There were numerous articles in August 2017 that covered a wide range of topical issues. Here are five of the best stories you might have missed… (click the headline to finish reading the story)

Peace at Last? – Final Guidance on Lay Summaries of Clinical Study Results Released

After a long wait, it was at the beginning of August that the final guidance on lay summaries of clinical trial results was released as part of the EudraLex Volume 10 update (see references). Everybody in the new field of lay summaries had eagerly awaited the arrival of the final guidance as it was expected to remove a lot of insecurity on the interpretation of the EU clinical trial regulation.

The EU clinical trial regulation 536/2014 was the first regulation worldwide that mandates a “summary of study results that is understandable to laypersons” for all clinical trials conducted in the European Union. This was a big step towards transparency and greater patient friendliness. For the first time a document summarizing the results of a clinical study needs to be developed explicitly for a lay audience.

Disclosure of Clinical Trial Data by the EMA: Where are we now?

When, and in what circumstances, a third party can access clinical trial data submitted to the European Medicines Agency (EMA) once a product has been authorized continues to be a hot topic in the European Union (EU). The EMA has stated that one of its key goals is the publication of clinical trial data once the decision-making process is complete. This is because, it is said, it is important to establish trust and confidence in the regulatory system so the public has a better understanding of the regulatory decision-making process.

The EMA’s position has received the support of academic researchers and patient groups. There appears to be a perception that companies have, in the past, hidden “unhelpful” data and have not been pro-active in publishing negative results, so that many believe companies cannot be trusted to independently release data about their products…

Baskets of Cancer Drugs – And an Umbrella

Modern drug development faces increased pressures to generate data to make timely go/no-go decisions throughout the development cycle – from discovery to filing. In the clinical development space, typical clinical studies seek to generate data in well-defined patient populations. For instance, oncology therapies are tested by tumor type, which is classically seen as the major source of patient variability. Enroll a set number of ovarian cancer patients, give them a defined chemotherapy regimen, and measure the outcome. But in the era of precision medicine, there is increasing evidence of genetic and/or immunologic drivers of disease that may be independent of the tumor type. But subdividing the patient populations decreases the pool of patients in which to test new therapeutics. This combination of modern decision-making pressures, alongside more niche patient populations, obligates new ways to test these therapies. Enter: the master protocol.

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Protocol Feasibility in the EMR age

Classic protocol feasibility is conducted in several steps that can often take weeks or months before we can truly understand evidence of our capability to recruit patients for a clinical trial. These steps often include feasibility questionnaires, phone screens with potential principal investigators (PIs), pre-study site visits (PSSVs), and patient chart reviews. The initial identification of patients to support enrollment can often be depicted in a “funnel” as shown below…

How to Avoid Choosing the Wrong CRO – Science or Art?

First of all, learning to “avoid choosing the wrong CRO” is neither science nor an art. There is no right or wrong. Over the years, I have selected many CROs – small to large – using various outsourcing strategies, and I’ve supported many biotech companies in their outsourcing strategy. What I’ve discovered is that choosing the wrong CRO mostly depends on the sponsor, and their outsourcing strategy and oversight.

Outsourcing poses a unique challenge to any organization and the challenges are multi-faceted. Traditionally many companies choose CROs based on…