Columns | A Closing Thought

With the term "innovation" a buzzword du jour these days, the important quest for industry is to reimagine R&D using its new capabilities to apply real-world evidence, patient engagement, and collaborative technologies.

For those still waiting, the time is now to get compliant on FDA's new data submission requirement.

With cell-based therapies possessing multistep supply chains and complex track and trace, logistics management systems can be useful for trials even in the protocol-planning stage.

The need to move beyond a point-solutions approach to one built around applications designed to manage the end-to-end clinical trial process is crucial.

The need to involve regulators is crucial when the use of electronic data devices impacts the management of patient safety and evaluation of trial endpoints.

For programs such as the Precision Medicine Initiative’s Cancer MoonShot to have a chance at success, following a set of key technology mandates will be critical.

Search-engine data offers window to public consciousness around clinical trial research, participation.

Exploring three pivotal technology areas that could reshape global studies over the next 10 years.

Aligning patient-centric approaches with personalized medicine and biomarker use is transforming the design of Alzheimer's trials.

Combining PRO data with clinical feasibility data can make a difference in diabetes care.

With patents for many NBCDs soon to expire, the need for regulatory guidance regarding follow-on versions of these products is crucial.

The need for robust and standardized psychiatric outcomes measures in oncology trials has grown immensely

The technology necessary to meet the expected regulatory demands for assessing drug-impaired driving has emerged.

Redefining this paradigm may help dispel current misperceptions around RBM and better deliver on the promise of this growing approach.

The prevalence of cardiovascular toxicity associated with oncology drugs has triggered a new clinical discipline that aims to promote safer drugs and better outcomes for cancer patients.

While capable of conducting high-quality trials, the current oversight process can be expensive and inefficient.

Virtual CRA meetings hold a lot of potential, but work still needs to be done to ensure effectiveness.

Bring Your Own Device (BYOD) makes sense economically and socially and is the future of clinical trials.

Expect the FDA to be looking at a new metric in the drug approval process: driving safety.

We can simultaneously establish a database that identifies signals of risk for specific product classes, and also demonstrate products that might in fact reduce risk of suicidal ideation and behavior.

The goal is to have an evidence development framework that can answer a range of questions simultaneously.

We are now being encouraged by regulators worldwide to re-think our approach to monitoring and apply risk-based monitoring strategies rather than continue with our more traditional approaches.

The statistics show that fewer and fewer physicians are willing to take part in trials and that around half of those that do so once never do so again.

There are scarce or illdefined national and international regulations on quality control and standardization of biorepositories.

Consistent, effective process improvement can be the key to reducing delays and improving data accuracy.

Decision makers can increase collaboration, transparency, efficiency, and effectiveness, while reducing development risks.

Standard operating procedures need to be in place for the handling of suspected research misconduct.

Investigator training should not be a "one-off" session at the start of clinical trial.

A framework is needed to facilitate, promote, and reward basic and applied research for adults and children.

Modeling and simulation has been heralded for some time as a possible answer to the industry's woes.