursday, July 29, 2010

Game Changing Framework in Advancing Discoveries: ILRDP & Contest!

Advance Discoveries Contest! Shorten clinical trials. Reduce risk. Reduce cost. We need YOUR ideas!

Eighty billion drugs are predicted to come off patent in the next three years. EIGHTY BILLION DOLLARS WORTH OF DRUGS FALLING OFF PATENTS! There are indications that the release of patents may save money for the healthcare system as a whole because generics are expected to increasingly take the place of those coming off patent. However, while many patients require several drugs coming off patent, there are no replacements for many of them. As a result, pharmaceutical, biopharma, medical device and biotech companies have two key imperatives:

  • "Advance discoveries," aka, reduce clinical trial cycle time
  • Reduce the escalating costs (Total Cost of Ownership) and risks associated with drug development… while maintaining quality

In response, Advanced Clinical has just launched the game-changing framework to deliver the best clinical trial results within the “Business of R&D.”

AC has analyzed clinical trials across all phases and has identified a series of ways to accelerate delivery timelines. As a result, we have either met or exceeded timelines by 10-40 percent. In addition, we have identified key risks, risk mitigation techniques as well as leading practices to accelerate trial delivery. Finally, we have identified Key Performance Indicators, which are a measurable means to ensure the best performance against timelines.

How have we done this? Using ILRDP as the foundational framework, Advanced Clinical augmented its offerings and capabilities to be able to help Life Sciences companies identify the capabilities that are important to “what they do”, aka, be more effective, as well as ensure “how they do it”, aka, be more efficient in clinical clinical planning as well as clinical operations:

  • Our unique strategic sourcing approach to CRO (Program Management, Functional Sourcing, Managed Services Provider) – We work collaboratively with clients to reach strategically sourced solutions as a Clinical Research Outsourcer (CRO) to create breakthrough value
  • Consulting services help clients gain breakthrough performance through Portfolio Strategy, ILRDP Transformation, and Workforce Strategy
  • Talent man­agement (Contract Staffing, Asset Transfer, Executive Search) – Provide a platform for talented individuals to establish and grow their career, working for us as consultants. Our clients are matched with the perfect consultants
  • Technology solutions that cover end-to-end data management and reporting / analytics needs (Software as a Service Technology platform, including EDC, IVRS, CTMS and CDM as well as Analytics and Reporting)

By advancing discoveries through ILRDP we are now able to execute clinical trials at lowest total cost of ownership (TCO) and highest probability of success with robust quality, safety and efficacy. We go beyond for our clients and consultants and have created the highest standards in the industry, as we have gone to all industry segments to pull best in class practices, tools and techniques and have codified these into everything we do. The result: the best, most effective solution …We advance discoveries through insight.

How do you advance discoveries? NOW--Win an iPad!

Advanced Clinical wants to ask pharmaceutical, biotechnology and medical device companies, “How do you advance discoveries?” What are the best practices you use to shorten clinical trials? How do you reduce risk and cost in drug development? Do you have a strong risk management approach, employee training, or metrics management? Advanced Clinical would like your ideas to create Industry Leading Trial Performance in clinical research.

Let us know how you advance discoveries here. If you win, your ideas will be part of our press release August 17th and you will win an iPad! The winning list of ideas will be posted end of August, 2010.

See www.advancedclinical.com

Friday, July 9, 2010

Advancing Discoveries: Regulatory and Risk Decisions in Adaptive Designs

Although adaptive designs produce numerous benefits for clinical trials, there are also a number of risks associated with it. Below, Advanced Clinical outlines some of the key risks when conducting adaptive designs as well as ways people mitigate them. Also are some FDA-accepted designs, including the more well known Bayesian approach.


What are the big, key risks?
One major concern is the effect of adaptive designs on statistical measures. Though addressed broadly, the issue of preservation of type I error rate remains a key issue in adaptive design. Also, changes in sample size, hypotheses, and other statistical measures affect the validity of the outcome data in clinical trials. Logistic concerns include methods on how to collect data. With interim decision making, data must be collected rapidly, and with short follow-up times in order for that data to remain relevant to the current state of the study. The main procedural issue to be followed closely relates to data review, careful decision making, and implementation of decisions during adaptive trials while maintaining trial integrity.


Click picture for full view!



How do you mitigate those risks?
To mitigate risks that come with adaptive design, careful planning pre-clinical trial must take place. The right statistical measures must be in place and through simulation, the right statistical changes must be determined in case interim data suggests changes on statistical procedures. During clinical trials, it is recommended to have a Data Monitoring Committee (DMC) to review interim results and determine whether relative changes can be made. Also during trials, the use of clinical technologies such as EDC, IVRS and IWRS as well as light EDC are highly recommended in order to deal with the logistic concern of quick, responsive data analysis.

Some commonly accepted designs approved by the FDA (click picture for full view!)



Bayesian Adaptive Dose Allocation Approach (click picture for full view!)

See www.advancedclinical.com

Wednesday, July 7, 2010

Advancing Discoveries: Adaptive Designs in Clinical Trials

What is Adaptive?

In the past several decades there has been a recognized trend of increased spending within pharmaceutical, biopharmaceutical, medical device as well as biotechnology research without a proportional increase in success rate of clinical trials - there used to be 8 IDAs for 1 commercial success; now 16 INDs for 1 commercial success. Some of these could be due to diminishing improvement margins for new drugs, unchanging failure rates, escalating costs, and other clinical limitations. By advancing discoveries, Advanced Clinical seeks to determine the most efficient and effective way to conduct clinical trials without decreasing the safety or efficacy of the trial. Adaptive designs have recently become the frontrunner in advancing clinical trials. Adaptive designs are clinical study designs that utilize accumulating clinical data to modify the study as it progresses, without undermining the validity and integrity of the trial. Not all clinical trials are suited for adaptive design. Stay tuned for our next blog post on Adaptive Risk Management, and FDA accepted adaptive designs/regulatory perspectives!

Why do it?

Adaptive clinical designs save resources and increases efficiency of the clinical trial. Greater flexibility within the adaptive design framework can translate into better treatment of patients within trials (stopping ineffective/dangerous doses early), more efficient drug development, and better use of available resources (need for less patients). Adaptive designs are not only advantageous to drug development, but they are ethically beneficial to the patients. Trials can be cut earlier if they are ineffective, thus efficiently and effectively ensuring patients are well served with the appropriate dosages. This is most important not only because the clinical trial can save resources by cutting off ineffective arms, but the trial can also stop harmful treatments early on in order to prevent patient harm and preserve the overall safety of the clinical trial. Adaptive designs for clinical trials provide efficient tools to demonstrate the safety and effectiveness of new medical products in faster timeframes with more certainty, at lower costs, and with better information.

Types of Adaptive Design Options (click picture to view!)

With adaptive study design, there are many design options that affect different aspects of a trial. above are some of the more widely known adaptive options.

What are the Pros and Cons of Adaptive Design? (click picture to view!)

Adaptive designs, though having a lot of advantages, can have some disadvantages as well. Stay tuned for our next blog posting about the risks and regulatory perspectives surrounding adaptive designs.

Also, don't forget to add our facebook page! www.facebook.com/advclinical

See www.advancedclinical.com