Risk-assessment approach recommended for biomarker-driven cancer clinical trials — sciencedaily

Their risk assessment approach for designing and conducting cancer clinical trials include risks to patient safety, operational risks, and biomarker development risks, and for each risk they evaluate possible consequences, provide solutions along with examples of these as well as references to helpful resources. Concerning protocol design, the working group recommends items that a protocol should include as well as items that should be assessed during protocol development. For the conduct of the trial, they make recommendations for the close monitoring of variability in test results, and they also make recommendations for particular aspects following completion of the trial.

Dr. Jacqueline Hall, who coordinated this NCI, NCRI, and EORTC working group says, «We readily acknowledge that in today’s clinical trial landscape, many stakeholders play a role in clinical trials. These include regulators, public authorities, and patients, amongst others. By opening this discussion to others, we hope to find solutions to the varied challenges facing molecularly driven clinical research.»

Support for this research came from the EORTC Charitable Trust and the UK Department of Health’s National Institute for Health Research Biomedical Research Centres funding scheme.

Cuba, eu talks aim to reset stalled relations

HAVANA (AP) After two decades of disagreements, failed stabs at rapprochement and mutual recriminations, officials from the European Union and Cuba were sitting down together Tuesday to discuss hitting the reset button on their soured relationship.

While EU officials say concerns about democracy and human rights will continue to influence the bloc’s policy, recent visits by Cabinet level officials from France and the Netherlands suggest an increasing openness to engaging the Communist run nation.

«There’s certainly a will on the part of the EU to perhaps freshen the agenda and move to a different basis for formulating their relations,» said Paul Webster Hare, a lecturer in international relations at Boston University and former British ambassador to Cuba.

At the same time, he said, «It’s very important that there is a core set of principles democratic tolerance, freedom of the press and so on so it would be unrealistic of the Cubans to expect all of that to simply drop away.»

Cuban officials have said they welcome the negotiations and are prepared to discuss any and all issues on a basis of mutual respect.

Cuba is the only Latin American nation that does not have a political and cooperation agreement with Brussels.

Since 1996, EU policy toward Cuba has been guided by the so called Common Position, which rules out full relations with Havana until it makes reforms in areas such as more diverse political participation and freedom of expression.

A number of European firms pulled out back then as Cuba was slow to pay its bills and former President Fidel Castro hardened his rhetoric against Brussels.

Relations hit a nadir in 2003 after Cuba imprisoned 75 government opponents during a crackdown on dissent. The EU instituted limits on high level visits to the island, reduced cultural cooperation and began inviting dissidents to visit European embassies in Cuba.

Cuba responded by accusing Brussels of hypocrisy for ignoring alleged human rights violations by its own member states and allies.

The Common Position does not have the same teeth as the 52 year old U.S. embargo against Cuba, which outlaws most American trade with and travel to the island.

European companies are still free to trade with Cuba and some do, most notably Spanish hoteliers and French spirits distributor Pernod Ricard.

However a more flexible EU policy could lead to more government level cooperation between Cuba and the continent, and in turn encourage more European investment.

The talks come at a crucial moment when Havana is hoping that a recently approved law will lure badly needed foreign capital to stimulate its economy.

The EU began lifting some sanctions unilaterally in 2008, the year Fidel Castro retired from the presidency permanently and power passed to his younger brother Raul.

The younger Castro has since introduced economic reforms that allow some increased free market activity, and eliminated an exit visa requirement that for decades made it difficult for Cubans to travel overseas. He has also released the last of the 75 jailed in 2003, although harassment and brief detentions of dissidents remain common.

Raul Castro has also said he will step down by the time his current term ends in 2018, although there’s no sign that Cuba intends to allow multi party elections anytime soon.

«The Common Position that still exists is a document that is already 18 years old,» said EU Ambassador to Cuba Hernan Portocarrero. «And what we want to do now is find a convergence between the Common Position, which contains very important political principles, and the majority of member states that have a constructive bilateral relationship» with Cuba.

Christian Leffler, a high ranking EU official for the Americas, was heading the delegation. Representatives from both sides were scheduled to meet Tuesday and Wednesday behind closed doors in the Cuban capital.

No deal is expected to emerge immediately.

«We are open to dialogue with the European community on a basis of respect,» Cuban Vice President Miguel Diaz Canel said last week. «And we will facilitate everything that we are able to build from a position of respect, from a position of equality.»

Associated Press writer Peter Orsi in Havana contributed.

Andrea Rodriguez is on Twitter