Transparency in clinical trials

In response to a growing demand from stakeholders, Novo Nordisk has – like most other pharmaceutical companies – started to register its clinical trials activities in accordance with ICMJE, industry associations’ policy and the FDAMA 113 Act.

We’re conducting our business in a transparent way, and offering information on our clinical trials activities should be seen in this perspective. There is growing awareness about the ethical performance of the pharmaceutical industry in general, and through this initiative we want to make Novo Nordisk’s policies in this area known.

Users

It is difficult to tell exactly who will become the main users of this site. It could be healthcare professionals looking into the company’s portfolio of clinical trials to check out new innovations and see how far advanced they are in the development phases; or looking for opportunities to join as clinical investigators; or checking out the site for relevant studies for their patients.

Patients or relatives could be looking for general information on a given clinical trial if they have been offered the opportunity to participate, or to explore the possibilities of participating in a clinical trial.

Ethics committees or health authorities might use the site as a quick search facility to search Novo Nordisk’s clinical trial programme. Competitors and investors will, of course, also be frequent visitors to the website.

Challenges

The main challenges related to clinical trials are the expectations for new innovative products to be developed as fast as possible, especially for the treatment of serious diseases where no effective treatment exists – while at the same time requirements constantly increase to make sure the products that reach the market have been proved to be safe and efficacious. The dilemma is to provide more data on the new products in a shorter time span, meeting stricter requirements.

What and how

The level of information being shared corresponds to what we have previously been publishing on www.clinicaltrials.gov and www.clinicalstudyresults.org.

In terms of clinical trials registration, Novo Nordisk is fully compliant with the ICMJE-suggested 20 data item dataset. Novo Nordisk registers all clinical trials in phases II to IV, which were ongoing or initiated after 1 July 2005. We have chosen to include all phase II trials, even though strictly speaking some of them are not required to be registered as they do not all fall into the category of hypothesis testing.

As regards clinical trial results, Novo Nordisk provides information on trials finalised after October 2002 for all marketed products. We include on the results side all interventional clinical trials sponsored by Novo Nordisk. Our clinical trial investigators have the right to publish the results of the trials they participate in, and to make sure this right is protected, we will state that the trial results are in the process of being published from LPLV + 1 year, and as soon as the publication is available, the reference to the paper will be added. If it turns out to be impossible to have the trial published within the timeline of LPLV + 2 years, a summary of the trial results is published in the results section of the website. The summary is based on the trial report synopsis and is in format and content consistent with what is required by and submitted to health authorities.

Novo Nordisk has chosen to comply with the current ICMJE requirements, which do not at present require phase I trials to be included. As some phase II trials and some phase IV trials do not meet the requirements for registration, we have chosen to avoid confusing messages on which trials are covered in our clinical trials registration policy and simply decided to register all phase II to IV trials.

Transparent

We have set up our own trials registry to be able to provide more transparent access to our clinical trials information. Our own site includes trials where Novo Nordisk has the responsibility as trials sponsor (seen in a regulatory context). If you search for Novo Nordisk on www.clinicaltrials.gov, hits will also include trials performed by other institutions if Novo Nordisk’s name is mentioned somewhere in the registered information, maybe as one who has supported a clinical trial financially.

We will continue to register our clinical trials at www.clinicaltrials.gov to comply with the current ICMJE requirements, which require companies to register clinical trials on a website provided by a non-for-profit organisation. Our use of the website www.clinicaltrials.org has now been limited to a reference and a link to the novonordisk-trials.com website. The reason is that the site only allows for manual input of information, making it time-consuming to keep the information up-to-date.

Developing countries

There is often a local requirement to undertake trials in a given country in order to have the product registered in that country. As Novo Nordisk intends to market its products globally we need to perform trials in developing countries as well. Novo Nordisk doesn’t perform clinical trials in countries where we do not intend to market the product in question. Furthermore, many highly skilled investigators and eligible patients are available in developing countries. We do not see any problems in performing trials in developing countries as we always apply the same high ethical standards according to existing guidelines and the Helsinki declaration, no matter where we perform the trial globally.

Future

Both the FDA and EMEA have some initiatives in relation to a more innovative approach towards providing information on new potential drug candidates. Within the clinical trials arena the use of Adaptive Clinical Trials Designs is being investigated heavily to see if these more complicated but at the same time more flexible ways of performing clinical trials can offer a benefit in terms of reducing the time for developing new medicinal products. At the same time the use of advanced IT tools will make clinical trials more efficient.

“We have set up our own trials registry to be able to provide more transparent access to our clinical trials information”