Collaboration between industrial and nonindustrial partners

Some trials involve collaboration between industrial and non-industrial partners. Examples are trials involving unlicensed drugs or drugs that although licensed are being used outside the licensed indication, and trials involving new designs of equipment or appliances such as stents or prostheses not yet regarded as standard. In addition, industry may provide partial financial support to trials for which it is not the main sponsor.

A company's support for a trial can involve providing drug free or at reduced cost, contributing towards per-patient payments to collaborating centres and the trials office's administrative costs and salaries, and promoting the trial within the oncological community.

The following principles should be observed in such collaborative trials, and should be agreed by the collaborating bodies and trial sponsor in a formal contract. These principles should be established as early as possible in the course of exploratory discussions. Companies, universities and Government, charitable or other organizations are usually experienced in collaborating with each other and are often well aware of the issues involved.

♦ Establish the need for collaboration and its purpose and nature. This is best done through the process of initial informal discussions and correspondence between the collaborating bodies, leading to the drafting of a formal contract.

♦ Accrual into a collaborative trial should not start until the contract has been signed, if the trial is dependent on drug or money from the company or companies involved.

♦ The body with scientific control of the trial must be unambiguously stated. This includes its planning, its design, its conduct, its analysis and publication of the findings. The non-industrial research group conducting the trial should normally retain scientific control of the trial.

♦ The trial data belong to the group conducting the trial. The contract must state what access, if any, other collaborative bodies, including the industrial partner, will have to the data or the results of the trial. Normally, they will only have access to results when they have been published. If the data monitoring and ethics committee recommends discontinuing the trial or making a major modification to the protocol, and the trial supervisors accept its recommendation, then the industrial and any other collaborating bodies should be informed straight away of the decision and the reasons for it.

♦ Results of analyses and data required by a company for licensing and regulatory purposes will often only be released to the company when the results of the trial have been published or accepted for publication. It is essential to agree in advance what data will be supplied in confidence to the company and the licensing body for licensing and regulatory purposes, and when.

♦ The group conducting the trial are responsible for reporting adverse effects of treatment. They will, however, immediately report serious adverse events to the company if an unlicensed drug is being tested.

♦ The company's support should be stated on the patient information sheet and acknowledged in all publications and presentations of the trial.

In establishing these principles, drawing up a contract and avoiding misunderstanding, the following questions need to be answered.

♦ What is the license status of any drug being provided? Is the drug licensed for the clinical indication to be used in the trial and, if so, will it be administered in accordance with normal clinical practice? Is it licensed but for a different indication or dosage schedule? Is it unlicensed?

♦ What are the arrangements for labelling and delivering supplies of drug to collaborating centres?

♦ Who is the named company contact? Who is the named contact for the group conducting the trial? Correct channels of communication must be established and maintained.

♦ What has already been discussed and provisionally agreed on an informal basis? All relevant correspondence must be copied to all concerned and kept for reference. Also, notes should be made of any discussions or telephone conversations. We recommend writing a letter to all concerned, summarizing what was said.

♦ What have the company agreed to contribute? What have the collaborating investigators agreed to in return?

♦ What has been agreed concerning indemnity, compensation, data release, adverse event reporting, monitoring, and audit?

Informal agreement will usually be reached quite rapidly between the collaborators' representatives. However, formal legal advice to either group can take time to obtain. It is therefore advisable to get contracts drafted as early as possible.

When a trial is investigating an unlicensed drug or a licensed drug but for a new indication, it is particularly important for the industrial and non-industrial partners to agree the level of source data verification and monitoring visits to collaborating centres. These activities maybe more extensive than in other trials and may well involve the need to employ and fund additional staff or for industrial and non-industrial staff to work together on these issues. If regulatory approval is required, how this will be obtained must be agreed.

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