Review of clinical trials law

EMEA Highlights

The European Commission has revealed plans to review the EU Clinical Trials Directive which came into force in 2004. The rules governing medical research across Europe have been under fire from the medicines industry and doctors, who say the law has bound researchers with red tape without boosting innovation.

The move could see an expanded role for the European Medicines Agency, with some stakeholders pushing for a harmonised EU clinical trials application procedure instead of the fragmented system that exists at present. However, this kind of harmonising has proven politically difficult in the past.

The directive was originally brought in as part of efforts designed to raise the standards of research in Europe but it has led to higher insurance costs and a steep increase in paperwork for researchers, regulators and ethics committee.

Pharmaceutical companies have had to add staff to cope with the additional administrative burden, but for some academic researchers the work involved in complying with the rules has made it unattractive to run clinical trials in teaching hospitals.

A series of workshops has been held around Europe to canvas the opinions of the European Medicines Agency, national regulators, industry groups, ethics committees, and academics, as part of a process that will feed in to revamping the directive.

All are agreed that the law must be overhauled, although precisely how it can be done quickly remains a matter for debate.

Stem cell concerns

The European Medicines Agency has expressed concern over unregulated medicinal products containing stem cells, warning that access to stem-cell medicinal products should be under strictly controlled conditions only.

Patients with a range of serious and life-threatening diseases have been offered stem cell treatments, according to the EU medicines regulator, despite the fact that no such products have yet been authorised in Europe. In special circumstances, such as clinical trials, stem cells may be used, said the EMA.

The authorities added that there are no concerns about haematopoietic cells used for transplantation to restore bone marrow function, as these are not classed as medicinal products.

The Agency’s Committee for Advanced Therapies is warning that using stem cells in uncontrolled conditions may result in little or no benefit to patients and could even be detrimental. Quality and safety checks are less likely to be up to the usual standard required of licensed products, it said.

CHMP reviews guidance

The EMA’s Committee for Medicinal Products for Human Use (CHMP) is to review its guidelines for a range of treatment types including hepatitis C, schizophrenia and overactive bladder. 

The first guidelines on the clinical evaluation of direct acting antiviral agents for chronic hepatitis C were published last year but must now be revised to take account of technical issues that arise when designing research on particular patient subgroups.

The field has evolved since the guidance was written, says the EMA, with phase III trials now underway in treatment-naive and treatment-experienced patients. In addition, more data has emerged on drug resistance, and guidelines on trials in children are also needed.

Separately, guidance on clinical trials on treatments for schizophrenia will be updated to cover new treatment strategies and to define what kind of data is needed in children and adolescents.

The Agency’s guidelines on testing products for urinary incontinence are expected to be updated by the end of the year following a consultation process. The EMA says there is a need to clarify the registration requirements for the term “overactive bladder” (OAB) which is not used in the current guideline despite being referred to in the therapeutic indications for a number of recently approved products.

New authorisations

The CHMP adopted a positive opinion to grant a marketing license for Daxas (roflumilast) from Nycomed GmbH, intended for the treatment of chronic obstructive pulmonary disease association with chronic bronchitis in adult patients as add-on to bronchodilator treatment.

The committee adopted a revised positive opinion, recommending a the granting of a conditional marketing authorisation for Votrient (pazopanib hydrochloride), 200mg and 400mg for oral use. The drug, from Glaxo Group Ltd., is intended for the treatment of advanced renal cell carcinoma. The revision was triggered by the removal of Votrient from the orphan drug register at the request of the manufacturer.

Paediatric investigations

The Paediatric Committee (PDCO) adopted opinions agreeing paediatric investigation plans (PIPs) for several medicines including:

• Bisoctrizole / titanium dioxide, from Orfagen, in the therapeutic area of dermatology

• Clindamycin phosphate / sodium bituminosulphonate, from Ichthyol-Gesellschaft Cordes, Hermanni & Co. in the therapeutic area of dermatology

• Anagrelide hydrochloride monohydrate, from Shire Pharmaceutical Contracts Ltd, in the therapeutic area of haematology-hemostaseology

• Adalimumab, from Abbott Laboratories Limited, in the therapeutic area of immunology-rheumatology-transplantation / dermatology / gastroenterology-hepatology

• Fidaxomicin, from FGK Representative Service GmbH, in the therapeutic area of infectious diseases

• Boceprevir, from SP Europe, in the therapeutic area of infectious diseases.