Clinical development plan executing

A sponsor of a medical product entering the development phase must have a clinical development plan, which is created by experienced executives and consultants having expertise and experience in the disease state for which the product is intended. Once the plan is created, with appropriate input from regulators, the plan drives a clinical development budget, with consideration of the desired timeframe for projected producf approval. After the plan is created, the management team determines the "make vs. buy" strategy, which determines the elements of fhe plan that will be outsourced. 

Assuming the clinical development plan proceeds smoothly, the formal transfer of analytical methods takes place during the latter part of clinical phase III. At this point, the requirements for analytical technical transfer are outlined between R D and operations, and are suitably executed. After successfully meeting appropriate acceptance criteria, the receiving laboratory is... 

There can be no substitute for excellent planning and this is why a substantial portion of this chapter has been devoted to a consideration of the important elements of the clinical development programme. There needs to be a clear and concise map of activities leading to compilation of the clinical section of the regulatory dossier and beyond. However, good the programme is, there will be a successful outcome only if it is executed in an efficient and timely manner. The important factors are ... 

This is a crucial area and one which should be given maximum attention during the planning process, as the length of time required to ensure adequate clinical trial supplies can never be underestimated. Inadequacy of clinical trial supplies can be a reason for delay in the execution of a clinical development programme. The explanation is likely to be threefold. 

Various methods have been and are used for the calculation of internal costs, two of which have been published widely the Hoechst Marion Roussel model, derived and published by Thom Hill (Hill and Hubbard 1996) and the MSD BARDS model (Papazian and Wise 1995). A reliable and reproducible method must include the calculation of the cost of a full time equivalent (FTE) employee for each function or task involved in executing and managing the project. Hill s model (Table 42.4) provides a useful illustration of how this may translate into sterling or dollars. This exercise is in itself useful (i.e. even if there are no definite plans to outsource), since clinical development functions are working increasingly in an environment of cost containment. Obviously, such calculations also provide a necessary basis for the comparison of internal costs vs. proposed CRO costs for... 

Proper and comprehensive planning of a clinical trial is essential to the successful development of any drug. Clinical trial design is a subject whose scope is too broad to be undertaken in this text, and only a brief overview of the subject is presented below. The interested reader is referred to the Further Reading section at the end of this chapter. The general principles presented below are relevant to phase II, and particularly phase III, clinical trials. As the bulk of the estimated 300-500 million required to develop a drug is spent on clinical trials, a poorly planned and/or executed clinical trial can be very costly to the drug developer. 

The protocol is a written document (see Section II.C.I) that describes the necessary parts of a stability study. It details the basic plan that will be executed, and its two major components include the tests to be performed and the schedule of testing that is planned. The types of batches that require a protocol are clinical, formulation development, registration, and marketed product. In addition, compatibility of a product with a vehicle (e.g., an injectable product in an intra venous saline solution) is often studied to support the use of injectable products for hospital use. Probe stability studies are generally more experimental in nature and may not be suitable for a formal written protocol. 

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