A personal take on Panel 1. Discussion leader: Daniel Kuritzkes.
Panel 1 focused on ways to integrate salvage therapy research into existing networks and structures including government-sponsored clinical trials networks, observational cohorts, and industry-sponsored trials. Though the panel discussed a number of environments in which salvage research is hindered, it concluded that a solution to most of the obstacles must involve greater communication between all stakeholders at much earlier stages in the drug development process.
Dr. Kuritzkes laid out 3 primary areas of focus for the group, all of which demand greater collaboration between industry, the Food and Drug Administration (FDA), academic researchers, and activists:
To better integrate salvage research into the drug approval process and registration trials;
To explore new drugs in combination earlier in the development process -- even when the drugs are produced by different companies; and,
To identify ways for Expanded Access (EA) programs to collect more meaningful data without limiting access to treatment or overburdening physicians who participate in EA programs.
Regarding new drug development, industry representatives expressed those concerns most companies have about doing any type of research that could jeopardize their chances for FDA approval. In cases where a company hoped to gain approval for first-line therapy, this often led them to delay critical pharmacokinetic and drug interaction studies that would allow salvage trials to move forward earlier in the drug development process. Industry representatives also noted that because the clinical research staff at the largest companies are so internally focused on attaining drug approval, they do not often interact with community or academia early enough to fully understand the needs and considerations of people living with HIV until well after plans are underway.
However, some in the activist community suspect that industry researchers believe they are already sensitive to such concerns and are conducting the appropriate types of research. In addition, activists suspect these representatives meet with the community largely as a courtesy and because they consider it politically necessary. Getting input "after the fact" is largely a choice they make rather than an accident.
Activists encounter the results of this poor communication constantly. They are asked to give feedback about the plans for a clinical trial only to discover that the company has already submitted the trial design to the FDA and researchers, thereby ensuring that critical suggestions cannot be incorporated. Likewise, companies will claim that they cannot make certain changes because the FDA will not allow them, but when contacted by activists, the FDA claims otherwise, leaving activists in the position of having to decide whom to believe. Early and open communication among all parties would significantly improve this situation.
One researcher suggested that a meeting be held to bring together industry, the FDA, and community (both researchers and activists) to identify areas of common interest that could remove at least some of the obstacles standing in the way of salvage research using new drugs. Most panelists agreed this was a good idea and asked the Forum for Collaborative HIV Research to explore hosting such a meeting. Granted, the issues described during this breakout session have persisted for years despite previous meetings of this type. Nevertheless, pursuing the idea may still be worthwhile.
A particular benefit of such a meeting would be the chance to identify those areas where existing clinical trial networks may be most ideally suited to carry out necessary research. This is particularly critical when studying 2 new drugs produced by different companies. A group formed in the mid-1990s called the Inter-Company Collaborative (ICC) sought to achieve such a goal, but initiated little meaningful research. One major stumbling block the ICC grappled with was anti-trust laws. The panel suggested that the government's clinical trial networks could provide just the kind of neutral playing field necessary to minimize anti-trust concerns. For this to be successful, however, companies would be required to work much more collaboratively with community activists, the FDA, and government researchers to reduce bureaucracy and conflicting priorities. Still, companies are also concerned that the side effects of one drug might become associated with all the drugs used in such trials. This issue leads some companies to fear that such trials run the risk of damaging their chances of approval.
Greater collaboration and coordination could also improve the process by which meaningful data can be collected from EA programs. However, rather than place additional reporting burdens on an already overwhelmed network of community physicians, the panel suggested that large existing cohorts could serve as a model for data collection purposes. Use of EA programs to collect consistent and reliable data could provide earlier safety and drug interaction data and allow companies and researchers to more quickly identify prospective participants for follow-up studies. But this will be impossible to accomplish without resources going directly to the physicians who must collect and report the data.
Greater integration of salvage research into the drug development process will not be easy. The upcoming recompetition of government grants for AIDS research could significantly change existing clinical trials networks. Even changes for the better could delay new salvage research as all parties adapt to new systems and structures. Moreover, the escalating crisis in healthcare and drug access in the US is making treatment of people in salvage situations more difficult. Increasing drug prices combined with shrinking public and private healthcare resources are leading to growing numbers of people living with HIV/AIDS who have neither expert care nor access to new treatments. However, little has been easy in the fight against AIDS, and the panel unanimously agreed that greater communication and collaboration among industry, community, and government is a critical next step to increase and enhance clinical trials for people who have few treatment options.
David Evans is the Information and Advocacy Associate with Project Inform (projectinform.org).
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