Special feature: Top 10 clinical trial mistakes

This special feature is brought to you by James Cameron of McCullough Robertson.

Clinical trials play a vital role in the development of safe treatments and medical devices and it is no surprise that the experimental nature of human research makes clinical trials a heavily regulated field.

The documentation associated with preparing for and managing a clinical trial creates a number of legal obligations and rights between investigators, sites, sponsors, contract research organisations (CROs), ethics committees and the Therapeutic Goods Administration (TGA).

Often the pressure to avoid delay in commencing a clinical trial can lead to legal and contractual aspects of the process being overlooked. These simple oversights can be costly to the parties involved and may hinder or prevent approval by legal and regulatory authorities such as the TGA and the US Food and Drug Administration (FDA).

Here are 10 common clinical trial mistakes you should avoid.

1) Agreements not reflective of GCP responsibilities

The ‘Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), annotated with TGA comments’ (GCP Guideline) and the National Statement 2007 (National Statement) set out the key responsibilities of each party involved in a clinical trial in Australia.

Compliance with these documents is mandatory. Both the sponsor and principal investigator for a clinical trial certify that they will conduct the clinical trial in accordance with these documents when they notify under the CTN scheme.

In the haste to initiate a trial site or negotiate a CRO agreement, parties often make the mistake of failing to consider whether the outline of their roles and responsibilities is consistent with the GCP Guideline, the National Statement and other applicable guidelines.

A clinical trial agreement, protocol or CRO agreement should only be negotiated by persons trained in good clinical practice (GCP) that have a strong understanding of the roles and responsibilities of each party under GCP. Ideally any clinical trial agreement and protocol should include provisions that resolve inconsistency in a manner that is compliant with GCP.

2) Non-compliant ICFs

Informed consent related issues are among the most commonly cited deficiencies in GCP compliance inspections of clinical trial investigators and sites. The GCP Guideline sets out requirements for the form and content of Informed Consent Forms (ICFs).

Common mistakes made in drafting ICFs include:

• failing to address the requirements of the GCP Guideline
• inadequate explanation of compensation rights for injury and who will cover those costs
• explanation of risks in the ICF not matching those set out in the Investigator Brochure
• inaccurate or misleading statements in respect of privacy law and access to patient records
• failing to use plain English to explain issues in a way the patient can understand
• poor layout that makes the ICF difficult to read

3) Failing to consider relevant regulatory documentation

The regulations and guidelines relating to clinical trials are numerous and dynamic. While the clinical trial agreements published by Medicines Australia require compliance with the GCP Guideline, there are a number of other regulatory documents applicable to clinical trials in Australia.

Both sites and sponsors often make the mistake of failing to properly acknowledge the key regulatory documents relevant to clinical trials in Australia. These include:

• the GCP Guideline
• the National Statement
• the Declaration of Helsinki 2008
• the Australian Code for the Responsible Conduct of Research (mandatory compliance for NHMRC funded research)

There is also a plethora or other guidelines issued by the TGA in respect of particular products and devices.

Regulatory documents are frequently updated or superseded so it is important to ensure that references to those documents are references to the correct edition, even when using clinical trial agreements approved by Medicines Australia.

Not all regulatory documents require mandatory compliance, so consideration should also be given to whether all terms of a particular code or guideline should apply to the particular clinical trial in question.

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