Blinding of Investigational Materials

Why Should You Attend:

• How do you go about masking the identity of a drug?
• How do government regulations affect the blinding process?
• What type of testing is needed to assure drug integrity?
• What are my options and how do I select the proper method of blinding?
• What is a double dummy design?
• Do placebos have to be blinded?
• How do I blind a comparator drug product?
• What if I cannot adequately blind the drug products?
• How exact do I need to be when blinding products?

This webinar will address these questions and other areas of obscurity to help attendees effectively prepare blinded products for clinical trials. Knowing the important parameters and being aware of some of the issues that might derail plans could mean the difference between starting a study on time and delaying the introduction of a new product. Although complexities may exist, a smooth running clinical supply operation will make the entire process look easy and flawless. This course will highlight best practices and techniques in blinding of investigational drug products.

Areas Covered in the Webinar:

• Types and phases of clinical trials
• Types of blinded clinical trials
• Basic techniques used in blinding
• Importance of documentation during the labeling operation
• Issues with blinding comparators
• Secondary packaging – kits
• Types of labeling used in clinical supply
• Labeling requirements that may break the blind
• Primary and secondary labeling operations with blinded samples
• Importance of documentation during the labeling operation
• Emergency procedures for breaking the blind

Who Will Benefit:

• Entry level clinical supply professionals
• R&D heads of small and start-up companies
• Heads of virtual pharmaceutical companies
• Clinical operations personnel who wish to learn more about the clinical supply process
• Project managers involved in clinical trials

Instructor Profile:

Donald Levine, D.Ph., FAPhA, CQA, has spent 40 years in the pharmaceutical industry with Plough, Inc., Schering-Plough, and Merck. During this period, he has worked in liquid/semi-solid and solid formulations, process development, packaging development, tech transfer, consumer relations, pharmacovigilance, product safety, clinical, clinical operations, and clinical supply. He believes that the wide variety of work experience, in so many areas of R&D, was the key to his leading the global clinical supply group for Merck consumer care from a US domestic operation to a one that supports studies on a global basis. He believes that in addition to getting all the ‘rights’, the one thing a clinical supply professional needs to ensure is to make the supplies as patient friendly as possible in order to increase patient compliance.

Mr. Levine is now president of DJL Pharma Consultants, LLC, and provides consultation and contractors to universities, established pharmaceutical companies and start-up research companies.

Topic Background:

The clinical supply process is one of the more critical functions leading to the success of a clinical trial. It is the responsibility of the clinical supply professional to assure that the right drug, at the right dosage, gets to the right patient in the right package with the right label, right on time. Most Phase 3 and Phase 4 clinical trials are conducted in a manner to prevent some or all of the personnel involved in the clinical study to be unaware of the medication given to any one patient. This process is called blinding.

Blinding of investigational materials is not always as straightforward as one might assume. It is the responsibility of the clinical supply professional to assure the blinded products do not adversely affect the conduct of the clinical trial, and that the results are reliable from a supply point of view.

The main purpose of blinding is to eliminate bias during the clinical trial. The type of study, the type and size of dosage forms, and primary and secondary packaging all play a major role in the blinding of drug products. Your project timeline has to include the blinding process, whether manufacturing a product from scratch or manipulating an existing product, analytical testing, stability testing and clinical packaging and labeling.

The blinding process can consume time and money. These considerations need to be addressed during the clinical trial planning period. Regardless of the size of the company you represent, these two factors often dictate the final study design. You must be able to defend your position on the availability of the investigational materials, the testing requirements, and blinding technique, while justifying the approach you have chosen to best meet the protocol specifications.

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