how we implement six sigms on clinical research side.

Dear All

I thank you for your valuable time. Please advise how best can we empower Six Sigma into Clinical Research domain.

It would be appreciated if a conspicuous version is available for review and reckoning.

 

Thanks & Regds

Nandakuamr

I am still awaiting a response for the query posted on the blog.

It is highly essential and important for our organisation to covene and adopt all our activities in accordance with international operating procedures.

Regds

Nandakumar

Hi Gurmeet/Nandakumar,

I would like to just add another line. Can you tell me what is the most challenging which is forcing you to apply Six sigma? If you have the answer then that would be the start point for our discussion whether we need to do a project or not.

Am sure this would give you some food for thought.

Regards

Sudhir

Dear Gurmeet and Nandakumar

I am a Project Management professional(PMP) with six sigma green belt and working in clinical research enviournment. I have applied my skills in invoicing process for the projects and identified the gaps in billing for the services. Thus ended up creating a process which is now a SOP for the organization. I am aware about the challenges in monitoring and site management.

Please clarify your concerns and i will try my best to assist you.

Thank you

Regards

Shalini

Hello All,

Clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond.

• Phase 1 trials usually deal with investigating the studied drug in a minor number of research subjects who are healthy volunteers

• The goal of phase 2 trials is to grasp additional understanding of the studied drug's safety and efficacy. It also determines the appropriate dose to be administered to deliver the desired treatment effect while minimizing the safety risk of future research subjects. This usually requires more than 100 patients to demonstrate relevant results, although the actual number of subjects varies widely based on the disease under study. Thus, multiple clinics are utilized to recruit subjects with the disease under study to sufficiently enroll the study(ies) in a reasonable period of time.

• Phase 3 trials often exposes more than 1000 research subjects with the disease, and is usually performed at many clinics (sometimes well over 100) to enroll the trial (or trials). There is a focus on the effectiveness of the study drug in a variety of demographic and socioeconomic subjects with variants of the disease under study. A comparison is usually made with standard drugs available on the market. It is imperative that the drug is shown to be effective and safe in this phase.

• In phase 4, the aim is to further characterize the safety of the drug through the identification of unknown adverse reactions and to potentially research new therapeutic indications. Companies often use this phase to gain exposure to different physicians and clinics, which aids in the marketing of their product.

• Further Trials - Clinical research continues throughout the lifetime of the drug to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the drug is released into the market, and Pharmacovigilance where the safety of marketed drugs, biologics or medical devices are monitored.The focus of clinical research is wide enough to include important items such as data management, medical writing, regulatory consultation, and biostatistics.

Given the above background, one can see the Six Sigma tools application at each phase more clearly.

 

In all the phases, you need to choose the right sample sizes of subjects, you need to carry out sufficient and conclusive experimentation (DoE), you need to prove or disprove hypothesis, you need a systematic sequence and engagement of right participants, you need to gather and analyze Voice of the Customer correctly and you need to keep an eye on your goal, budget and timelines.

 

Phase 4 is commonly more than 10 year period for a drug. One area where Six Sigma projects should happen (with great impact on researching companies and on mankind) relates to a reduction in clinical research time cycle without losing on accuracy.