There were numerous articles in July 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)

Nonadherence: One of the Practical Issues Impacting Signal Detection in Clinical Trials

According to a 2015 report from the Tufts Center for the Study of Drug Development, the success rates of molecules entering clinical development has dropped to a remarkably low rate of 11.8 percent. This ranges from an encouraging 23.9 percent for anti-infectives to the abysmal 4.7 percent for drugs affecting the central nervous system (CNS). There are a number of reasons why CNS drug development brings up the rear when success rates in drug development are assessed…

Two Roads Diverge at the Pharma Crossroads: Part I

The pharmaceutical industry is moving in a direction where, in the not too distant future, a pause by the industry at the clinical trial crossroads will give rise to two roads diverging in a binary fashion. New innovations in terms of how clinical trials will be conducted, and with how new medicines will be approved by regulatory agencies. One road will lead the industry to innovations in the field of virtual clinical trials, where patients in a study will be monitored by their electronic mobile or wearable devices.

9 Essential Components of a Clinical Trial Agreement

Whether you are new to clinical research agreements or a contracts ninja, at any given moment there is at least one agreement you can think of that could have been worded differently.

You either have scars from overpaying for services or not receiving expected payment for the services rendered.

Or a clinical site ended up publishing data from trial subjects without giving the sponsor an opportunity to review the results.

In this post, I’ll share nine essential components of a clinical trial agreement (CTA). You’ll learn the purpose of these components and how they can protect you in the event of a conflict or a disagreement.

So let’s get started…

Patient Engagement in Drug Development: Building Guardrails to Ensure Patient Privacy

The transformative value of collaboration between pharmaceutical companies developing drugs and devices and the people living with health challenges is widely recognized within the health care industry. Clinical trial teams and patient volunteers have expressed the benefits of serious interchange that includes sharing the patient experience. Widely accepted and supported in an increasing number of pharmaceutical companies such as Lilly, Sanofi and Novartis, the partnership embodied in the terms “patient engagement” and “patient centricity” has moved from a novel concept to one that is expected by clinical trial teams and patients as well as by health authorities.

Writing the Best RFP to Attract the Relevant Service Providers

The purpose of the RFI is to gain the maximum information about potential partners (contract research organizations – CROs) and determine if they have the capabilities to be included in a more formal request for proposal (RFP) process. Receiving information from the partners might not be enough. The sponsor should ideally invite partners for a formal presentation.

During the RFI process, sponsors should identify which CROs should receive the RFP and what information should be gleaned from each.

 

PHOTO CREDIT: Rob Nguyen