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Therapeutic progress

New products or techniques are only worthwhile if they translate into better care for patients. Clinical data may mean little in terms of improving patients’ health, and lives. How can we know genuine progress when we see it? 

Gambling with patients’ well-being

When drug regulatory agencies grant marketing authorisation on the basis of initial data, they are betting that subsequent trials will confirm these results. And if they do not demand follow-up studies or at least one confirmatory trial, they are gambling with the well-being of patients.

Back to basics

Choosing and administering a new drug is less and less likely to provide better care. The process of innovation is running on empty. We need to demystify new drugs, and to rediscover essential drugs that are still useful. And seize the opportunity to return drugs to their rightful place in treatment, with both humility and ambition.

Non-inferiority = a non-event!

So-called "non-inferiority" trials make a mockery of the concept of therapeutic advance. What patients and healthcare professionals need are substantial improvements in survival, quality of life, and safety.

Rare diseases: more new drugs, mixed results

Patients suffering from rare diseases are entitled to drugs that have been adequately evaluated, and that can give them concrete guarantees, not just hope.

Second-line drugs: no to second-rate evaluations

It is not acceptable that second-line treatments should be even more poorly evaluated than first-line drugs.

Combined end points

The pharmaceutical industry and regulatory agencies make do increasingly with methodological shortcuts. These shortcuts may gain time and money, but they also make it difficult to obtain clearcut answers.

Needs oriented research at a standstill

For several years there has been a noteworthy lack of new drugs offering important benefits. Rather than raising our arms in despair, perhaps we should accept the situation and engage in a little lateral thinking.

ISDB declaration: what is an innovative drug?

The joint declaration issued by the International Society of Drug Bulletins (ISDB) defines exactly what features a new drug must have to be considered as a real therapeutic advance. Therapeutic advance can be provided in three ways: better efficacy; fewer adverse effects; better convenience to patients.