Contracts clinical trials

Until recently, pure paper-based data collection systems have predominated in clinical trials. However, they are still being used by many contract research organizations (CROs) either because of financial constraints that prevent them from investing in newer technology or because they deal with small clinical trials that do not justify that investment. Other CROs consider the paper-based data collection method to be the safest and most reliable approach to data collection. 

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

Research is also strongly influenced by the admittedly legitimate interests of the pharmaceutical industry examples of this include contract clauses reserving copyright, the initial selection of researchers and topics, and the recent consolidation of the position of companies specializing in clinical trials (to the detriment of academic centres). Frequently there is a conflict of interests between social welfare and private welfare that does not necessarily amount to fraud or malpractice, but which should be made public - through... 

In 1975, the first commercial entity was formed to provide multicenter, outpatient clinical trial contracting services in the United States. This was the beginning of the modern Contract Research Organization (CRO) industry. It is now composed of thousands of domesfic and infernafional firms involved in medical producf evaluations in humans. The total annual expense globally for clinical trials and related functions necessary for commercial, governmenf, and academic therapeutic product development is estimated at US 50 billion, of which about US 15 billion is outsourced to the contract services market. 

Nichol, F.R., Contract clinical research value to in-house drug development, in Clinical Drug Trials and Tribulations, Cato, A., Sutton, L., and Cato 111, A., Eds., Marcel Dekker, New York, 2002, chap. 21. 

Source Clinical Trial, Contract Pharma, June 2001. 

There is a growing reliance by sponsors on contracting out part or all of the work of the clinical trial to a subcontractor. Manufacturers... 

There is serious shortage of medically qualified personnel in Japanese pharmaceutical companies, or worse is the fact that they do not recognise the importance of such expertise in-house. The new GCP requires sponsoring companies to either employ or contract medical professionals in order to obtain medical advice in preparing protocols and conducting clinical trials. 

An outline of the data from non-clinical studies must be submitted to the PMDA with the protocol for the proposed clinical study before commencing the clinical trial. A notification is required for each protocol. The list of items required for Clinical Trial Plan Notification is shown in Table 23.4. Furthermore, supplementary data must be added on entry to subsequent clinical phases, that is, general clinical trials and comparative trials. Such data are reviewed by the PMDA, and for this purpose the sponsor must wait for 30 days after submitting the initial notification before executing a contract with the medical institute. For a subsequent notification, the review period is reduced to 14 days. The notification also... 

Japanese GCP requires that the head of the medical institute and the sponsor must execute a study contract, and does not allow the investigator to directly contract with the sponsor. Historically, a clinical trial is considered as an activity of the hospital as a whole, not of an individual investigator. The reason behind this is that the investigator cannot conduct any study without the full support of hospital staff and access to hospital facilities. The head of the medical institute is responsible for organising an IRB in-house or to make it available outside the hospital, if the hospital is not large enough to maintain an IRB. Once the sponsoring company submits the clinical study plan to the hospital, the head of the medical institute should submit the study document to the IRB for their opinion. The head cannot be a member of the IRB, is not allowed to discuss or vote on the clinical trial, but nevertheless attendance to the IRB is not prohibited. 

In the case where it is evident that medical institution adversely interfered with the proper clinical trial by violating GCP, protocol or the contract, the sponsor can cancel the contract... 

WHEREAS the Sponsor wishes to contract with the NHS Trust to undertake a sponsored clinical trial entitled ... 

For the purpose of this indemnity, the expression agents shall be deemed to include without limitation any nurse or other health professional providing services to the NHS Trust under a contract for services or otherwise and any person carrying out work for the NHS Trust under such a contract connected with such of the NHS Trust s facilities and equipment as are made available for the Clinical Trial. 

A dimension of the increasing disintegration of pharmaceutical R D is the growing use of contract research organizations (CROs) to conduct clinical trials of new drugs. By 1999, 23% of trials were outsourced to CROs (Azoulay 2004, pp. 1593,1600). In general, the more data-intensive projects are outsourced, while knowledge-intensive projects are more frequently undertaken within pharmaceutical companies (p. 1592). 

---