Phases of clinical trials

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Found another link from University of Pittsburgh, which provides an excellent understanding of different phases of clinical trials:
http://www.clinicalresearch.pitt.edu/docs/comparison_of_clinical_trial_phases.pdf

Different types of clinical trials

Types of clinical trials:

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Winning strategies!!!

If you are a growing CRO, this is what you can do to smell the sweet taste of success faster!

· List companies in market you intend to penetrate and categorize them into primary and secondary accounts. Some clients are strategically significant for business, and hence deserve that extra special treatment-the key accounts. Key (high market share value) accounts will be defined based on profitability and large sales potential.

· Each key account will then go through a client profiling system which will be implemented by the Business Development Team . There will be three critical stages to qualify and implement sales plan for each & every account –Discovery, Planning & Implementation. The following section gives an overview of the procedures that will be followed to ensure revenues flow into the company.

1. Discovery-During this phase, the key account is profiled in the backdrop of the industry drivers and the client’s key products & differentiators are studied; any prior history in dealing with the account and competitive analysis conducted are mapped in this section. The Discovery phase sets the right foundation on which the key account can be approached and build successful business. With a better understanding of competitor’s products and services, CROs can provide appropriate services at more competitive prices.

2. Planning-Once discovery phase provides sufficient evidence of profitability of the account, it is suggested that one can move to the Planning stage. At this juncture, the author suggests that CROs can collate information on identifying key opportunities and setting goals specific to the client. A preliminary opportunity objective is established and important personnel within the organisation mapped to streamline the sales process. With tools such as opportunity analysis and value statement worksheet, the task is broken down further. The sales objective statement defines what each CRO is selling, at what price to be delivered and on a precise deadline. Delivery milestones and long objectives are set accordingly.

3. Implementation- This where it all narrows down to- converting the prospect into a client. An implementation plan is designed to ensure actual sales work begins, bearing in mind all the research done to capture the account and generate revenues. The best tactic is applied to establish value to meet the desired outcome by the due date. The plan is visited periodically to check progress and revaluate if changes are found necessary. The plan is tested by revisiting objectives and realigning with the company's overall business objectives.