O big data é uma virada de jogo em muitos setores. O sector da saúde pode ganhar ainda mais do que a maioria, considerando como os avanços neste domínio podem salvar vidas, e não apenas dinheiro. O desenvolvimento da medicina, em particular, poderá dar grandes passos em frente graças ao big data.
Como é o processo de desenvolvimento de medicamentos?
Desenvolver um novo medicamento é um processo longo e caro. É preciso um média de 12 anos levar um medicamento desde a descoberta até ao lançamento, e isso custa milhões de dólares. Esses prazos e despesas extremos decorrem principalmente de dois fatores: há muitos obstáculos regulatórios a serem eliminados e muitas informações a serem coletadas e processadas.
O cronograma de desenvolvimento típico se divide em cinco fases gerais. Primeiro, os cientistas devem descobrir candidatos a medicamentos, que são moléculas que apresentam potencial para tratar uma determinada condição. Em seguida, realizam pesquisas pré-clínicas para testá-los e transformá-los em medicamentos utilizáveis.
Uma vez que as empresas farmacêuticas tenham um medicamento, devem testá-lo através de uma série de ensaios clínicos. Este é um processo de quatro etapas e apenas 30% dos medicamentos chegar à fase final. Depois de concluir esses testes e refinar o medicamento conforme necessário, as empresas enviam os resultados ao FDA para aprovação.
Depois que um medicamento obtém a aprovação do FDA, as empresas farmacêuticas podem liberá-lo ao público. No entanto, eles ainda precisam monitorá-lo. Este último estágio de desenvolvimento envolve monitoramento contínuo para observar quaisquer problemas que não surgiram nos ensaios clínicos ou na revisão da FDA.
O papel do Big Data no desenvolvimento de medicamentos
O big data melhora significativamente quase todas as etapas desse processo. Aqui está uma análise mais detalhada de seu papel crescente no desenvolvimento de medicamentos.
1. Impulsionando a descoberta de medicamentos por IA
A primeira e uma das mais impactantes aplicações de big data no desenvolvimento de medicamentos está na fase de descoberta. Grandes volumes de dados estabelecem as bases para modelos de aprendizado de máquina simularem interações entre várias moléculas. Esses modelos de IA podem encontrar candidatos promissores a medicamentos em tempo recorde.
Algumas ferramentas de descoberta de medicamentos de IA identificaram tratamentos potenciaisem questão de diasquando de outra forma levaria meses. A partir daí, os modelos de aprendizagem automática podem prever o desempenho de um medicamento para agilizar a fase de investigação pré-clínica. Essa velocidade significa que medicamentos que salvam vidas podem chegar ao mercado mais cedo, o que não seria possível sem big data.
2. Identificando necessidades não atendidas
Da mesma forma, o big data pode facilitar a descoberta de oportunidades para novos medicamentos. Criar um novo tratamento eficaz é em grande parte uma questão de encontrar uma área onde as opções actuais não satisfaçam as necessidades de todos. Os dados médicos de vários grupos demográficos podem revelar estas lacunas para que as empresas farmacêuticas saibam o que analisar.
Esse tipo de análise preditiva já é comum na área da saúde. Algumas empresas usam big datapara encontrar resultados ruins para os pacientesque sugerem uma necessidade de melhoria. Outros analisam-no para prever surtos de doenças, iniciar o processo de desenvolvimento de medicamentos e garantir um tratamento mais rápido.
3. Simplificando os ensaios clínicos
O big data também tem aplicações extensas para a longa fase de ensaios clínicos. Primeiro, pode ajudar a identificar áreas de teste ideais. Encontrar uma população com um número suficiente de pacientes dispostos, com as condições necessárias e com diversidade suficiente, é um desafio. Coletar e analisar big data sobre a demografia de uma área torna tudo muito mais rápido.
As empresas farmacêuticas também podem extrair big data desses testes assim que estiverem em andamento. A coleta do máximo de informações em tempo real possível durante todo esse processo de teste dá aos pesquisadores as evidências necessárias para futuras revisões da FDA. A velocidade do big data também significa que eles podem detectar e resolver possíveis problemas de segurança mais cedo.
4. Monitoramento de possíveis problemas
Os big data também podem melhorar a fase de monitorização pós-comercialização do desenvolvimento de medicamentos. A FDA lembra mais de 1.000 medicamentos cada ano. Reconhecer a necessidade destas ações mais cedo garantiria que menos pessoas enfrentassem problemas.
A recolha de dados de várias fontes e locais em busca de sinais de alerta de problemas relacionados com medicamentos ajuda os reguladores a detectar problemas precocemente. Eles podem então modificar o próprio medicamento, suas recomendações de prescrição ou qualquer outra coisa para proteger a saúde das pessoas.
Desafios com Big Data no desenvolvimento de medicamentos
Por mais benéficos que sejam esses casos de uso, o big data enfrenta alguns obstáculos na área da saúde. A principal delas é a questão da privacidade do paciente. Regulamentações como a HIPAA dificultam o acesso a alguns registros médicos, e os aplicativos de big data devem garantir a privacidade para evitar o vazamento de informações confidenciais de saúde.
As ferramentas de big data também costumam apresentar uma curva de aprendizado. Muitas empresas farmacêuticascitar a falta de talentos relevantescomo um dos principais obstáculos à utilização desta tecnologia. Esta lacuna de talentos torna um desafio implementar estas ferramentas e adaptá-las de forma eficaz à empresa específica.
Os custos são outro problema. O desenvolvimento de medicamentos já é caro e a infraestrutura digital e o software de IA necessários para armazenar e processar big data estão longe de ser baratos. Consequentemente, as pequenas empresas farmacêuticas podem ter dificuldades em utilizar esta tecnologia em toda a sua extensão.
Soluções potenciais
Felizmente, existem soluções possíveis para esses problemas. Um promissor55,3% das organizações de saúdeaumentaram os seus orçamentos para a segurança cibernética no último ano. À medida que a IA e outras tecnologias de dados se tornam comuns, também surgirão mais serviços de big data em conformidade com a HIPAA. Essas tendências tornarão o investimento em big data mais seguro para as empresas farmacêuticas.
Embora ainda seja um desafio atrair talentos tecnológicos, as empresas farmacêuticas podem enfrentar a escassez requalificando a sua força de trabalho existente. Muitas plataformas de big data e IA também estão se tornando cada vez mais fáceis de usar à medida que esse mercado amadurece. Consequentemente, estas lacunas de talentos tornar-se-ão menos preocupantes ao longo do tempo.
Da mesma forma, os custos do big data cairão à medida que a tecnologia melhorar e o mercado crescer. As empresas farmacêuticas também podem distribuir estes custos através de uma implementação gradual. Aplicar esta tecnologia em um pequeno caso de uso antes de expandi-la lentamente para outros produzirá um melhor retorno do investimento.
Big Data está mudando a indústria farmacêutica
Embora os desafios permaneçam, o big data já está a agitar a indústria farmacêutica. Esta tecnologia tem o poder de mudar a forma como os investigadores desenvolvem novos medicamentos.
Estas melhorias poderão levar ao lançamento de medicamentos mais baratos e mais acessíveis em prazos muito mais curtos. Por sua vez, os resultados de saúde melhorariam para uma maior variedade de pacientes. Tudo começa com o reconhecimento do potencial do big data.
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